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Indian Journal of Pharmaceutical Education and ResearchNOW IN
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IJPER · Lens · Formulation and Optimization of Fast Dissolving Thin Strips of Desvenlafaxine HCl by Using Quality by Design (QbD) Approach

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Article · Volume 59, Issue 3 · pp. 913–922

Formulation and Optimization of Fast Dissolving Thin Strips of Desvenlafaxine HCl by Using Quality by Design (QbD) Approach

Ganesh Kumar1, Meenakshi Bhatt2, Archana Dhyani3

  1. 1Department of Pharmaceutics, Himalayan School of Pharmaceutical Sciences, Swami Ram Himalayan University, Dehradun, Uttarakhand, INDIA.
  2. 2Food and Drug Administration, Price Monitoring Regulatory Unit, FDA, Dehradun, Uttarakhand, INDIA.
  3. 3Department of Pharmaceutics, School of Pharmacy, Graphic Era Hill University, Dehradun, Uttarakhand, INDIA.

Abstract

Aim: The present work was aimed to formulate and optimize fast dissolving thin strips of Desvenlafaxine Hydrochloride using QbD.Materials and Methods: The solvent casting method was used to formulate fast dissolving thin strips. The drug (Desvenlafaxine HCl), polymer (pullulan), super disintegrant (Croscarmellose sodium), plasticizer (Poly Ethylene Glycol- (PEG-400), saliva stimulating agent (citric acid), sweetening agent (mannitol and aspartame) and water (solvent) were used in the preparation of the strips. The study involved a 3-level factorial design in which the effect of Pullulan Polymer (A), Croscarmellose Sodium (B) and Poly Ethylene Glycol (C) on 3 response variables disintegration Time (X), percent swelling index (Y) and percent Dissolution Efficiency (DE%15) were analyzed.Results: From the studies, it was found that F12 formulation (containing 30% pullulan, 5% CCS and 7.5% PEG) was the optimized formulation that showed improved important strip characteristics including disintegration time, swelling index and dissolution efficiency after 15 min.

Keywords: Crospovidone; Disintegration time; Dissolution efficiency; Dysphagia; Fast dissolving; strips; Microcystalline Cellulose; Quality by Design

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