Capsules

Question 1

What are capsules

Answer 1

Solid dosage forms composed of gelatin and designed to contain a drug containing formulation

Question 2

2 types of capsule

Answer 2

Hard - 2 pieces
Soft - one piece

Question 3

Advantages of capsules

Answer 3

Avoids manufacture operations for tablets such as granulation and drying

Can be for adults to increase oral bioavailability of poorly soluble therapeutic agents - liquid filled

Convents for liquids to be orally administered - actuate dosing

Question 4

Disadvantages of capsule

Answer 4

Specials manufacturing equipment

Potential stability problems of liquid fills

Problems with homogeneity of full weight

Question 5

Why hard

Answer 5

For a materials that cannot be as easily formulated as tablets due to:
- change polymorphic form on compression
- degrade on compression
- water sensitive and not easily dry granulated

Question 6

Capsule design

Answer 6

2 piece capsules

Shorter part is the cap and fit over the open end of the longer body

Have locking grooves and dimples to close

Question 7

Capsule sealing

Answer 7

HCG sealing for liquid or semi-solid filling

2 methods:
- gelatine ban sealing
- hydroalcoholic solvent seal

Question 8

Capsule size

Answer 8

8 sizes

000 (largest) - 5

Weigh capacity of each size varies according to combination of drugs and their densities

Question 9

Composition of HGC

Answer 9

Contains following:
- gelatine
- colourants
- wetting agents
- preservatives

Question 10

Gelatin

Answer 10

Natural
Prepare by hydrolysis of collagen

2 types:
A- derived from acid hydrolysis of collagen
B - derived from alkali hydrolysis of collagen

Question 11

Why gelatin

Answer 11

Used for >100yr

• Safety: it is nontoxic, widely used in foodstuffs and acceptable for use worldwide.
• Solubility: it is readily soluble in biological fluids at body temperature.
• Film forming properties: it is capable of producing strong flexible films
• Ease of processing

Question 12

Quality of gelatine

Answer 12

Grade is defined by bloom strength which is defined as weight g required to depress a plunger to a defined depth within an aged gelatine gel at 10 degrees

higher the bloom the more rigid

Hard capsule = bloom of 200-250
Soft capsule = boom of 150

Question 13

Colourants

Answer 13

Give distinct appearance

Can be water soluble dyes or water insoluble pigments

Question 14

Wetting agents

Answer 14

Ensure the luracted metal moulds are uniformly covered when dipped in gelatine solutions

Help water penetration to facilitate dissolution

Question 15

Preservatives

Answer 15

Added formally in process t prevent morbidly contamination

HGC contain a lot of moisture singly bonded to the gelatin

Question 16

HGC manufacturing dip coating

Answer 16

Involves metal moulds at room temperature being dipped into hot gelatine solution which gels to form a film. Its friend, cut and removed from mould and 2 part joined together

Question 17

Capsule shel thickness is controlled by….

Answer 17

Gelatin viscosity

Question 18

Types of material for filling

Answer 18

Dry solids - powders, granules

Semisolids

Liquids - non aqueous

Question 19

Excipients

Answer 19

• Diluents: increase the bulk of the working mass.
• Lubricants: reduces powder to metal adhesion.
• Glidants: improve powder flow.
• Wetting agents: improve water penetration.
• Disintegrants: produce disruption of powder mass.
• Stabilizers: improve product stability.

Question 20

Drugs that aren’t recomended to be formulated into HGC

Answer 20

Potent
Low therapeutic index

Question 21

Ideal properties of diluents

Answer 21

• Good flow: obtainable using free flowing diluents and glidants.
• No adhesion: obtainable using lubricants.
• Cohesion: important for plug formation, using compressible diluents.

Question 22

Powder filling of HGC

Answer 22

Same operation: open - fill - close

Question 23

Dependant and independant dosing

Answer 23

Dependent ; depends on the capsule’s body size, the dose is achieved by complete filling of capsule body.

Independent; controlled by the filling machine, fill is compressed into ‘plug’ at low compression forces

Question 24

Bench scale

Answer 24

Used in hospitals for small batched
The halves are separated and powder spread to fill the capsule body. Body is locked. Powder is placed onto surface of body plate and spread to fill bodies. Cap plate in positioned over body and cap uses are rejoined.

Question 25

Uniformity of weight is dependant on….

Answer 25

good flow properties of powder

Question 26

Types of industrial large scale manufacturing

Answer 26

Semi-auto

Machines with help of personnel. Dose achieved by complete fillin of capsule body

Auto

Uses a dosing disk and tamping finger to fill capsules. Finger compresses material in holes. Independant dosing

Question 27

Soft gel capsules

Answer 27

Variety of shapes but most common is oval

Can be coated enterically or with delayed-release material