PHRM 331 – Week 5

Pharmaceutics Lab I: Powders, Suppositories, and Capsules

Overview

Compounded oral dosage forms are the most frequently prescribed non-sterile dosage forms in pharmacy. In today’s
lab, students will prepare three different types of dosage forms: powder papers, suppositories, and capsules. Students
will be hand filling capsules by punch method. Additionally, students will be preparing cocoa butter suppositories by
fusion method.

Objectives Pharmacists’ Patient Care Process

1. Perform mathematical calculations related to the

compounding procedures found in this outline.
2. Identify the role of each ingredient during the
preparation of dosage forms.
3. Prepare medication in powdered form and package in
specially folded powder papers.
4. Practice appropriate techniques for filling empty
gelatin capsules with a powder.
5. Prepare, label, and dispense suppositories.

Schedule

Activity Time (minutes)

Lab Outline / Lab Equipment Check In 15

Compounding – 3 products 120*

*An average of 40 minutes per prescription/product

Assignments

Assignment Points Due Date & Time How to Submit

Checked off by instructor for each
Complete Exercises I & II 15 By the end of lab
compounded product
Complete Exercise III – Turn in completed capsules in box marked with
5 By the end of lab
Compounding Capsules your name – graded based on accuracy
**Students will receive a zero (i.e. 0 points) for the lab if they do not participate.

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Compounding Procedures

Exercise I. Powder Papers

A. Objective: To prepare medication in powdered form and package in specially folded powder papers. Powder
papers contain one dose of medication in powder form. Powder papers are also referred to as charts.
B. A prescription reads:
ASA 5 gr.
Belladonna Extract ¼ gr.
Diphenhydramine HCl ¾ gr.
M. Ft. Chart, DTD #3
SIG: One chart qhs prn for sleep.
C. Calculations

Ingredient Quantity Quantity*4 (1 extra)

ASA 5 gr

Belladonna Extract ¼ gr

Diphenhydramine HCl ¾ gr

D. Procedure
a. Measure out the belladonna extract and place in a glass mortar.
b. Gradually add the measured amount of diphenhydramine and mix thoroughly.
c. Gradually add the ASA and blend until totally homogenous.
d. Divide into 4 equal doses and weigh each dose.
e. Package as a Powder Paper/Chart. See the instructional video found via this weblink:
https://pharmlabs.unc.edu/labexercises/compounding/powders/videos/
f. Let the instructors observe your product and then discard in the solid waste container.

Exercise II. Cocoa Butter Suppositories Prepared by Fusion Method

A. Objective: To prepare 3 cocoa butter suppositories containing tannic acid by fusion.
a. Cocoa Butter is an emollient.
b. Cocoa Butter is Theobroma Oil, a polymorphous, natural fat used as a suppository base.
c. Theobroma Oil exhibits polymorphism; thus, it is capable of existing in four polymorphic forms:
i. Gamma form (γ) – melts at 18˚C
ii. Alpha form (α) – melts at 22˚C
iii. Beta prime (β’) – melts at 28˚C
iv. Beta form (β) – melts at 34.5˚C. Beta form is the natural form and the most stable form.
d. Do NOT use a scrubbing pad or any abrasive products to clean suppository molds. Only use soap and
paper towels to clean.

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B. A prescription reads:
Tannic Acid 0.2 g
Cocoa Butter q.s.
D.T.D. # 3
Sig.: Insert rectally as needed.
Refrigerate. For external use only.

C. Calculations

Amount needed to make Working formula

Ingredient
1 (ONE) suppository (Amount needed to make 4 suppositories)
Tannic Acid

Cocoa Butter 2g

D. Procedure
a. Lightly lubricate the inside of each cavity of the suppository mold with a cotton swab dipped in glycerin.
b. Weigh approximately 8 g of grated cocoa butter: 2 gm per suppository. You will make 3 suppositories and
you have 2 grams extra to account for any loss during the procedure.
c. Fill a 100 mL beaker with about 30 mL of tap water. Place 100 mL beaker on a hot plate to form a hot water
bath. Set the hot plate set around 100 ˚C and heat the 100 ml beaker for a few minutes.
d. Place cocoa butter in a 50 mL beaker and place 50 mL beaker in hot water bath with slow stirring. Melted
cocoa butter should maintain opalescent, creamy appearance. If the appearance of melted cocoa butter is
clear yellow liquid, start over.
**The temperature of the cocoa butter should be 34 to 35 °C. DO NOT OVERHEAT. The temperature of the
bath should not exceed 40 °C. If the mass becomes a clear yellow, start over. You have overheated the
cocoa butter and altered the polymorphic form. **
e. When the mass is a uniform, creamy, viscous fluid, slowly add tannic acid in small quantities to the softened
cocoa butter until smooth. Stir in between additions. While stirring, do NOT whip. DO NOT HEAT ABOVE
35°C.
f. Pour the creamy melt into the mold. The melt must be stirred during pouring to keep the mass
homogenous. Pour the base into each cavity to a convex over-fill as the base will contract upon cooling.
g. Allow the suppositories to solidify at room temperature for approximately 30 minutes before transferring to
ice bath. Do not put the mold in ice bath until the suppositories have congealed, or the base will contract
too rapidly and a thin cavity will form down the center of each suppository.
h. Place mold in an ice bath wrapped in a piece of foil with your ID paper on the top and allow it to harden.
i. Trim the congealed suppository before opening the mold using a warmed spatula. Lightly and gently warm
the steel spatula on a hot plate. Lay spatula flat on the tops of the suppositories for a couple of seconds and
then gently scrape the excess cocoa butter with edge of the spatula until the suppository is level with the
top of the mold, being careful not to chip the suppository.
j. Your suppositories preparation will be evaluated for pharmaceutical elegance and points will be given based
on how well you prepare your compounded suppositories.

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Exercise III. Oral Capsules
A. Objective: To prepare and fill gelatin capsules manually with powder and calculate the weight variation of
compounded capsules for quality control.
a. Acetaminophen – analgesic, antipyretic
b. Aspirin – analgesic, antipyretic, anti-inflammatory
c. Caffeine – stimulant
B. A prescription reads:
Acetaminophen 125 mg.
Aspirin 162.5 mg.
Caffeine 32.5 mg.
M. Ft. DTD Caps. #v
SIG: One capsule q4h for pain with full glass of water.

C. Calculations

Ingredient Quantity Quantity*8

Acetaminophen 125 mg

Aspirin 162.5 mg

Caffeine 32.5 mg

D. Procedure
a. Triturate the acetaminophen and aspirin tablets in a porcelain mortar separately and transfer the powder
in separate weighing boats.
b. Blend the powders obtained from acetaminophen and aspirin tablet with caffeine in a glass mortar by
using geometric dilution.
c. After blending, weigh the powder to determine the total weight of powder for 8 capsules.
𝐓𝐨𝐭𝐚𝐥 𝐰𝐞𝐢𝐠𝐡𝐭 𝐨𝐟 𝐩𝐨𝐰𝐝𝐞𝐫
Weight of the powder to be filled in a single capsule (A) =
𝟖
d. Weigh 5 empty capsules and calculate the average weight of the empty capsule shell.

Average weight of empty capsule shell (B) = _______ mg

e. Place the powder on a clean ointment tile and flatten to a lightly packed depth of about one-half of the
length of the body of the capsule to be filled.
f. Make sure that your hands are clean and dry before filling the capsules.
https://pharmlabs.unc.edu/labexercises/compounding/capsules/videos/

g. Weigh each filled capsule and remove or add powder to get the intended weight of filled capsule.
Intended weight of each capsule = Weight of powder filled in a single capsule (A) + Average weight of empty
capsule shell (B)

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 h. Weight of each capsule should not be less than 90% and not more than 110% of the intended weight of
each capsule.

Capsule # Weight of Finished Capsule % of Intended Weight

1
2
3
4
5

The number of capsules with the appropriate weight (within 10% above or below intended weight) will result a
grade as follows:
 Five capsules with appropriate weight - 5 points
 Four capsules with appropriate weight - 4 points
 Three capsules with appropriate weight - 3 points
 Two capsules with appropriate weight - 2 points
 One capsule with appropriate weight - 1 point
 No capsules with appropriate weight - 0 points
NOTE: If a student does not compound capsules that are within 10% of the intended weight, the student will
receive the score designated above and will be required to repeat the activity until appropriately weighted
capsules are made. To repeat the activity, make up sessions will scheduled by course coordinator.

i. Clean the filled capsules by wiping each carefully with paper tissue.
j. Submit your capsules to instructor in the provided container, labeled with your name.

Don’t forget clean your work bench after you finish! Lab areas that are not clean at the conclusion of lab will result in
a 5 point deduction.