Lecture 5: Capsules

Question 1

Capsules

Answer 1

-solid
-AI enclosed in small shell

Question 2

Hard-shelled capsules

Answer 2

-for dry, powder ingredients
-gelatin capsules
-polymer capsules

Question 3

soft-shelled capsules

Answer 3

-for liquids and AIs dissolved or suspended in liquid

Question 4

Gelatin capsules

Answer 4

-gelatin, sugar, water, color
-13-16% moisture
-packaging NEEDED to prevent issues with humidity

Question 5

gelatin capsules at high humidity

Answer 5

-absorb moisture
-distorted and lose shape

Question 6

gelatin capsules at low humidity

Answer 6

-lose moisture
-brittle and crumble

Question 7

Polymer capsules (HPMC)

Answer 7

-vegetable source
-moisture only 4-6%
-more resistant to change in humidity

Question 8

Prep of hard gelatin capsules

Answer 8

-prep formulation and select capsule size
-fill shells
-close and seal
-clean and polish
-manual or automatic

Question 9

soft capsules

Answer 9

-most made of gelatin
-may have preservative
-can be solution or suspension
-sealed

Question 10

water-immiscible volatile and nonvolatile liquids

Answer 10

-vegetable and aromatic oils
-hydrocarbons
-esters, ethers, organic acids

Question 11

water-miscible nonvolatile liquids

Answer 11

-polyethylene glycols
-nonionic surface-active agents (polysorbate 80)

Question 12

water-miscible Volatile liquids

Answer 12

-NOT suitable for soft gelatin capsules
-easily migrate through shell
-alcohols, ketones, acids, amines, esters

Question 13

Advantages of soft capsules

Answer 13

-drug can be liquid
-dose precision
-more homogeneity
-drug dissolved so it rapidly releases

Question 14

Disadvantages of soft capsules

Answer 14

-some drugs may migrate to shell
-some drugs can degrade in liquid state

Question 15

Capsule regulation

Answer 15

-added substances
-containers for dispensing
-disintegration test
-dissolution test
-weight variation (hard vs soft)
-content uniformity and labeling
-stability testing
-moisture permeation

Question 16

Regulations of added substances in capsules

Answer 16

-harmless in used quantities
-do not exceded minimum amounts required to provide unintended effect
-do not impair product’s bioavailability, theraputic efficacy, safety
-do not interfere with requisite assays and tests

Question 17

Containers for dispensing capsules

Answer 17

-tight
-well-closed
-light-resisitant

Question 18

Disintegration test for capsules

Answer 18

-basket rack assembly
-37degree water
-disintegrate completely into a soft mass with no firm core and only some fragments of the gelatin shell

Question 19

Dissolution test for capsules

Answer 19

-paddle method
-basket method

Question 20

content uniformity of capsules

Answer 20

-9/10 within 85-115%
-none outside of 70-125% label claim
-additional testing required if they are outside

Question 21

Content labeling requirement of capsules

Answer 21

-must be labeled to express quantity of each active ingredient in each dosage unit

Question 22

Stability testing of capsules

Answer 22

-intrinsic stability of drug
-environmental factors

Question 23

Moisture permation test of capsules

Answer 23

-package together with color-revealing desiccant pellet
-exposing the packaged unit to known relative humidity over specified time
-observe desiccant pellet for color change (moisture absorption)
-compare pretest and posttest weight