Dosage form articles for external mucosal applications

Patent metadata

Field	Value
Publication number	US-2017312228-A1
Application number	US-201515523661-A
Country	US
Kind code	A1
Filing date	Nov 16, 2015
Priority date	Nov 27, 2014
Publication date	Nov 2, 2017
Grant date	—

Abstract

A dosage form article consisting of a hard capsule coated with a surface modifying coating wherein the coating is an aqueous composition comprising water and a muco-adhesive polymer selected from the group consisting of poly(acrylates), cellulose derivatives, hyaluronic acid, starch, poly(ethylene glycol), polysaccharides, collagen derivatives, and mixtures thereof, wherein the ratio of the muco-adhesive polymer to water is less than 0.15 by weight of the coating composition.

First claim

1 . A dosage form article comprising a hard capsule coated with a surface modifying coating composition wherein said coating is an aqueous composition comprising water and one or more muco-adhesive polymers comprising polyacrylates, cellulose derivatives, hyaluronic acid, starch, polyethylene glycol, polysaccharides, collagen derivatives, or mixtures thereof, wherein the ratio of said muco-adhesive polymer to water is less than 0.15, by weight of the coating composition, and wherein said coating is present in an amount of less than 2.5% by weight of the empty capsule.

2 . A dosage form article according to claim 1 wherein the ratio of said muco-adhesive polymer to water is from greater than 0 to 0.14, by weight of the coating composition.

3 . A dosage form article according to claim 1 wherein the coating is present in an amount of less than or equal to 2%, by weight of the empty capsule.

4 . A dosage form article according to claim 1 wherein the capsule is made of a shell material comprising gelatin, hydroxypropyl methylcellulose (HPMC), pullulan, or any mixture thereof.

5 . A dosage form article according to claim 1 wherein the muco-adhesive polymer comprises a polyacrylate selected from one or more carboxypolymethylenes with an average particle size of less than 0.5 microns.

6 . A dosage form article according to claim 5 wherein the carboxypolymethylene comprises a homopolymer of acrylic acid polymerized in ethyl acetate and crosslinked with a polyalkenyl polyether.

7 . A dosage form article according to claim 1 wherein the muco-adhesive polymer comprises pullulan.

8 . A dosage form article according to claim 1 wherein the coating is applied to the capsule in the form of a liquid.

9 . A dosage form article according to claim 1 wherein the muco-adhesive polymer is present in an amount of from 0.5% to 15%, by weight of the coating composition.

10 . A dosage form article according to claim 1 wherein at least 80% of the outer surface of said capsule is coated with said coating.

11 . A dosage form article according to claim 1 wherein the coating further comprises 0.1% to 5% by weight of said coating composition of one or more plasticizers.

12 . A dosage form article according to claim 1 wherein the coating consists of water, the muco-adhesive polymer(s), one or more plasticizers and optionally one or more dissolution enhancers.

13 . A method of imparting adhesiveness and rapid capsule disintegration to a hard capsule coated with an aqueous coating comprising water and one or more muco-adhesive polymers comprising polyacrylates, cellulose derivatives, hyaluronic acid, starch, polyethylene glycol, polysaccharides, collagen derivatives, or any mixture thereof.

14 . A dosage form article according to claim 1 wherein the coating is a dip coating.

15 . A dosage from article according to claim 1 wherein the coating comprises at least two muco-adhesive polymers and wherein at least one of said polymers is a carboxymethylenes and at least one other said polymer is pullulan.

16 . A dosage form article according to claim 1 wherein the ratio of said muco-adhesive polymer to water is from 0.010 to 0.1.

17 . A dosage form article according to claim 1 wherein the ratio of said muco-adhesive polymer to water is from 0.010 to 0.013.

18 . A dosage from article according to claim 15 wherein the at one of the at least two muco-adhesive polymers has an average particle size of less than 0.5 microns,

Assignees

• Capsugel Belgium Nv

Inventors

• Cade Dominique Nicolas
• Straub Hugues

Classifications

• A61K9/0034

  Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants · CPC title

• A61K9/4816

  Wall or shell material · CPC title

• A61K9/4891 Primary

  Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004) · CPC title

• A61K47/38

  Cellulose; Derivatives thereof · CPC title

• A61K47/36

  Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin · CPC title