Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

EXERCISE NO. 4

PREPARATION OF ACETAMINOPHEN CAPSULES

I. Intended Learning Outcomes:

At the end of the exercise, the student should be able to
1. Identify the ingredients based on their physical characteristics and describe
their function in the preparation
2. Compound Acetaminophen Capsules using appropriate method of
preparation
3. Select appropriate container for the product
4. Prepare the label for the product accurately and neatly
5. Comply with the standards and regulations set by CGCP

II. Discussion:
Capsules are solid dosage forms in which medicinal agents and/or inert
substances are enclosed in a small shell of gelatin. Gelatin capsule shells may be hard
or soft, depending on their composition. The shells may be composed of two pieces, a
body and a cap, or they may be composed of a single piece. Two- piece capsules are
commonly referred to as hard-shell capsules, and one-piece capsules are often referred
to as soft-shell capsules.

The advantages of capsules are (1) masking the unpleasant taste, (2) allowing
the mixture of components that could not be mixed with other vehicles, (3) can alter the
release rate of APIs by adding hydroxypropyl methylcellulose (HPMC), (4) allowing
incorporation of several components into one dosage form, (5) providing an accurate
dosage size for liquids, semisolids, and powders, and (6) providing a dosage form that
is easier to swallow and more acceptable to the patient.

Hard gelatin capsule shells are used in most commercial medicated capsules.
They are also commonly employed in clinical drug trials to compare the effects of an
investigational drug with those of another drug product or placebo. The community
pharmacist also uses hard gelatin capsules in the extemporaneous compounding of
prescriptions. The empty capsule shells are made of gelatin, sugar, and water. Hard
gelatin capsules are filled extemporaneously by punch method while capsule filling
machines are used for large scale production. Determining the size of capsule to use for
a particular dosage involves assessing the density or fluffiness of the powder,
comparing it to known weights of various reference powders with published capsule size
capacities, and then filling and weighing the capsule. Capsules available from largest to
smallest includes 000, 00,0,1, 2, 3, 4, and 5.

Soft gelatin capsules are made of gelatin to which glycerin or a polyhydric alcohol
such as sorbitol has been added. Soft gelatin capsules, which contain more moisture
than hard capsules, may have a preservative, such as methylparaben and/or
propylparaben, to retard microbial growth. Soft gelatin capsules may be oblong, oval, or
round. They may be single colored or two toned and may be imprinted with identifying

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markings. Soft gelatin capsules are used to encapsulate and hermetically seal liquids,
suspensions, pasty materials, dry powders, and even preformed tablets. Soft gelatin
capsules are pharmaceutically elegant and are easily swallowed. They are prepared
either by plate process or rotating die process.

III. Materials
Acetaminophen Capsule #1
Starch Mettler balance
Mortar and Pestle Pill Tile
Spatula (Porcelain or Metal) Soft Gauze

IV. Formula
Acetaminophen...................................................0.825 g
Starch.................................................................1.65 g
To make 10 capsules

V. Compounding Procedure
1. Weigh all the ingredients accurately.
2. Mix acetaminophen, and starch by triturating in a mortar and pestle to reduce to
a fine and uniform powder.
3. Divide the powder by individual weighing
4. Remove the body of the capsule from the cap
5. Using punch method, hold the body or base of capsule punch the powder
repeatedly until filled.
6. Place back the cap of the filled base of the capsule.
7. Wipe and clean the capsule with a soft gauze or tissue paper.
8. Place in an appropriate container.
9. Label properly.

VI. Questions:
1. What are the different steps in preparing empty hard gelatin capsules?
2. Enumerate the capsule sizes with their corresponding fill volume in grains and
milligram.
3. Enumerate the different methods of sealing capsules. Describe them briefly.

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

Name: ________________________________ Date: ______________________

Year and Section: _______________________ Rating: ____________________

EXERCISE NO. 4

PREPARATION OF ACETAMINOPHEN CAPSULES

Synonym/Latin Name:
Use of Preparation:
Method of Preparation:
Appropriate Container:
Storage Condition:

Formula for 2 capsules:

Ingredients Quantity Use in Formula

Calculations:

Answers to Question:
1. What are the different steps in preparing empty hard gelatin capsules?

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

2. Enumerate the capsule sizes with their corresponding fill volume in grains and
milligram.

3. Enumerate the different methods of sealing capsules. Describe them briefly.

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

RUBRICS FOR PHARMACEUTICS 1 (LAB) PREPARATION

5 4 3 2
Exemplary Accomplished Developing Beginning
Skills
Procedural Student thoroughly Student follows the Student follows the Student follows the
Knowledge and carefully procedure with sufficient procedure with procedure with full
followed each supervision minimal or limited supervision
procedure supervision

Use of Student uses Student Uses tools, Student Uses tools, Student Uses tools,
Equipment appropriate tools, equipment and equipment and equipment and
equipment and materials with sufficient materials with limited materials with full
materials with control or minimal control supervision in
evidence of control in manipulating
manipulating
Return of Student always Student Returns Student Requires Student Requires
Equipment return clean equipment with only some reminders to constant reminders
equipment with no minimal reminders return equipment to return equipment
reminders
PPE, Student is tidy, with Student is mostly tidy, Student is sometimes Student is untidy,
Courtesy complete laboratory wears the complete tidy, wears incomplete wears only laboratory
and safety gear (head cap, lab laboratory gear after laboratory gear, gown, not respectful
gown, mask and being reminded, mostly sometimes respectful of others, not mindful
gloves) respectful of respectful of others, of others, sometimes of safety, and leaves
others, mindful of mostly mindful of safety, mindful of safety, and the area messy even
safety, and leaves and leaves the area leaves the area messy after being reminded.
the area clean clean only after being even after being
reminded. reminded.
Product
10 8 6 4
Exemplary Accomplished Developing Beginning
Final Student’s final Student’s final product Student’s final product Student’s final
Product product conforms to minimally conform to the minimally conform to product does not
the expected expected outcome with the expected outcome conform to the
outcome 1 mistake 2-3 mistakes expected outcome
*Elegance
*Stability
*Capsule is sealed
properly
*Capsule is clean
Packaging Student Student displays a good Student shows some Student does not
and demonstrates an understanding of how to understanding of how demonstrate
labelling accurate and label the product. to label the product. understanding of
complete Layout organized in a Layout somewhat how to label the
understanding of how satisfactory manner but organized with lack of product. Layout
to properly label the lack 1 information 2-3 information poorly arranged; lack
product. Layout well presented Layout was totally dis- more than 4
organized with Layout was not aligned align information
proper alignment properly The size of the label is The total appearance
The container used is Label was not properly not appropriate for the of the label is
clean and attached but is it neat. container unpresented
appropriate The container used is The container used is The container used
somewhat clean and dirty is not appropriate
appropriate

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Laboratory Exercises in Pharmaceutical Dosage Forms and Drug Delivery System and Medical Devices

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