CHAPTER 2
PHARMACEUTICAL TECHNOLOGY
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2.1.
Simple choice
Select the correct answer by marking the appropriate capital letter. There is only one correct
answer.
1. Which properties of the pharmacons are the most important in their biopharmaceutical
classification (Biopharmaceutical Classification System, BCS)?
A) Their solubility and intestinal permeability
B) Their solubility and lipophilicity
C) Their intestinal permeability and stability
D) Their solubility and toxicity
E) Their solubility, melting point and lipophilicity
2. What are preformulation investigations?
A) Only investigations according to the Pharmacopoeia for the identification of a dosage form
containing a pharmacon
B) Preliminary experiments before the development of a new pharmacon, including marketing
research and business strategy
C) All those investigations which characterize the pharmaceutical stock material/s and the
compositions made from them
D) Solubility investigations of pharmacons before pharmaceutical formulation
E) Stability investigations of new pharmacons
3. Which are the phases of medical development of a new pharmacon?
A) Clinical phases I, II and III
B) Laboratory investigations, clinical phases 0, I, II, III and IV
C) Marketing research, budgeting, synthesis of the new pharmacon, clinical trials and
registration procedure
D) Phase 0 and clinical phases I, II, III and IV
E) A potential new pharmacon can be tested immediately in a clinical trial and, in the event of
positive results, it can be registered
4. In which phase of medical development is the registration procedure?
A) Before phase 0
B) Continuously during clinical phases II and III
C) After clinical phase IV
D) In clinical phase III
E) During phase 0
5. Which medicines are called original preparations?
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A) Those preparations which were authorized first according to the complete documentation
of the registration procedure
B) Preparations which have undergone a simplified registration procedure without patent
protection
C) Preparations which are under preformulational investigation and are not under patent
protection
D) Preparations which contain an active agent whose patent protection is running out and
registered with a simplified procedure
E) Medicines which are used to replace preparations which have the same active agent
content but are not available
6. What are the characteristics of generics?
A) Chemical equivalence, the same active agent as in the original preparation and the same
external properties as the original preparation
B) Chemical, biological and therapeutic equivalence with the original preparation
C) The duration of the registration procedure is similar to that of the original preparations
D) The same active agents and excipients have to be used, but bioequivalence is not essential
E) The original preparations can not be replaced by generics
7. Which of the following statements relating to patents is correct?
A) The duration and the areal validity of patent protection are unrestricted
B) The public patent documentation can not be investigated because of the protection of the
products
C) The product patent can easily be evaded; it is not absolute protection
D) The preparation patent and the product patent are equivalent terms
E) The patent ensures the invention from the aspect of the law
8. Which of the following statements is correct?
A) The GMP does not extend to the requirements of personal and material hygiene
B) The GLP is that part of quality assurance which comprises a requirement system for the
production
C) In Hungary, any activities related to pharmaceutical production can be carried out only in
possessment of valid authorization by the National Institute of Pharmacy
D) The ISO is a quality assurance system which is compulsory and required by the authority
E) The Absolute Quality Policy System is a term equivalent to the GXP
9. Which of the following statements relating to validation is correct?
A) A predefined method is used, according to predefined conditions, to confirm that the
manufacturing apparatus, the technology and the staff are capable and suitable for
reproducible production of the product with the required quality
B) The validation lasts for an unlimited time
C) The criteria of validation are not the precursory calibration of machines and apparatus
D) The process validation is independent of the qualification of machines and apparatus
E) The validation is not applicable to confirm that a method or an apparatus afford exactly the
same results as required, within a defined deviation, according to the defined combination of
input parameters
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10. Which of the following statements relating to the first-cost of production is correct?
A) The first-costs of products can be continuously decreased without limit
B) The first-costs of products have a minimum value
C) The first-cost of a product depends on only a low number of parameters
D) The first-cost is independent of the costs of raw materials, work payment and amortization
E) The first-cost is independent of the expense of research and the extent of the production
11. Which of the following statements relating to scaling-up is correct?
A) The scale of a technological process can be increased unlimitedly without causing changes
in the quality of the products
B) Laboratory experiments can be scaled up proportionally to the industrial scale
C) Laboratory experiments must be studied by means of pilot measurements, after which
industrialization can be performed
D) Scaling-up does not require technological modifications
E) The point of scaling-up is that the laboratory-scale experiments are planned in such a way
that they can be applied immediately on an industrial scale
12. Which of the following is the goal of pharmaceutical formulation?
A) The complete characterization of pharmaceutical materials used in the preparation of
medicines
B) The choice of the optimal packaging technology for the different dosage forms during the
development of the medicine
C) Validation of the optimal manufacturing technology
D) Experimental determination of all those variables which are important in the elaboration of
the instructions for the optimal manufacturing of a pharmaceutical preparation
E) Provision of the stability of original preparations designed for registration
13. Which of the following methods does not lead to solubility enhancement?
A) Increase of the degree of dispersity
B) Solubilizing
C) The use of co-solvents
D) Binding polar groups into the molecule
E) The formulation of water-soluble salts
14. Which of the following solvents is not an especially polar solvent?
A) Water
B) Glycerine
C) Chloroform
D) PEG
E) Ethyl alcohol
15. Which of the following statements relating to dissolution is not true?
A) In a dissolving material, the binding forces break due to the solvation interactions
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B) When solvation evolves more energy than the lattice energy, dissolution is accompanied
by the release of heat
C) When the lattice energy is higher than the solvation energy, dissolution is an exothermic
process
D) Solution heat is used for the thermodynamic characterization of dissolution, which is the
enthalpy difference of the material before and after dissolution
E) Dissolution will occur if the following conditions are fulfilled: ΔG < 0, ΔH < TΔS
16. Which of the following statements relating to nasal drops is not true?
A) Nasal drops do not have an irritative effect and do not influence the function of the nasal
mucous membrane and the nasal cilia unfavourably
B) Aspects which have to be considered in the preparation of nasal drops: setting the proper
osmotic pressure, pH and viscosity, and microbiological preservation
C) On the administration of nasal drops, systemic side-effects must be considered
D) Nasal drops are grouped in nasal therapeutic systems, since they are capable of a rapid
systemic effect
E) Nasal drops can be simply administered and have a rapid onset of action
17. Which of the following statements relating to ear drops is not true?
A) The use of ototoxic active agents must be avoided
B) A topically lower concentration of the active agent is needed
C) Solvents which are often used for the preparation of ear drops are propylene glycol,
macrogol and glycerine
D) Preparations which are used for the treatment of an injured ear or a perforated eardrum
must be sterile
E) Ear drops must be heated up to body temperature before administration and the patient
must lie on his/her side for 10 minutes after administration
18. Which of the following procedures is not suitable for increasing the extent of dissolution?
A) Decreasing the particle size
B) Stirring
C) Elevation of the temperature
D) Forming a porous surface
E) Avoiding turbulent flow
19. Which of the following statements concerning dissolution is true?
A) Dissolution is based on dispersion
B) The basis of dissolution is the overcoming of the energy of solvation and of the crystal
lattice
C) Dissolution is the preparation of a fluid (rarely a solid) disperse system
D) During dissolution, materials with different consistency are dispersed in the solvent in
molecular and/or colloidal size
E) The basis of dissolution is the increase of the degree of dispersity and the specific surface
area
20. Which of the following is a normal drop?
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A) The dosage form called gutta
B) The drop formed by a normal dropper in the vertical position
C) The average mass calculated from 100 g of drops at a temperature of 19-21 °C
D) The number of drops in 1 g of liquid
E) The amount of active agent in 1 drop of oral preparations administered as drops
21. How do the surface tension and the temperature of a solution influence the number of
drops of a solution?
A) On reduction of the surface tension, the drop mass increases and the number of drops
decreases. The temperature has no influence
B) On increase of the surface tension or temperature, the number of drops increases
C) On reduction of the surface tension, the drop mass increases and the number of drops
decreases. On increase of temperature, the number of drops decreases
D) On reduction of the surface tension, the drop mass decreases, and the number of drops
therefore increases. On increase of the temperature, the drop size decreases because this
reduces the surface tension
E) The effects of these two factors are independent of one another and they do not influence
the drop mass
22. Which of the following is the basis of soaking?
A) Extraction performed at room temperature, which usually lasts for 6 days, according to the
specifications of the Pharmacopoeia
B) Intermittent extraction at room or elevated temperature; some pharmacopoeias individually
specify a soaking duration of 6 to 10 days
C) Continuous extraction at room temperature for 6 days; the duration of double soaking is 12
days
D) Continuous extraction at room or elevated temperature, for 6 days
E) Continuous extraction at room or elevated temperature. The 6-day extraction specified by
the Pharmacopoeia can be reduced proportionally if mixing or shaking is used in the
procedure
23. What empirical connection has been established between the concentration of an extract
prepared by maceration and the amount of extracting fluid applied?
A) A linear function
B) An exponential function
C) A power function
D) A reciprocal connection
E) There is no connection
24. How does mixing or agitation influence the result of maceration?
A) It increases the extraction percentage
B) It does not improve the result of extraction, but it accelerates the development of the
equilibrium section
C) It increases the active agent content of the extract and decreases the duration of extraction
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D) It does not influence either the effectiveness or the duration, but it improves the energy
balance of the procedure
E) It does not influence the result of the procedure, but it makes it more expensive
25. What is shearing stress?
A) The shearing force referred to unit surface
B) The distortion force referred to unit surface
C) The deformation force referred to unit surface
D) The pulling force referred to unit surface
E) The pressing force referred to unit surface
26. What is ideal-viscous flow?
A) The shifting of fluid layers on each other
B) The friction of fluid layers
C) The turbulent flow property of fluid layers
D) The lamellar flow of fluid layers
E) The simple realignment of fluid layers
27. What is typical for pseudoplastic flow?
A) On the appearance of deformation, the viscosity usually increases
B) The viscosity decreases first, and then increases drastically
C) The viscosity usually decreases with increase of the shearing stress
D) The viscosity first increases, and then gradually decreases
E) The viscosity usually increases with decreasing shearing stress
28. What measurements can be performed with a rotational viscosimeter?
A) Determination of flow curves and stress–strain curves, or rather their temperature
functions
B) Determination of flow curves and stress–strain curves, or rather their dynamicity
C) Determination of flow curves, or rather their temperature functions
D) Determination of stress–strain curves, or rather their temperature functions
E) Determination of flow curves and stress–strain curves, or rather their variables
29. Which of the following is true for the operation of rotational viscosimeters?
A) In all types, the external roll moves
B) In all types, the internal roll moves
C) Due to the braking effect of the examined material, the torsional spring deforms and this
deformation is converted into a signal by an apparatus
D) Due to the braking effect of the examined material, the torsional spring deforms and this
deformation is measured directly by the apparatus
E) Shearing stress is the independent variable; rotational and shearing speed are the dependent
variables
30. What is the zeta-potential?
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A) The electrokinetic potential on the boundary between the adhered layer on the surface of
the particles and the shifting layer
B) Particle migration in the electric field of force in the direction of the opposite pole,
according to the positive or negative surface charge of the given particle
C) If the dispersion of the suspended particles streams through a capillary system, a potential
difference arises between two points of the system
D) During particle movement (sedimentation), it is the potential difference which can be
measured between two points of the sedimentation column
E) In a capillary network, in a porous system a liquid flow occurs due to the effect of the
static potential fall
31. What is the upper flow limit in rheology?
A) That point of the flow curve where the system becomes Newtonian
B) That point of the flow curve where deformation begins
C) That point of the flow curve where permanent deformation commences
D) That point of the flow curve where the material takes up a thixotropic character
E) That point of the flow curve where structural viscosity appears
32. Which of the following properties of suspensions is influenced by the zeta-potential?
A) No property, because suspended particles are not soluble in water (or in the dispersion
medium), they do not dissociate to ions, and therefore they do not have an electrokinetic
potential
B) The stability of the dispersity degree, by influencing the attractive and repulsive forces
between the particles
C) The stability of distribution, by influencing the sedimentation
D) The viscosity of suspensions, by increasing the electroviscous effect
E) The rate of dissolution of the active agent
33. What is the definition of consistency?
A) The summarized macroscopic properties of a material (e.g. an ointment, cream, etc.)
B) The flow limit and thixotropic structure degradation of a system
C) The flow limit, thixotropic structure degradation and regeneration of a system
D) The elastic, viscous or viscoelastic properties of a system
E) The resistance of a system against a mechanical effect; this resistance can be quantitatively
characterized by rheological functions and values
34. How is the viscosity of ointments changed by temperature elevation?
A) It decreases to some degree; this decrease has an exponential character in a given
temperature range
B) It does not change because there is a basic requirement that good consistency has to be
constant in the range between room temperature and the temperature of the skin
C) It increases because heat causes the Brownian movement of structural elements to
increase, which results in a viscosity increase
D) Various changes can be observed: melting of carbohydrate and lipogels, or the coalescence
of emulsion systems, resulting in a significant increase in their viscosity
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E) Only the viscosity of macromolecular gels exhibits a characteristic change because of
dehydration; the viscosity of other ointments decreases slightly or does not change
35. Which of the following phenomena is based on adsorption?
A) The elimination of pyrogens
B) The adhesion of talc powder to the body surface
C) The interaction which limits the smooth rolling of powders
D) Extension of the coating liquid on the tablet
E) The dosing accuracy of solutions administered as drops
36. Which of the following is typical of colloid disperse systems?
A) The particle size range is 1-500 nm
B) The particle size range is 1-500 mm
C) The movement of the particles is static
D) The system does not display pronounced optical properties
E) There is interaction only between the dispersion medium and the disperse part
37. How can the phenomenon of osmosis be defined in disperse systems?
A) The phenomenon of osmosis occurs only in heterogeneous disperse systems, so it can not
be defined in colloid and homogeneous disperse systems
B) The phenomenon of osmosis can be defined in colloid and homogeneous systems if the
disperse system is separated from the dispersion medium by a semipermeable membrane
C) The phenomenon of osmosis can not be defined in disperse systems
D) Diffusion is more typical than osmosis for disperse systems, which is caused by the
thermal movement of the particles
E) The phenomenon of osmosis can be defined only for real solutions
38. Which of the following statements is true for coherent systems?
A) The most important characteristic of coherent systems is their connected structure
B) A connected structure can be prepared only by coagulation or flocculation
C) Structural networks which are formed from macromolecules can not form a coherent
structure
D) The formation of coherent systems is not accompanied by an entropy increase
E) The formation of coherent systems is always accompanied by an entropy decrease
39. What is the most important element in the concept of a drug?
A) A product of vegetable, animal, mineral or synthetic origin
B) Well-defined quality and content of the active agent
C) Appropriate for direct application
D) Achievement of therapeutic aim
E) It must be official in the Pharmacopoeia
40. Which is the correct definition of dosage forms?
A) Pharmaceutical preparations produced from basic drug substances are called dosage forms
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B) Pharmaceutical preparations suitable for direct application are called dosage forms
C) Registered industrial products, galenic preparations and preparations included in Formulae
Normales are called dosage forms
D) All medical substances used for diagnostic, therapeutic or preventive purposes are called
dosage forms
E) Pharmaceutical substances prepared from active agents and excipients are called dosage
forms
41. How does the Pharmacopoeia define excipients?
A) Excipients are all those materials which are administered to the human body with
diagnostic, therapeutic or preventive purposes
B) Excipients are all those materials which have the aim of influencing the structure and
function of the human or animal body pharmacologically
C) Excipients (except for the active agents) are all the components which are contained in
pharmaceutical preparations, or used for their preparation
D) Excipients are compounds of vegetable, animal, mineral or synthetic origin which are used
for medical purposes
E) Excipients are all those materials which influence the human body with a therapeutic
purpose
42. Which of the following is the definition of a preparation base according to the
Pharmacopoeia?
A) A preparation base (except for the active agents) is all those components contained in the
pharmaceutical preparation, or used for its preparation
B) A preparation base is the vehicle of a semisolid or solid preparation which consists of the
active agent(s) with one or more excipients
C) A preparation base is the vehicle of a liquid preparation which consists of the active
agent(s) with one or more excipients
D) A preparation base is a pharmaceutical preparation suitable for direct application
E) A preparation base is the state of the vehicle of a dosage form necessary to produce the
given preparation
43. What is turboextraction?
A) Maceration shortened by high-speed mixing
B) Percolation connected with high-speed mixing
C) Double maceration
D) Extraction by ultrasound
E) Industrial-scale extraction based on the counter-current principle
44. What is vibroextraction?
A) Maceration shortened by high-speed mixing
B) Percolation connected with high-speed mixing
C) Double maceration
D) Extraction by ultrasound
E) Industrial-scale extraction based on the counter-current principle
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45. What is the main point of percolation?
A) Periodical extraction based on through-flowing
B) Continuous extraction based on through-flowing
C) Periodical extraction based on the counter-current principle
D) Continuous extraction based on the counter-current principle
E) Extraction carried out by heat, when the vapour of the extracting fluid is situated after
condensation on the drug-containing column; the solvent is continuously evaporated from the
extract and the process is continued until the percolate no longer contains active agent
46. What is the main point of counter-current extraction?
A) The drug-containing column is upright and the extracting fluid flows slowly downwards
B) The extracting fluid flows upwards through the upright drug-containing column
C) Both the extracting fluid and the drug flow downwards in the worm-geared extractor
D) Both the extracting fluid and the drug move, but in opposite directions
E) The concentration difference between the cell fluid and filling fluid is maintained by the
horizontal movement of both the fluid and the drug to be extracted
47. What is the extraction percentage?
A) The dry material content of the drug prepared for extraction
B) The whole active agent content of the applied amount of drug to be extracted
C) The percentage of the whole active agent content of the applied drug in the extract
D) The percentage of the whole active agent content remaining in the drug after extraction
E) The percentage active agent content of the prepared extract or tincture
48. How is it possible to maintain the concentration difference between the cell fluid and the
filling fluid on the extraction of drugs (preparation of extracts and tinctures)?
A) By careful comminution (crushing) of the drug
B) By drying of the drug
C) By decreasing the amount of cell liquid
D) By increasing the amount of filling fluid or by renewing it
E) By increasing the temperature
49. Which statement is not true?
A) Classification according to the generations of dosage forms shows the enormous
improvement in the development of dosage forms and in their therapeutic effects
B) Classical dosage forms (tablets, solutions, tinctures, suppositories, ointments, etc.) belong
among the first-generation dosage forms
C) In classical dosage forms, the drug release is not modified, and the dissolution of the active
agent therefore depends on its physicochemical properties
D) Third-generation dosage forms are therapeutic systems in which the active agent is
absorbed only in the target organ
E) Second-generation dosage forms are prolonged, sustained and pulsatile drug-release
preparations
50. Which of the following statements concerning dosage forms is not true?
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A) With the development of the defined mode of administration, the dosing unit of a medicine
is called the dosage form
B) From the aspect of drug release, we can distinguish between classical and modified drug
release dosage forms
C) From the aspect of state, we can distinguish between liquid and solid dosage forms
D) The official Pharmacopoeia groups preparations according to two main principles: the
mode of drug release and the way of administration
E) From the aspect of material structure, dosage forms can be incoherent (disperse) or
coherent systems
51. Which of the following modifications can not be considered a chemical one?
A) Hydrolysis
B) Steric restructuring
C) Enzymatic degradation
D) Polymerization
E) Polymorphic modification
52. What type of energy is used in disintegration processes?
A) Thermal
B) Mechanical
C) Gravitational
D) Electromagnetic
E) Radiational
53. What is grinding energy needed for?
A) The power consumption of machines used to decrease particle size
B) The energy needed to make microfissures in the internal structure of solid materials
C) The work needed to enlarge the surface of a given particle-sized material with a standard
weight
D) The quotient of the work involved and the extra surface area produced
E) The particle size ratio of the input and the output aggregate from the machine used to
decrease particle size
54. Which of the following statements concerning the theory and practice of grinding is true?
A) During grinding, a mechanical force is exerted on the framework of the material and, due
to this, the connected particles are separated along the microfissures
B) Hard materials can be ground most efficiently by cutting and rubbing
C) Apparatus working with shearing force is the most suitable for the grinding of brittle
materials
D) If several sets of apparatus are connected consecutively, we speak about a circular grinding
process
E) The correct order for connecting the equipment consecutively is: ball mill - cone crusher beater mill, which is the succession in which the grist passes through the apparatus
55. What is the size reduction degree?
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A) The quantity of material milled in a given time that falls through the chosen sieve
B) The ratio of the particle sizes of materials entering and leaving the size-reducing
equipment
C) The ratio of the quantities of materials leaving the size-reducing equipment and materials
left on the sieve
D) The relation between the size-reduction work and the particle size
E) The relation between the size-reduction work and the specific surface area
56. Which of the following statements relating to size reduction is false?
A) Size reduction increases the specific surface area of solids
B) This operation is usually performed by machine
C) Size reduction, breaking, pulverization and milling can not be exactly differentiated from
one another
D) Size reduction is a primary unit operation in the production of several medical preparations
(e.g. granulation, suspension preparation and dissolution)
E) Size reduction could not be the last procedure of a pharmaceutical industrial process
57. What is the critical rotation speed in revolutions per minute of the ball mill?
A) The rotation speed at which the force of gravity is offset by the centrifugal force, and the
balls move together with the jar
B) The rotation speed at which the balls reach the highest point of the jar and from here hit the
material to be milled
C) The rotation speed at which the balls move out from their condition of equilibrium and
start to break and crush the material to be milled
D) The rotation speed at which the efficacy of size reduction is highest
E) Double the rotation speed of the operational milling
58. What is the operating principle of colloid mills?
A) The fluid mixture to be emulsified is pressed through a small opening
B) In equipment consisting of rotor and stator and working at high rotation speed, a shearing
force is effective
C) They work by ultrasound
D) They work by chemical energy
E) They decrease the interfacial surface tension by heat transport
59. What is the definition of drying?
A) Drying is a pharmaceutical industrial operation based on heat transport
B) It is an operation based on heat transport, used on a small scale, a medium scale and a large
scale. The heat content change with the concentration gradient causes the heat transport
C) Drying usually means heat transport, but mention may be made of drying at room
temperature or moisture absorption at lower temperature
D) Drying means water withdrawal from moisture-containing solid materials, usually by
evaporation through heat transport. Withdrawal of moisture from gases and liquids can be
classified here
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E) Drying is a caloric operation with the aim of decreasing or eliminating the moisture content
of a system
60. Drying is a combined heat and material transport process. What are the steps of material
transport?
A) The moisture is transported inside the material and then to the gas space as vapour
B) The adhesive moisture leaves the system, then the absorption moisture, and finally the
balance moisture
C) First the physically adsorbed moisture and then the chemically bound moisture leaves the
system
D) The free moisture leaves first, then the bound moisture, and finally the capillary moisture
E) There is no difference in material transport, but the heat transport can occur by conduction,
convection and radiation
61. Is there any relation between the heat transport factor and the particle size during the
drying of solid materials by fluid convection?
A) No
B) On increase of the particle diameter, the heat transport becomes poorer in all cases
C) There is no evident relation in every case
D) The porosity must be taken into consideration
E) On increase of the particle diameter, the heat exchange usually decreases, but the porosity
and the quality of the particle also play a role
62. During the drying of porous particles, the material transport occurs in three steps. What
are these steps?
A) A constant-rate section, a decreasing-rate section and the final section
B) An increasing-rate section, a constant-rate section and the final section
C) A decreasing-rate section, a constant-rate section and the final section
D) Evaporation of a surface thin layer, then macrocapillary moisture and then microcapillary
moisture
E) Evaporation of a surface thin layer, then microcapillary moisture and then macrocapillary
moisture
63. What type of drying procedure occurs during the operation of freeze-drying apparatus
(cryodehydrators)?
A) A procedure with periodical operation, involving a static layer without an air flow
B) A procedure with periodical operation, involving mobile layer with an air flow
C) A procedure with continuous operation, involving a static layer
D) A procedure involving tight particle fitting and a mechanical mobile layer
E) A procedure involving loosened particle fitting and a mechanical mobile layer
64. What type of drying procedure occurs during the operation of vibrating dryers?
A) A procedure with periodical operation, involving a static layer
B) A procedure with continuous operation, involving a static layer
C) A procedure involving tight particle fitting and a mobile layer
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D) A procedure involving loosened particle fitting and a mobile layer
E) A procedure involving unhindered movement of the system
65. What type of drying procedure occurs during the operation of fluidized bed dryers?
A) A procedure with periodical operation, involving a static layer
B) A procedure with continuous operation, involving a static layer
C) A procedure involving tight particle fitting and a mobile layer
D) A procedure involving loosened particle fitting and a mobile layer
E) A procedure involving unhindered movement of the system
66. Why is it dangerous in practice to continue drying after the critical moisture content is
reached?
A) Because the material overdries
B) Because the temperature increase of the material can result in degradation
C) Because the efficiency of drying decreases
D) Because the particles aggregate
E) Because the flow of the medium slows down
67. Which of the following statements relating to crystallization is true?
A) Polymorphic modifications can not be formed during the procedure
B) Crystal formation is mainly determined by the temperature and the concentration of the
dissolved material
C) The speed of the process is the speed of nodule formation
D) Supersaturation can be reached only by cooling the solution
E) The size of the crystals does not depend on the supersaturation of the solution
68. What type of function describes the connection between the dispersion time and the
mixing time during the mixing of solid materials?
A) A linear function
B) An exponential function
C) A power function
D) A reciprocal function
E) No function is known
69. Which of the following statements relating to mixing is true?
A) The degree of mixing is not influenced by the electrostatic charge
B) The movement of the material in the mixing equipment is ensured only by mechanical
mixers
C) Mixing is a hydrodynamic procedure in all cases
D) The efficacy of mixing depends on the shape of the applied apparatus
E) The mixing effect is enhanced by the movement of the shifting material in the cube and
polygonal mixer
70. What type of flow is caused by propeller mixers during the mixing of fluids?
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A) No flow is caused; only diffusion occurs
B) Tangential flow
C) Axial flow
D) Radial flow
E) Vertical flow
71. From which factors can the Euler value of mixing be calculated?
A) From the power demand of the mixer
B) From the power demand and the diameter of the mixing element
C) From the diameter of the mixing element, the mixing rotation speed and the power demand
D) From the diameter of the mixing element, the mixing rotation speed, the viscosity of the
liquid and the power demand of the mixer
E) From the diameter of the mixing element, the mixing rotation speed, the density of the
liquid and the power demand of the mixer
72. How can pneumatic mixing be induced?
A) A stream breaker plate is built into the turbine mixer
B) Several disks are fitted on the axle of the mixer
C) The turbine is placed in the liquid not perpendicularly to the surface, but at an angle of
approximately 45°
D) By flowing gas or steam bubbles into the liquid
E) The liquid is warmed up and propelled by a circulating pump
73. What is the purpose of filtration?
A) The elimination of impurities
B) The separation of solid materials
C) The clarification of liquids
D) The separation of solid material from a liquid or aeriform medium
E) Clarification of each of the three states from mechanically carried contaminating materials
74. What is the relation between the filterability of solid particles and their electrokinetic
potential?
A) No relation
B) If the zeta-potential is close to zero, the material can be filtered easily
C) If the zeta-potential is -200 mV, the particle is well-filterable
D) If the zeta-potential is higher than -200 mV, the particle can be filtered with difficulty
E) The higher the zeta-potential, the better the filterability of the material because of the
increasing aggregation
75. Which of the following factors influences the minimal fluidization rate?
A) The height of the column
B) The quantity of the charge
C) The shape of the particles
D) The size of the particles
E) The free volume fraction
16
76. Which of the following fluidization anomalies are used in coating by the geyser
technology?
A) Bubble formation
B) Crushing
C) Channel formation
D) Gas plug formation
E) Aggregation of the particles
77. Which is the correct (operational) sequence during fluidization granulation?
A) Wetting, mixing, agglomeration, drying
B) Mixing, wetting, agglomeration, drying
C) Agglomeration, mixing, wetting, drying
D) Mixing, drying, agglomeration
E) Wetting, agglomeration, mixing, drying
78. What is the operational principle of homogenizers used to prepare emulsions?
A) The fluid mixture to be emulsified is pressed through a small opening
B) In equipment consisting of a rotor and stator and working at high rotation speed, a shearing
force is effective
C) They work by ultrasound
D) They work by chemical energy
E) They decrease the interfacial surface tension by heat transport
79. Which of the following types of water with different levels of purity is official in the
Pharmacopoeia?
A) Aqua demineralisata
B) Aqua destillata
C) Aqua purificata
D) Aqua bidestillata
E) Aqua destillata pro injectione
80. What does the number indicating the type of macrogols in the Pharmacopeia mean?
A) The average number of oxyethylene groups
B) The average degree of polymerization of ethylene glycol
C) The relative molar weight depending on the number of oxyethylene groups
D) The branching ability of the polymer structure
E) The dynamic viscosity of the 50 w/w% polymer solution
81. Which of the following is the most characteristic definition of ointments?
A) Ointments are semisolid systems
B) Ointments are gels characterized by plasticity
C) Ointments are used for external application
D) Ointments consist of active agent(s), base(s) and excipient(s)
17
E) The active agent exists in dissolved or suspended form
82. With which of the following equipment can the dropping temperature of ointments be
determined?
A) A rotational thermometer
B) An Ubbelohde thermometer
C) A Zshukov instrument
D) A penetrometer
E) A pycnometer
83. How can the consistency of a system be characterized?
A) Through the investigation of macroscopic properties
B) By thixotropic structure destruction
C) By flow limit, thixotropic structure destruction and regeneration
D) Through investigation of the elastic properties of the system
E) Through investigation of properties which indicate the resistance against mechanical
impact. The resistance can be quantitively characterized with rheological functions and index
numbers
84. What is natural vaseline?
A) A rectified product of residues from petroleum refineries
B) The product mentioned above diluted with mineral oil
C) A product obtained from paraffin waxes and mineral oils
D) A product obtained from microcrystalline waxes and liquid paraffin
E) A product obtained by dilution with mineral oil from ozokerite
85. Which of the following semisolid preparations forms a colloid coherent system?
A) An ointment
B) A paste
C) A gel
D) A suppository
E) A cream
86. What kind of ointment base is absorptive?
A) An ointment base forming a w/o emulsion
B) An ointment base forming an o/w emulsion
C) An ointment base forming an amphiphilic cream
D) An ointment base forming a jelly microemulsion
E) An ointment base penetrating into the deeper layers of the skin
87. Which of the following are indispensable components of hydrophilic creams?
A) Hydrophilic and lipophilic phases
B) An oil phase, a water phase and an emulsifying agent
C) An oil phase, a water phase and emulsifying agents with low and high HLB values
18
D) An oil phase, a water phase, emulsifying agents and a hygroscopic excipient
E) An ointment base and an active agent
88. Which of the following rheological properties is characteristic of hydrogels?
A) Structure viscosity
B) Thixotropy
C) Elastic character
D) Thixotropy and elastic character
E) Stress relaxation
89. How is the viscosity of ointments changed by decreasing temperature?
A) The viscosity of lipophilic ointments does not change; the viscosity of hydrophilic
oitments decreases
B) It increases to some extent and the increase is exponential in a given temperature range
C) It does not change because it is a basic requirement that the consistency must be constant
between room temperature and the temperature of the skin
D) The viscosity decreases, because the temperature decrease results in increasing Brownian
movement of the structural elements, which results in a decreased viscosity
E) Only the viscosity of macromolecular gels displays a characteristic change due to
dehydration; the viscosity of other ointments decreases slightly or does not change
90. In what type of dosage form can the phenomenon of syneresis be observed?
A) Syneresis is the creaming of emulsions
B) Syneresis is the decreasing in volume when suspensions settle
C) Syneresis is the shrinking of the internal structure of ointments and gels, and the separation
of the internal fluid
D) Syneresis is the hardening of pastes
E) Syneresis means the rancidity of fats
91. By which method in the Pharmacopoeia is the consistency of ophthalmic ointments
controlled?
A) By determining the dropping temperature
B) With the Hoppler viscosimeter (of falling ball type)
C) With a rotational viscosimeter
D) With a penetrometer
E) With a consistometer
92. Which of the following suppository bases is used in moulding technology for the
preparation of rectal suppositories?
A) Butyrum cacao
B) Massa Macrogoli
C) Adeps solidus 50
D) Adeps solidus 3
E) Adeps solidus compositus
19
93. Which of the following suppository bases is recommended in the literature for moulding
technology for the preparation of ovula?
A) Butyrum cacao
B) Massa Macrogoli
C) Adeps solidus 50
D) Adeps solidus 3
E) Paraffinum solidum
94. What of the following is the definition of rectal suppositories in the Pharmacopoeia?
A) Cone-, cylinder- or torpedo-shaped solid preparations
B) Solid preparations which melt at body temperature
C) Divided solid preparations which are applied in body cavities and dissolve in humours
D) Solid single-dose preparations suitable for rectal administration due to their shape, size and
consistency
E) Preparations which contain a hydrophilic, lipophilic or lipohydrophilic suppository base
and an active agent in dissolved, emulsified or suspended form
95. Adeps solidus is a mixture containing...
A) mono-, di- and triglycerides of saturated fatty acids
B) triglycerides of saturated and unsaturated fatty acids
C) mono- and diglycerides of saturated and unsaturated fatty acids
D) mono- and triglycerides of saturated and unsaturated fatty acids
E) triglycerides of palmitic, stearic and oleic acids
96. What is the advantage of the partial glyceride content of solid fat?
A) Rancidity is not possible
B) A good water-uptake ability
C) The melting temperature is around body temperature
D) Appropriate consistency because of the partial ester content
E) Preparation can be performed by moulding and compression technology
97. What does the displacement factor mean?
A) It means the number of grams of suppository base with which 1 g of the active agent has
equal space-feeding
B) It means the number of grams of active agent pushed out by 1 g of the suppository base
C) It means the number of grams of cocoa-butter with which 1 g of the crystalline active agent
has the same expansion
D) It means the correction factor by which the amount of active agent has to be multiplied in
order to obtain the mass of active agent to be weighed
98. How much time is needed for the disintegration of medical suppositories according to the
specifications of the Pharmacopoeia?
A) One hour
20
B) Depending on the type of suppository base, suppositories made with a water-insoluble
suppository base must melt within 10 minutes, while water-soluble suppositories must
dissolve within 30 minutes
C) Water-insoluble suppositories must melt within 15 minutes, while water-soluble
suppositories must dissolve in 30 minutes
D) Water-insoluble suppositories must melt within 30 minutes, while water-soluble
suppositories must dissolve within 60 minutes
E) Water-insoluble suppositories must melt within 60 minutes, while water-soluble
suppositories must dissolve within 30 minutes
99. Which of the following investigations are compulsory according to the Pharmacopoeia in
the case of vaginal preparations?
A) Consistency
B) Melting
C) Weight uniformity
D) Sterility
E) Pyrogenicity
100. Which of the following characteristics do rectal capsules have?
A) The active agent can be dosed exactly
B) Only thermosensitive active agents can be processed
C) The active agent is exposed to oxidative changes
D) The capsule can not be closed hermetically
E) Only materials with high solubility can be filled into the capsule
101. Which theoretical mathematical correlation of the work of size reduction is given by the
following formula?
1 1 
N = C1  − 
 x x0 
A) The Bond correlation
B) The Langdon correlation
C) The Rittinger correlation
D) The Kirpicsev and Kick correlation
E) The Riegelman correlation
102. Which of the following particle size ranges can be achieved by micronization?
A) 5–10 μm
B) 1–10 μm
C) 10–100 μm
D) 0.1–0.5 μm
E) 1000–2000 μm
103. Which size ranges of nanocrystals can be achieved by nanonization?
21
A) 0.1–1000 nm
B) 0.1–100 nm
C) 100–1000 nm
D) 2000–3000 nm
E) 1–10000 nm
104. Which of the following micronization procedures belong among disintegrating (top
down) operations?
A) Turbula mixing
B) Colloid milling, high-pressure homogenizing
C) Melt-crystallization
D) Supercritical crystallization
E) Salting-out crystallization
105. Which of the following procedures of nanocrystal production belong among integrating
(bottom up) operations?
A) Colloid milling, high-pressure homogenizing
B) Application of high-intensity ultrasound
C) Ball milling
D) Crystallization from solution, or from the melt
E) Turbula mixing
106. Which of the following properties of crystalline active agents does not change during
nanonization?
A) The perimeter
B) The specific surface area
C) The melting point
D) The length
E) The shape
107. Which of the following statements concerning microemulsion systems is false?
A) Their state in all cases is a liquid or gel
B) They are thermodynamically unstable, isotropic (= independent of the extensional
direction) systems
C) Their types: o/w, w/o, bicontinuous
D) Their drop size is in the range 1-200 nm
E) They are formed spontaneously from emulsifying agents, oil and water, in a defined ratio
108. Which of the following statements relating to the advantages of nanoparticles over
microparticles is false?
A) Nanoparticles are easier to suspend and form dispersions in aqueous liquids
B) Nanoparticles have higher accessibility to cells and cell organs
C) Nanoparticles have smaller average hydrodynamic diameters
D) Due to their smaller size, nanoparticles have a lower dispersity degree and a larger specific
surface area
22
E) Nanoparticles (200 nm) can be sterilized since they can be filtered with membrane filters
with a pore size of 0.22 μm.
109. Which of the following statements concerning solid lipid nanoparticles and the methods
for their production is false?
A) Solid particles are formed from liquid drops in the colloid size range during the
preparation
B) They have the advantage of long-term physical stability
C) Their “hot” preparation method prescribes the application of a high-pressure
homogenizator
D) The use of organic solvent is not needed for their production
E) The active agent must be dissolved or solubilized in melted lipids
110. Which of the following statements concerning the liposomes is true?
A) The phospholipid bilayer lets through water molecules, anions and cations, and the
permeability of anions is 5 orders of magnitude higher than that of cations
B) Pharmacons incorporated into liposomes have only a restricted therapeutic effect
C) Liposomes consist of lipids or lipid combinations; they form a monolayer and can not form
a multilayer
D) The intravenous and intramuscular applications of liposomes are known, but oral
administration is not possible
E) With liposomes, passive targeting and direct passage of the active agent to the cells are not
possible
111. Which of the following statements concerning the purposes of application of
microcapsules and microspheres is false?
A) Incompatibilities can be bypassed due to the separation of components that react with each
other
B) They are used as vaccine adjuvants (matrix forming, excipients of vaccines)
C) They are used for the acceleration of the coagulation of emulsion drops, to promote
increased stability
D) They are used to improve flowability and compressibility
E) They are used to provide controlled active agent release
112. Which of the following correlations describes the formula defining the half-life of
coagulation of aerosols?
T1/ 2 =
1
1
=
n0W
n0 4 DR
A) The Stokes correlation
B) The Cunningham half-life
C) The Freundlich specific coagulation time
D) The Martin half-life
E) The Feret equation
113. Which of the following materials is not suitable as a propellant in aerosols?
23
A) Propane
B) Butane
C) Hexane
D) Isobutane
E) A mixture of propane-butane
114. Which of the following vehicles is preferred in the industrial formulation of dry powder
inhalers?
A) Lactose
B) Mannitol
C) Trehalose
D) Talc
E) PVP
115. By which method are aerosols prepared for pharmaceutical use?
A) Sublimation-condensation
B) Dispersion
C) Vapour precipitation of liquids
D) By vaporization in an exothermic reaction followed by condensation
E) Chemical synthesis
116. Which of these statements relating to pharmaceutical aerosols is false?
A) Hydrocarbon propellants are applied in aerosols for external use
B) Chlorinated hydrocarbon propellants are susceptible to polymerization
C) An advantage of hydrocarbon propellants is that they are non-flammable
D) Chlorinated fluorinated hydrocarbon propellants are non-flammable
E) Chlorinated hydrocarbon propellants are incompatible with certain plastics
117. Which of the following phenomena is not typical for the operating principle of dry
powder inhalers?
A) Vibration
B) Phase separation
C) Turbulence
D) Changing direction
E) Laminar flow
118. What of the following partial processes does emulsification consist of?
A) Dispersion and/or condensation
B) Dispersion and distribution of the dispersed particles
C) Dispersion of one of the liquids into drops, production of a common boundary surface, and
stabilization of the drops against coalescence
D) Decrease of the boundary surface of immiscible liquid phases with emulsifying agents,
which have the required HLB value, and ensure the stability of the distribution
24
E) Dispersion and/or condensation, followed by ensuring the stability of the distribution with
viscosity-increasing excipients
119. Which of the following is typical for microemulsions?
A) Emulsified droplets are submicroscopic in size and are thermodynamically unstable
systems
B) They are transparent fluids, thermodynamically stable systems formed by a mechanical
effect
C) They are spontaneously formed, thermodynamically unstable fluids or gels
D) They are spontaneously formed, thermodynamically stable, transparent fluids or gels
E) Emulsified droplets are microscopic in size and are thermodynamically unstable systems
120. Which of the following is the operating principle of homogenizators used to prepare
emulsions?
A) They decrease interfacial surface tension by heat transport and by increasing pressure
B) The fluid mixture to be emulsified is pressed through a small opening
C) They function by the conversion of chemical energy
D) In equipment consisting of a rotor and stator and operating at high rotation speed, shearing
forces are effective
E) They cause dispersion by the application of ultrasound
121. What does the kinetic stability of emulsions mean?
A) The constancy of the degree of dispersity and of homogeneous distribution
B) The decrease of interfacial free energy
C) The phase inversion of emulsions
D) The result of an accelerated stability test
E) The migration of an emulsifying agent from the interfacial surface into the phases
122. What is the measurement principle of the Coulter-counter method, used to determine the
stability of distribution of emulsions?
A) The measurement of infrared light reflexion
B) Nephelometric measurement
C) Direct optical measurement of particles
D) Measurement of UV ray diffraction on the surface of emulsified drops
E) The electric field of force established by electrodes is modified by the particles which pass
through a capillary, in the ratio of their particle size
123. Which of the following statements relating to the advantages of the application of
macroemulsions is not true?
A) The co-application of lipid-soluble and water-soluble active agents is possible
B) Thermodynamically stable systems are simple to prepare and have a long self-life
C) Patient compliance is better on the oral administration of oils
D) Bioavailability can be enhanced
E) Prolonged drug release can be provided
25
124. Which of the following statements relating to complex emulsions is not true?
A) In complex emulsions, the dispersion medium is emulsified in the disperse part
B) Their stability is increased by gel forming of the oily or aqueous medium
C) They are thermodynamically stable, transparent systems
D) Two main types are known: w/o/w and o/w/o
E) They are prepared by phase conversion
125. What is the operating principle of homogenizators?
A) Interfacial surface tension is reduced in homogenizators by heat transfer and increasing
pressure
B) An emulsifiable liquid mixture is forced through a small gap by pressure in the
homogenizator
C) The conversion of chemical energy
D) In equipment consisting of a rotor and stator and operating at high rotation speed, shearing
forces are effective
E) They cause dispersion by the application of ultrasound
126. Which of the following partial processes does suspension (dispersion of solid particles in
a dispersion medium) consist of?
A) Wetting – sedimentation – redispersion
B) Wetting – mixing – sedimentation
C) Grinding – sieving – homogenizing
D) Wetting – decreasing particle size – stabilizing
E) Grinding – wetting – settling
127. Which of the following is the effect of macromolecular materials in suspensions?
A) A preservative effect
B) Both stabilizing and a flocculating effect
C) A wetting effect
D) Only a stabilizing effect
E) Only a flocculating effect
128. Which of the following properties of suspensions is influenced by the zeta-potential?
A) The stability of the degree of dispersity, by influencing the attractive and repulsive forces
between the particles
B) No property because suspended particles are not soluble, they do not dissociate into ions,
and therefore they do not have electric charge
C) The rate of dissolution of the active agent
D) The stability of distribution of the active agent, by influencing the sedimentation
E) The viscosity of suspensions, by increasing the electroviscous effect
129. What is the half-life of a suspension?
A) The time necessary for half of the particles to sediment
26
B) The time for the potential of the electric double layer around the particles to decrease by
half
C) The time for half of the active agent content of the suspension to decompose
D) The time for the active agent of a resuspended suspension to sediment
E) The time necessary for the particles of a sedimenting suspension to move half of the
available distance
130. What type of sedimentation exists in pharmaceutical suspensions?
A) Hindered, free and flocculated sedimentation
B) Only free sedimentation
C) Only hindered sedimentation
D) Hindered and free sedimentation
E) Sedimentation caused by orthokinetic and perikinetic coagulation
131. What is the rheological character of suspensions?
A) Structure viscosity
B) A thixotropic character
C) Rheopex properties
D) Structure viscosity, a thixotropic character and rheopex properties
E) Only ideal-viscous character in sufficiently stabilized suspensions
132. Which of the following statements relating to aseptic medicine preparations is incorrect?
A) The goal in aseptic medicine preparation is to avoid microbiological and mechanical
inpurities
B) The air supply of aseptic workplaces is ensured by HEPA filters
C) The pollution of the air-space of a workplace suitable for aseptic medicine preparation
must be regularly controlled according to a defined programme
D) At an aseptic workplace, only the minimum number of staff needed for the work processes
can be present
E) The active agents and the excipients used in the production of aseptic medicine
preparations must be sterile and pyrogen-free in all cases
133. How can the micro-organism content of the air of a manipulator be decreased?
A) By the use of ethylene dioxide
B) By the application of infrared radiation
C) By the application of ultraviolet radiation
D) By the air-proof closure of the workplace
E) By evolution of a nitrogen atmosphere
134. Which of the following statements concerning aseptic medicine preparation is incorrect?
A) Different aseptic medicine manufacturing operations are performed in separate places with
appropriate air purity
B) The work areas must be supplied with conditioned air, of predefined standard quantity and
quality
27
C) The substances used for the preparation of injections and infusions can not contain
apathogenic micro-organisms
D) Especially high-risk work processes are performed in isolators
E) Airlocks inhibit the inflow of external air to aseptic workplaces
135. What is the difference in pressure conditions between the airspace of aseptic workplaces
with different purity requirements?
A) The pressure is higher in the place with lower requirements than in the place with higher
requirements, to prevent the passage of mechanical contamination
B) The two work areas must be separated from each other hermetically
C) The pressure of the two work areas must be equal in order to prevent air mixing
D) The pressure is higher in the place with higher requirements than in the place with lower
requirements, to prevent the passage of mechanical contaminations
E) Passing between the two work areas is possible only through an airlock, so that the
difference in air pressure is negligible
136. Which of the following statements relating to germicide lights is incorrect?
A) On the application of germicide lights, shadow space must be taken into consideration
B) Germicide lights can be used in a manipulator which is applied in the pharmacy as well
C) With the correct application of germicide lights, a sterile work area can be developed
D) Germicide lights can be applied only before working or in work pauses, except where
persons do not stay or stay only temporarily (e.g. corridors or airlocks)
E) The ultraviolet radiation of germicide lights is harmful for the eyes
137. Which of the following statements relating to aseptic medicine preparation is incorrect?
A) The goal of preparation under aseptic circumstances is to guarantee the sterility of
products produced from sterilized components
B) Aseptic production can mean the aseptic transfer of products into containers fitted with a
closing device
C) Aseptic production can mean the operational steps including aseptic mixing of the
components of dosage forms and the subsequent aseptic packaging
D) In the preparation of materials for infusion, materials controlled by the manufacturer in a
complete investigation and appropriate for all defined requirements can be used
E) For aseptic production, only bacterial endotoxin-free materials can be used
138. Which of the following statements relating to ophthalmic preparations is incorrect?
A) For the treatment of an injured or operated eye, only single-dose eye drops can be applied
B) To achieve the isotonicity of eye drops, only sodium chloride can be used
C) Eye drops can not contain the active agent only in dissolved form
D) In multiple-dose eye drops, microbiological preservatives are used, unless the active agent
acts as a preservative
E) Magistral eye drops can be stored in a disposable, plastic, sterile container with droppers
139. Which solvent for eye drops can be applied for alkaloid active agents in magistral
medicine preparations?
28
A) Solvens pro oculoguttis cum benzalkonio
B) Hydrogelum carbomerae pro oculoguttis
C) Solvens viscosa pro oculoguttis
D) Solvens pro oculoguttis cum thiomersalo
E) Solutio ophthalmica cum benzalkonio
140. Which of the following statements relating to ophthalmic pharmaceutical preparations is
false?
A) The anhydrous preparation base can be sterilized before use
B) Semisolid ophthalmic preparations are marketed in a tube with a cannula
C) Ophthalmic medical lamellas are marketed in sterile containers, packed individually
D) Only o/w emulsion preparation bases are suitable for the preparation of ophthalmic
ointments with appropriate microbiological purity
E) Similarly to eye drops, ophthalmic ointments can be single- or multiple-dosed
141. Which material can be applied for isotonicity when the active agent is silver nitrate?
A) Anhydrous glucose
B) Potassium nitrate
C) Sodium chloride
D) Boric acid
E) Boric acid and sodium tetraborate in a suitable ratio
142. Which of the following statements relating to ophthalmic preparations is incorrect?
A) Semisolid ophthalmic medical preparations can contain the active agent in dissolved,
emulsified or suspended form
B) Polysorbates cause irritation of the eye
C) For dissolving active agents, the solvent quantity can not be higher than 15% of the
complete weight of the ophtalmic preparation base
D) The maximum weight of multiple-dosed ophthalmic ointments in the FoNo is 10 g
E) The preparation base which is in emulsion form can not be sterilized by heat
143. Which of the following components does not contain the preparation “Carbomer gel for
eye drops”?
A) Carbomer
B) Sodium hydroxide
C) Water for injection
D) Sodium chloride
E) Cetrimide
144. Which of the following groups includes parenteral preparations prepared by vacuum
sublimation according to the Pharmacopoeia?
A) Concentrates for preparing injections and infusions
B) Gels for injections
C) Parenteral pharmaceutical implants
D) Powders for preparing injections and infusions
29
E) Injections
145. Which of the following statements relating to sorbitol infusion is correct?
A) In the preparation of a 5% sorbitol infusion, acidification of the solution is important from
the aspect of stability
B) A sorbitol infusion can not be sterilized at 121 °C
C) The metabolism of sorbitol is insulin-independent
D) 40% sorbitol solution is used for volume expansion
E) Sorbitol can not be administered together with amino acid-containing infusions because of
the Maillard reaction
146. In which combination is ethanol used in infusion therapy?
A) As an adjuvant for volume supplements
B) For infusions used in acidosis therapy
C) In infusions for osmosis therapy, to increase the effect of sugar alcohols
D) In lipid emulsions, to reduce the viscosity of the external phase
E) As energy carrier besides reducing sugars
147. Which of the following statements relating to peritoneal dialysing solutions is incorrect?
A) Peritoneal dialysing solutions must be sterile and applied after warming to body
temperature
B) These solutions can not contain reducing sugars or sugar alcohols
C) Dialysing solutions are applied directly to the peritoneum
D) They possess a higher osmotic pressure than that of the human serum
E) They are applied for the elimination of metabolites from the body
148. What concentration units are used officially for the quantity of infusion components?
A) g/1000 mL
B) g/100 mL
C) mol/L
D) mval/L
E) mmol/L
149. Which of the following can not be applied by intravenous administration?
A) Real solutions with hypertonic concentration
B) Lipid emulsions
C) Suspension injections
D) Microemulsion injections
E) Colloid solutions
150. Which of the following statements relating to injections is incorrect?
A) Various preparation requirements must be satisfied depending on the route of
administration
B) Multiple-dosed injections are prepared with microbiological preservative
30
C) Injections in emulsion form can be administered intramuscularly
D) Cosolvents can not be applied in injections
E) Powder ampoules are prepared from active agents which can not be stored in dissolved
form without decomposition
151. Which of the following statements relating to pellets is not correct?
A) Their surface is smooth
B) Their structure is compact
C) Their flowability is worse than that of powders
D) Their shape is spherical
E) They are multiparticular dosage forms
152. Which of the following statements relating to the preparation of granules is correct?
A) Granules can be prepared only in a wet way
B) Crust granules are formed by granulation with binding materials
C) In sinter granulation, polymers with high molecular weight are used as binding materials
D) Granules can be prepared by spherical crystallization
E) In reconstruction granulation, the particle size continuously decreases
153. Which of the following statements relating to the flow properties of granules is correct?
A) A knowledge of the flow properties is important in tabletting to avoid lamination
B) The angle of repose of the granules can be calculated from the correlation of the tapped
and poured densities
C) A lower Carr index indicates poorer flow property
D) The flowability of granules can be investigated in friabilator according to the
specifications of the Pharmacopoeia
E) Flow properties may be modified in the event of a high moisture content due to forces
arising from surface tension
154. Which of the following statements relating to disintegration excipients is correct?
A) The ideal disintegrant has a low hydrating capacity
B) The disintegrating effect of starch is based on its capillary-active effect
C) The effects of most disintegrants are based on gas formation
D) Cellulose derivatives are used as disintegrants and as binding materials
E) Polyvidone is applied in 20-30 w/w % as an excipient of disintegration
155. Which of the following statements relating to coating liquids suitable for film coating is
incorrect?
A) They can contain plasticizers
B) They can not contain plasticizers
C) They could contain pigments
D) The coating liquid can be a mixture of solvents
E) They could contain polyols (polyhydric alcohol)
156. Which of the following indicates the sequence of phases of tabletting?
31
A) Resistance, adhesion, elasticity
B) Agglomeration, resistance, adhesion, elasticity
C) Elasticity, agglomeration, resistance, adhesion
D) Resistance, adhesion, elasticity, agglomeration
E) Agglomeration, resistance, elasticity, adhesion
157. Which of the following statements relating to pellets is incorrect?
A) Their shape is usually spherical
B) Their structure is compact
C) The goal of their application is immediate drug release
D) They have good flow properties
E) They can be produced with a high-shear apparatus
158. Which of the following is the goal of film coating?
A) Quick disintegration
B) Intestinosolvent properties
C) Flavouring
D) Protection of the mucous membrane of the intestines againt the active agent of the tablet
E) Friability of a tablet can be decreased by film coating
159. Which of the following statements relating to film coating is correct?
A) Film coating can be performed in a pan coater with conventional moulding technology
B) Film coatings can be grouped into gastric- and intestinal-soluble coatings
C) By applying gastric-solvent coatings, primarily the active agent is protected from the
gastric acid
D) By applying a film coating, the effects of digestive enzymes in the gastrointestinal tract do
not have to be taken into consideration
E) Plasticizers are primarily applied as excipients for film coating to reach a prolonged effect
160. Which of the following statements relating to talc powders is incorrect?
A) Talc powders used for wound healing must be sterilized; if the components do not allow
this, the preparation must be aseptic
B) Talc powders must have water and oil uptake ability
C) Talc powders must have appropriate powder rheological properties
D) Bolus alba is a common excipient of talc powders
E) Aerosil can be applied for the dispersion of the liquid components of talc powders
161. Which of the following statements relating to capsules is correct?
A) Gelatine capsules are sensitive to air humidity
B) Only soft gelatine capsules can be applied for magistral medicine preparations
C) Hard gelatine capsules can not contain dye
D) Soft gelatine capsules consist of two capsule-halves
E) Solf gelatine capsules disintegrate quickly, so they are not suitable for the production of
modified drug release preparations
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162. Which of the following statements relating to soaps is correct?
A) Soaps are heavy metal salts which are formed with fatty acids
B) Alkaline earth metal soaps are well soluble in water
C) Alkali metal soaps are applied as lubricants during tabletting
D) Potassium soaps have ointment consistency
E) Soaps are applied only as excipients
163. Which of the following statements relating to packaging materials is correct?
A) The closing device of a medical container is not part of the package
B) Hydrolytic resistance expresses the physical stability of plastic containers for
pharmaceutical use
C) Hydrolytic resistance is determined by the standardization of release of the alkali content
from the glass
D) The most commonly applied polymers for the production of plastic containers are
polymethacrylates, methacrylic acid esters and dimethylaminoethylmethacrylate
E) The transmittance of closing devices made from elastomer materials must be investigated
164. Which of the following statements relating to hydrolytic resistance is correct?
A) Hydrolytic resistance is resistance to the dissolution of organic materials from the glass
B) A glass container of type 1 is usually suitable for all medical preparations except those for
parenteral administration and human blood
C) Glass containers of type 1 are made from neutral glass with low hydrolytic resistance
D) Glass containers of type 3, usually made from sodalime-silicate glass, possess moderate
hydrolytic resistance
E) In glass containers of type 2, parenteral preparations which do not contain water, powders
for parenteral use and non-parenteral preparations can be stored
165. Which of the following statements relating to the stability of pharmaceutical preparations
is incorrect?
A) Chemical stability is the chemical uniformity of the components of the preparation, or
modifications between a defined limit values according to the instructions
B) Stability relations are described quantitively by the Nernst equation
C) Modification of the crystalline structure can influence drug stability
D) A pharmaceutical preparation is microbiologically stable if the germ number does not
change after successful exposure
E) According to the semiquantitative observations of van’t Hoff, if, on a 10 °C increase of
temperature, the reaction rate increases 2-4-fold
166. Which of the following statements relating to incompatibility is correct?
A) In the case of eutectic formation, the steric inhibition of incompatible particles can be
avoided by adding at least 10% of Aerosil
B) If necessary, the pH of the solution can be modified with 2 M nitric acid
C) Eutectic formation of menthol and camphor is not incompatibility because the distribution
of the liquid formed results in better homogeneity
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D) The isotonicity of eye drops containing silver is usually set with 10% mannitol solution
E) The pH of solutions containing papaverine chloride and phenobarbital sodium alters with
the ratio of the components
167. Which of the following statements relating to the stability of incompatibility is
incorrect?
A) The original prescription can be modified only to such an extent that it does not influence
unfavourably the absorption and effect of the drug, taking into consideration the site and the
mode of administration
B) If the homogeneous distribution of the components and the dosing of the prescribed liquid
dosage form can not be provided in solution form, or a solution can not be prepared, the
medicine is prepared according to the rules for preparing powders
C) To avoide incompatibilities, only those excipients can be used which are in the
Pharmacopoeia or authorized by the National Institute of Pharmacy
D) The quantity of excipient applied is subtracted from the weight of the prescribed vehicle
E) If the pharmacon is not soluble at defined concentration in the prescribed solvent, a soluble
derivative can be applied
168. Which of the following statements relating to fluidized bed granulation is correct?
A) The apparatus is totally closed, and the danger of contamination can be minimized
B) The granules have a poorer physical aspect than granules prepared by other methods
C) By fluidized bed granulation, wet granulation can be divided into two operational groups
D) Heat- and moisture-sensitive materials can not be applied in fluidized bed granulation
E) In industrial practice, fluidized bed granulation is not common
169. Which of the following statements relating to rotary tabletting machines is incorrect?
A) The efficacy can be enhanced by doubling the number of batching sites
B) Precompression is frequently applied during tabletting
C) During the adjustment of the apparatus, setting of the level is not needed
D) Powder or granule mixtures are batched with a batching grid
E) During compression, the upper and the lower punches are pressurized
170. Which of the following statements is typical of fluidized film coating?
A) The duration is longer for fluidized film coating than for pan coating
B) The weight of the coated tablet is much more than the weight of the tablet core
C) The operation can be automated
D) Vapour of the applied solvent can reach the air space of the production area
E) The hardness of the tablet core can be lower than in operations with a pan coater
171. Which of the following procedures is not suitable for the preparation of microcapsules?
A) Coacervation
B) Spray-freezing
C) Fluidization
D) In apparatus with high shearing forces
E) Interfacial polymerization
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172. Which of the following statements relating to powders is correct?
A) Powders can contain liquid components
B) Powders are intermediate products which must be processed further
C) The degree of size reduction and pulverization of powders is most frequently determined
by methods based on laser measurements
D) Flow properties of powders are determined by the application of a rotational viscosimeter
E) Divided powders can not contain a component with a strong effect
173. Which of the following excipients can be applied as a lubricant?
A) Alkali metal soaps
B) PEG 6000
C) Colloid silica
D) Polyvidone
E) Polysorbate derivatives
174. Which of the following is typical for Zydis technology?
A) It is applied in the case of pulsatile drug release preparations
B) Prolonged effects can be achieved
C) The structure of the preparation obtained with this technology is compact
D) Preparations obtained with this technology play an important role in the therapy of the
colon
E) One of the main steps in Zydis technology is lyophilization
175. Which of the following statements relating to the investigation of friability is correct?
A) The investigation of friability is one of the official methods of investigating the dragee
dosage form
B) The investigation is performed with a volumeter
C) The investigation is performed with dragees from which the dust is removed with a brush
D) The result of the investigation is the weight loss of the preparation, caused by the abrading
scraps, particles and dust, correlating with the weight of the investigated preparation; the
result is expressed as a percentage
E) The permitted friability in the official Pharmacopoeia is 10%
176. In which type of glass container can acidic or neutral aqueous solutions for parenteral
use be stored?
A) In glass containers of type 1 and type 2
B) In a glass container of type 3
C) Only in a glass container of type 1
D) Only in a glass container of type 2
E) Only in a glass container of type 3
177. In the general guidelines for stability, which of the following percentages is the
maximum permitted decrease in the active agent content in pharmaceutical preparations up to
the end of the shelf-life of the preparation?
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A) 0.1%
B) 1%
C) 3%
D) 5%
E) 10%
178. Which of the following modifications can not be considered a chemical one?
A) Hydrolysis
B) Tautomerization
C) Enzymatic oxidation
D) Condensation
E) Polymorphic modification
179. Which of the following is the correct sequence of part-processes in the wet granulation
process?
A) Homogenizing, wetting, kneading, granulating, drying, regranulating
B) Wetting, homogenizing, kneading, granulating, drying, regranulating
C) Homogenizing, wetting, drying, regranulating
D) Homogenizing, wetting, kneading, granulating, regranulating, drying
E) Homogenizing, granulating, wetting, kneading, drying, regranulating
180. Are the systems used as drugs in thermodynamic equilibrium?
A) Yes
B) In solid form they are; in solution they are not
C) In solution they are not; in suspension they are
D) The majority are not in a thermodynamically equilibrated state; they therefore strive to
achieve a state characterized by a minimum of energy
E) The thermodynamic equilibrium state is achieved only in the case of substances stored at
low temperature, in well-stoppered containers, protected from light
181. What does the law for the rate of chemical reactions express?
A) The number of molecules participating in the reaction
B) The concentration of the substance involved in the reaction
C) The correlation between the degradation rate and temperature
D) The correlation between the degradation rate and external factors (pressure, light, oxygen,
etc.)
E) The relationship between the degradation rate and the concentration of the substance
182. What is the essence of incompatibility?
A) Incompatibility is an undesirable interaction
B) It is a non-visible change which occurs between the active agents or between the active
agents and the excipients
C) Incompatibilities are therapeutic interactions
D) The older name for interaction is incompatibility
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E) Incompatibility is the collective designation for physical degradation
183. Which of the following excipients can increase the binding force to a significant degree
in the dry granulation process?
A) Carboxymethyl amylopectin glycolate
B) Macrogol 4000
C) Magnesium stearate
D) Lactose
E) Talc
184. Which of the following statements relating to the porosity of granules is correct?
A) The porosity influences only the properies of the granules
B) The porosity is determined with an Andreasen apparatus
C) Porosity is the ratio of the total volume of the pores in the granules to the total volume of
the granules
D) If the granule is water-soluble, porosity is measured with a pycnometer
E) A porous granule contains much air, which results in adhering during tabletting
185. The following figure shows different phases of the operation of an excentric tablet
machine. Which is the correct sequence of the operations?
A) 1, 2, 3, 4, 5
B) 3, 1, 5, 2, 4
C) 1, 3, 5, 4, 2
D) 3, 4, 5, 1, 2
E) 3, 1, 4, 2, 5
186. Which of the following excipients is not used as an additive of plastic blisters?
A) Filler
B) Antistatic
C) Glidant
D) Antioxidant
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E) Plasticizer
187. Which of the following macromolecular materials can be applied in the case of
granulation with a binding material?
A) Sucrose syrup
B) Polyvidone
C) Bentonite
D) Colloid silica
E) Xylitol
188. Which of the following excipients can be used as binding material and as disintegrant?
A) Sorbitol
B) Polyvidone
C) Gelatine
D) Bentonite
E) Polymethacrylate
189. Which of the following statements is true for both pellets and granules?
A) The particles are cylindrial
B) They can be intermediates or final products
C) Their surface is rough
D) Their texture is porous
E) Their size is 4-6 mm
190. Which of the following statements relating to the excentric tableting machine is correct?
A) The table of the machine moves
B) The feeding hopper of the machine does not move
C) It has a higher productivity than the rotary tabletting machine
D) Both punches press during operation
E) They operate periodically
191. Which of the following can cause the capping of tablets?
A) High moisture content
B) Low compression speed
C) An excessive quantity of the binding material
D) The presence of aerophilic components
E) Vibration of the feeding hopper
192. Which of the following statements relating to the stability of medicines is correct?
A) The stability of a pharmaceutical preparation depends only on the incompatibility of the
components
B) The stability of a preparation is influenced by external factors, e.g. temperature, moisture
content and light
C) Changes in the microbiological purity of the preparations do not influence stability
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D) From the results of accelerated stability investigations, we can deduce the physical
changes in the preparation in all cases
E) Five climate zones are distinguished from the aspect of stability investigations
193. Which of the following indicates how the decomposition by hydrolysis can be avoided?
A) The application of light-protective materials
B) The exclusion of oxygen
C) Setting the optimum pH
D) The application of inert gases
E) The application of surface-active agents
194. Which of the following statements relating to starch is correct?
A) It can be applied only as binding material
B) It can be applied only as disintegrant
C) The disintegrating effect is a result of its capillary-active property
D) Mucilage prepared from starch is applied as a moisture-binding material
E) A chemically modified variant of starch, which is soluble in the cold, is frequently used
195. Which of these materials can not be applied to form film coatings?
A) Oleic acid glycerides
B) Cellulose ethers
C) Cellulose esters
D) Methacrylic acid co-polymers
E) Polyethylene glycols
196. Which of the following is not suitable for particle size determination?
A) The Andreasen barrel (apparatus)
B) The Enslin apparatus
C) The Wiegner tube
D) A projection microscope
E) The Coulter counter
197. Which of the following requirements is correct as concerns talc powders?
A) It is not necessary to investigate the oil-uptake ability of talc powders, but only their wateruptake ability
B) The particle size of talc powders must be less than 320 μm
C) Talc powders can clot a little
D) Good flow properties are not needed for talc powders
E) One requirement for the applicability of talc powders is appropriate adherence on the skin
198. Which of the following describes sinter-bridge formation?
A) Tiny crystals arise during compression
B) The crystals are in the same orientation in the direction of the axis with higher thermal
conductivity
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C) Lamination of the tablet due to heat
D) Excursion of the structure of the crystal lattice in parallel levels
E) A melt layer is formed in the structure of the preparation due to the low melting point of
one of the components of the tablet
199. Which of the following statements relating to deformations during tabletting is correct?
A) During compression twin formation, part of the crystal jumps to a twin position as
compared with the other part
B) Crystal parts undergo excursion in parallel levels due to polymorphism
C) Tiny crystals are formed due to the different thermal properties of the axes of the crystals
D) The zeta-potential alters during tabletting
E) The crystals break randomly due to translation
200. Which of the following statements relating to the residual moisture content of granules is
correct?
A) The moisture content of granules must always be in the range 2.5-3.5%
B) The moisture content of granules influences the further processing and the quality of the
product significantly
C) Moisture content can only be determined by drying
D) The optimum moisture content need not be fixed in tablet prescriptions
E) There is no relation between the moisture content of granules and the air humidity
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