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DDS LEC > Capsules > Flashcards

Capsules Flashcards

1
Q

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

A

Capsule

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2
Q

Advantages of Using Capsule

A

✓ 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.

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3
Q

Two kinds of capsule shells

A

Hard Gelatin capsules
Soft Gelatin capsules

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4
Q

Used in most commercial medicated capsules

A

Hard gelatin capsules

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5
Q

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

A

Hard gelatin capsules

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6
Q

Hard gelatin capsules is consist of 2 sections

A

Capsule body & shorter cap

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7
Q

Characteristics of Hard gelatin capsule

A

Clear, colorless and essentially tasteless

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8
Q

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

A

Titanium dioxide

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9
Q

Empty capsule shells are made of:

A

Water
Sugar
Gelatin

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10
Q

Gelatin is obtained by

A

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

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11
Q

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

A

Gelatin

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12
Q

Normally, hard gelatin capsules contains:

A

13% to 16% moisture

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13
Q

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

A

distorted and lose rigid shape

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14
Q

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

A

Brittle and crumble when handled.

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15
Q

What are the desiccant materials often used?

A

Silica gel

Activated charcoal, Clay

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16
Q

Is gelatin capsule soluble in cold water and warm water?

A

In cold only soften while in hot water is rapidly dissolve

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17
Q

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

A

Soft gelatin capsule

18
Q

Contain more moisture than hard capsule

A

Soft gelatin capsule

19
Q

Soft gelatin capsule, May contain preservatives such as

A

Methylparaben and Propylparaben

20
Q

Use of soft gelatin capsule

A

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

21
Q

Characteristics of soft gelatin capsules

A

Oblong, oval or round

22
Q

Advantages of Soft gelatin capsules are

A

Pharmaceutically elegant and are easily swallowed

23
Q

Uses of soft gelatin capsules

A

For water-immiscible volatile and non-volatile liquids

Water-miscible non-volatile liquids

Water-miscible and relatively non-volatile compounds

24
Q

Example of water-immiscible volatile and non-volatile liquids

A

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

25
Q

Example of Water-miscible non-volatile liquids

A

polyethylene glycol and non-ionic surface-active

Polysorbate 80

26
Q

Example of Water-miscible and relatively non-volatile compounds

A

propylene glycol
isopropyl alcohol

27
Q

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:

A
  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.
28
Q

Requirements of containers for Dispensing capsules

A

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

29
Q

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

A

Disintegration Test for Capsules

30
Q

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

A

Dissolution Test for Capsules

31
Q

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.

A

Weight Variation of Hard Capsule

32
Q

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.

A

Weight Variation of Soft Capsule

33
Q

Amount of active ingredient, determined by assay

A

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.

34
Q

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

A

Content labeling requirements

35
Q

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

A

Stability Testing

36
Q

Factors Affecting Drug Stability Testing

A

Temperature
Humidity
Light

37
Q

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

A

Moisture Permeation Test

38
Q

Examples of some official capsules

A

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

39
Q

Capsule size chart

A

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

40
Q

The biggest capsule size 000 is for?

A

Veterinary use

41
Q

Medications commercially prepared into soft gelatin capsules

A

Acetazolamide
Chloral hydrate Cyclosporine
Cyclosporine
Docusate sodium Ethosuximide
Ranitidine HCl

DDS LEC (6 decks)

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