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    Vol 59, Issue 3, 2025

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

    Updated:2 Mins Read
    Ganesh Kumar1, Meenakshi Bhatt2 and Archana Dhyani3
    Author informationCitations

    1Department of Pharmaceutics, Himalayan School of Pharmaceutical Sciences, Swami Ram Himalayan University, Dehradun, Uttarakhand, INDIA

    2Food and Drug Administration, Price Monitoring Regulatory Unit, FDA, Dehradun, Uttarakhand, INDIA

    3Department of Pharmaceutics, School of Pharmacy, Graphic Era Hill University, Dehradun, Uttarakhand, INDIA

    Corresponding author.

    Correspondence: Dr. Archana Dhyani, Department of Pharmaceutics, School of Pharmacy, Graphic Era Hill University, Dehradun, Uttarakhand, INDIA. Email: archana.dhyani@gmail.com

    Author Notes

    November 28, 2024; January 15, 2025; April 07, 2025.

    Copyright and License information

    Copyright ©2025 Authors
    This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
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    Published in: Indian Journal of Pharmaceutical Education and Research, 2025; 59(3): 913-922. Published online: 09 May 2025DOI: 10.5530/ijper.20255095

    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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