RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
M. PHARM SYNOPSIS
YEAR OF ADMISSION: 2011
TITLE OF THE SYNOPSIS
“FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF
SALBUTAMOL SULPHATE”
BY
SIDHYARTHA SARKAR
M. PHARM, PART- I
DEPARTMENT OF PHARMACEUTICS,
UNDER THE GUIDANCE OF
Dr. Prasanth V.V., (M. Pharm, Ph.D)
Professor & HOD
DEPARTMENT OF PHARMACEUTICS
INSTITUTION
GAUTHAM COLLEGE OF PHARMACY
R. T. NAGAR, BANGALORE-32,
KARNATAKA
1
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
1
Name of the candidate and
address
SIDHYARTHA SARKAR
PERMANENT ADDRESS
S/O PRANESH SARKAR
POST- BAGHMARA
DIST- SOUTH GARO HILLS
MEGHALAYA
PIN- 794102
PRESENT ADDRESS:
GAUTHAM COLLEGE OF PHARMACY,
BHUVANESHWARI NAGAR,
SULTANPALYA,
R.T.NAGAR POST,
BANGALORE – 560032.
2
Name of the institution
3
Course of study and subject
4
Date of the admission
5
Title of the topic:
GAUTHAM COLLEGE OF PHARMACY,
BHUVANAESHWARI NAGAR,
SULTANPALYA,
R.T.NAGAR POST,
BANGALORE – 560032.
MASTER OF PHARMACY IN
PHARMACEUTICS
09/05/ 2011
“FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF
SALBUTAMOL SULPHATE”
2
6. SUMMARY OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Oral route of drug administration is the most preferred route for administration of
various drugs. Oral delivery is currently the gold standard in the pharmaceutical industry
where it is regarded as the safest, most convenient and most economical method of drug
delivery having the highest patient compliance. It is the most widely accepted, up to 5060% of total dosage form. Solid dosage forms are popular because of ease of administration,
accurate dosage, self-medication, pain avoidance and most importantly the patient
compliance. The most popular solid dosage forms being tablets and capsules; but for some
patients the difficulty to swallow (dysphasia) is one of the important drawback of this
dosage forms. Drinking water plays an important role in the swallowing of oral dosage
forms. Often times people experience inconvenience in swallowing conventional dosage
forms such as tablet when water is not available, in the case of the motion sickness
(kinetosis) and sudden episodes of coughing during the common cold, allergic condition
and bronchitis. For these reasons, tablets that can rapidly dissolve or disintegrate in the oral
cavity have attracted a great deal of attention1.
The concept of Orodispersible Tablets (ODTs) emerged with an objective to
improve patient’s compliance. These dosage forms rapidly disintegrate and/or dissolve to
release the drug as soon as they come in contact with saliva, thus obviating the need for water
during administration, an attribute that makes them highly attractive for Paediatric and
geriatric patients. Difficulty in swallowing conventional tablets and capsules is common
among all age groups, especially in elderly and dysphagic patients2. Oro-dispersible tablets
are not only indicated for people who have swallowing difficulties, but also are ideal for
active people3.
Orodispersible Tablets are also known as, mouth dissolving tablets, rapimelts, meltin-mouth tablets, fast disintegrating tablets and fast dissolving tablets. These are the solid unit
dosage forms/entities containing medicinal substances which disintegrate or dissolve rapidly
in oral cavity usually within a few seconds even without the need of water or chewing. As the
tablet disintegrates in mouth, this can enhance the clinical effect of drug through pregastric
absorption from the mouth, pharynx and oesophagus in such cases, bioavailability of drug is
significantly enhanced by avoiding first pass hepatic metabolism than those observed with
conventional tablets4.
3
United States Food and Drug Administration (FDA) define orally disintegrating
tablets as “A solid dosage form which contain a medicinal substance or active ingredient
which disintegrates rapidly within few seconds when placed on a tongue. US Food and Drug
Administration Center for Drug Evaluation and Research (CDER) defines, in the ‘Orange
Book’, an ODT as “a solid dosage form containing medicinal substances, which disintegrates
rapidly, usually within a matter of seconds, when placed upon the tongue”.
European Pharmacopoeia described orally disintegrating tablets as ‘uncoated tablets intended
to be placed in the mouth where they disperse rapidly before being swallowed’ and as tablets
which should disintegrate within 3 minutes5.
About 35% of the general population in addition to 30-40% of elderly
institutionalized patients and 18-22% of all persons in long term care facilities suffer from
dysphagia, i.e. difficulty in swallowing6. One study showed that 26% out of 1576 patients
experienced difficulty in swallowing tablets due to their large size, followed by their surface,
shape and taste7. Recent market studies indicate that more than half of the patient population
prefers ODTs to other dosage forms and most consumers would ask their doctors for ODTs
(70%), purchase ODTs (70%), or prefer ODTs to regular tablets or liquids (>80%)8.
Mainly ODTs are prepared by various techniques, such as direct compression, solid
dispersion moulding, sublimation and by the use of super disintegrants such as
crosspovidone, croscarmellose sodium, sodium starch glycolate. Of the above techniques, the
simple one is direct compression, which is cost effective. The super disintegrants are added to
this formulation to enhance the disintegration of tablet into smaller particles which provides
rapid onset of action9.
ODTs offer the luxury of much more accurate dosing than the primary alternative,
oral liquids. This segment of formulation is especially designed for dysphagic, geriatric,
pediatric, bed-ridden, travelling and psychotic patients who are unable to swallow or refuse to
swallow conventional oral formulations10.
Salbutamol sulphate is a selective β2-adrenergic agonist and represents an
effective drug for the treatment of asthma and the symptomatic alleviation of bronchospasm.
Asthma is a chronic inflammatory disease, which includes bronchial hyperactivity and
bronchospasm characterized by hyper responsiveness of tracheo-brochial smooth muscle to
variety of stimuli, resulting in narrowing of air tubes often accompanied by increased
secretions and mucosal edema resulting in breathlessness or dyspnoea, wheezing cough, chest
congestion and anxiety about being unable to breathe. It is a hydrophilic drug with a pKa of
9.2 and a log P value of 0.11. It is usually given by inhalation or slow intravenous injections,
4
in the management of severe asthmatic attacks. Actually, most (or all, in several countries)
products containing this drug are administered by inhalation. The plasma half-life of the drug
has been estimated to range from 4 to 6 hours, so the recommended dose in adults and
children is usually given every 4 to 6 hours. Even when short-acting β2-adrenergic receptor
agonist is given as an inhalation, it has been suggested that majority of the dose is swallowed
and absorbed from the gut and intravenous injections are painful administration11,12,13. A fast
dissolving tablet form would thus be advantageous and patient compliant, as salbutamol
sulphate is water-soluble and its preparation into a fast dissolving form would render it to
dissolve rapidly and thereby result in rapid absorption without any lag time. Hence an attempt
was made for preparation of mouth dissolving tablet of salbutamol sulphate with an aim of
reducing the lag time and providing faster onset of action to relieve the acute asthmatic effect
immediately14.
6.2 OBJECTIVES OF THE STUDY
To formulate and evaluate orodispersible tablets containing β2 receptor agonistsalbutamol sulphate for bronchial asthma and to investigate the effect of super disintegrants
on the release profile of the drug from the tablets.
Pre formulation studies including

Complete characterization of the drug and polymers, and its analytical method
development

Screening of excipients for compatibility

Selection of suitable technology for preparing fast dissolving tablets

Formulation of fast dissolving tablets with different polymers and super
disintegrants

Evaluation of the physico-chemical characteristics of the prepared tablets like
diameter, weight uniformity, hardness, content uniformity etc

To assess the stability of the prepared formulations as per ICH guidelines
5
6.3 REVIEW OF LITERATURE
Keny et al15., prepared mouth disintegrating tablets of rizatriptan benzoate using
superdisintegrants crospovidone, carboxymethylcellulose calcium, Indion 414 and Indion 234
by direct compression method. The tablets prepared were evaluated for thickness, uniformity
of weight, content uniformity, hardness, friability, wetting time, in vitro and in vivo
disintegration time, mouth feel, in vitro drug release and assay by high performance liquid
chromatography. The tablets disintegrated in vitro and in vivo within 4 to 7 s and 6 to 19 s,
respectively. Almost 90% of drug was released from all formulations within 20 min. The
drug release from the formulations followed first order kinetics. Stability studies of the tablets
at 40±2 o /75%±5% RH for 1 mo showed non significant drug loss. The formulation
containing combination of crospovidone and Indion 234 was found to give the best results.
Apart from fulfilling all official and other specifications, the tablets exhibited higher rate of
release.
Senoy et al16., optimized the dissolving tablets of diclofenac sodium was developed by using
direct compression after incorporating super disintegrants such as cross linked carboxy
methyl cellulose, sodium starch glycolate and cross linked povidone in different
concentrations and evaluated the effect of their concentrations on the characteristics of fast
dissolving tablets mainly in terms of disintegration time and dissolution rate. Tablets
containing cross linked carboxy methyl cellulose showed better disintegrating character along
with rapid release.
Ajaykumar Patil et al17., prepared mouth dissolving tablets of montelukast sodium by direct
compression method using superdisintegrants such as croscarmellose sodium and
crospovidone. The compatibility of the drug in the formulations was confirmed by IR studies.
The formulations were subjected to precompression and postcompression parameters and the
results were found to be within acceptable limits. The formulated tablets disintegrated in less
than 26.33 sec fulfilling the official requirements for dispersible tablets. The rapid drug
dissolution was observed in the formulations containing croscarmellose sodium and followed
first order release kinetics. Finally, it can be concluded that mouth dissolving tablets of
montelukast sodium can be prepared by direct compression method using croscarmellose
sodium as superdisintegrant.
Mahajan et al18., developed mouth dissolving tablets of sumatriptan succinate using super
disintegrants like sodium starch glycolate, carboxy methyl cellulose, treated agar and
microcrystalline cellulose and dissolve in saliva and swallowed without water. There is
limited reference of work done about the use of ion exchange resins in oro dispersible tablets
6
for taste masking and rapid disintegration. Hence, it was planned to employ this technique for
ambroxol hydrochloride, as the model drug.
Patel et al19., developed fast dissolving tablets of etoricoxib. Granules containing etoricoxib,
menthol, crospovidone, aspartame and mannitol were prepared by wet granulation technique.
Menthol was sublimed from the granules by exposing the granules to vacuum. The porous
granules were then compressed in to tablets. Alternatively, tablets were first prepared and
later exposed to vacuum. The tablets were evaluated for percentage friability and
disintegration time. A 32 full factorial design was applied to investigate the combined effect
of 2 formulation variables: amount of menthol and crospovidone. The results of multiple
regression analysis indicated that for obtaining fast dissolving tablets; optimum amount of
menthol and higher percentage of crospovidone should be used. A surface response plots are
also presented to graphically represent the effect of the independent variables on the
percentage friability and disintegration time. The validity of a generated mathematical model
was tested by preparing a checkpoint batch. Sublimation of menthol from tablets resulted in
rapid disintegration as compared with the tablets prepared from granules that were exposed to
vacuum. The optimized tablet formulation was compared with conventional marketed tablets
for percentage drug dissolved in 30 min (Q 30 ) and dissolution efficiency after 30 min (DE
30 ). From the results, it was concluded that fast dissolving tablets with improved etoricoxib
dissolution could be prepared by sublimation of tablets containing suitable subliming agent.
Raghavendrarao et al20., developed rapidly disintegrating tablets carbamazepine, which is a
bitter drug poor solubility in biological fluids is the major problem with this drug has also its
poor bioavailability after oral administration. The rate of absorption or the extent of
bioavailability for such a poor soluble drug is controlled by rate of dissolution in GIT fluids.
Hence, to enhance the solubility of the drug a complex of carbamazepine was prepared with
β-cyclodextrin and this complex was compressed into tablets.
Gnanaprakash et al21,. prepared fast dissolving tablets of valdecoxib in the oral cavity with
enhanced dissolution rate. The fast dissolving tablets of valdecoxib was prepared with some
carriers (polymers) and super disintegrants such as polyvinyl pyrrolidone (PVP), sodium
carboxy methyl cellulose (SCMC), crospovidone NF and β – cyclodextrin. The above
mentioned all carriers and superdisintegrants were taken in different proportions of 5, 10, and
15%. All the formulations of the fast dissolving tablets of valdecoxib were prepared by direct
compression technique. The blend was examined for angle of repose, bulk density,
compressibility index and Hausner’s ratio. The prepared tablets were evaluated for hardness,
drug content uniformity, friability, disintegration time and dissolution rate. The prepared
formulations drug release was found to be comparable with the marketed dispersible tablets.
7
Gohel et al22., developed mouth dissolving tablets of nimesulide. Granules containing
nimesulide, camphor, crospovidone and lactose were prepared by wet granulation technique.
Camphor was sublimed from the dried granules by exposure to vacuum. The porous granules
were then compressed. Alternatively, tablets were first prepared and later exposed to vacuum.
The tablets were evaluated for percentage friability, wetting time, and disintegration time. In
the investigation, a 32 full factorial design was used to investigate the joint influence of 2
formulation variables: amount of camphor and crospovidone. The results of multiple linear
regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets
should be prepared using an optimum concentration of camphor and a higher percentage of
crospovidone. A contour plot is also presented to graphically represent the effect of the
independent variables on the disintegration time and percentage friability. A checkpoint batch
was also prepared to prove the validity of the evolved mathematical model. Sublimation of
camphor from tablets resulted in superior tablets as compared with the tablets prepared from
granules that were exposed to vacuum. The systematic formulation approach helped in
understanding the effect of formulation processing variables.
Shirsand et al23., prepared fast dissolving tablets of clonazepam by direct compression
method with a view to enhance patient compliance. A 32 full factorial design was applied to
investigate the combined effect of two formulation variables: amount of crospovidone and
microcrystalline cellulose. Crospovidone (2-8% w/w) was used as superdisintegrant and
microcrystalline cellulose (20-40% w/w) was used as diluent, along with directly
compressible mannitol to enhance mouth feel. The tablets were evaluated for hardness,
friability, thickness, drug content uniformity, in vitro dispersion time, wetting time and water
absorption ratio. Based on in vitro dispersion time (approximately 16 s); the formulation
containing 2% w/w crospovidone and 40% w/w microcrystalline cellulose was found to be
promising and tested for in vitro drug release pattern (in pH 6.8 phosphate buffer). Short-term
stability (at 40 degrees /75% relative humidity for 3 mo) and drug-excipient interaction. The
optimized tablet formulation was compared with conventional commercial tablet formulation
for drug release profiles. This formulation showed nearly five-fold faster drug release (t(50%)
3.5 min) compared to the conventional commercial tablet formulation (t(50%) 16.4 min).
Short-term stability studies on the formulation indicated that there are no significant changes
in drug content and in vitro dispersion time (P<0.05).
Narmada et al24., formulated fast dissolving tablet of amlodipine besylate for rapid action by
3
sublimation method using a 2 full factorial design. FT-IR and D.T.A studies revealed that
there was no physico-chemical interaction between amlodipine besylate and other excipients.
All formulations are evaluated for pre-compression and post-compression parameters,
8
wetting time, water absorption ratio. The results obtained showed that the quantity of starch
potato, sodium starch glycolate, camphor significantly affect response variables. The results
indicate that the optimized tablet formulation provides a short DT of 8 sec with sufficient
crushing strength and acceptable friability. Stability studies of optimized formulation
revealed that formulation is stable.
Bhupendra et al25., formulated directly compressible orally disintegrating tablets of
cinnarizine with sufficient mechanical integrity, content uniformity, and acceptable
palatability to assist patients of any age group for easy administration. Effect of varying
concentrations of different superdisintegrants such as crospovidone, croscarmellose sodium,
and sodium starch glycolate on disintegration time was studied. Absorption ratio (R) for each
of three superdisintegrants at concentrations studied. Considering the ‘R’ values and
disintegration time, crospovidone was significantly superior compared to other two
superdisintegrants tested. Release of drug was faster from formulations containing 6%
crospovidone (CP5) compared to the marketed convetional cinnarizine tablet. Finally
concluded that directly compressible orally disintegrating tablets of cinnarizine with lower
friability, acceptable taste, and shorter disintegration times were obtained using crospovidone
at optimized concentrations.
Ganesh kumar et al26., studied about the fast dissolving tablets of chlorpromazine Hcl in the
oral cavity with enhanced dissolution rate. The tablets were prepared with five
superdisintegrants eg: Sodium starch glycolate, crospovidone, croscarmellose, L-HPC,
pregelatinised starch, The blend was examined for angle of repose, bulk density, tapped
density, compressibility index and Hausners ratio. The tablets were evaluated, It was
concluded that the fast dissolving tablets with proper hardness, rapidly disintegrating with
enhanced dissolution can be made using selected superdisintegrants.
Shailendra Kumar et al27., prepared fast disintegrating combination tablets of omeprazole
and domperidone by using pertinent disintegrant. using mannitol as diluent and sodium
saccharin as sweetening agent along with three different levels of disintegrant. The
superdisintegrant used in this study were kollidon CL, Ac-Di-Sol and SSG. The tablets were
evaluated. Using the same excipients, the tablets were prepared by direct compression and
were evaluated in the similar way. Drug content was estimated by using HPLC method and
also assay of sample was compared with standard drugs (omeprazole and domperidone).
Omeprazole and domperidone were well resolved and the retention times were around 9.01
and 6.2 respectively. From the results obtained, it can be concluded that the tablet
formulation prepared with 4.76% Ac-Di-Sol (internally cross linked form of sodium
carboxymethylcellulose) ie. 10 mg showed disintegration time of 15 seconds in vitro.
9
Nagendrakumar et al28., prepared fast dissolving tablets of fexofenadine Hcl by effervescent
method with a view to enhance patient compliance. Three super-disintegrants viz.,
crospovidone, croscarmellose sodium and sodium starch glycolate along with sodium
bicarbonate and anhydrous citric acid in different ratios were used and directly compressible
mannitol (Pearlitol SD 200) to enhance mouth feel. The prepared batches of tablets were
evaluated for hardness, friability, drug content uniformity and in vitro dispersion time. Based
on the in vitro dispersion time (approximately 20 s), three formulations were tested for in
vitro drug release pattern in pH 6.8 phosphate buffer, short-term stability at 40 degrees /75%
RH for 3 mo and drug-excipient interaction (IR spectroscopy). Among the three promising
formulations, the formulation ECP(3) containing 8% w/w of crospovidone and mixture of
24% w/w sodium bicarbonate 18% w/w of anhydrous citric acid emerged as the best (t(50%)
4 min) based on the in vitro drug release characteristics compared to conventional
commercial tablet formulation (t(50%) 15 min). Short-term stability studies on the
formulations indicated that there are no significant changes in drug content and in vitro
dispersion time (P<0.05).
7. MATERIALS AND METHODS
MATERIALS
Drug
: Salbutamol sulphate
Polymers
: MCC, Starch, Sodium Starch Glycolate (Primojel), Polyplasdone XL,
Croscarmellose sodium ( Ac-Di-Sol), L- Hydroxy propyl cellulose etc
or any other suitable polymers.
METHOD
: Direct compression method 29, 30, 31, 32
EVALUATION PARAMETERS
 Preformulation studies
 Weight variation test33
 Thickness uniformity test33
 Hardness and friability34
 Content uniformity test34
 Wetting time and water absorption ratio35
 In-vitro disintegration time / dispersion time36
 Dissolution studies37
 Stability evaluation of selected formulations as per ICH guidelines
 Drug –polymer compatibility study and surface morphology study of formulation
using FTIR/DSC38, 39
10
7.1 Source of data:
Data will be obtained from drug invention today, Pub med, science direct, Medline,
US patent office website and other internet facilities, literature search and related articles
from library of Gautham College of Pharmacy.
7.2 Method of Collection of Data

Literature review including pub med/med line and internet search

Lab experiment
7.3 Does the study require any investigation or interventions to be
conducted on patients or other humans or animals?
NA
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
NA
11
8. REFERENCES
1. Debjit Bhowmik, Chiranjib B., Krishnakanth, Pankaj, Margret Chandira. “Fast dissolving
tablet : An overview”. Journal of Chemical and Pharmaceutical Research. 2009; 1(1):
163-177.
2. Rajeshree Panigrahi, Saiprasanna Behera. “A review on fast dissolving tablets”. Webmed
Central Quality and patient safety. 2010; 1(9): 1-16.
3. Seager H. “Drug delivery products and zydis fast dissolving dosage form”. journal.
Pharm. Phamacol. 1998; 50: 375-382.
4. Rakesh Pahwa, Mona Piplani, Prabodh C. Sharma, Dhirender Kaushik and Sanju Nanda.
“Orally disintegrating tablets - Friendly to pediatrics and geriatrics”. Archives of Applied
Science Research. 2010; 2 (2): 35-48.
5. Sharma Chandan, Dangi Varun, Gupta Ashish, Ahamad Dabeer and Ahmad Ayaj.
“Orally disintegrating tablets : A Review”. International Journal of Pharmacy and Life
sciences. 2010; 1(5): 250-256.
6. Manoj Ashok Wagh, Kothawade Parag Dilip, Kishor Sahebrao Salunkhe, Nayana Vijay
Chavan, Vandana Radheshyam Daga. “Techniques used in orally disintegrating drug
delivery system”. International Journal of Drug Delivery. 2010; (2): 98-107.
7. Dali Shukla, Subhashis Chakraborty, Sanjay Singh, Brahmeshwar Mishra. “Mouth
dissolving tablets I: An overview of formulation technology.” Sci Pharm. 2009; 77: 309–
326.
8. Jaysukh J. Hirani, Dhaval A. Rathod, Kantilal R. Vadalia. “Orally disintegrating tablet :
A Review”. Tropical Journal of Pharmaceutical Research. 2009; 8 (2): 161-172.
9. Susijit Sahoo, B. Mishra, P.K. Biswal, Omprakash Panda, Santosh Kumar Mahapatra,
Goutam Kumar Jana. “Fast dissolving tablet: As a potential drug delivery system”. Drug
Invention Today. 2010; 2(2): 130-133.
10. Dali Shukla, Subhashis Chakraborty, Sanjay Singh, Brahmeshwar Mishra. “Mouth
dissolving tablets II: An overview of evaluation techniques”. Sci Pharm. 2009; 77: 327341.
11. Prasanth V.V., Ayarivan P., Sam T. Mathew, Ashok Kumar B. “Development and
characterization of eudragit based mucoadhesive buccal patches of salbutamol sulphate”.
Saudi Pharmaceutical Journal. 2011; 19(4): 207-214.
12. Puratchikody A., Prasanth V.V., Sam T. Mathew and Ashok kumar B. “Mucoadhesive
patches of Salbutamol sulphate for unidirectional buccal drug delivery: Development and
evaluation”. Current Drug Delivery. 2011; 8: 416-425.
12
13. Puratchikody A., Prasanth V.V., Sam T. Mathew, Ashok Kumar B. “Development and
characterization of mucoadhesive patches of salbutamol sulphate for unidirectional buccal
drug delivery”. Acta Pharmaceutica. 2011; 61: 157-170.
14. Sarasija Suresh, Pandit V., Joshi H.P. “Preparation and evaluation of mouth dissolving
tablets of salbutamol sulphate”. Indian Journal of Pharmaceutical Sciences 2007; 69(3):
467-469.
15. Keny R.V., Desouza C., Lourenco C.F. “Formulation and evaluation of rizatriptan
benzoate mouth disintegrating tablets”. Indian J Pharm. Sci. 2010; 72(1): 79-85.
16. Shenoy V., Agrawal S., Pandey S. “Optimizing fast dissolving dosage forms of
Diclofenac sodium by rapidly disintegrating agents”. Indian Journal Pharm. Science.
2003; 65(3): 197-200.
17. Ajaykumar Patil, Taqiuddin Aman, Nithin Bhargava B., Abhilash P., Madhuri Turaga,
Supriya Kulkarni. “Formulation and evaluation of mouth dissolving tablets of
montelukast sodium”. Research Journal of Pharmaceutical, Biological and Chemical
Sciences. 2011; 2(3): 268.
18. Mahajan H.S., Kuchekar B.S., Badhan A.C. “Mouth dissolve tablets of sumatriptan
succinate”. Indian Journal of Pharm. Science. 2004; 66(2): 238-240.
19. Patel D.M. and Patel M.M. “Optimization of fast dissolving eterocoxib tablets prepared
by sublimation technique”. Indian Journal of Pharmaceutical sciences. 2008; 70(1): 7176.
20. Raghavendrarao N.G., Patel T., Gandhi S. “Development and evaluation of
carbamazepine fast dissolving tablets prepared with a complex by direct compression
technique”. Asian Journal of Pharmaceutics. 2009; 97-103.
21. Gnanaprakash K., Mallikarjuna Rao K., Chandra Sekhar K.B., Madhusudhana Chetty C.,
Alagusundaram M., Ramkanth S. “Formulation and evaluation of fast dissolving tablets
of valdecoxib”. International Journal of PharmTech Research(USA): 0974-4304.
22. Gohel M., Patel M., Amin A., Agarwal R., Dave R., Bariya N. “Formulation design and
optimization of mouth dissolve tablets of nimesulide using vacuum drying technique”.
AAPS Pharm. Sci. Tech. 2004; 5(3): 1-6.
23. Shirsand S.B., Suresh S., Swamy P.V. “Formulation design and optimization of fast
dissolving clonazepam tablets”. Indian J Pharm Sci. 2009; 71(5): 567-72.
24. Narnada G. Y., Mohini K., Prakash Rao B., Kumar K. S. “Formulation, evaluation and
optimization of fast dissolving tablets containing amlodipine besylate by sublimation
method”. Ars Pharm. 2009; 50(3): 129-144.
13
25. Bhupendra G. Prajapati and Satish N. Patel. “Formulation, evaluation and Optimization
of orally disintegrating tablet of cinnarizine”. e -Journal of Science & Technology. 2010;
5(5): 9-21.
26. Ganesh kumar Gudas, Manasal B., Rajesham V.V., Kiran Kumar S., Prasanna Kumari J.
“Formulation and evaluation of fast dissolving tablets of chlorpromazine Hcl”. Journal
of Pharmaceutical Science and Technology. 2010; 2(1): 99-102.
27. Shailendra Kumar Singh, Dinanath Mishra, Rishab Jassal, Pankaj Soni. “Fast
disintegrating combination tablets of omeprazole and domperidon”. Asian Journal of
Pharmaceutical and Clinical Research. 2009; 2(3): 74-82.
28. Nagendrakumar D., Raju S.A., Shirsand S.B., Para M.S., Rampure M.V. “Fast dissolving
tablets of fexofenadine Hcl by effervescent method”. Indian J Pharm Sci. 2009; 71(2):
116-9.
29. Radke R.S., Jadhav J.K., Chajeed M.R. “Formulation and evaluation of orodispersible
tablets of baclofen”. International Journal of ChemTech Research. 2009; 1(3): 517-521.
30. Manivannan rangaswamy, balasubramanian ayyasamy, senthikumar raju. “Design and
evaluation of fast dissolving tablet of terbutaline sulfate”. Asian journal of
pharmaceuticals. 2009; 215-217.
31. Mohsin A. A., Nimbalakr N. E., Sanaullah S., Aejaz A. “Formulation and evalution of
mouth dissolving tablets of amitriptyline hydrochloride by direct compression technique”.
International Journal Of Pharmacy And Pharmaceutical Sciences. 2010; 2(1): 204-210.
32. Anish chandy, sandeep gupta, ashish manigauha, alok singh thakur. “Comparative
evaluation of disintegrants in orodispersible tablets of famotidine”. International journal
of current pharmaceutical research. 2010; 2(3): 44- 46.
33. Khanna R., Agarwal S.P., Ahuja A. “Preparation and evaluation of mucoadhesive buccal
films of clotrimazole for oral candida infections”. Indian J. Pharm. Sci. 1997; 59: 299 –
305.
34. Jain C.P. and Naruka P.S. “Formulation and evaluation of fast dissolving tablets of
valsartan”. International Journal of Pharmacy and Pharmaceutical Sciences. 2009; 1(1):
220-226.
35. Alanzi F.K. “Evaluation of spray and freeze dried excipient bases containing
disintegration accelerators for formulation of metoclopramide orally disintegrating
tablets”. Saudi Pharmaceutical Journal. 2007; 15: 105-119.
36. Abdelbary G., Eouani C., Prinderre P., Joachim J., Reynier J.P., Piccerelle P.H.
“Determination of the In vitro disintegration profile of rapidly disintegrating tablets and
14
correlation with Oral Disintegration”. International Journal of Pharmaceutics. 2004; 292:
29-41.
37. United State Phamacopeia Convention. NF Ashian Edition. 2004; 74-5.
38. James R.L., Matroprolol Tartrate. In: Klaus Florey, Editor- Analytical profiles of drug
substances. London: Academic press. 2005; 12: 325.
39. John G.H., Wyka B.E., Clotrimazole. In: Klaus Florey, editor- Analytical profiles of drug
substances. London: Academic press. 2005; 11: 225.
.
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9.
Signature of Candidate
10.
Remarks of the guide
SIDHYARTHA SARKAR
The above information is true to the best of my knowledge and the work will be done under my
guidance.
11.
11.1 Name and Designation of Guide
Dr. Prasanth V.V., (M.Pharm, Ph.D)
Professor & HOD
Department of Pharmaceutics,
Gautham College of Pharmacy,
Sultanpalya, R.T Nagar (P.O)
Bangalore – 560032
11.2 Signature
11.3 Co-Guide (IF ANY)
NA
11.4 Signature
11.5 Head of the Department
Dr. Prasanth V. V., (M.Pharm, Ph.D)
Professor & HOD
Department of Pharmaceutics,
Gautham College of Pharmacy,
Sultanpalya, R.T Nagar (P.O)
Bangalore – 32, Karnataka.
11.6 Signature
12.
12.1 Remarks of the Principal
The above mentioned information is correct and I recommend the same for approval.
12.2 Signature
Mrs. ARCHANA P. SWAMY. M.Pharm, (PhD)
Principal
Gautham College of Pharmacy
Sultanpalya, R.T Nagar (P.O)
Bangalore – 32, Karnataka.
16