- The present research work is to formulate and evaluate a generic formulation equivalent of Efavirenz capsule 200 mg to the Branded product SUSTIVA 200 mg manufactured by Bristol Myers Squibb.
- To evaluate the release characteristics of the dosage form through dissolution test using media and parameters recommended in compendium.
- To evaluate the stability of formulated dosage form under accelerated stability condition. (40°C / 75% RH – Up to 12 Weeks)
In this present study oral dispersible films of an anti hypertensive drug were prepared by using wet Granulation method.
The formulation of Efavirenz Capsules, 200 mg were tried using various excipients MCC PH102, Hydroxypropyl Cellulose, Poloxamer 407, Crospovidone, Pruv. Among all the formulations, B10(Optimised) prepared and the evaluation parameters were found satisfactory compared with that of the other batches.
|Purified Water, USP||QS|
The dissolution test was performed using USP type II(Paddle) apparatus, 900 ml of Purified Water with 1% SLS at 37 ± 0.5°C and 50 rpm. The test was performed for 75 minutes, and the samples were replaced with fresh dissolution medium. Cumulative percentage drug release was calculated. The results of stability studies were interpreted with respect to assay (the value should be between 90%-110% of label claim).The related substance results obtained across the stability condition should be complying to in-house specification and ICH specification. There should be mass balance between the generated assay and RS data. With respect to water content, data is generated for reporting the results and compared across the stability condition.
|Time (mins)||B10 Mean % Drug Release|