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Optimized Vildagliptin Microsphere Formulation and in vitro Characterization Using 23 Factorial Design Analysis

1, 1, 1, 1

  1. 1Department of Pharmaceutics, School of Pharmacy, Sri Balaji Vidyapeeth (Deemed to be University) , Puducherry, INDIA.

CORRESPONDENCE

Dr. Sundaramoorthi Revathi

Department of Pharmaceutics, School of Pharmacy, Sri Balaji Vidyapeeth (Deemed to be University), Puducherry-607402, INDIA.

revathis79@gmail.com

Received: 01-07-2024; Revised: 10-09-2024; Accepted: 09-01-2025.

Volume 59, Issue 2s (Supplement) · pp. s433-s442 · 2025 · DOI: 10.5530/ijper.20250227

ABSTRACT

Background: Vildagliptin is a dipeptidyl peptidase-4 inhibitor employed for the intervention of non-insulin-dependent diabetes mellitus which has a short half-life. The intention of this work is to devise and qualify vildagliptin microspheres to analyse the impact of two different-polymers, encapsulating agents, and stirring speeds for sustained drug release.Materials and Methods: The formulations were crafted by method of solvent evaporation and developed by applying 23 complete factorial designs. The independent variables are the polymers (X1), encapsulating agents (X2) and stirring speed (X3). The dependent variables are particle size (Y1), degree of swelling (Y2), encapsulation efficiency (Y3), in vitro drug release studies (Y4). The kinship between independent and dependent variables were demonstrated using response surface diagrams. Additionally, the formulated microspheres were analysed for the parameters practical yield, kinetics of drug release and morphology.Results: The particle size and degree of swelling of microspheres were influenced substantially by the hydrophilic characteristic of the polymer used. The loading efficiency and the percentage of drug release was found to be ameliorated in water insoluble Eudragit RS 100 microspheres. The microspheres batch VGM6 prepared was observed to be suitable in accordance with loading efficiency 76.3% and slow percentage of drug release 71.78% in 8 hr following Hixson-Crowell kinetics and was characterized by SEM for morphology.Conclusion: The similarity and dis-similarity factors show that the rate of drug profiles were similar to each other and the formulation releases the drug slower than that of the innovator brand.

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    Revathi, S., Anitha, P., Jenifer, S., & Rajan, S. S. (2025). Optimized Vildagliptin Microsphere Formulation and in vitro Characterization Using 23 Factorial Design Analysis. Indian Journal of Pharmaceutical Education and Research, 59(2s), s433-s442. https://doi.org/10.5530/ijper.20250227

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    © 2025 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0