By Dennis Douroumis
Hot-melt extrusion (HME) - melting a substance and forcing it via an orifice lower than managed stipulations to shape a brand new fabric - is an rising processing expertise within the pharmaceutical for the guidance of assorted dosage types and drug supply structures, for instance granules and sustained free up pills.
Hot-Melt Extrusion: Pharmaceutical Applications covers the most instrumentation, operation ideas and theoretical heritage of HME. It then specializes in HME drug supply platforms, dosage types and scientific experiences (including pharmacokinetics and bioavailability) of HME items. ultimately, the ebook comprises a few fresh and novel HME functions, scale -up issues and regulatory matters. subject matters coated include:
- principles and die layout of unmarried screw extrusion
- twin screw extrusion recommendations and practices within the laboratory and on construction scale
- HME advancements for the pharmaceutical industry
- solubility parameters for prediction of drug/polymer miscibility in HME formulations
- the impression of plasticizers in HME
- applications of polymethacrylate polymers in HME
- HME of ethylcellulose, hypromellose, and polyethylene oxide
- bioadhesion houses of polymeric motion pictures produced via HME
- taste protecting utilizing HME
- clinical stories, bioavailability and pharmacokinetics of HME products
- injection moulding and HME processing for pharmaceutical materials
- laminar dispersive & distributive blending with dissolution and purposes to HME
- technological issues concerning scale-up of HME processes
- devices and implant structures by way of HME
- an FDA point of view on HME product and method understanding
- improved strategy knowing and keep an eye on of an HME technique with near-infrared spectroscopy
Hot-Melt Extrusion: Pharmaceutical Applications is an important multidisciplinary advisor to the rising pharmaceutical makes use of of this processing expertise for researchers in academia and operating in drug formula and supply, pharmaceutical engineering and processing, and polymers and fabrics science.
This is the 1st publication from our fresh sequence Advances in Pharmaceutical know-how. Find out extra concerning the sequence here.
Content:
Chapter 1 Single?Screw Extrusion: ideas (pages 1–21): Keith Luker
Chapter 2 Twin?screw Extruders for Pharmaceutical Hot?melt Extrusion: expertise, options and Practices (pages 23–42): Dirk Leister, Tom Geilen and Thobias Geissler
Chapter three Hot?Melt Extrusion advancements within the Pharmaceutical (pages 43–69): Ana Almeida, Bart Claeys, Jean Paul Remon and Chris Vervaet
Chapter four Solubility Parameters for Prediction of Drug/Polymer Miscibility in Hot?Melt Extruded Formulations (pages 71–92): Andreas Gryczke
Chapter five The effect of Plasticizers in Hot?Melt Extrusion (pages 93–112): Geert Verreck
Chapter 6 functions of Poly(meth)acrylate Polymers in soften Extrusion (pages 113–144): Kathrin Nollenberger and Jessica Albers
Chapter 7 Hot?Melt Extrusion of Ethylcellulose, Hypromellose and Polyethylene Oxide (pages 145–175): Mark corridor and Michael Read
Chapter eight Bioadhesion homes of Polymeric motion pictures Produced via Hot?Melt Extrusion (pages 177–199): Joshua Boateng and Dennis Douroumis
Chapter nine style protecting utilizing Hot?Melt Extrusion (pages 201–221): Dennis Douroumis, Marion Bonnefille and Attila Aranyos
Chapter 10 medical and Preclinical stories, Bioavailability and Pharmacokinetics of Hot?Melt Extruded items (pages 223–237): Sandra weapons and man Van den Mooter
Chapter eleven Injection Molding and Hot?Melt Extrusion Processing for Pharmaceutical fabrics (pages 239–259): Pernille Hoyrup Hemmingsen and Martin Rex Olsen
Chapter 12 Laminar Dispersive and Distributive blending with Dissolution and purposes to Hot?Melt Extrusion (pages 261–284): Costas G. Gogos, Huiju Liu and Peng Wang
Chapter thirteen Technological issues concerning Scale?Up of Hot?Melt Extrusion approaches (pages 285–300): Adam Dreiblatt
Chapter 14 units and Implant platforms by means of Hot?Melt Extrusion (pages 301–321): Andrew Loxley
Chapter 15 Hot?Melt Extrusion: An FDA viewpoint on Product and method figuring out (pages 323–331): Abhay Gupta and Mansoor A. Khan
Chapter sixteen more desirable strategy knowing and keep an eye on of a Hot?Melt Extrusion procedure with near?Infrared Spectroscopy (pages 333–353): Chris Heil and Jeffrey Hirsch
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Additional info for Hot-Melt Extrusion: Pharmaceutical Applications
Sample text
When this happens, shear deformation is insufficient to break the agglomerations into their constituent parts. Agglomerations within a polymer matrix define a poorly mixed product. Many ingenious schemes are known to improve the basic screw. Since the 1950s, a variety of mixers have been available. Some of these force material into small spaces for additional shearing. Some divide the flow into many streams so that smaller masses are sheared more effectively. Some make use of pins embedded in the root of the screw and some cut the screw flights.
It shows that the SFEM Elongator is elongationally dominant because it breaks down blends of high viscosity ratios that cannot be dispersed by shear alone. 14 is a plot of mixtures processed on four different mixers: two batch and two continuous. The numbers indicate the MI (melt index) of the PE component in the 70% PP (polypropylene) 30% PE (polyethylene) blend. The vertical axis shows the distribution of the minor phase domains. Domains are actually like spheres: the lower the number, the smaller the diameter and the better the mixing.
The jamming is reflected in higher screw torque, which we see as higher motor load. The ACR must be high enough to squeeze out the air from the feedstock, but not so high that it prevents material from flowing to the next section. The lower bulk density of some HME mixtures also requires a change to the screw. Since there is a lower bulk density in the feed flights, there is also less mass. A 3:1 ACR is general-purpose only because pellets are the most common feedstock. These dense pellets will generally fill the screw once the air is removed during compression and create a stable flow.