Available Online through - International Journal of Pharmacy and ...
Available Online through - International Journal of Pharmacy and ...
Available Online through - International Journal of Pharmacy and ...
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Naga Pranitha Chodavarapu * et al. /<strong>International</strong> <strong>Journal</strong> Of <strong>Pharmacy</strong>&Technology<br />
In vitro Disintegration Test (U.S.P.)<br />
The U.S.P. device to test disintegration uses 6 glass tubes that are 3” long; open at the top <strong>and</strong> 10 mesh screen at<br />
the bottom end. To test for disintegration time, one tablet was placed in each tube <strong>and</strong> the basket rack was positioned<br />
in a 1-L beaker <strong>of</strong> 0.1 N Hydrochloric acid at 37 ± 20 C such that the tablet remain 2.5 cm below the surface <strong>of</strong> liquid<br />
on their upward movement <strong>and</strong> not closer than 2.5 cm from the bottom <strong>of</strong> the beaker in their downward movement.<br />
The basket containing the tablets was moved up <strong>and</strong> down <strong>through</strong> a distance <strong>of</strong> 5-6 cm at a frequency <strong>of</strong> 28 to 32<br />
cycles per minute. Floating <strong>of</strong> the tablets can be prevented by placing perforated plastic discs on each tablet.<br />
According to the test, the tablet must disintegrate <strong>and</strong> all particles must pass <strong>through</strong> the 10 mesh screen in the time<br />
specified. If any residue remains, it must have a s<strong>of</strong>t mass.<br />
In Vitro Buoyancy Studies:<br />
The in vitro buoyancy was determined by floating lag time, per the method described by Rosa et al. The tables<br />
were placed in a 100-mL beaker containing 0.1N HCL. The time required for the tablet to rise to the surface <strong>and</strong> float<br />
was determined as floating lag time. 16<br />
In Vitro Dissolution Pr<strong>of</strong>ile Studies:<br />
The rate <strong>of</strong> metformin hydrochloride release from metformin hydrochloride sustained release tablets was<br />
conducted using Dissolution Testing Apparatus II (Paddle method). The dissolution test was carried out using 900 ml<br />
<strong>of</strong> 0.1 N HCI, at 37 ± 0.5 Celsius <strong>and</strong> 75 rpm. A sample (10 ml) <strong>of</strong> the solution was withdrawn from the dissolution<br />
apparatus at every hour up to eight hours <strong>and</strong> withdrawn volume was replaced with fresh dissolution media. The<br />
samples were filtered <strong>through</strong> a 0.45 µ membrane filter, the sample was diluted to suitable concentration with 0.1N<br />
HCl. Absorbance <strong>of</strong> these solutions was measured at 233nm using UV spectrophotometer. 11<br />
IJPT | June-2011 | Vol. 3 | Issue No.2 | 2725-2745 Page 2730