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AssigneeEuroceltique, S.A.
InventorsHubert Rein, Klaus-Jurgen Steffens
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The invention relates to a method for producing pharmaceutical forms or preliminary stages thereof by means of extrusion. The pharmaceutical form has a matrix which the active agent is contained essentially, and whose essential characteristics are determined by the extrusion process and which comprises a polysaccharide and/or derivative thereof and/or a complex thereof and/or any mixture of the aforementioned substances with other substances and/or saccharides and/or derivatives thereof as an essential constituent, and at least one pharmaceutically active substance. The invention also relates to a pharmaceutical form which has a matrix in which the active agent is contained essentially, and whose essential characteristics are determined by the extrusion process, and which comprises a polysaccharide and/or derivative thereof and/or a complex thereof and/or any mixture of the aforementioned substances with other substances and/or saccharides and/or derivatives thereof as an essential constituent, and at least one pharmaceutically active substance. Finally, the invention also relates to the use of said pharmaceutical form for producing granulates for tabletting and filling capsules, for further processing using injection molding techniques and as an auxiliary material for direct tabletting and/or for producing monobloc pharmaceutical forms.
A method for producing a controlled release matrix, comprising co-extruding through an extruder a composition comprising a dry mixture of at least one pharmaceutically active agent and at least one starch, wherein the temperature at the orifice of the extruder during the extrusion process is below 100° C. under normal pressure, and wherein the co-extruding is under sheer force, temperature and pressure conditions such that the starch in the extruded controlled release matrix is vitrified, and wherein up to 15% by weight water is added to the composition prior to co-extruding.
A controlled release matrix, comprising at least one starch and at least one pharmaceutically active agent, wherein the starch in the matrix is vitrified, and wherein the starch and pharmaceutically active agent were co-extruded.
Dependencies are inferred from the claim text.