Delayed release pharmaceutical preparations
First Claim
1. A delayed release pharmaceutical preparation in granular form comprising intermixed particles of at least one orally administrable therapeutically active agent and a substantially non-toxic water-soluble calcium salt selected from the group consisting of calcium levulinate, calcium gluconate, calcium citrate and calcium chloride, at least part of said particles of said agent and said salt being enveloped by solidifying a melt of at least one triglyceride of a fatty acid of 12 to 18 carbon atoms, said salt being present in an amount to provide at least 11/2 moles of calcium ion for each mole of said triglyceride and forming a substantially insoluble calcium soap with the fatty acid produced upon hydrolysis of said triglyceride in the intestinal tract, the granules of said preparation being of a grain size between about 0.1 mm. and about 1.0 mm. and containing between about 1 and 50% of said agent.
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Abstract
A novel delayed release pharmaceutical preparation which is free of added enzymes and thus is stable on storage is provided. The preparation comprises particles of the therapeutically effective agent, a water-soluble calcium salt, and, if desired, a filler material, stabilizer, and other additives uniformly embedded in a triglyceride of fatty acids with 12 to 18 carbon atoms, thereby forming a granular preparation of a grain size between about 0.1 mm. and about 1.0 mm. A process of producing such a preparation is also disclosed.
54 Citations
10 Claims
- 1. A delayed release pharmaceutical preparation in granular form comprising intermixed particles of at least one orally administrable therapeutically active agent and a substantially non-toxic water-soluble calcium salt selected from the group consisting of calcium levulinate, calcium gluconate, calcium citrate and calcium chloride, at least part of said particles of said agent and said salt being enveloped by solidifying a melt of at least one triglyceride of a fatty acid of 12 to 18 carbon atoms, said salt being present in an amount to provide at least 11/2 moles of calcium ion for each mole of said triglyceride and forming a substantially insoluble calcium soap with the fatty acid produced upon hydrolysis of said triglyceride in the intestinal tract, the granules of said preparation being of a grain size between about 0.1 mm. and about 1.0 mm. and containing between about 1 and 50% of said agent.
Specification