Oral Dosage Forms Capsules

Question 1

Define capsules

Answer 1

Latin: Capsula (small box)
-Solid preparations for oral administration with hard (two-piece) or soft shell (one-piece)

Question 2

Hard capsules description

Answer 2

-most manufactured
-2 sections: body and cap
-Powders and Granules can be filled in the body
-Advantages: elegant, portable, easy to swallow

Question 3

Formulation of hard shell capsules

Answer 3

1. Diluents or fillers (to fill capsule space)
2. Lubricants (reduce powder to metal adhesion)
3. Glidants (improve powder flow)
4. Wetting agents (improvewater penetration)
5. Disintegrants (disruption of powder mass)
6. Stabilizers (improve product stability)

Question 4

Extemporaneous compounding for hard shell capsules

Answer 4

Recommend a minimum weight for filling a capsule is 100mg
-if less, a diluent should be added by trituration
-commonly used diluents: lactose, magnesium carbonate, starch, kaolin
-always calculate extra 2 capsules in order to allow small loss

Question 5

Soft shell capsule definition

Answer 5

-consist liquid or semi-solid matrix inside one-piece outer gelatin shell
-drug compound in solution or suspension
-fill-in hydrophilic or lipophilic or both
-Capsule shell consists gelatin, water, elasticized
-Types:
1. Orally administered (release contents in stomach)
2. Chewable (drug present in shell)
3. Twist-off (designed with a tag to be twisted off)

-Advantages: improve drug absorption, improve patient compliance, uniform dose)

Question 6

Formulation of soft shell capsules

Answer 6

1. Gelatin (shell)
2. Placticizers (to make softgel elastic)
3. Water (ensure proper processing during gel preparation and encapsulation)
4. Colourants (synthetic or natural for product identification)
5. Opacifiers (produce an opaque shell to protect light-sensitive drugs from photodegradation

Question 7

Evaluation test for soft shell capsules

Answer 7

In-process testing
-gel ribbon thickness
-soft gel seal thickness
-fill matrix weight and capsule shell weight
-soft gel shell moisture level and soft gel hardness at the end of drying stage

Question 8

Storage of capsules

Answer 8

-store in a cool and dry place
-softgel products stored in 20-24°C
-extemporaneous preparation expiry date 1 month

Question 9

Containers

Answer 9

-similar to tablets
-susceptible to moisture: include dessicants

Question 10

Special labels

Answer 10

-swallow with a glass of water
-before or after food

Question 11

Important criteria of capsule fills

Answer 11

-release active content in a form that is available for absorption
-capable being filled uniformly
-comply with requirements of pharmacists and drug regulation

Question 12

Evaluation test for both capsules

Answer 12

Finished product testing
-capsule appearance
-active ingredient assay and related Substances
-fill weight
-content uniformity
-microbiological testing

Question 13

Quality control test

Answer 13

1. Standard for content of active ingredients (determined amount of active ingredient by the method in the assay)
2. Disintegration (determines if tablets or capsules disintegrate within the prescribed time when placed in a liquid medium under prescribed experimental conditions)
3. Uniformity of weight

Question 14

Methods of disintegration test

Answer 14

1. Introduce one capsule to each tube and syspend apparatus in a beaker containing 600ml water at 37°C
2. If hard capsules appears on the surface, discs may be added
3. Operate apparatus for 30mins, remove assembly from the liquid

Question 15

Uniformity of weight method

Answer 15

1. Weigh an intact capsule
2. Open capsule without losing any part of the shell, remove contents
3. Weigh and shell
4. Weight of the contents is the difference between weighing
5. Repeat procedure with further 19 capsules selected at random
6. Determine average weight