Back to results
US 6,270,807 B1Granted
Taste-masked pharmaceutical composition
AssigneeL. Perrigo Company
InventorsDouglas Willard Danielson, Shirish A. Shah
Life of this patent
Estimating the term…
Abstract
A chewable dosage form containing a histamine H2-receptor antagonist in an amount which is effective to treat a gastrointestinal disorder is provided in a palatably acceptable form. The dosage form comprises granules containing the histamine H2-receptor antagonist, which are provided with a taste-masking coating comprising a water-insoluble, water-permeable methacrylate ester copolymer in which the coating is applied to the granules in an amount which provides a taste-masking effect for a relatively short period during which the composition is being chewed by a patient, but which allows substantially immediate release of the histamine H2-receptor antagonist after the composition has been chewed and ingested.
Claims20
A chewable dosage form comprising:
- a histamine H2-receptor antagonist in an amount which is effective to treat a gastrointestinal disorder, the histamine H2-receptor antagonist selected from the group consisting of ranitidine, nizatidine, famotidine, sufotidine, roxatidine, bisfentidine, tiotidine, lamtidine, niperotidine, mifentidine, zaltidine and loxtidine, the histamine H2-receptor antagonist being present in the form of granules which are provided with a polymeric coating, the polymeric coating being present in an amount which is sufficient to mask the taste of the histamine H2-receptor antagonist, but which allows substantially immediate release of the histamine H2-receptor antagonist after the dosage form is chewed and swallowed, the polymeric coating consisting essentially of a methacrylate ester copolymer which is water-insoluble and water-permeable, and optionally a minor amount of one or more ingredients selected from emulsifiers, wetting agents, drying agents, curing accelerators and stabilizers.
A chewable dosage comprising:
- a histamine H2-receptor antagonist in an amount which is effective to treat a gastrointestinal disorder, the histamine H2-receptor antagonist being selected from the group consisting of ranitidine, anitidine, nizatidine, famotidine, sufotidine, roxatidine, bisfentidine, tiotidine, lamtidine, niperotidine, mifentidine, zaltidine and loxtidine, the histamine H2-receptor antagonist being present in the form of granules which are provided with a polymeric coating, the polymeric coating being present in an amount which is sufficient to mask the taste of the histamine H2-receptor antagonist, but which allows substantially immediate release of the histamine H2-receptor antagonist after the dosage form is chewed and swallowed, the polymeric coating consisting essentially of a water-insoluble and water-permeable methacrylate ester copolymer and optionally a minor amount of one or more ingredients selected from emulsifiers, wetting agents, drying agents, curing accelerators and stabilizers, wherein the methacrylate ester copolymer has the general formula:
- wherein R is an alkyl group having 2 to 12 carbon atoms or an aminoalkyl having from 1 to 12 carbon atoms, and n1, n2 and n3 are selected so that the polymer has a molecular weight of from about 100,000 to about 1,000,000.
A chewable dosage form comprising:
- famotidine in an amount that is effective to treat a gastrointestinal disorder, the famotidine being present in the form of granules that are provided with a polymeric coating, the polymeric coating being present in an amount that is sufficient to mask the taste of the famotidine, but which allows substantially immediate release of the famotidine after the dosage form is chewed and swallowed, the polymeric coating consisting essentially of a methacrylate ester copolymer that is water-insoluble and water-permeable and optionally a minor amount of one or more ingredients selected from emulsifiers, wetting agents, drying agents, curing accelerators and stabilizers, wherein the methacrylate ester copolymer has the general formula:
- wherein R is an alkyl group having from 2 to 12 carbon atoms or an aminoalkyl having from 1 to 12 carbon atoms, and n1, n2 and n3 are selected so that the polymer has a molecular weight of about 800,000, and wherein the ratio of n1:n2 is from about 1:2 to about 2:1, and the ratio of n3:(n1+n2) is at or below about 1:15.
A method of forming a chewable dosage form containing a histamine H2-receptor antagonist, comprising:
- granulating a mixture comprising a histamine H2-receptor antagonist, a binder, and a carrier to form granules having a size of from about 150 microns to about 400 microns;
- applying a polymeric coating to the granules in an amount which is sufficient to mask the taste of the histamine H2-receptor antagonist wherein the dosage form is chewed, but which allows substantially immediate release of the histamine H2-receptor antagonist after the dosage form has been chewed and swallowed, the polymeric coating consisting essentially a methacrylate ester copolymer which is water-insoluble and water-permeable and optionally a minor amount of one or more ingredients selected from emulsifiers, wetting agents, drying agents, curing accelerators and stabilizers;
- and
- compressing the polymer coated granules, either alone or with one or more of extra-granular excipients, adjuvants, fillers and/or other active ingredients, to form a chewable tablet.
1 more element
Dependencies are inferred from the claim text.