TITLE OF EXPERIMENT
Uniformity of diameter, thickness and hardness
DATE OF EXPERIMENT
12th December 2013
OBJECTIVE
- To study the uniformity of diameter, thickness and hardness of tablets especially in pharmaceutical preparation.
INTRODUCTION
Tablets are solid dosage forms usually obtained by single or multiple compressions of powders or granules. Tablets contain one or more active ingredients. They may contain excipients such as diluents, binders, disintegrating agents, glidants, lubricants, and so on. When such excipients are used it is necessary to ensure that they do not adversely affect the stability, dissolution rate, bioavailability, safety or efficacy of the active ingredient(s), there must be no incompatibility between any of the components of the dosage form.
Oral dosage forms such as tablets and capsules have to follow the pharmacopoeial standard. The standards that are found in the British Pharmacopoeia and United Pharmacopoeia including the uniformity of diameter, uniformity of weight, content of active ingredient, uniformity of content, disintegration, hardness, friability and dissolution. The uniformity of diameter and weight may increase the patient compliance due to their uniform size of appearance. The uniformity of active ingredient and content will make sure the dosage supplied to the patients is correct and preventing from overdose cases and so on. Uniformity in disintegration and dissolution will make sure that each tablet and capsule will have similar reaction when metabolized in the body. There are also non-pharmacopoeial standards that are not included in the British Pharmacopoeia and United Pharmacopoeia, but still influence the properties of the tablets and capsules which is bioavailability or bioequivalence of the tablets and capsules.
METHOD
1. 10 tablets were selected and tests for uniformity of diameter, thickness and hardness was 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
1) Mean thickness of tablet
= (5.11+5.09+5.09+5.03+4.99+5.08+5.09+5.05+4.97+5.05)/10
= 5.06 mm
2) Mean hardness of tablet
=(136.9+162.4+137.6+127.3+125.2+145.9+133.2+138.0+167.2+133.2 )/10
= 140.7 N
3) Mean diameter of tablet
= (12.84+12.83+12.83+12.81+12.81+12.84+12.85+12.87+12.82+12.88)/10
= (128.38 mm)/10 = 12.84 mm
So, the mean diameter of tablet is 12.84 mm, indicate that the deviation of individual unit from the mean diameter should not exceed ± 3%
4) Find the percentage error for each tablet
Percentage error = | individual diameter- mean diameter / mean diameter | x 100%
note: the value of percentage error = value for standard deviation for each tablet
DISCUSSION
This experiment is carried out to determine the diameter, thickness and hardness of the tablets. Based on the result, we can say that all the ten tablets are passing Standard Operation Procedure (SOP) since the deviation of individual unit is not exceeding ±3 %. The mean diameter is 12.84 mm and the diameter obtained for all the ten tablets have such similar values. This aspect is very important in producing the tablets which have similar or uniform diameter and size. The uniform size of tablets may help to increase the patient compliance and avoid them from being confuse with different size of the tablets. Different size of the tablets may cause the patient to think that the drugs or tablets have different amount of active ingredient. From the results, we find that all the diameters of the tablets are more than 12.5 mm. So, the deviation should be +/- 3%. The results for diameter are accurate because all the deviations of the tablets are less than +/- 3%. This means that the tablets generally have uniform diameter and size. The second aspect is the thickness. From the result, we find that the mean of the thickness is 5.06 mm. It is generally the same as each of the individual tablet. So, it means that the tablets also have uniformity in the thickness. The third aspect is hardness. The hardness of tablets depends on the weight of the material used, space between the upper and lower punches at the time of compression and pressure applied during the compression. From the result, we find that the average of hardness of the tablets is 140.7 N. The instrument measures the force required to break the tablets.
For this experiment, since we used machine to test the diameter, thickness and hardness of the tablet, so, we can reduce the probability to get more error. Although we used the machine, but we also have to be careful like make sure the machine is in good condition, clean, use it with the correct way and so on.
QUESTIONS
1) What are the objectives of the tests for uniformity of diameter and uniformity of content?
-The objectives of the tests for uniformity of diameter are to increase the patient compliance by increasing the quality of product appearance and also to prevent any confusion towards the patient about the dosage of the medications. The objectives of the tests for uniformity of content are to ensure uniform dosage supplied to the patient and prevent from overdose cases due to non uniform amount of active ingredients in the capsules or tablets.
2) State the types of tablets and capsules that must be tested for the uniformity of diameter and uniformity of content.
- Uniformity of diameter was introduced by the BP in 1958 to remove doubt. Uniformity of diameter tests involves all the uncoated and coated tablets and it is not applicable for the enteric tablets, film-coated tablets and sugar-coated tablets. For uniformity of content tests, it involves all tablets.
3) Give reasons for the non-compliance to test for uniformity of weight.
-The reasons for non-compliance to test for uniformity of weight are uneven feeding of granules into the die and due to irregular movement of the lower punch that cause variation in capacity die space.
4) Why does dissolution test suitable to be used for batch to batch quality control?
- Drug absorption from a solid dosage form after oral administration depends on the release of the drug substance from the drug product, the dissolution or solubilization of the drug under physiological conditions, and the permeability across the gastrointestinal tract. Because of the critical nature of the first two of these steps, in vitro dissolution may be relevant to the prediction of in vivo performance. Based on this general consideration, in vitro dissolution tests for immediate release solid oral dosage forms, such as tablets and capsules, are used to assess the batch to batch quality of a drug product
5. Explain the difference found in the procedure for dissolution test in the United States Pharmacopoeia and the British Pharmacopoeia.
- In United States Pharmacopoiea (USP) only involved 4 types of apparatus which are basket type, paddle type, recipocrating cylinder, flow through cell types; whereas British Pharmacopoeia (BP) involves 3 apparatus which are basket type, paddle type, and flow through cell type. Besides that, for testing in conventional-released dosage forms, in USP the thermometer is removed after dissolution medium is equilibrate to 37°C °C, whereas in BP, the test may also be carried out with the thermometer in place, provided it is shown that results equivalent to those obtained without the thermometer are obtained.The difference in the procedure found in USP and BP could be due to the different standard of level of dissolution set by the regulation of different countries. Besides that, the linearity of the test conducted by both countries may be different
CONCLUSION
The diameter obtained for all the ten tablets have such similar values where the mean diameter of the tablet is 12.84mm indicate that the deviation of individual unit should not exceed ±3%. From the result, the data for the diameter are accurate because all the deviation of the tablets not exceeds +/-3 % .The mean thickness of the tablet is 5.06 mm and the hardness of the tablets is 140.7 N.
REFERENCES
http://apps.who.int/phint/en/p/docf/
http://www.slideshare.net/ShekharPrasad1/4-12524129
Lecture note ‘QUALITY ASSESSMENT OF ORAL DOSAGE FORMS’
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