Pharma gyan Pandit

Quality Control of Capsules

Capsule is a shell or a container prepared from gelatin containing one or more medicinal and/or inert substances. The gelatin capsule shell may be soft or hard depending on their formulation. Capsules are intended to be swallowed whole by the patient.

Capsules are preparations with hard or soft shells, of various shapes and capacities, usually containing a single dose of medicament. Types of capsules: hard, soft, enteric, and modified-release capsules.

Quality Control Tests for Capsules:

I.      Standard for content of active ingredients in capsules:

This test determines the amount of active ingredient by the method in the assay. 

II.      Disintegration:

Disintegration is the state in which no residue except fragments of capsule shell, remains on the screen of the test apparatus or adheres to the lower surface of the disc.  The disintegration test determines wither tablets or capsules disintegrate within a prescribed time when placed in a liquid medium under the prescribed experimental conditions. 

Method:

According to the B.P. and applies to hard and soft capsules.

Introduce one capsule into each tube and suspend the apparatus in a beaker containing 600 ml water at 37^oC. If hard capsules float on the surface of the water, the discs may be added. Operate the apparatus for 30 minutes; remove the assembly from the liquid. The capsules pass the test if

1.      No residue remains on the screen of the apparatus 

2.  If a residue remains, it consists of fragments of shell is a soft mass with no palpable core

4.      If the disc is used, any residue remaining on its lower surface should only consist of fragments of shell.

III.      Uniformity of Weight:

This test applies to all types of capsules and it is to be done on 20 capsules.

Method:

Weigh an intact capsule. Open the capsule without losing any part of the shell and remove the contents as completely as possible. Weigh the shell. The weight of the contents is the difference between the weighing. Repeat the procedure with a further 19 capsules selected at random. Determine the average weight.

Limit:

Not more than two of the individual weights deviate from the average weight by more than the percentage deviation shown in the table below, and none deviates by more than twice that percentage.

Average Wt of Capsule Content	Percentage Deviation
Less than 300 mg	10
300 mg or more	7.5

Observation Table:

Capsule Number	Wt. of intact capsules (A)	Wt. of empty shell (B)	Wt of contents = A - B
up to 20
Total wt			X

Average weight = X / 20

Upper limit = average weight + (Average weight * % error)

Lower limit = average weight - (Average weight * % error)