Laboratory Technology Pharmaceutical Report GROUP 4B: TABLET AND CAPSULES (Experiment 1)

INTRODUCTION OF QUALITY OF TABLETS AND CAPSULES

Tablets and capsules are common dosage form of drugs. As we know that in the production of tablets mostly, the tablets itself does not only contain the active ingredients of the drug but it also consists of adjuvants such as the binding agent, glidant, disintegrant, lubricants and etc. The purpose of adding the adjuvants is to ensure the stability, uniformity and the function of the drugs to a maximum level which then perhaps will produce the best quality of tablets. Same goes to capsules also as it just differ from tablets in terms of coating. There are two types of capsules that are hard capsules and soft capsules.

For hard capsules it consists of powdered while for soft capsules normally consists of liquid. The coated capsules itself is made up from gelatin normally. In British Pharmacopoeia and United State Pharmacopoeia had set such a standard on uniformity of diameter, uniformity of weight, content of active ingredient, uniformity of content, disintegration and dissolution. Moreover there are also have number of quality control procedures but there is no info about the non-pharmacopoeias (thickness, hardness and friability).

Thus, we had conducted some experiments to demonstrate the application of a number of selected physical dosage performance test on tablets and capsules sample.

Experiment 1 : Uniformity of diameter, thickness and hardness

Objective :

To test uniformity on diameter, thickness and hardness of the tablets with Tablet Testing Instrument.

Date : 12 December 2013

Introduction :

Among different choices of routes of administration, oral dosage forms like tablets and capsules are usually the most convenient choice as it’s the simplest and easiest way for any patient to take a medication. Tablets are made of a compressed powdered substance containing an active drug and excipients while capsules refer to small soluble container which is usually made of gelatin that encloses a dose of an oral medicine or vitamin. There are a number of quality control procedures which are non-pharmacopoeial standards carried out such as the uniformity of diameter, thickness and hardness to ensure the efficiency the delivery of drugs. Tablets are used in the following experiment. Uniformity of the diameter and hardness of tablet follows the pharmacopoeial standard and is used for uncoated and coated tablets whereas the thickness test is not found in pharmacopoeia. The uniformity of diameter test is not applicable to enteric-coated, film coated and sugar coated tablets. All these tests can be completed using the instrument PHARMATEST PTB 311.

Materials and Apparatus :

Paralgin tablets, PHARMATEST PTB 311(Tablet Testing Instrument)

Procedures :

1. 10 tablets were selected and tests for uniformity of diameter, thickness and

hardness were carried out using the Tablet Testing Instrument (PHARMATEST PTB 311).

2. The deviation of individual unit from the mean diameter should not exceed ±5% for tablets with diameter of less than 12.5 and ±3% for diameter of 12.5 mm or more.

Results and Calculations :

Tablet	Diameter (mm)	Thickness (mm)	Hardness (N)
1	13.12	5.38	140.58
2	13.12	5.41	153.37
3	13.11	5.45	154.44
4	13.12	5.44	148.57
5	13.11	5.45	165.63
6	13.15	5.46	150.53
7	13.12	5.39	158.70
8	13.12	5.45	143.24
9	13.13	5.47	167.77
10	13.11	5.43	158.67
Mean	131.21/10= 13.12	54.33/10 = 5.43	1541.51/10= 154.15

Percentage of deviation from mean diameter (%) =

Mean of diameter for the tablets– Diameter of each tablet

Mean diameter for the tablets

Percentage average of deviation for diameter of each unit:-

Tablet 1 :0%

Tablet 2 :0%

Tablet 3: 0.08%

Tablet 4: 0%

Tablet 5: 0.08%

Tablet 6: 0.23%

Tablet 7: 0%

Tablet 8: 0%

Tablet 9: 0.08%

Tablet 10: 0.08%

Discussion :

Based on the data obtained, the mean diameter of all the tablets is 13.12mm and all these tablets with diameter of more than 12.5mm does not exceed ±3% for the deviation of each unit from their mean diameter. The uniformity of diameter of tablet is included in pharmacopoeial standard. According to the pharmacopoeial standard, the deviation of each tablet from the mean diameter should not exceed ±5% for tablets with diameter of less than 12.5mm and ±3% for diameter of 12.5 mm or more which means all the tablets tested in the experiment are qualified as their diameter is within the standard range. The slight deviations of diameter of the tablets might be caused by the uneven feeding of granules into die or may be due to the irregular movement of lower punch as the die and punches determine the diameter and shape of tablet.

For the test of uniformity of thickness and hardness, both of these test are not under pharmacopoeial standard previously. However, uniformity of hardness test has been newly added to pharmacopoeial standard. These are parts of a manufacturer’s own product specification. Any variation in thickness within a particular lot of tablets or between manufacturer’s lots should not be clear to the naked eye for consumer acceptance and it should be controlled to facilitate the progress of packaging. The thickness may vary with no change in weight due to difference in the granulation and pressure applied to the tablets, wear and tear on length of punches as well as on the speed of tablet compression.

The hardness test on tablets should be conducted to determine the rate and extent to which active ingredient is absorbed and becomes available at the site of action and to ensure the tablets possess sufficient mechanical strength and resistant force to withstand mechanical shock during handling in production, packaging, distribution and storage. This is because hardness of tablet also can affect its disintegration. If the tablet is too hard, it may not disintegrate in the required period of time. If the tablet is too soft, it could not withstand the handling during subsequent processing such as coating and packaging.

If the tablets batch do not obey these test in real manufacturing process, the manufacturer will remanufacture the tablets by modifying the ingredients used whether in amount of ingredients or change the types of ingredients. This is to ensure only drugs with good properties and good quality control will be supplied to patients.

Conclusion :

The tablets tested have uniform diameter, thickness and hardness and they are under the range of standard properties required.

References :

Kibbe, A.H., ed. Handbook of Pharmaceutical Excipients. 3rd Edition ed. 2000, American Pharmaceutical Association & Pharmaceutical Press, Washington, DC & London, UK.
http://www.pharmainfo.net/tablet-evaluation-tests/content-uniformity
http://www.scribd.com/doc/59995285/11-Evaluation-of-Tablets