Capsules Flashcards
Solid dosage forms in which medicinal agents and/or inert substances are enclosed in a small shell of gelatin.
Capsule
Advantages of Using Capsule
✓ 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.
Two kinds of capsule shells
Hard Gelatin capsules
Soft Gelatin capsules
Used in most commercial medicated capsules
Hard gelatin capsules
Commonly employed in clinical drug trials to compare the effects of an investigational drug with those of another drug product or placebo.
Hard gelatin capsules
Hard gelatin capsules is consist of 2 sections
Capsule body & shorter cap
Characteristics of Hard gelatin capsule
Clear, colorless and essentially tasteless
HGC may be colored with various FD & C and D&C dyes and made opaque by adding agents such as
Titanium dioxide
Empty capsule shells are made of:
Water
Sugar
Gelatin
Gelatin is obtained by
Partial hydrolysis of collagen obtained from the skin, white connective tissue and bones of animals.
Stable in air when dry but is subject to microbial decomposition when it becomes moist
Gelatin
Normally, hard gelatin capsules contains:
13% to 16% moisture
If stored in an environment of high humidity, additional moisture is absorbed by the capsules and they may be
distorted and lose rigid shape
In an environment of extreme dryness, some moisture normally present in the gelatin capsule is lost, and the capsules may become
Brittle and crumble when handled.
What are the desiccant materials often used?
Silica gel
Activated charcoal, Clay
Is gelatin capsule soluble in cold water and warm water?
In cold only soften while in hot water is rapidly dissolve
Made of gelatin which glycerin or a polyhydric alcohol such as sorbitol has been added.
Soft gelatin capsule
Contain more moisture than hard capsule
Soft gelatin capsule
Soft gelatin capsule, May contain preservatives such as
Methylparaben and Propylparaben
Use of soft gelatin capsule
Used to encapsulate and hermetically seal liquids, suspensions, pasty materials,
dry powders and even deformed tablets
Characteristics of soft gelatin capsules
Oblong, oval or round
Advantages of Soft gelatin capsules are
Pharmaceutically elegant and are easily swallowed
Uses of soft gelatin capsules
For water-immiscible volatile and non-volatile liquids
Water-miscible non-volatile liquids
Water-miscible and relatively non-volatile compounds
Example of water-immiscible volatile and non-volatile liquids
vegetable oils
aromatic oils
aromatic hydrocarbons
aliphatic hydrocarbons
chlorinated hydrocarbons
ethers
esters
alcohols
organic acids
Example of Water-miscible non-volatile liquids
polyethylene glycol and non-ionic surface-active
Polysorbate 80
Example of Water-miscible and relatively non-volatile compounds
propylene glycol
isopropyl alcohol
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:
- 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 compendia assays and tests.
Requirements of containers for Dispensing capsules
tight, well closed, light resistant, and/or all of these.
Test for hard and soft gelatin capsules follows the same procedure and
uses the same apparatus with uncoated tablets
Disintegration Test for Capsules
Test for capsules uses the same apparatus, dissolution medium, and test
as that for uncoated and plain-coated tablets.
Dissolution Test for Capsules
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.
Weight Variation of Hard Capsule
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.
Weight Variation of Soft Capsule
Amount of active ingredient, determined by assay
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.
All official capsules must be labeled to express the quantity of each active ingredient in each dosage unit.
Content labeling requirements
Test for capsules to determine the intrinsic stability of the active drug molecule and the influence of environmental factors.
Stability Testing
Factors Affecting Drug Stability Testing
Temperature
Humidity
Light
The USP requires this test for the single-unit and unit-dose containers to ensure their suitability for packaging capsules.
Moisture Permeation Test
Examples of some official capsules
Acyclovir
Amoxicillin
Ampicillin
Cephalexin
Diphenhydramine HCl
Oxazepam
Paromomycin
Tetracycline HCl Vancomycin HCl Zidovudine
Capsule size chart
Smallest to largest
5-4-3-2-1-0-00-000
The biggest capsule size 000 is for?
Veterinary use
Medications commercially prepared into soft gelatin capsules
Acetazolamide
Chloral hydrate Cyclosporine
Cyclosporine
Docusate sodium Ethosuximide
Ranitidine HCl
