EXAM 3 L5

Question 1

T/F: Capsules are solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small shell

Answer 1

True

Question 2

Two types of capsules:

Answer 2

-Hard-Shelled - caps are normally used for dry, powder ingredients
-Soft shelled - caps used for liquid and for active ingredients that are dissolved or suspended in liquid (e.g. oil)

Question 3

Hard caps types

Answer 3

-Gelatin caps
-Polymer capsules (Hydroxypropyl methylcellulose, or HPMC)

Question 4

Gelatin Capsules:

Answer 4

-Compositions: gelatin (collagen from animals), sugar, water, coloring agents
-Contains 13-16% of moisture
-At high humidity, absorbs moisture and becomes distorted and loses rigid shape
-In low humidity, it loses moisture and becomes brittle and crumble
-Packing is necessary to prevent quality issues caused by low and high humidity

Question 5

Polymer Capsules (HMPC):

Answer 5

-Vegetable source (vegetarian caps)
-Less moisture content, only 4-6%
-More resistant to dry or humid environment

Question 6

Preparation of filled hard gelatin caps:

Answer 6

-Developing and preparing the formulation and selecting the capsule size
-Filling the capsule shells
-Capsule closing and sealing
-Cleaning and polishing the filled capsules

Question 7

Soft capsules properties:

Answer 7

-Majority made of gelatin
-May have preservative
-Can be solution or suspensions
-A sealed capsule

Question 8

Soft capsules, water-immiscible volatile and nonvolatile liquids

Answer 8

-Vegetable and aromatic oils,
-Aromatic and aliphatic hydrocarbons
-Chlorinated hydrocarbons
-Ethers
-Esters
-Organic Acids

Question 9

Soft Caps, Water-Miscible Nonvolatile liquids:

Answer 9

-Polyethylene glycols
-Nonionic surface active agents (ex. polysorbate 80)

Question 10

Soft caps properties cont.

Answer 10

-Liquids that can easily migrate through the cap shell are NOT SUITABLE for soft gel caps
-These materials include water-miscible volatile compounds like: alcohols, ketones, acids, amines, and esters

Question 11

Advantages of soft capsules:

Answer 11

-Drug can be a liquid form
-The liquid fill is metered into individual caps thus a high degree of precision in dose is achieved
-A higher degree of homogeneity is possible
-Because the drug is dissolved it is rapidly released

Question 12

Disadvantages of soft capsules:

Answer 12

-Some drugs may migrate to the shell
-Some drugs can degrade in the liquid state

Question 13

Compendial Requirements for Caps: Added Substances

Answer 13

-Are harmless
-Do not exceed the minimum amounts required to provide their intended effect
-Do not impair the product’s bioavailability, therapeutic efficacy, or safety
-Do not interfere with requisite compendial assays and tests

Question 14

Compendial Requirements for Caps

Answer 14

-Containers for dispensing caps
-Disintegration test for caps
-Dissolution test for caps
-Weight variation
-Content uniformity
-Content labeling requirement
-Stability Testing
-Moisture permeation test

Question 15

Containers for dispensing capsules

Answer 15

-Tight
-Well-closed
-Light-resistant

Question 16

Disintegration test for capsules

Answer 16

-Basket rack assembly
-37 degrees C water or suitable fluid
-Disintegrate completely into a soft mass with no firm core and only some fragments of the gelatin shell

Question 17

Dissolution test for caps

Answer 17

-Paddle Method
-Basket method

Question 18

Weight variation

Answer 18

-Hard capsules
-Soft capsules

Question 19

Content Uniformity

Answer 19

-9 out of 10 within 85%-115%
-None outside of 70%-125% of label claim
-Additional testing required if they are outside

Question 20

Content labeling requirement

Answer 20

All official capsules must be labeled to express the quantity of each active ingredient in each dosage unit

Question 21

Stability Testing:

Answer 21

-Intrinsic stability of the active drug molecule
-Environmental factors: temperature, humidity, light, formulative components and container and closure system

Question 22

Moisture Permeation Test:

Answer 22

-Package the dosage unit together with a color-revealing desiccant pellet
-Exposing the packaged unit to known relative humidity over a specified time
-Observe the desiccant pellet for color change (indicating the absorption of moisture), and compare the pretest and posttest weight of the packaged unit