Date of Award
M.S. in Pharmaceutical Science
Pharmaceutics and Drug Delivery
Michael A. Repka
People suffer dysphagia when swallowing hard tablets and capsules. Gelatin based soft chewable tablets was used as an alternative and novel drug delivery format to overcome dysphagia. But conventional method of producing gelatin based soft chewable tablets has many potential issues. The objective of this study is using glycerol and hot-melt extrusion technique to address potential issues and optimizing the formulation. Gelatin (15%), acetaminophen (30%), saccharin (1.5%), xylitol (6.5%), sodium chloride (2%) and six different ratios of water (45-0%) and glycerol (0-45%) were used in seven formulations. The extrusion process temperature of formulation 1-6 and formulation 7 were 90 ëšc and 140 ëšc, respectively. Near-infrared spectra were collected during extrusion to monitor the quality consistency. Scanning electronic microscopy images of tablets' cross-section were taken by Joel model sem. Differential scanning calorimetry was used to characterize the crystal states of each formulation. Texture profile analysis test was used to evaluate the physical properties of tables. In vitro drug release was conducted by using usp-ii dissolution apparatus. 45 days' stability studies were carried out to evaluate the stability of each formulation. Near-infrared spectra shothat formulation 1-6 was uniform and formulation 7 was not uniform and different with the others. From differential scanning calorimetry results, formulation 1 and 2 had crystal of acetaminophen. In drug content experiment, formulation 1 was most inaccurate and formulation 6 is most accurate. Formulation 5 had best physical and chemical stability in texture profile analysis and in vitro drug release studies. Using glycerol and hot-melt extrusion successfully addressed the potential issues of conventional method. Formulation 5 is the best formulation in seven formulations.
Xu, Pengchong, "A Novel Acetaminophen Soft-Chew Formulation Produced Via Hot Melt Extrusion With Inline Near-Infrared Monitoring As A Process Analytical Technology Tool" (2018). Electronic Theses and Dissertations. 1096.