Capsules

Question 1

Solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small shell of gelatin.

Answer 1

Capsule

Question 2

Advantages of Using Capsule

Answer 2

✓ Conveniently carried as compared with liquid medications. With capsules, there is no need for spoons or other measuring devices which may be inconvenient and may result in less than accurate dosing
✓ Readily identified
✓ Easily taken
✓ Tasteless when swallowed.

Question 3

Two kinds of capsule shells

Answer 3

Hard Gelatin capsules
Soft Gelatin capsules

Question 4

Used in most commercial medicated capsules

Answer 4

Hard gelatin capsules

Question 5

Commonly employed in clinical drug trials to compare the effects of an investigational drug with those of another drug product or placebo.

Answer 5

Hard gelatin capsules

Question 6

Hard gelatin capsules is consist of 2 sections

Answer 6

Capsule body & shorter cap

Question 7

Characteristics of Hard gelatin capsule

Answer 7

Clear, colorless and essentially tasteless

Question 8

HGC may be colored with various FD & C and D&C dyes and made opaque by adding agents such as

Answer 8

Titanium dioxide

Question 9

Empty capsule shells are made of:

Answer 9

Water
Sugar
Gelatin

Question 10

Gelatin is obtained by

Answer 10

Partial hydrolysis of collagen obtained from the skin, white connective tissue and bones of animals.

Question 11

Stable in air when dry but is subject to microbial decomposition when it becomes moist

Answer 11

Gelatin

Question 12

Normally, hard gelatin capsules contains:

Answer 12

13% to 16% moisture

Question 13

If stored in an environment of high humidity, additional moisture is absorbed by the capsules and they may be

Answer 13

distorted and lose rigid shape

Question 14

In an environment of extreme dryness, some moisture normally present in the gelatin capsule is lost, and the capsules may become

Answer 14

Brittle and crumble when handled.

Question 15

What are the desiccant materials often used?

Answer 15

Silica gel

Activated charcoal, Clay

Question 16

Is gelatin capsule soluble in cold water and warm water?

Answer 16

In cold only soften while in hot water is rapidly dissolve

Question 17

Made of gelatin which glycerin or a polyhydric alcohol such as sorbitol has been added.

Answer 17

Soft gelatin capsule

Question 18

Contain more moisture than hard capsule

Answer 18

Soft gelatin capsule

Question 19

Soft gelatin capsule, May contain preservatives such as

Answer 19

Methylparaben and Propylparaben

Question 20

Use of soft gelatin capsule

Answer 20

Used to encapsulate and hermetically seal liquids, suspensions, pasty materials,
dry powders and even deformed tablets

Question 21

Characteristics of soft gelatin capsules

Answer 21

Oblong, oval or round

Question 22

Advantages of Soft gelatin capsules are

Answer 22

Pharmaceutically elegant and are easily swallowed

Question 23

Uses of soft gelatin capsules

Answer 23

For water-immiscible volatile and non-volatile liquids

Water-miscible non-volatile liquids

Water-miscible and relatively non-volatile compounds

Question 24

Example of water-immiscible volatile and non-volatile liquids

Answer 24

vegetable oils
aromatic oils
aromatic hydrocarbons
aliphatic hydrocarbons
chlorinated hydrocarbons
ethers
esters
alcohols
organic acids

Question 25

Example of Water-miscible non-volatile liquids

Answer 25

polyethylene glycol and non-ionic surface-active Polysorbate 80

Question 26

Example of Water-miscible and relatively non-volatile compounds

Answer 26

propylene glycol isopropyl alcohol

Question 27

Substances added to official preparations, including capsules, to enhance their stability, usefulness, or elegance or to facilitate their manufacture may be used only if they:

Answer 27

1. harmless 2. Do not exceed the minimum amounts required to provide their intended effect; 3. Do not impair the product’s bioavailability, therapeutic efficacy, or safety; 4. Do not interfere with requisite compendia assays and tests.

Question 28

Requirements of containers for Dispensing capsules

Answer 28

tight, well closed, light resistant, and/or all of these.

Question 29

Test for hard and soft gelatin capsules follows the same procedure and uses the same apparatus with uncoated tablets

Answer 29

Disintegration Test for Capsules

Question 30

Test for capsules uses the same apparatus, dissolution medium, and test as that for uncoated and plain-coated tablets.

Answer 30

Dissolution Test for Capsules

Question 31

Ten capsules are individually weighed and their contents removed. The emptied shells are individually weighed and the net weight of the contents is calculated by subtraction.

Answer 31

Weight Variation of Hard Capsule

Question 32

The gross weight of 10 intact capsules is determined individually. Then each capsule is cut open and the contents are removed by washing with a suitable solvent.

Answer 32

Weight Variation of Soft Capsule

Question 33

Amount of active ingredient, determined by assay

Answer 33

within the range of 85% to 115% of the label claim for 9 of 10 dosage units assayed, with no unit outside the range of 70% to 125% of the label claim.

Question 34

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

Answer 34

Content labeling requirements

Question 35

Test for capsules to determine the intrinsic stability of the active drug molecule and the influence of environmental factors.

Answer 35

Stability Testing

Question 36

Factors Affecting Drug Stability Testing

Answer 36

Temperature Humidity Light

Question 37

The USP requires this test for the single-unit and unit-dose containers to ensure their suitability for packaging capsules.

Answer 37

Moisture Permeation Test

Question 38

Examples of some official capsules

Answer 38

Acyclovir Amoxicillin Ampicillin Cephalexin Diphenhydramine HCl Oxazepam Paromomycin Tetracycline HCl Vancomycin HCl Zidovudine

Question 39

Capsule size chart

Answer 39

Smallest to largest 5-4-3-2-1-0-00-000

Question 40

The biggest capsule size 000 is for?

Answer 40

Veterinary use

Question 41

Medications commercially prepared into soft gelatin capsules

Answer 41

Acetazolamide Chloral hydrate Cyclosporine Cyclosporine Docusate sodium Ethosuximide Ranitidine HCl