Chapter.

7
7. SUMMARY

Summary & Conclusion

In conventional dosage form, the concentration of drug in the blood fluctuates over successive doses. This happens due to drug releases immediately after administration, so concentration of drug in the blood rise quickly to a high value followed by sudden decrease to a very low level. API is water soluble, so its conventional dosage form is solubilized quickly and also volume of distribution is high. It may chances of drug accumulation in the tissue and causes side effects so decided to prepare sustained release formulation of drug which releases drug slowly for a longer period of time.

For Extended release preparation need polymer which releases drug retard drug release (slowly) to get longer effect of the drug. For this reason selected HPMC polymers which are used for the extended release (sustained release) formulation .Polymers like HPMC K4M, HPMC K15M, HPMC K100M, is high viscosity polymer so released drug slower in the body than required. But viscosity. only HPMC not retard released drug due to its low its

So we used HPMC in the combination with the viscosity increasing agent HPC (hydroxypropayl cellulose) like HPMC K4M. In F/001, used HPMC K100M with concentration of 4% but due to its lower viscosity it released drug faster and not even remained for 12 hours. In F/002, tablet was prepared by HPMC k100M (Higer viscosity) concentration of 4% but got the same result,.

In F/003, took HPMC K100M (5%) and got somewhat faster drug release. In F/004, took HPMC K100M (6%) polymer at that time we got drug release slow and not got the result which we needed for sustained release formulations.

From these results decided in F/005 and F/006 used HPMC+HPC in combination at the ratio HPMC K100M +HPMC K4M (1%+5%) & (2%+4%) respectively. But not got the release profile of the drug in extended release manner. Now in batch F/007 used HPMC K100M+HPMC K4M (3%+3%). In that formula we got the result perfect this was needed. So decided that it was optimized formula and start the accelerated stability study of that batch.

In this, samples were placed in the 40C/75%RH for 1 month. Than collect the samples every month and evaluate the samples by dissolution study which gave the above 80 % F2value. The prepared sustained release tablet was stable.

NIMS Institute of Pharmacy, NIMS University Jaipur

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Chapter.7

Summary & Conclusion

CONCLUSION:The study was undertaken with the aim to Formulation and evaluation of Antiepileptic extended release tablet using HPMC grade of polymer as retarding agent. From the above results and discussion, it is concluded that the formulation of extended release tablet of Antiepileptic drug containing HPMC K100+HPMC K4M, which are taken as ideal or optimized formulation of extended release tablet for 12 hours release as it fulfils all the requirement of extended release tablet and study encourages further clinical trials and long term stability study on this formulation.

NIMS Institute of Pharmacy, NIMS University Jaipur

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