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Evaluation of Tablets
Evaluation of Tablets
standards and tests to ensure the quality of tablets. The standards and tests may be given as follows: a. b. c. d. e. f.
g. A.
Thickness and diameter Weight variation Hardness Friability Drug content Disintegration time In- vitro dissolution and its Kinetics studies THICKNESS AND DIAMETER (Lachman et al., 1990) The thickness of individual tablets is measured with a
micrometer, which gives us information about the variation between tablets. Tablet thickness should be within a 5% variation of a standard value. Any variation in thickness within a particular lot of tablets or between manufacturers lots should not be clear to the unaided eye for consumer acceptance of the product. In addition, thickness should be controlled to smooth the progress of packaging.
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WEIGHT VARIATION TEST (USP, 2000) The weight variation test would be a satisfactory method
for determining drug content uniformity of drug distribution. In practice this test is performed by taking 20 tablets, from a batch. 20 tablets are weighed at a time and the average weight is taken. Then the tablet is weighed individually. The percentage deviation can be determined by using the following formula. The percentage deviation can be determined by using the following formula.
% Deviation
weight
X 100
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C.
HARDNESS TEST (USP, 2000) The hardness of the tablet is important for drug products
that have bioavailability problem or that are sensitive to altered dissolution release profiles as a function of the compressive force employed. Tablet hardness is the force necessary to break the tablet diametrically. Hardness is sometimes termed the tablet crushing strength. To perform this test the tablets are located between two anvils and force is applied to the anvils, and the strength required to break the tablet is noted. If the tablet is too hard, the disintegration time is long and cannot meet up the dissolution specification, if its too soft, it cannot withstand handling when dealing with processes such as coating or packaging and shipping operations. The force with which the tablet is broken is expressed in kilograms and a hardness of 4Kg is usually well thought-out to be the minimum for satisfactory tablets. Oral tablets have a hardness of 4 to 10kg ; but,
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hardness of the formulated Paracetamol tablets. From each batch 3 tablets were taken at random and subjected to test. The mean of these 3 tablets were calculated. D. FRIABILITY TEST (USP, 2000) It is a measure of tablet strength. It is frequently measured using Roche friabilator. The normal revolution of this friabilator is 25rpm. The friability is determined using the following formula. F = 100 (1-w/w0) Where w0 = weight of tablets before friability w = weight of tablets after friability It is expressed in percentage. For conventionally
compressed tablets, the limit is 0.5% to 1% of their weight, chewable tablet have high friability values. When capping is observed on friability testing the tablet should not be considered for commercials use. E. WETTING TIME (Gohel et al., 2004) A circular tissue paper of 10cm diameter were placed in a Petri dish having an internal diameter of 10 cm. 10 ml of water
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temperature of the dissolution medium was maintained at 370C 20C. The agitation intensity was 50 rpm. The sampling time
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percentage of drug released against Time, First order (equation 2) as Log cumulative percentage of drug unreleased against Time, and Higuchi model (equation 3) as Cumulative percentage of drug released against Square root of time. C = K0 t where as time in (equation 1)
K0 indicates zero order rate constant expressed concentration per time and t indicates the hours.
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A graph of concentration against time gives a straight line with a slope equal to K0 and intercept the origin of the axis. log C = log C0 K t/2.303 where C0 be the initial concentration of drug, K be the first order constant, and t is the time. Q = K t1/2 where (equation 3) (equation 2)
Drug release were plotted in Korsmeyer equation (equation 4) as Log cumulative percentage of drug released against Log time, and the exponent was calculated from straight line. Mt / M = K tn where (equation 4) the slope of the
Mt / M is the fraction of solute release, t is the release time, K is the kinetic constant
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