To study the uniformity of diameter, thickness and hardness of antibiotic tablet using the tablet testing experiment ( PHARMATEST PTB 311).
Introduction:
Tablet uniformity is important and is used to make sure that every tablet contains the amount of drug substances intended with only little variation among tablets within a batch. Due to the increased awareness of physiological availability, the uniformity test has been included for all coated and uncoated tablets. Among the various oral dosage forms, tablets are the most common and easiest way to be administered. Tablets are defined as solid preparations each containing a single dose of one or more active ingredients and obtained by compressing uniform volumes of particles. Besides, tablets are used mainly for systemic drug delivery but also for local drug action. Related to this reason, there is experiment conducted to test on the uniformity of diameter, hardness and thickness of the tablets which will influence the efficiency of the tablets to delivery drugs.
PHARMATEST PTB 311 is one of the most popular instruments for measuring thickness up to 15mm, diameter up to 40mm and hardness up to 300N. Uniformity of the diameter of tablet follows the pharmacopoeial standard. All of the percentage average deviation value must not exceed ± 5% for tablets with diameter less than 12.5 and ± 3% for diameter of 12.5 mm or more. All of this test could be done by using PHARMATEST PTB 311. The thickness and hardness test are both under non-pharmacopoeial standards and is widely used by the manufacturers itself.
Apparatus and Materials:
250 mg film coated tablet Ettrocin, Table Testing Instrument (PHARMATEST PTB 311)
Procedure:
1. Ten antibiotic tablets are chosen.
2. All the tablets are tested for uniformity of diameter, thickness and hardness using the Tablet Testing Instrument (PHARMATEST PTB 311).
3. The tablet is put in the upright positioning in order to measure the thickness.
4. Tablet Testing Instrument (PHARMATEST PTB 311) is then turned on.
5. The tablet is put in the flat position in order to determine the diameter of the tablets.
6. The tablet is then broken down in order to determine the hardness.
7. The readings of the testing are measured and recorded in a table.
8. Step one to seven are repeated for the remaining nine tablets.
9. The mean value for each parameters are calculated.
10. Standard deviation is also calculated by using Formula 1 as shown in the calculation part.
11. 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.
Result and Calculation:
FORMULA
Deviation= [ | Initial diameter- Average diameter | ] / Average diameter X 100%
Tablet 1:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.82-12.82| ] / 12.81 x 100% =0%
Tablet 2:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.81-12.82| ] / 12.82 x 100% =0.08%
Tablet 3:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.79-12.82| ] / 12.82 x 100% =0.23%
Tablet 4:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.84-12.82| ] / 12.82 x 100% =0.16%
Tablet 5:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.82-12.82| ] / 12.82 x 100% =0%
Tablet 6:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.84-12.82| ] / 12.82 x 100% =0.16%
Tablet 7:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.82-12.82| ] / 12.82 x 100% =0%
Tablet 8:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.80-12.82| ] / 12.82 x 100% =0.16%
Tablet 9:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.82-12.82| ] / 12.82 x 100% =0%
Tablet 10:
Deviation=[ |Initial diameter-Average diameter | ] / average diameter x 100%
Average diameter
=[ |12.82-12.82| ] / 12.82 x 100% =0%
Discussion:
This experiment is carried out to measure the diameter, thickness and hardness of the antibiotic
tablets. The measurements that obtained can be used to determine the uniformity of the tablets.
This uniformity in diameter involves in pharmacopoeial standards, for examples, British Pharmacopoeia and US Pharmacopoeia. Meanwhile, thickness and hardness involve in non-pharmacopoeial standards. Hence, the standard deviation of the diameter for all the tablets are calculated.
However, there is a difference found in the procedure for dissolution test in the Unites States Pharmacopoeia (USP) and the British Pharmacopoeia (BP). In USP, typical acceptance criteria for the amount of active ingredient dissolved, expressed as a percentage of the labeled content (Q), are in the range of 75% to 80% dissolved. Meanwhile in BP, the amount of active ingredient dissolves must not less than 70%. In USP, if the test failed, a retest may be carried out in three stages with
different amount of tablets. In BP, if the test failed, a retest may be carried out using the same number
of units of tablets.
It is very important to determine the uniformity in diameter,thickness and hardness of a tablet. This can be due to a few aspects , for examples , manufacturers and patients.Uniformity of diameter tests involves all the uncoated and coated tablets except for the enteric tablets, film-coated tablets and sugar-coated tablets. For uniformity of content tests, it involves all tablets.
In turn of manufacturers, the uniformity of diameter, thickness and hardness is important as the manufacturing process follow Standard Operation Procedure (SOP). This uniformity is important in packaging process. For example, the suitable size of the tablets can be packed into the blister pad of tablets. In turn of patients, patient compliance. The uniform size of tablets can avoid from being confused that different size of tablets indicate the different types of drug. Hence, patients might have overdose due to the excessive taking of the same drugs. As a result, if it is a severe overdose or overdose for a drug that has a narrow therapeutic index, then the effect is lethal.
Besides, the uniform size of the tablet also indicates the precise dose of the drug. The drugs will consist of correct proportion of active ingredient and excipient. The correct amount of active ingredient is important as to produce the desire therapeutic effects. The correct amount of excipient his important as to optimize the pharmaceutical profile of the drugs, for example, the drug will release the active ingredient at the correct amount, time and place and also the drug is stable before it reaches the target site to produce therapeutic effect.
The deviation of diameter of the single tablet cannot exceed +/- 3% for diameter of 12.5 mm or more.
12.82 mm X 3% = 0.3846 mm + 3% from the average value
12.82 mm + 0.3846 mm =13.2046 mm -3% from the average value
12.82 mm - 0.3846 mm = 12.4354 mm
** HENCE, the diameter of tablet should be in the range of between or equal 12.4354 mm to 13.2046 mm.
From the results, the diameter obtained for all the ten tablets have such similar values as they have a small deviation if comparing with the average diameter in which the highest deviation is only 0.23% , does not exceed 3% and the range of the diameter of the tablets lie between 12.4354 mm to 13.2046 mm. The results are accurate. The results and calculations show that all these ten antibiotic tablets produced by the manufacture have uniform diameter and size.
From the results, the diameter obtained for all the ten tablets have such similar values as they have a small deviation if comparing with the average diameter in which the highest deviation is only 0.23% , does not exceed 3% and the range of the diameter of the tablets lie between 12.4354 mm to 13.2046 mm. The results are accurate. The results and calculations show that all these ten antibiotic tablets produced by the manufacture have uniform diameter and size.
Next aspect to be considered is the thickness. Tablet thickness is very important in quality control testing. The suitable thickness is very important and it can also explained in another two aspects which are manufactures and patients as well.
In turn of manufacturer, the tablets which are too thick might block the machine which causes the machine cannot function well. The thick tablets are easily broken, for examples, the capping and laminating tablets can be formed. These low quality tablets cannot be sold.In turn of patient, the thick tablets are also difficult to be swollen by the patients. The thick tablet cannot be easily degraded or lower solubility. The non degraded drugs cannot release the active ingredient at the correct time. The tablet which are too thick cannot be degradedand will remain in the body and produce toxic effects.
From the result, the mean thickness for all tablets is 5.53 mm. The result that obtained for all the ten
tablets have similar value. Hence, all the ten antibiotic tablets have the uniformity of thickness.
Third aspect is the hardness. The testing of a tablets hardness plays an important role in both product development and subsequent quality control. High hardness values indicate the increased disintegration times and reduced dissolution values. Too low the hardness value is also not favorable as the drug will easily degraded before it reached the target site. Hence, a suitable hardness of drug is very important.
From the result of the experiment, the mean hardness is 135.92 N.
F = mg
F= force in Newton, m= mass in kg and g= acceleration due to gravity which is constant 9.8 N/kgHence,
F= mg
m= F/g
=135.92/9.8
= 13.869 kg
First information:Oral tablets normally have a hardness of 4 to 10kg.
Second information: Hypodermic and chewable tablets softer which have a hardness of 3 kg and some sustained release tablets are much harder which have a hardness of 10 -20 kg.
* HENCE, the antibiotic tablets can be considered as sustained release tablet as it has the hardness of 13.869 kg if measured in kg unit.
Conclusion:
Diameter, thickness and hardness are three important aspects need to consider during the manufacture of the tablets as to produce the quality tablet and also produce higher therapeutic effect.References:
1. https://answers.yahoo.com/question/index?qid=20121008144739AAvSjdu
2. http://www.copleyscientific.com/home/pharmaceutical-testing/hardness-testingbreaking- force/introduction-to-tablet-hardnesstesting
3. http://www.slideshare.net/mobile/mallikarjunvasm/quality-control-tests-for-tablets
4. Michael E. Aulton, Aulton’s Pharmaceutics The Design and Manufacture of Medicines, Third
Edition, Page 461-466
How about the computation for the tablet thickness?
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