Controlled release oral dosage form
First Claim
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1. A sustained-release pharmaceutical preparation comprising:
- (a) a core comprising;
(i) a therapeutically effective dose of a calcium channel blocker;
(ii) an osmopolymer having a high and/or low molecular weight;
(iii) optionally, an osmagent;
(iv) an organic acid;
(v) optionally, a disintegrant, (vi) optionally, a lubricant; and
(vii) optionally, at least one pharmaceutically acceptable inert ingredient, (b) optionally, a seal coating surrounding said core, and;
(c) a water-insoluble coating comprising;
(i) a water insoluble polymer;
(ii) a plasticizer; and
(iii) a dissolution enhancing agent.
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Abstract
A sustained-release pharmaceutical preparation is disclosed in which a calcium channel blocker, preferably verapamil, core is surrounded by an optional seal coat layer and a water-insoluble coating.
60 Citations
37 Claims
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1. A sustained-release pharmaceutical preparation comprising:
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(a) a core comprising;
(i) a therapeutically effective dose of a calcium channel blocker;
(ii) an osmopolymer having a high and/or low molecular weight;
(iii) optionally, an osmagent;
(iv) an organic acid;
(v) optionally, a disintegrant, (vi) optionally, a lubricant; and
(vii) optionally, at least one pharmaceutically acceptable inert ingredient, (b) optionally, a seal coating surrounding said core, and;
(c) a water-insoluble coating comprising;
(i) a water insoluble polymer;
(ii) a plasticizer; and
(iii) a dissolution enhancing agent. - 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, 27, 28, 29, 30, 31, 32)
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33. The sustained-release pharmaceutical preparation wherein the core consists essentially of:
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30-50% of the calcium channel blocker;
2-10% of the organic acid;
10-35% of the low molecular weight osmopolymer;
10-20% of the high molecular weight osmopolymer;
2-10% of the disintegrant;
2-10% of the osmagent;
0.1-2% of the lubricant; and
the semipermeable coating consists essentially of;
70-80% water-insoluble polymer;
3-20% plasticizer; and
10-20% dissolution enhancing agent. - View Dependent Claims (34, 35, 36, 37)
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Specification