Preformulation and Formulation Studies of the Poly Herbal Syrup of Hydroalcoholic Extracts of Zingiber officinale and Piper nigrumby Nirmala Korukola, Vinay Kumar Medisetti, Swathisri Sravanam, Kumar Raju Sanga, by India.

摘要

The main goal of this study was to develop a stable formulation of Efavirenz as an immediate release tablet using design of experiments. Tablets were prepared by using wet granulation method. A 32 Central Composite Design (CCD) was selected to optimize the formulation of the varied response variable (Dissolution). The two factors Croscarmellose Sodium and HydroxyPropyl Cellulose were determined as the critical material attributes from preliminary studies and varied as required by the experimental design. The screened factors of overlay plot were incorporated into a suitable experimental design to optimize the process formulation. A 22 factorial design (FD) was selected to screen the process formulation .The two factors Water Uptake and Hardness were varied as required by the experimental design. In-vitro % drug release Q15, Q30 and Q45 were taken as response variable. A design space was created using desired levels of response variables and a composition was selected as optimized formulation, which is compared with the marketed formulation for similarity factor. The results revealed that dissolution rate was found to be directly proportional to concentration of disintegrant and inversely proportional to concentration of binder, hardness and % water uptake (w/w).