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 varied dosage types and drug supply platforms, for instance granules and sustained unlock capsules.
Hot-Melt Extrusion: Pharmaceutical Applications covers the most instrumentation, operation ideas and theoretical heritage of HME. It then makes a speciality of HME drug supply platforms, dosage types and scientific reviews (including pharmacokinetics and bioavailability) of HME items. eventually, the e-book comprises a few contemporary and novel HME purposes, scale -up concerns and regulatory matters. issues coated include:
- principles and die layout of unmarried screw extrusion
- twin screw extrusion ideas 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 by means of HME
- taste overlaying utilizing HME
- clinical experiences, 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 concerns on the topic of scale-up of HME processes
- devices and implant platforms by means of HME
- an FDA point of view on HME product and strategy understanding
- improved procedure figuring out and keep an eye on of an HME strategy with near-infrared spectroscopy
Hot-Melt Extrusion: Pharmaceutical Applications is an important multidisciplinary consultant 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.
Chapter 1 Single?Screw Extrusion: ideas (pages 1–21): Keith Luker
Chapter 2 Twin?screw Extruders for Pharmaceutical Hot?melt Extrusion: know-how, suggestions 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 impression of Plasticizers in Hot?Melt Extrusion (pages 93–112): Geert Verreck
Chapter 6 purposes 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 movies Produced through Hot?Melt Extrusion (pages 177–199): Joshua Boateng and Dennis Douroumis
Chapter nine style covering 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 functions to Hot?Melt Extrusion (pages 261–284): Costas G. Gogos, Huiju Liu and Peng Wang
Chapter thirteen Technological concerns regarding Scale?Up of Hot?Melt Extrusion procedures (pages 285–300): Adam Dreiblatt
Chapter 14 units and Implant platforms by way of Hot?Melt Extrusion (pages 301–321): Andrew Loxley
Chapter 15 Hot?Melt Extrusion: An FDA standpoint on Product and strategy figuring out (pages 323–331): Abhay Gupta and Mansoor A. Khan
Chapter sixteen better method realizing and keep an eye on of a Hot?Melt Extrusion method with near?Infrared Spectroscopy (pages 333–353): Chris Heil and Jeffrey Hirsch
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Additional info for Hot-Melt Extrusion: Pharmaceutical Applications
Longer elements (1/2 L/D) introduce higher shear while shorter elements (1/8 L/D) improve dispersive mixing. 4 Distributive Flow Elements Distributive ﬂow elements generate a low-energy mixing. The distributive ﬂow dominates over shear ﬂow. These types of elements may be used to incorporate liquids into a melt further downstream of the extruder barrel. Each element combines an outer grooved and inner plain diameter disk. The orientation of the elements alters on both shafts. Due to the notched outer disk, distributive ﬂow elements have a non-self-wiping geometry.
7b), resulting in a cold compressed solids bed that ‘ﬂoats’ within melted material. The solids bed is now isolated from metal contact; developing a good-quality melt is now unlikely if this solids bed simply proceeds down-channel. 8. 4 The oldest design (the Uniroyal) is depicted in the ﬁgure, but a variety of designs are available. A common problem with barrier screws is compaction of the solids bed such that the solids bed stops moving. This prevents the continual ﬂow of material movement through the screw.
G. injection molding) are widely used and accepted in the modern plastics industry. As the process is very robust and fairly easy to scale up, it is used from laboratory scale where only a few hundred grams of materials are being used up to production scale of >60 tons per hour output. In the 1980s, the company BASF was among the ﬁrst to apply the technology of HME for pharmaceutical applications . The process has became more and more popular in pharmaceutical research and production since then, as it offers some features which cannot be accessed by other means.
Hot-Melt Extrusion: Pharmaceutical Applications by Dennis Douroumis