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
The fabrication of subcutaneous implants can be done using the continuous manufacturing technique known as Hot-Melt Extrusion (HME). This study aimed to evaluate the quality and physical and chemical properties of subcutaneous implants including their drug release profile, stability, and performance manufactured through HME and to assess the applicability of HME in the continuous manufacturing process. Overall, the study aimed to contribute to the advancement of manufacturing processes for subcutaneous implants, with the potential to improve their efficacy and patient outcomes.
To formulate the implant for patients with schizophrenia, a formulation was developed using a combination of Haloperidol (HLP) (an antipsychotic), Polycaprolactone (a polymer), and Kolliphor P 188 (a solubilizing excipient). The amount of HLP per implant (F3) is 30 mg and having dimensions of 2.25 mm (diameter) × 50 mm (length). The selection of polymer and excipient was based on their biodegradable, biocompatible nature in the body also possess low melting point (60°C). The superior rheological and viscoelastic properties render PCL easy to manufacture and manipulate into a wide range of three-dimensional platforms (i.e., porous scaffold, micro- and nanocarriers, and implantable devices). The formulation was developed using a combination of solvent evaporation and HME techniques to achieve a better uniform distribution of the drug throughout the polymer. The developed implant underwent additional characterization processes, including content uniformity, differential scanning calorimetry (DSC), Fourier transforms infrared spectroscopy (FTIR), Scanning electron microscopy (SEM), in vitro drug release studies, and stability studies, to show the release profile of the formulation. Results showed that content uniformity (97-101%) and targeted drug releases of 0.5 mg per day were achieved.
Recommended Citation
Jaiswal, Shivam, "Formulation and Development of Haloperidol Implant for Patients with Schizophrenia." (2023). Electronic Theses and Dissertations. 2522.
https://egrove.olemiss.edu/etd/2522