International Research Journal of Education and Technology

Controlled release tablets were prepared by different approaches using different polymers, individually or mixture. All the designed formulations were evaluated for their drug content, weight variation, hardness, friability and in vitro release profile. Preformulation studies indicated that Duloxetine (DL) was non-hygroscopic, poor flowing and highly soluble between pH 1.2 to 10. Solid state stability studies showed that Duloxetine (DL) was stable and compatible with various excipients for sufficient time period. In addition, DSC and FTIR studies also indicated the compatibility of Duloxetine (DL) with excipients used for controlled release formulations. Controlled release formulations were prepared using hydrophilic polymers (HPMC 15K, HPMC
100K, sodium CMC, carbopol) alone or in combination using wet granulation process. Multi granules based CR tablets were prepared with mixing the granules of hydrophilic polymers and hydrophobic polymers in different proportions. The quality control parameters of all the formulations were found to be satisfactory and within the official pharmacopoeial limits suggesting used process can produce good quality products.

Keyword: Duloxetine (Dl), Preformulation Studies, Characterization, Results