Assignment # 5: CAPSULES

Answer the following questions:

1. Why are tablets and capsules preferred over other pharmaceutical dosage forms?
The reason as to why tablets and capsules preferred over other pharmaceutical dosage forms
as they are convenient therefore, they can be self-administered and can be carried easily. It is
also least expensive dosage form as it is easy and cheap to package compared to others.
Lastly, it is most taken orally thus, slower onset and a more prolonged, but less potent effect
than medication administered by other routes.
2. Define capsules.
Capsules are solid dosage form wherein medicinal agents and excipients are enclosed within
a small outer shell.
3. Give instances when capsules should be kept intact and swallowed whole.
Capsules are filled capsules thus, they are intended to be swallowed as whole. However,
there are special cases wherein capsules are not taken. This practice is very common in
hospitals and extended care facilities for a caregiver to open capsules or crush to mix food or
drink for children or other patients that are unable to swallow solid dosage forms. Keep in
mind that this practice is done only with the concurrence of the pharmacist, since the drug-
release characteristics of certain dosage forms can be altered and can adversely affect the
patient’s welfare.
4. What materials are gelatin made of? What happens to gelatin capsules in the presence of
excess humidity? In extreme dryness?

Commonly gelatin is composed of gelatin, white connective tissue, bones of animal and
partial hydrolysis of collagen obtained from skin. The effects of excess humidity to gelatin
capsules; there will be additional moisture absorbed by the capsules, and they may become
distorted and lose their rigid shape. Prolonged exposure to high humidity can affect in vitro
capsule dissolution. This is seen in capsules containing tetracycline, chloramphenicol, and
nitrofurantoin. Meanwhile, extreme dryness may lead capsules to become brittle and
crumble when handled. It is common in gelatin capsules to loss its moisture.

Give examples of:

a) Desiccant: silica gel, clay, and molecular sieves

b) Diluent: kaolin, lactose, mannitol, and dibasic calcium phosphate
c) Surfactant: ethylene, propylene oxide, sorbitan esters, ethoxylates, and copolymers
d) Opaquant: titaniumdioxide Silicates (talc, Aluminumsilicate)
e) Colorant: FD&C Blue no.1 – brilliant blue and FD&C Red no.40 – Allura Red
 f) Disintegrant: Modified Sodium starch glycolate and crosslinked polyvinylpyrrolidone
(crospovidone)
5. What is gamma scintigraphy? Give its use.
Gamma scintigraphy is defined as a noninvasive procedure that entails the use of a gamma
ray- emitting radiotracer incorporated into the formulation with a gamma camera coupled to
a data recording system. The resultant pharmacoscintographic evaluation shows the date
about the transit and drug-release patterns of the dosage form as well as the rate of drug
absorption from the various regions of the gastrointestinal tract. This method is used in three
ways. First, this used as a drug and dosage form evaluation for newly developed product. It is
also utilized in determining whether a correlation exists between in vitro and in vivo
bioavailability for immediate- release products. Lastly, it can assess the integrity and transit
time of enteric-coated tablets through the stomach and route to the intestines.
6. What are the uses of Heidelberg capsule?
Heidelberg capsules are used for nonradioactive means to measure gastric pH, gastric
residence time, and gastric emptying time of solid dosage forms in fasting and non-fasting
human subjects.
7. Name the steps of preparing hard gelatin capsule shells.
• Preparation of the gelatin solution
• Dip-coating the gelatin solution on to metal pins
• Rotation of the dip-coated pins
• Drying of the gelatin-coated pins
• Stripping and trimming
• Joining of the trimmed capsule shell
• Printing
8. What are the different capsule shell designs?
Generally there are two types of capsule which are the soft and hard gelatin capsule. First,
hard gelatin capsules are differentiated by the following: opaque hard gelatin capsules, clear
hard gelatin capsules, colored opaque hard gelatin capsules, colored transparent hard gelatin
capsules. Spansule capsules, pulvules, snap-fit, coni-snap, and coni-snap supro capsules.
Meanwhile, soft gelatin capsules are either made as tubs, twist-off, special shapes, oval,
round or oblong.
9. How would you minimize capsule splitting (telescoping)?
The way to minimize capsule splitting is by making sure all the capsules are perfectly
rounded. Check the alignment of the cap and body bushings and also protect the capsule
shells from direct exposure to the environment.
10. What are the different capsule sizes? What weight range of powdered materials can be
placed in capsules?
 • 000 – 950 mg

• 00 – 650 mg

• 0 – 450 mg

• 1 – 300 mg

• 2 – 250 mg

• 3 – 200 mg

• 4 – 150 mg

• 5 – 100 mg
11. What are the 4 steps of filled hard gelatin capsules?
• Step 1: Development of formulation
• Step 2: Selection of Capsule Size
• Step 3: Filling the Capsule Body
• Step 4: Sealing the Capsule
• Step 5: Cleaning and polishing of filled capsules

12. Name the goal product formulation for capsules?

• Accurate dosage
• Good bioavailability
• Ease of filling and production
• Stability
• Elegance

13. What particle size range are obtained through:

a) Milling: Particle size may be reduced by milling to produce particles ranging from
about 50 to 1,000 mm.
b) Micronization: Produces particles ranging from about 1 to 20 mm.
14. When are the following used for fill in hard gelatin capsules?
a) pellet mixture: The pellets aid in drug release to be more predictable and reliable,
offering a pathway towards more accurate and efficient medicine.
b) Paste: these are fixed or volatile oils, which may be placed in locking gelatin capsules
to ensure retention of the liquid. The liquid is then mixed with an inert powder to
make a wet mass or paste, wherein it is placed in a capsule.
c) Capsule: These are solid dosage form in which medicinal agents and excipients are
enclosed within a small outer shell.
 d) tablet
15. How will the retail pharmacist ensure that she has enough fill in materials for compounding
small number of capsules?
16. What is the “punch” method of fill in hard gelatin capsule?
17. What are the different ways of capsule sealing?
18. What are the soft gelatin capsules?
19. Differentiate hard gelatin from soft gelatin capsules
20. Give the 2 methods of preparing soft gelatin capsules?
21. Enumerate the different liquids which can be encapsulated?
22. Give the criteria for materials which can be added to active ingredients.
23. What kinds of container should be used for dispensing capsules?
24. Explain briefly the ff. tests for capsules?
a) disintegration test d) weight variation for hard and soft capsules
b) dissolution test e) moisture permeation test
c) content uniformity
25. What are the advantages of unit dose and strip packaging?
26. Name some of drug substances commercially prepared into soft gelatin capsules.
27. What are the appropriate methods in the inspection, counting, packaging & storage of
capsules?