Electronic Theses and Dissertations

Date of Award

1-1-2023

Document Type

Thesis

Degree Name

M.S. in Pharmaceutical Science

First Advisor

Michael A. Repka

Second Advisor

Dr. Walter Chambliss

Third Advisor

Eman Ashour

School

University of Mississippi

Relational Format

dissertation/thesis

Abstract

Hypertension (HTN) can lead to heart attack, cardiac arrest, or coronary heart disease, and eventually death without proper treatment. Amlodipine Besylate (AMB) was approved by, US Food and Drug Administration in 1987, as a monotherapy for the management of HTN. AMB is commercially available in tablet (2.5, 5, and 10 mg) and solution (1mg/mL) dosage forms. However, adherence to the properly prescribed dosage form is critical and difficult for patients with chronic diseases such as HTN to prevent illness progression and death. The objective of the study was to develop AMB-loaded subcutaneous implants to reduce the frequency of administration, thus, improving patient compliance during HTN management. AMB subcutaneous implants were prepared by the continuous hot melt extrusion technology with dimensions of 7.5cm (length) by 2 mm (diameter) and were subsequently characterized. The implants were characterized for thermal characteristics, drug-excipient incompatibilities, surface morphology, fracturability, in vitro release, and stability studies. DSC showed that the drug was in the crystalline state in the fabricated implants. Scanning Electron Microscopy (SEM) revealed a smooth surface. The lead formulation presented good drug content and was stable over 15 days (last time point tested). The lead formulation showed an extended drug release profile over 15 days. The lead formulation showed good fracturability during textural analysis. Therefore, the hot melt extruded implants could serve as an alternative management strategy for conventional amlodipine besylate formulation.

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