Abstract

PREFORMULATION STUDIES OF SELECTED SSRI’s USED FOR TREATMENT OF DEPRESSION

Dr. Divya Budarapu*, Dr. U. Mohan Kumar, P. Sravanthi, K. Venkata Subbamma

.

Abstract

Pre-formulation studies investigate the physical and chemical properties of an active pharmaceutical ingredient to determine factors that may influence the formulation, development and stability of final product. Overall preformulation parameters contributes in streamlining efficacy, safety and stability of the product and ensures quality drug product to reach the market. Postpartum depression is a mood disorder experienced by mother’s post child delivery. It can be treated by antidepressants like Fluoxetine, Sertraline, Amitriptyline and others. Aim: The aim of the present work is to study the preformulation parameters of selective serotonin reuptake inhibitors (SSRI’s) like Fluoxetine HCl and Sertraline HCl used for the treatment of postpartum depression. Materials and methods: Fluoxetine HCl (FLX) exhibits limited solubility in water but dissolves readily in ethanol and methanol. The typical adult dose ranges from 20- 60mg/day. Sertraline Hydrochloride (STR) is a slightly water-soluble drug, the minimum effective oral adult dose of Sertraline is 50mg/day in-case of depression. The preformulation studies like solubility profile, FTIR, SEM, dissolution studies and melting point were carried out for both the drugs.

Keywords: SEM, DSC, FTIR, mood disorder, stability, melting point, solubility, preformulation studies.