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S O L I D S
S U P P O S I T O R I E S
C O M P O U N D I N G
POLYBASE
TM
POLYBASETM
Water Soluble - Water
Miscible Suppository Base
Paddock POLYBASE
Size
NDC
1 lb
0574-0309-16
5 lb
0574-0309-05
Polybase is a pre-blended suppository base used to simplify the process
involved in the extemporaneous compounding of suppositories.
Applications
Polybase is used as a pharmaceutical base in the preparation of suppositories
when a water-soluble or water-miscible base is preferred.
How to Use - TIPS:
• Be sure that the suppository mold is clean and completely dry before use.
• Do not refrigerate or freeze mold before pouring, since the cold temperature
may cause surface fissuring or fracturing of suppositories.
• Coating of suppository mold with lubricant is not necessary with Polybase.
Polybase has excellent mold release characteristics.
Suppository Directions:
• Weigh Polybase and place it in a Pyrex®* beaker, stainless-steel beaker, crucible
or another appropriate container with a pouring lip.
• Melt Polybase 60°C-71°C (140°-160°F) using a water bath, hot plate, burner,
or another temperature-controlled heating device. Polybase is very heat stable
and can be heated to 93°C (200°F) without affecting its chemical characteristics.
• Stir the melted Polybase with a spatula or stirring rod while incorporating the
medication into the melted Polybase. Mix until a homogenous suspension is formed.
• When the homogenous suspension is 43°C (110°F), pour mixture into the suppository mold. Slightly overfill the mold to account for contraction while cooling.
• Refrigerated suppositories will set up in 15-30 minutes. Do not freeze.
• Trim suppositories with a razor blade or spatula. Break the mold apart carefully and remove the finished suppositories.
© 2010 Paddock Laboratories, LLC
*Pyrex® is a registered trademark of Corning Inc.
0309-02-0610
• The recommended storage for suppositories is in a
glass container or a chipboard suppository box under refrigeration.
CAUTION: Suppositories made with Polybase should not be stored or
dispensed in polystyrene containers.
Properties
Polybase consists of a homogeneous mixture of various molecular
weight polyethylene glycols. These specific polyethylene glycols exhibit
excellent stability at room temperature due to their high melting points.
Polybase releases medication by dissolving in the rectal or vaginal
canal rather than melting, providing a longer disintegration time.
Ingredients
Polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80
Specifications
Appearance: White solid
Odor: Mild polyethylene glycol odor
Specific Gravity: 1.177 @ 24°C (75°F)
Moisture: 2% MAX
Form: Solid @ 24°C (75°F)
Now part of the Perrigo Family
POLYBASE Formulating & Compounding Examples
CHLORAL HYDRATE 500 mg/suppository,
12 each (2.20 gram blanks)
Chloral hydrate
Polybase
6.00 gm
20.63 gm
1. Heat Polybase to melting, 140°-160°F.
2. Add chloral hydrate to melted Polybase, slowly stirring until uniform.
3. Quickly pour into molds.* Cool and dispense.
INDOMETHACIN 50 mg/suppository, 12 each
(2.20 gram blanks)
Indomethacin powder
Polybase
0.60 gm
25.87 gm
1. Heat Polybase to melting, 140°-160°F.
2. Add indomethacin to melted Polybase, slowly stirring until
uniform.
3. Quickly pour into molds.* Cool and dispense.
*Calibrate your molds before use.
CALIBRATION OF MOLD AND DETERMINATION OF
DENSITY FACTOR
1. Melt Polybase and pour several blank suppositories (6-10).
Weigh each suppository and calculate the average weight (A).
2. Weigh quantity of Polybase necessary for 10 suppositories (use
average weight calculated in 1).
3. Weigh 1.00 gram medication (B = gm medication per suppository).
4. Melt Polybase and incorporate the medication with constant
agitation.
5. Pour 10 suppositories. Weigh each suppository and calculate
the average weight (C).
6. Determine Density Factor:
B
A–C+B
where:
= Density Factor for Medication
A
B
C
= average weight of blank
= weight of medication per suppository
= average weight of medicated suppository
7. Divide weight of medicament required for each suppository by
density factor of medication to find replacement value of
Polybase.
EXAMPLE: 400 mg Medicament/suppository
(Medicament density factor = 1.00)
0.40 gm/1.00 = 0.40 (gm Polybase replaced by 0.4 gm of
drug)
8. Subtract this quantity from blank suppository:
EXAMPLE: (blanks = 2.20 gm each)
2.20 gm Polybase
-0.40 gm Weight Polybase replaced by 0.40 gm medicament
1.80 gm Polybase is required per suppository
9. Add together the amount of base and the amount of drug to
find the total weight of each suppository.
Example:
1.80 gm Polybase
+0.40 gm Medicament
2.20 gm Total weight of each suppository
10. Multiply weight of each suppository times the quantity of
suppositories for the entire batch.
EXAMPLE: To make 24 suppositories
2.20 gm x 24 = 52.80 Total Batch
24 x 0.40 gm = 9.60 gm Medicament
24 x 1.80 gm = 43.20 gm Polybase
52.80 gm Total Batch
Sample Suppository Formulas
(Assuming blank weight 2.2 gm**)
Using Polybase and density factor 1.00
25 mg Suppositories
Increased by 10%***
100-count yield
Polybase
217.50 gm
239.25 gm
Medicament
2.50 gm
2.75 gm
TOTAL
220.00 gm
242.00 gm
50 gm Suppositories
100-count yield
Polybase
215.00 gm
Medicament
5.00 gm
236.50 gm
5.50 gm
TOTAL
220.00 gm
242.00 gm
100 mg Suppositories
100-count yield
Polybase
210.00 gm
Medicament
10.00 gm
231.00 gm
11.00 gm
TOTAL
220.00 gm
242.00 gm
200 mg Suppositories
100-count yield
Polybase
200.00 gm
Medicament
20.00 gm
220.00 gm
22.00 gm
TOTAL
220.00 gm
242.00 gm
400 mg Suppositories
100-count yield
Polybase
180.00 gm
Medicament
40.00 gm
198.00 gm
44.00 gm
TOTAL
220.00 gm
242.00 gm
**Calibrate your molds before use.
***Increased by 10% to allow for overfill and shrinkage.
Contraindications
Polybase is contraindicated in persons who have shown hypersensitivity to any of the listed ingredients.
All information presented is intended to demonstrate the application of Paddock vehicles for compounding. Paddock products are sold on the understanding that purchasers will make their own
determinations as to the suitability, safety and effectiveness of their applications. The uses presented by Paddock are only to assist our customers in exploring possible applications. All information
and data presented are believed to be accurate and reliable, but are presented without the assumption of any liability by Paddock Laboratories. Paddock Laboratories does not warrant against
infringements of patents of third parties by reason of any uses made of the vehicles in combination with other material or in the operation of any process, and purchasers assume all risks of patent
infringement by reason of any such use, combination or operation.
Order through your wholesaler. For additional information please contact
Paddock Laboratories at 1-800-328-5113 or www.paddocklabs.com
Now part of the Perrigo Family