A - Human Necessities – 61 – K
Patent
A - Human Necessities
61
K
167/164, 167/179
A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/28 (2006.01) A61K 9/50 (2006.01)
Patent
CA 1198370
ABSTRACT OF THE DISCLOSURE A pharmaceutical, oral-controlled release, multiple-units formulation and method for its production are provided herein. The individual units comprise particles containing a sparingly-soluble, active substance and a dispersion-enhancing substance which is readily soluble in intestinal fluids. The dispersion-enhancing substance is present in intimate admixture with the active substance. The particles are combined with at least one dis- integration-enhancing substance into cross-sectionally substantially-homo- geneous cores, the cores being coated with a coating which is substantially resistant to gastric conditions and which is erodable under the conditions prevailing in the small intestine. The formulation may be prepared by a method comprising the steps co-comminuting sparingly-soluble, active sub- stance with a dispersion-enhacing substance which is readily soluble in intestinal fluids, thereby to obtain particles in which the active substance is intimately admixed with said dispersion-enhancing substance. The particles are combined into cross-sectionally, substantially-homogeneous cores together, with at least one component which enhances the disintegration of the cores in intestinal fluids. The cores are then coated with a coating which is substantially resistant to gastric conditions, and which is erodable under the conditions prevailing in the small intestine. As the coating is erodable in an alkaline environment only, the active substance is not released until the units arrive at a section of the small intestine with an alkaline pH. Thus, a reduction and delay of the peak plasma concentration is obtained without affecting the extent of drug availability. A coating of the above- defined type may also be used when the active substance is a substance which exerts an irritating effect on the gastric mucosa and/or is unstable in an acidic environment.
416035
Bechgaard Helle
Houmýller Peter
Benzon Pharma A/s
Borden Ladner Gervais Llp
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