International Journal of Drug Delivery Technology
Volume 16, Issue 10s, 2026

Optimization of Low-Substituted Hydroxypropyl Cellulose, Ethyl Cellulose and Partially Pregelatinized Maize Starch in Zolpidem Tartrate MUPS Using Factorial Design

1* Ujjwal Rana, 2 Dr. Gunjan Jadon, 3 Dr. Awadh Kishor, 4 Dr. P K Choudhury

1*Department of Pharmacy, Pacific Academy of Higher Education and Research University, Udaipur, Rajasthan, India. Email: ranaujjwal999@gmail.com

2Department of Pharmaceutical Chemistry, Pacific College of Pharmacy, PAHER, Udaipur, Rajasthan, India. Email: jadon_gunjan@yahoo.in

3Department of Pharmaceutical Chemistry, Pacific College of Pharmacy, PAHER, Udaipur, Rajasthan, India.

4Department of Pharmaceutical Chemistry, Pacific College of Pharmacy, PAHER, Udaipur, Rajasthan, India.

*Corresponding Author: Ujjwal Rana

Abstract

The present study was aimed to optimize the levels of Low-Substituted Hydroxypropyl Cellulose (Metalose LH31), Ethyl Cellulose (Ethocel® Std. 10) and Partially Pregelatinized Maize Starch (Starch 1500) in Zolpidem Tartrate (Hemitartrate) MUPS. A factorial design with three center points was used to evaluate the individual and cumulative effects of these formulation variables on critical dissolution parameters at 30, 90 and 240 minutes which was critical for matching the in vitro profile with the reference. Dissolution testing was performed using USP Apparatus I in 0.01 N hydrochloric acid. Statistical analysis using Design-Expert® software demonstrated that Ethyl Cellulose had a significant impact on drug release at all time points, while interaction effects between polymers influenced early and middle phase dissolution behavior. The optimized formulation met all predefined dissolution acceptance criteria, confirming formulation robustness. The study highlights the effectiveness of a Quality by Design (QbD) based approach for achieving a controlled and reproducible release profile in extended-release formulations.

Keywords: Multiple Unit Pellet Systems (MUPS), Zolpidem tartrate, Factorial Design, Formulation, Dissolution Optimization, Quality by Design.

How to cite this article: Rana U, Jadon G, Kishor A, Choudhury PK. Optimization of Low-Substituted Hydroxypropyl Cellulose, Ethyl Cellulose and Partially Pregelatinized Maize Starch in Zolpidem Tartrate MUPS Using Factorial Design. Int J Drug Deliv Technol. 2026;16(10s): 663-670; DOI: 10.25258/ijddt.16.10s.80

Source of support: Nil.

Conflict of interest: None