The New Jersey Institute of Technology's
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Title:	The kinetics of drug dissolution in polymers during hot-melt extrusion
Author:	Fang, Huayang
View Online:	njit-etd2015-068 (xi, 33 pages ~ 1.7 MB pdf)
Department:	Department of Chemical, Biological and Pharmaceutical Engineering
Degree:	Master of Science
Program:	Chemical Engineering
Document Type:	Thesis
Advisory Committee:	Gogos, Costas G. (Committee chair) Tomkins, R. P. T. (Committee member) Simon, Laurent (Committee member) Bilgili, Ecevit Atalay (Committee member) Ioannidis, Nicolas (Committee member)
Date:	2015-05
Keywords:	Drug dissolution Polymers Hot-melt extrusion
Availability:	Unrestricted
Abstract:	Extrusion has been a most important and widely used continuous process in polymer processing for over one hundred and fifty years. However, it has only been recently applied and adopted by the pharmaceutical industry to prepare solid oral dosage formulations with increased bioavailability for the poorly-water soluble drugs and controlled release characteristics for the water-soluble drugs. In pharmaceutical Hot-melt extrusion poorly water soluble drug particulates are mixed with water soluble polymer excipient particulates and fed in the extruder, where the polymer is melted, after which the drug particulates begin to dissolve into the polymer melt. Extrusion-generated mixing accelerates dissolution process. One issue concerning the pharmaceutical industry is the degradation of drugs when they are exposed to relatively high temperatures of the extrusion process (usually 100 °C above ambient). In order to keep drugs from thermally degrading and at the same time achieving complete dissolution, the dissolution kinetics of drugs (APIs) must be specified for any given excipient/API pair, and a variety of extrusion conditions. In this work the Brabender Batch Mixer is utilized to determine such kinetic data at different concentrations and temperatures by connecting the exponential torque decay after the introduction of the API to the API dissolution. The time to complete the decay is then associated with the average residence time needed for complete dissolution.