Practical Pharmaceutics-III (Tablets)

Dr. Sultan Alkaleh

Quality control of Capsules

Introduction
Define :
Capsules are gelatin shells filled with the ingredients that make up an individual dose.

Advantages as pharmaceutical dosage forms:

1. They may be used to mask the unpleasant tastes, aromas, or appearance of a drug.
2. They allow powders to be dispensed in an uncompressed form, thus allowing for
quicker dissolution and absorption of the drug following oral dosing (as compared with
tablets).
3. They offer the pharmacist versatility to prepare any dose desired for a variety of
administration routes (e.g. oral, inhalation, rectal, or to be diluted for vaginal, rectal, oral
or topical use).
4. They may be easier than tablets for some people to swallow.
5. They can be make to alter the release rate of the drug.

Disadvantages or limitations include the following:

They are easily tampered with (although techniques exist for preventing this).
They are subject to the effects of relative humidity and to microbial contamination.
They may be difficult for some people to swallow.
More expensive (commercially).

Practical Pharmaceutics-III (Tablets)

Dr. Sultan Alkaleh

Uniformity of Weight of Capsules

Purposes:
. To test the uniformity of weight of capsules
. To ensure the consistency of dosage unit
The term uniformity of dosage unit is defined as the degree of uniformity in the amount of
the drug substance among dosage units.

Procedures :
- Weigh 20 capsules individually (i.e. determine the weight of each tablet alone; X , X , X X )
1

20

- Calculate the average weight of capsules.

Limits according to U.S.P

Average weight of tablet
Less than 80 mg
80 mg to 250 mg
More than 250 mg

Deviation (%)

Number of tablets

10
20
7.5
15
5
10

Minimum 18
Maximum 2
Minimum 18
Maximum 2
Minimum 18
Maximum 2

300mg
<134

5+-

134-324

7.5+-

>324

10+-

Limit:
>>Not more than two of the tablets differ from the average weight by more than the % error listed, and no tablet
differs by more than double that percentage.

Calculation :
Average net weight of capsule = Total net weight of 20 tablets
20

The percentage of deviation is calculated using the formula as below.

Weight of net wieght of capsule Average weight of net weight of capsule
100
Average weight of net weight of capsule

Practical Pharmaceutics-III (Tablets)

Dr. Sultan Alkaleh

Average net weight of capsule = Total net weight of 20 tablets = 296.3 mg

20

Results :

Discussion
For the capsules, all 20 capsules have average net weight of 296.3 mg. Therefore, it is under the category
of 300mg and above category. All the capsules have the percentage of deviation within the + 7.5%, which did
not exceed the limitation, so, all of the 20 capsules pass the test.

Conclusion
From this experiment, the percentage deviation from the average weight does not exceed the
limitation. So, all the 20 capsules have uniform weight, which obey the standard properties required.

Practical Pharmaceutics-III (Tablets)

Dr. Sultan Alkaleh

Capsules Disintegration B.P

Objective:
To determine the time required for the capsule to break.

Procedures
Introduce one capsule into each tube and suspend the apparatus in a beaker containing 600 ml
water at 37oC.
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

No residue remains on the screen of the apparatus or,
If a residue remains, it consists of fragments of shell or,
Is a soft mass with no palpable core.
If the disc is used, any residue remaining on its lower surface should only consist of fragments
of shell