Capsules Flashcards
Definition of capsules?
Medicinal agents enclosed in a gelatin shell (hard or soft)
What is the composition of a capsule shell?
- Gelatin polymer (from animal collagen)
for vegetarians: Cellulose polymer (HPMC, starch) - Sugar
- Water
What are the two types of Gelatin?
One important property in regard to dissolution?
Gelatin is derived from pork skin and bones
Type A: acid treatment of pork skin
Type B: alkali treatment of bones
-the Gelatin solubilizes in hot water and gastric fluid
Which substances are also added to the Gelatin?
-SLS: a crosslinker for mechanical strength
-color
-antimicrobials as a preservative
-sulfur dioxide (0.15%) as a bleaching agent to remove color when Gelatin is derived from collagen
-titanium dioxide is an opacifier
What is the percent of moisture that comes from the water in hard and soft gelatin capsules?
Hard gelatin capsules: 13-16%
Soft gelatin capsules: 6-8%
What are the properties of hard capsules regarding hygroscopy and storage?
-it does not protect hygroscopic material because it contains moisture itself
-gelatin capsules are stable in air -> should be stored in conditions not too dry or too moist
-> too dry: fragile and break
-> too moisture: microbial decomposition and becomes soft
What are ways to ensure tamper-evident sealing?
Especially for OTC drugs!
-Colored gelatin band seal
-Heat welding process -> fuses cap and body -> thickness at juncture
-Liquid wetting agents at the contact area of the body and cap to thermally bond them
-Lightly coating of the inner cap with warm gelatin making it stick
What is the CONI-SNAP Desgin?
- Open position 2. Prelocked position 3. Locked position
locked rings come together with tapered rims for proper locking
Possible fillings of capsules and what is their purpose?
Another capsule, powder, pellet, tablet,
for liquids: mostly oils, not aqueous liquids
-if two tablets are not compatible to compound in one
-the pace of drug delivery
-for pellets: some can be coated, slowing down the release
What are the capsule sizes?
000 (largest) - 5 (smallest) , 8 sizes
What are the properties of soft Gelatin capsules?
-Elasticity due to glycerin and sorbitol
-6.8% moisture
-often supplements like Vitamin D
-gelatin is thicker compared to hard shell -> more viscosity
-used encapsulated, in suspensions, liquids, and pastes
-has preservatives and colors
CANNOT BE COMPOUNDED
What are the requirements (tests) that capsules need to undergo according to USP?
-Disintegration and Dissolution Test
-Weight Variation and Content Uniformity
-Content Labeling and Packing
-Stability Test and Moisture Permeation Test
Added Substances (Excipients)
What is GRAS quality?
Generally regarded and Safe for the added substances
-> they should be in harmless quantity (don’t use high volume if not needed), not impair bioavailability and therapeutic effect
What is the disintegration test?
Refers to the time needed for the disintegration of the shell and release the content -> should be less than 15-30 min for IR
What is the dissolution test?
-Assesses the drug release
Capsule put in the beaker and will be stirred and you will take samples to see how much drug has dissolved over time
