Patent ID: 8673350
Filing Date: 2014-03-18
Classification: A61K

Abstract:
1. An extruded and injection-molded multi-component pharmaceutical dosage form comprising a plurality of sub-units comprising: a capsule shell providing pulsatile release of a drug substance contained within the shell, wherein the shell comprises a substantially pH-independent pharmaceutical composition comprising: i) a copolymer of methyl acrylate, methyl methacrylate and methacrylic acid, with a molecular weight of about 220,000 and a ratio of free carboxyl groups to ester groups of 1:10 present in an amount of about 15 to about 50% w/w, ii) at least two hydroxypropylcellulose polymers, present in an amount of about 20% to about 70% w/w, wherein one of the hydroxypropylcellulose polymers is a hydroxypropylcellulose polymer with an average molecular weight of 80,000 and the second hydroxypropylcellulose polymer is selected from a group consisting of a hydroxypropylcellulose polymer with an average molecular weight of 140,000 and a hydroxypropylcellulose polymer with an average molecular weight of 370,000; iii) a lubricant present in an amount of about 10% to about 25% w/w; iv) at least one dissolution modifying excipient selected from a disintegrant, a swellable solid, a non-reducing sugar, a water soluble filler, a wicking agent, or an inorganic salt, in combination or mixture thereof, present in an amount of about 2.5% to about 70% w/w; v) a surfactant present in an amount of about 0 to about 10%, and vi) a plasticizer present in an amount of about 0 to about 10% w/w and/or a processing agent present in an amount of 0 to about 10% w/w; and a solid sub-unit comprising a pharmaceutical polymeric composition soluble, dispersible or disintegrable in a patient's gastro-intestinal environment for release of a second drug substance contained in the solid sub-unit, and wherein at least prior to administration to a patient, the capsule shell is filled with the drug substance, and the plurality of sub-units are assembled into the dosage form.