Development and Characterization of Different Dosage Forms Utilizing Hot-Melt Extrusion Technique
Date of Award
Ph.D. in Pharmaceutical Sciences
University of Mississippi
Hot melt extrusion (HME) is a promising technique for developing different dosage forms and improving products already on the market. Numerous studies have been published utilizing HME due to its advantages over conventional techniques. It is solvent-free, has few processing steps, continuous processing, and low cost. Furthermore, HME has the flexibility to be coupled with Fused Deposition Modeling (FDM) to develop complex dosage forms for patient-focused drug delivery. The first objective of this research work was to design and develop different dosage forms (capsule-in-capsule, and three-dimensional-printed tablet) of nifedipine/indomethacin fixed-dose combination (FDC) utilizing hot melt extrusion (HME) with or without fused deposition modeling (FDM) techniques. The developed dosage forms were intended to provide delayed-extended and immediate-release profiles for indomethacin and nifedipine, respectively. Nifedipine formulations showed significant improvement in release profiles, having 94% of the drug release at 30 minutes compared with the pure compound, which had a percent release of 2%. Furthermore, the release of indomethacin was successfully delayed at a pH of 1.2 and extended at a pH of 6.8. The second objective of this research work was to evaluate the printability of polyethylene oxide (PEO) polymers that have different molecular weights to fabricate three-dimensional (3D) printed oral films to extend the release profile of lidocaine hydrochloride. Hot-melt extrusion (HME) with fused deposition modeling (FDM) utilized to develop the 3D-printed films for topical use. The release study showed that the fabricated film with the composition of (10% lidocaine hydrochloride, 45% PEO-N80, and 45% PEO-1105) had an extended-release of lidocaine hydrochloride for up to 8 hours. The boiadhesion studies revealed that formulations (with the highest ratio of PEO-1105 45%) had higher values of peak force and work of adhesion with 1.5 N and 1.42 N.mm, respectively.
Althobaiti, Abdulmajeed, "Development and Characterization of Different Dosage Forms Utilizing Hot-Melt Extrusion Technique" (2022). Electronic Theses and Dissertations. 2419.
Available for download on Thursday, February 08, 2024