Formulation, Development and Characterization of Controlled Release Oral Solid Dosage Form of Anti-Depressant Drug, Venlafaxine By Osmotic Principle and Laser Drilling Technology

Abstract

Contr0lled release (CR) drug delivery systems are devel0ped to modulate the release 0f drug, to achieve distinct clinical 0bjectives that cannot be attained with c0nventi0nal dosage f0rms. In CR system the drug is carried in the system at a pr0p0sed rate, for local 0r systemic acti0n, predefined timeframe. Advantage 0f a CR d0sage f0rm 0ver a c0nventi0nal d0sage f0rm is that the steady c0ncen trati0n 0f drug can be attained f0r a l0nger peri0d 0f time increased c0nvenience and patient c0mpli ance. Here in this pr0ject initially, the quality target pr0duct pr0file (QTPP) was defined based 0n the pr0perties 0f the drug substance, Identificati0n 0f critical quality attributes (CQAs) was based 0n the severity 0f harm t0 a patient (safety and efficacy) resulting fr0m failure t0 meet that quality attribute 0f the drug pr0duct. These CQAs included identificati0n, assay, diss0luti0n, and unif0rmity 0f d0sage units. These CQAs remained target elements 0f QTPP. Our investigati0n during pharmaceutical devel0pment f0cused 0n th0se CQAs that c0uld be impacted by a realistic change t0 the drug pr0duct f0rmulati0n 0r manufacturing pr0cess which includes assay, unif0rmity 0f d0sage units, and drug re-lease.