2015
DOI: 10.1208/s12249-015-0360-7
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Hot-Melt Extrusion: from Theory to Application in Pharmaceutical Formulation

Abstract: Abstract. Hot-melt extrusion (HME) is a promising technology for the production of new chemical entities in the developmental pipeline and for improving products already on the market. In drug discovery and development, industry estimates that more than 50% of active pharmaceutical ingredients currently used belong to the biopharmaceutical classification system II (BCS class II), which are characterized as poorly water-soluble compounds and result in formulations with low bioavailability. Therefore, there is a… Show more

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Cited by 435 publications
(265 citation statements)
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“…15,17) Hot-melt extrusion is an established method that uses an extruder. 23,24) In contrast, the soaking method involves the simple soaking of a polymer filament in organic solvent saturated with the drug (in this case, a drug ethanoic solution) and the drug diffuses into the polymer filament. The soaking method is limited to drugs soluble in organic solvent, and the resulting loaded amount of drug is lower than obtained using the hot-melt extrusion method.…”
Section: Resultsmentioning
confidence: 99%
“…15,17) Hot-melt extrusion is an established method that uses an extruder. 23,24) In contrast, the soaking method involves the simple soaking of a polymer filament in organic solvent saturated with the drug (in this case, a drug ethanoic solution) and the drug diffuses into the polymer filament. The soaking method is limited to drugs soluble in organic solvent, and the resulting loaded amount of drug is lower than obtained using the hot-melt extrusion method.…”
Section: Resultsmentioning
confidence: 99%
“…A twin screw extruder, compared to single screw extruder, provides the following advantages: a higher dispersibility, easier feeding, a lower risk of overheating, higher process productivity, and a better modulation of process parameters [9,19,20].…”
Section: Preparation and Particle Characterizations Of Znso 4 /Sp Ncsmentioning
confidence: 99%
“…Materials can be thrown into the extruder, moved towards the die and homogeneously blended by rotating screws, and extruded from the die (or an orifice) [8][9][10][11]. During the HME process, the temperature of barrels is designed above the glass transition temperature (T g ) and sometimes over the melting temperature (T m ) of polymeric substances, and the drug can be molecularly dispersed in the polymer matrix [9,12,13].…”
Section: Introductionmentioning
confidence: 99%
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“…In HME process, rotating screws drive the physical mixture (drug+inactive excipients) above the glass transition temperature (Tg) and/or above the melting temperature (Tm) based on the type of material used in the formulation. Thus, uniform mixing of active pharmaceutical ingredient and thermoplastic binders, polymers, or both is achieved (3). Thus, HME technology is used to formulate granules, pellets, immediate and controlled release tablets, and transdermal and transmucosal drug delivery systems (4)(5)(6).…”
Section: Introductionmentioning
confidence: 99%