Adhesive device for application to body tissue

• US 4,900,554 A
• Filed: 12/23/1987
• Issued: 02/13/1990
• Est. Priority Date: 12/24/1986
• Status: Expired due to Term

• Current Assignee: Teikoku Seiyaku Co Limited (Teikoku Seiyaku)
• Original Assignee: Teikoku Seiyaku Co Limited (Teikoku Seiyaku)
• Inventors: Mizobuchi, Takafumi, Yanagibashi, Norio, Iwasaki, Setsuo, Konishi, Tatsuya, Konishi, Ryoji, Wato, Takahiko
• Primary Examiner(s): Robinson, Ellis P.
• Assistant Examiner(s): HORNE, LEON
• Application Number:
  US07/137,034
• Time in Patent Office: 783 Days
• Field of Search: 424/448, 424/449, 424/435, 524/35
• US Class Current: 424/448
• CPC Class Codes: A61F 2013/0071 containing active agent
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 15/585 Mixtures of macromolecular compounds
• CPC Class Codes: C08L 1/00 Compositions of cellulose, modified cellulose or cellulose derivatives
• CPC Class Codes: C08L 1/10 Esters of organic acids , i.e. acylates
• CPC Class Codes: C08L 1/12 Cellulose acetate
• CPC Class Codes: C08L 1/14 Mixed esters, e.g. cellulose acetate-butyrate
• CPC Class Codes: C08L 1/26 Cellulose ethers
• CPC Class Codes: C08L 1/28 Alkyl ethers
• CPC Class Codes: C08L 33/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical, or of salts, anhydrides, esters, amides, imides or nitriles thereof; Compositions of derivatives of such polymers

Abstract

An adhesive device for application to body tissue having an adhesive layer and a backing layer positioned over one side of the adhesive layer. The adhesive layer includes one or more acrylic acid polymers having adhesive properties upon dissolution or swelling in water, and at least one water insoluble cellulose derivative. The backing layer is water insoluble or sparingly water soluble.

Claims

1. An oral cavity adhesive device for application to a mucous membrane or oral cavity tissue of an individual, comprising:

an adhesive layer including a mixture of at least one acrylic acid polymer, a water-insoluble cellulose derivative, and a pharmaceutical preparation, said adhesive layer having an adhesive surface adherable to a mucous membrane or oral cavity tissue; and

a water-insoluble or sparingly water-soluble backing layer secured over said adhesive layer on a side opposite the adhesive surface;

wherein said acrylic acid polymer exhibits adhesiveness upon dissolution or swelling when applied to the mucous membrane or oral cavity tissue, and wherein the weight ratio of acrylic acid polymer to water-insoluble cellulose derivative is within a range which provides sustained adhesiveness of the adhesive layer with substantially no foreign body sensation.

2. An adhesive device as claimed in claim 1, wherein the water-insoluble cellulose derivative is ethyl cellulose, carboxymethyl cellulose, calcium carboxymethyl cellulose, carboxymethylethyl cellulose, cellulose acetate, cellulose acetatephthalate or hydroxypropylmethyl cellulose phthalate.

3. An adhesive device as claimed in claim 1, wherein the weight ratio of acrylic acid polymer to water-insoluble cellulose derivative is from about 99:

1 to about 50;

50.

4. An adhesive device as claimed in claim 1, wherein the weight ratio of acrylic acid polymer to water-insoluble cellulose derivative is from about 98:

2 to about 70;

30.

5. An adhesive device as claimed in claim 1, wherein the backing layer is ethylcellulose, cellulose acetate, cellulose acetatephthalate, hydroxypropylmethyl cellulose phthalate, vinyl acetate resin or a pharmacologically acceptable water-soluble polymer insolubilized by cross-linking.

9. An adhesive device as claimed in claim 1, wherein said pharmaceutical preparation comprises an analgesic inflammatory agent, a steroidal anti-inflammatory agent, an antihistimine, a local anesthetic, a bactericide, a disinfectant, a vasoconstriction, a hemostatic, a chemotherapeutic drug or an antibiotic, said pharmaceutical preparation being present in said adhesive layer in an amount of from about 0.001 to about 20 percent by weight.

10. An adhesive device as claimed in claim 1, wherein said pharmaceutical preparation comprises methylparaoxybenzoic acid.

11. An adhesive device as claimed in claim 1, wherein said pharmaceutical preparation comprises dibucaine hydrochloride.

12. An adhesive device as claimed in claim 1, wherein said pharmaceutical preparation comprises tranexamic acid.

6. A method for providing the sustained release of a pharmaceutical preparation to an individual, comprising the steps of:

(a) applying to a mucous membrane or oral cavity tissue of the individual an adhesive device comprising;

(1) an adhesive layer including a mixture of at least one acrylic acid polymer which exhibit adhesiveness upon dissolution or swelling when applied to said mucous membrane or oral cavity tissue and a water-insoluble cellulose derivative, and further including a pharmaceutical preparation; and

(2) a water-insoluble or sparingly water-soluble backing layer secured over said adhesive layer on a side opposite the adhesive surface; and

(b) contacting said adhesive device with a bodily fluid, thereby releasing said pharmaceutical preparation from said adhesive layer in a controlled manner;

wherein the weight ratio of acrylic acid polymer to water-insoluble cellulose derivative is within a range which provides sustained adhesiveness of the adhesive layer with substantially no foreign body sensation.

7. A method as claimed in claim 6, wherein the adhesive device is applied to oral cavity tissue.

8. A method as claimed in claim 6, wherein the oral cavity tissue comprises gingival tissue, lip tissue or a tooth.