Paula Mcmullen Davis

US Patent:

56701586, Sep 23, 1997

Filed:

Nov 15, 1995

Appl. No.:

8/558338

Inventors:

Paula Denise Davis - Cincinnati OH
Douglas Joseph Dobrozsi - Cincinnati OH
Gary Robert Kelm - Cincinnati OH
Kenneth Gary Mandel - Fairfield OH

Assignee:

The Procter & Gamble Company - Cincinnati OH

International Classification:

A61K 900
A61K 31715
A61K 4700

US Classification:

424400

Abstract:

The subject invention involves pharmaceutical compositions in dosage unit form, for peroral administration of bisacodyl to a human or lower animal having a gastrointestinal tract, with a lumen therethrough, with a small intestine and a colon with a junction therebetween, comprising: (a) a safe and effective amount of rapidly-dissolving bisacodyl means; and (b) a delivery means which prevents the release of bisacodyl from the dosage form into the lumen of the gastrointestinal tract during transport of the dosage form through the lumen until the dosage form is near the junction between the small intestine and the colon or in the colon, and which then releases the bisacodyl in the lumen near the junction between the small intestine and the colon or within the colon, The subject invention also involves methods for providing laxation for humans and lower animals in need thereof by peroral administration of such compositions.

US Patent:

56310226, May 20, 1997

Filed:

Jul 6, 1995

Appl. No.:

8/498612

Inventors:

Kenneth G. Mandel - Fairfield OH
Paula D. Davis - Cincinnati OH

Assignee:

The Procter & Gamble Company - Cincinnati OH

International Classification:

A61K 964

US Classification:

424456

Abstract:

A pharmaceutical laxative composition in unit dosage form, for peroral administration of picosulphate to a human or other animal subject, comprising a safe and effective amount of picosulphate in a rapidly dissolving matrix; and a proximal colonic delivery carrier which effects release of said picosulphate substantially near the junction between the small intestine and the colon or within the colon of said subject. This invention also involves methods for providing laxation for humans and other animals in need thereof by peroral administration of such compositions.

US Patent:

56562900, Aug 12, 1997

Filed:

May 17, 1995

Appl. No.:

8/442914

Inventors:

Gary Robert Kelm - Cincinnati OH
Gary Lee Manring - Hamilton OH
Paula Denise Davis - Cincinnati OH
Douglas Joseph Dobrozsi - Loveland OH
Kenneth Gary Mandel - Fairfield OH

Assignee:

The Procter & Gamble Company - Cincinnati OH

International Classification:

A61K 948
A61K 932
A61K 936
A61K 958

US Classification:

424456

Abstract:

The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine, comprising: a. a safe and effective amount of rapidly dissolving bisacodyl incorporated into or coated on the surface of a dosage form selected from the group consisting of a spherical substrate, an elliptical substrate, a hard capsule, or a compressed tablet, with a maximum diameter of about 3 mm to about 10 mm; and b. an enteric polymer coating material comprising at least one inner coating layer and one outer coating layer; wherein the dosage form has a smooth surface free from edges or sharp curves; the elliptical substrate and the hard capsule have a ratio of the long to short diameters of no greater than about 1. 5; the rapidly dissolving bisacodyl is released at a point near the inlet to, or within the colon; each of the inner coating layer(s) is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 5 to about 6. 3; and the outer coating layer is an enteric polymer that begins to dissolve in an aqueous media at a pH between about 6.

US Patent:

56519834, Jul 29, 1997

Filed:

May 17, 1995

Appl. No.:

8/442915

Inventors:

Gary Robert Kelm - Cincinnati OH
Gary Lee Manring - Hamilton OH
Paula Denise Davis - Cincinnati OH
Douglas Joseph Dobrozsi - Loveland OH
Kenneth Gary Mandel - Fairfield OH

Assignee:

The Procter & Gamble Company - Cincinnati OH

International Classification:

A61K 920
A61K 922
A61K 31715
A61K 4740

US Classification:

424452

Abstract:

The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen therethrough having an inlet to the colon from the small intestine, comprising: a. a safe and effective amount of rapidly dissolving bisacodyl incorporated into or coated on the surface of a dosage form selected from the group consisting of a spherical substrate, an elliptical substrate, a hard capsule, or a compressed tablet, with a maximum diameter of about 3 mm to about 10 mm; and b. an enteric polymer coating material; wherein the dosage form has a smooth surface free from edges or sharp curves; the elliptical substrate and the hard capsule have a ratio of the long to short diameters of no greater than about 1. 5; the rapidly dissolving bisacodyl is released at a point near the inlet to, or within the colon; the enteric polymer coating material begins to dissolve in an aqueous media at a pH between about 5 to about 6. 3; and the enteric polymer coating material has a coating thickness of at least about 250. mu. m.