Patient Friendly Formulations Utilizing Hot Melt Extrusion Technology
type: CreativeWork
description: This research work exhibited the new outlook of hot melt extrusion technology for orally disintegrating tablet, fast disintegration films and fixed dose combinations. Previous research demonstrated these applications by conventional formulation techniques which has inherent shortcoming of use of large amount of solvent and batch size manufacturing. This present work addressed some of the unique challenges which could provide patients ease of administration and reduce dosing frequencies, and moreover, mitigate the manufacturing challenges. For orally disintegrating tablet study, ethylcellulose, along with a suitable plasticizer, was used as a polymeric carrier. Pore forming agents were incorporated into the extruded matrix to enhance drug release. A modified screw configuration was applied to improve the extrusion processability and to preserve the crystallinity of the API. The milled extrudates were subjected to dissolution testing in an artificial salivary fluid and investigations using e-tongue, to assess the extent of masking of bitter taste of the API. There was an insignificant amount of drug released from the formulation in the salivary medium while over 80% of drug released within 30 min in 0.1 N HCl. ODTs were also developed with the extrudate mixed with mannitol and crospovidone. The quality properties such as friability and disintegration time of the ODTs met the USP specifications. The lead extrudate formulations and the ODTs prepared using this formulation were subjected to human gustatory evaluation. The formulations were found to mask the unpleasant taste of caffeine citrate significantly. Additionally, melt extrusion provided peculiar advantages for oral fast disintegrating film development. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and…
abstract: This research work exhibited the new outlook of hot melt extrusion technology for orally disintegrating tablet, fast disintegration films and fixed dose combinations. Previous research demonstrated these applications by conventional formulation techniques which has inherent shortcoming of use of large amount of solvent and batch size manufacturing. This present work addressed some of the unique challenges which could provide patients ease of administration and reduce dosing frequencies, and moreover, mitigate the manufacturing challenges. For orally disintegrating tablet study, ethylcellulose, along with a suitable plasticizer, was used as a polymeric carrier. Pore forming agents were incorporated into the extruded matrix to enhance drug release. A modified screw configuration was applied to improve the extrusion processability and to preserve the crystallinity of the API. The milled extrudates were subjected to dissolution testing in an artificial salivary fluid and investigations using e-tongue, to assess the extent of masking of bitter taste of the API. There was an insignificant amount of drug released from the formulation in the salivary medium while over 80% of drug released within 30 min in 0.1 N HCl. ODTs were also developed with the extrudate mixed with mannitol and crospovidone. The quality properties such as friability and disintegration time of the ODTs met the USP specifications. The lead extrudate formulations and the ODTs prepared using this formulation were subjected to human gustatory evaluation. The formulations were found to mask the unpleasant taste of caffeine citrate significantly. Additionally, melt extrusion provided peculiar advantages for oral fast disintegrating film development. Modified starch with glycerol was used as a polymer matrix for melt extrusion. Sweetening and saliva-simulating agents were incorporated to improve palatability and lower the disintegration time of film formulations. A standard screw configuration was applied, and…
author: Pimparade, Manjeet Bhagwan
keywords: Continuous manufacturing, E-tongue, Hot melt extrusion, Human taste panel, Oral fast disintergration, Taste masking, Pharmacy and Pharmaceutical Sciences
date published: 2017-01-01T08:00:00Z
date modified: 2026-07-24T03:06:53Z
provider: University of Mississippi
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: University of Mississippi