Date of Award

2023

Document Type

Dissertation

Degree Name

Philosophy (Ph.D)

Department

Pharmaceutical Sciences

First Advisor

Bhagwan D. Rohera

Second Advisor

Tanaji Talele

Third Advisor

Abu Serajuddin

Abstract

Three major challenges face the formulation of a successful hydrophilic polymer matrix. The objective of the formulation research is to concentrate on these issues. The first challenge is to maintain consistent drug release from these matrix systems; swelling and polymer dissolution occur when these systems are placed in a dissolution medium. A gel layer forms as the polymer swells, increasing the matrix tablet thickness. Polymer dissolution starts with chain disentanglement over time causing the matrix tablet thickness to gradually decrease until it undergoes complete dissolution. In the release of water-soluble drugs through a hydrophilic matrix, the thickness of the gel layer is a rate-controlling factor. The change in gel layer thickness over time makes achieving a constant drug release rate from these polymer matrices challenging. The second challenge is burst release from a polymer matrix system in the presence of alcohol. The third challenge is to control the critical variables that influence drug release from a hydrophilic matrix system. To optimize a matrix tablet formulation, it is critical to determine the role of these factors in drug release. In the present study, verapamil hydrochloride controlled release matrix tablet formulation was successfully developed. The front synchronization approach was used to achieve constant drug release. Hydrophilic polymers should form hydrogen bonds in the presence of a dissolution medium to change swelling behavior and maintain a constant gel diffusion layer around the polymer matrix. As a result, in this study, restrained swelling of a hydrophilic polymer via hydrogen bonding with an anionic or cationic polymer was used as a strategy to achieve a constant drug release from a hydrophilic matrix. In this study, an attempt was made to understand and optimize the factors that influence drug release from matrix systems, such as the ratio of rate-controlling polymer in the matrix, compression pressure, and tablet geometry, using a central composite experimental design. Utilizing the HPMC-RSPO combination, a matrix composition resistant to alcohol was developed.

Available for download on Saturday, July 11, 2026

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