Oral film-form base and preparation

Patent metadata

Field	Value
Publication number	US-9439872-B2
Application number	US-201514813797-A
Country	US
Kind code	B2
Filing date	Jul 30, 2015
Priority date	Aug 27, 2014
Publication date	Sep 13, 2016
Grant date	Sep 13, 2016

Abstract

The present invention aims to provide an oral film-form base and an oral film-form preparation which have a rapid dissolution profile in the mouth and sufficient film strength, give a good tactile impression when handled with fingers and favorable texture and taste in the mouth, and are administrable to those who have limitation in carbohydrate intake. The present invention relates to an oral film-form base including an edible polymer soluble in water and an organic solvent having a solubility parameter of 9.7 or higher, and particles of at least one compound selected from the group consisting of amino acid, dipeptide, and nucleotide, the particles of at least one compound selected from the group consisting of amino acid, dipeptide, and nucleotide being dispersed in the state of particles in the oral film-form base.

First claim

The invention claimed is:

1. An oral film-form base comprising
an edible polymer soluble in water and an organic solvent having a solubility parameter of 9.7 or higher, and
particles of at least one compound selected from the group consisting of amino acid, dipeptide, and nucleotide,
the particles of at least one compound selected from the group consisting of amino acid, dipeptide, and nucleotide being dispersed in the state of particles in the oral film-form base,
wherein the oral film-form base does not contain sugar or sugar alcohol.

2. The oral film-form base according to claim 1 , wherein the particles of at least one compound selected from the group consisting of amino acid, dipeptide, and nucleotide have an average particle size of 0.1 to 60 μm.

3. The oral film-form base according to claim 1 , wherein the edible polymer soluble in water and an organic solvent having a solubility parameter of 9.7 or higher is solid at ambient temperature.

4. The oral film-form base according to claim 3 , wherein the edible polymer soluble in water and an organic solvent having a solubility parameter of 9.7 or higher is at least one of polyvinyl pyrrolidone and hydroxypropyl cellulose.

5. The oral film-form base according to claim 4 , wherein the polyvinyl pyrrolidone has a weight average molecular weight of 2500 to 3000000.

6. The oral film-form base according to claim 4 , wherein the hydroxypropyl cellulose has a weight average molecular weight of 10000 to 1150000.

7. The oral film-form base according to claim 4 , wherein the hydroxypropyl cellulose has a hydroxypropoxyl substitution degree of 50 to 100%.

8. The oral film-form base according to claim 1 , produced using an organic solvent having a solubility parameter of 9.7 or higher.

9. An oral film-form preparation comprising the oral film-form base according to claim 1 and a drug dispersed or dissolved in the oral film-form base.

Assignees

• Nitto Denko Corp

Inventors

• Matsushita Kyohei
• Asari Daisuke
• Shishido takuya
• Hori Mitsuhiko

Classifications

• A61K31/46

  8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine · CPC title

• A61K47/36

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

• A61K9/006

  Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays · CPC title

• A61K31/715

  Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters · CPC title

• A61K47/38

  Cellulose; Derivatives thereof · CPC title