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1. Capsules are solid dosage forms that come in a variety of sizes and are either hard or soft gelatin capsules. They can contain powders, liquids, or pre-formed tablets and are commonly used to deliver pharmaceutical drugs. 2. Capsules undergo various tests to ensure quality including disintegration testing, weight variation testing, dissolution testing, and content uniformity testing. They are produced using machinery that involves processes like dipping, spinning, drying, cutting, and joining. 3. Important considerations in capsule formulation include accurate dosage, ease of filling, stability, bioavailability, and efficient production. Excipients are added to capsules to aid properties like cohesion, dissolution, dis

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Kristin Charm Mascareñas
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16 views

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1. Capsules are solid dosage forms that come in a variety of sizes and are either hard or soft gelatin capsules. They can contain powders, liquids, or pre-formed tablets and are commonly used to deliver pharmaceutical drugs. 2. Capsules undergo various tests to ensure quality including disintegration testing, weight variation testing, dissolution testing, and content uniformity testing. They are produced using machinery that involves processes like dipping, spinning, drying, cutting, and joining. 3. Important considerations in capsule formulation include accurate dosage, ease of filling, stability, bioavailability, and efficient production. Excipients are added to capsules to aid properties like cohesion, dissolution, dis

Uploaded by

Kristin Charm Mascareñas
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PHA 619: Pharmaceutical dosage forms Capsule sizes

Size Grains Mg
Capsules

- solid dosage forms


000 15 1000
- Cylindrical; enclosed in a small shell of
gelatin
00 10 750
- Hard or soft gelatin; made from starch or
cellulose
0 7.5 500

Capsules that should be kept intact and 1 5 400


swallowed whole

- Enteric coated
2 4 300
- Controlled release

- Taste-modi ed
3 3 200
- Liquid content

4 2 130
Chewable tablet, oral liquid, or injection may 5 1 65
be employed as an alternative

Hard gelatin
Di erent test for capsule

- 13%-16% moisture
1. Disintegration test: demonstrate how
rapidly a capsule disintegrate into tiny
Soft gelatin
pieces

- 6%-10% moisture
2. Weight variation

3. Dissolution

Kinds of container used for dispensing 4. Moisture permeation test

capsules
5. Content uniformity

1. Tight container: protects from Hard gelatin Capsules

contamination
- commercial medicated capsules

2. Well-closed container: protects from - Extemporaneous compounding of


extraneous solids
prescriptions

3. Light resistant container: protects from - Gelatin, sugar, water

photochemical reaction, deterioration


- Stable in air when dry

- Body and shorter cap

USP standard: 290 450 nm acceptable light - vegetarian capsules

wavelength
- Dipping, spinning, drying, stripping,
cutting, joining

Heidelberg Capsule

- pH-sensitive non-digestible Punch Method

radiotelemetric device
- punched repeatedly into the powder cake

- Size no. 0 gelatin capsule

Potent drug

Capsule shell design


-weighed after lling

1. Pulvules: with peg Non-potent


2. Spansules: sharp tapered ends


- rst lled capsule shall be weighed

3. Coni-snap: snap- t

Sealing

- with colored band gelatin

- Heat welding process

- With wetted agent

- Lightly coating the inner surface

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Composition of Gelatin
Machinery involved in the production of
- collagen, connective tissue, bones of capsules

animals

Gamma Scintigraphy

Soft gelatin Capsules


- non-invasive procedure

- more moisture
- Determine correlation between vitro and in
- Glycerin, polyhydric alcohol/ sorbitol
vivo bioavailability

- Encapsulate liquids, suspensions, pasty - Integrity and transit of enteric-coated


materials, dr powders, pre-formed tablets
tablets

- Dosage form evaluation

Methods of preparing

1. Plate prosess: use of molds

2. Rotary and reciprocating die processes

Robert P. Scherer

- Rotary die process

- 1933

Desicant

- protect against absorption of atmospheric


moisture

Opaquant

- reduces transparency

Diluents

- cohesion to the powders

Surfactant

- in uence the bioavailability of a drug


substance

Colorant

- make capsules distinctive

Disintegrant

- assist break-up in stomach

Goal product formulation for capsules

1. Accurate dosage

2. Ease of lling

3. Stability

4. Bioavailability

5. Production

Milling

- 50 - 1000 mm

- For dosages of 10mg or greater

Micronization

- 1 - 20 mm

- Low dosages less than 10mg

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