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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).

Limits according to U. determine the weight of each tablet alone.S. X .Weigh 20 capsules individually (i.e.5+- >324 10+- Limit: >>Not more than two of the tablets differ from the average weight by more than the % error listed. X . Weight of net wieght of capsule – Average weight of net weight of capsule × 100 Average weight of net weight of capsule . and no tablet differs by more than double that percentage. To test the uniformity of weight of capsules .Calculate the average weight of capsules.5 ± 15 ±5 ± 10 Minimum 18 Maximum 2 Minimum 18 Maximum 2 Minimum 18 Maximum 2 300mg <134 5+- 134-324 7. X … X ) 1 2 3 20 .Practical Pharmaceutics-III (Tablets) Dr. 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 : . Sultan Alkaleh Uniformity of Weight of Capsules Purposes: . Calculation : Average net weight of capsule = Total net weight of 20 tablets 20 The percentage of deviation is calculated using the formula as below.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.

the percentage deviation from the average weight does not exceed the limitation. Sultan Alkaleh Average net weight of capsule = Total net weight of 20 tablets = 296.3 mg 20 Results : Discussion For the capsules. . it is under the category of „300mg and above‟ category. Therefore.Practical Pharmaceutics-III (Tablets) Dr. which obey the standard properties required. all the 20 capsules have uniform weight. all of the 20 capsules pass the test. So. all 20 capsules have average net weight of 296. so. which did not exceed the limitation.5%. Conclusion From this experiment.3 mg. All the capsules have the percentage of deviation within the + 7.

Practical Pharmaceutics-III (Tablets) Dr. it consists of fragments of shell or.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. remove the assembly from the liquid.  If the disc is used. the discs may be added. any residue remaining on its lower surface should only consist of fragments of shell .  Operate the apparatus for 30 minutes.  Is a soft mass with no palpable core.  If a residue remains.  If hard capsules float on the surface of the water. Sultan Alkaleh Capsules Disintegration B. >The capsules pass the test if  No residue remains on the screen of the apparatus or.