Pharmaceutical formulations
First Claim
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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%, andvi) 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, andwherein 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.
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Abstract
The present invention is directed to novel pharmaceutically acceptable polymeric compositions suitable for injection molding of single or multi-component pharmaceutical dosage forms comprising a plurality of drug substance containing sub-units, being capsule compartments and/or solid sub-units comprising a solid matrix of a polymer which contains a drug substance, the sub-units being connected together in the assembled dosage form by a weld between parts of the assembled dosage form.
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Citations
26 Claims
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1. An extruded and injection-molded multi-component pharmaceutical dosage form comprising a plurality of sub-units comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification