Hot-melt extruded dosage forms

The materials used in the production of hot-melt extruded dosage forms must meet the same levels of purity and safety as those used in traditional dosage forms. Most of the compounds used in the production of hot-melt extruded pharmaceuticals have been used in the production of other solid dosage forms such as tablets, pellets, and transdermals. The materials used in hot-melt extruded products must possess some degree of thermal stability in addition to acceptable physical and chemical stability. The thermal stability of each individual compound and the composite mixture should be sufficient to withstand the production process. 

Hot-melt extruded dosage forms are complex mixtures of active medicaments and functional excipients. The functional excipients may be broadly classified as matrix carriers, release modifying agents, bulking agents, and miscellaneous additives. The selection and use of various excipients can impart specific properties to hot-melt extruded pharmaceuticals in a manner similar to those in traditional dosage forms. 

Table 1 Properties of selected carriers used in the design and production of hot-melt extruded dosage forms...

Plasticizers may also be incorporated into hot-melt extruded dosage forms to improve the physical-mechanical properties of the final dosage form. In transdermal films, the addition of a plasticizer to the... 

Carrier Used to Prepare Hot-Melt Extruded Dosage Forms... 

Zhu, Y. Mehta, K.A. McGinity, J.W. Influence of plasticizer level on the drug release from sustained release film coated and hot-melt extruded dosage forms. Pharm. Dev. Technol. 2006, 77(3), 285-294. 

The aim is to assist the developer in the two pivotal development questions of a hot-melt extruded dosage form. 

Andrews GP, Jones DS et al (2008) The manufacture and characterisation of hot-melt extruded enteric tablets. Eur J Pharm Biopharm 69(1) 264—273 Arkenau-Maric E, Bartholomaus J (2008) Process for the production of an abuse proofed dosage form, US 2008031197 Al, USPTO, pp 11. 

McGinity J, Repka M. Hot melt extruded films. Drug Deliv Technol 2004 4(7) 40-47. Sood A, Ashokraj Y, Panchagnula R. Use of extrusion spenronization to develop controlled release dosage forms for diltiazem hydrochloride. Pharm Tech 2004 April 62-85. Jalal IM, Malinowski HJ, Smith WE. Tablet granulations composed of spherical-shaped particles. J Pharm Sci 1972 61 1466-1468. 

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