Hot-melt extrusion (HME) - melting a substance and forcing itthrough an orifice under controlled conditions to form a newmaterial - is an emerging processing technology in thepharmaceutical industry for the preparation of various dosage formsand drug delivery systems, for example granules and sustainedrelease tablets.
Hot-Melt Extrusion: Pharmaceutical Applications coversthe main instrumentation, operation principles and theoreticalbackground of HME. It then focuses on HME drug delivery systems,dosage forms and clinical studies (including pharmacokinetics andbioavailability) of HME products. Finally, the book includes somerecent and novel HME applications, scale -up considerations andregulatory issues. Topics covered include:
* principles and die design of single screw extrusion
* twin screw extrusion techniques and practices in the laboratoryand on production scale
* HME developments for the pharmaceutical industry
* solubility parameters for prediction of drug/polymermiscibility in HME formulations
* the influence of plasticizers in HME
* applications of polymethacrylate polymers in HME
* HME of ethylcellulose, hypromellose, and polyethyleneoxide
* bioadhesion properties of polymeric films produced by HME
* taste masking using HME
* clinical studies, bioavailability and pharmacokinetics of HMEproducts
* injection moulding and HME processing for pharmaceuticalmaterials
* laminar dispersive & distributive mixing with dissolutionand applications to HME
* technological considerations related to scale-up of HMEprocesses
* devices and implant systems by HME
* an FDA perspective on HME product and processunderstanding
* improved process understanding and control of an HME processwith near-infrared spectroscopy
Hot-Melt Extrusion: Pharmaceutical Applications is anessential multidisciplinary guide to the emerging pharmaceuticaluses of this processing technology for researchers in academia andindustry working in drug formulation and delivery, pharmaceuticalengineering and processing, and polymers and materials science.
This is the first book from our brand new series Advancesin Pharmaceutical Technology. Findout more about the series here.