Hydrogel compositions with an erodible backing member

• US 9,084,723 B2
• Filed: 06/02/2014
• Issued: 07/21/2015
• Est. Priority Date: 05/01/2001
• Status: Expired due to Fees

• Current Assignee: A. V. Topchiev Institute of Petrochemical Synthesis, Russian Academy of Sciences,, Corium LLC
• Original Assignee: A. V. Topchiev Institute of Petrochemical Synthesis, Russian Academy of Sciences,, Corium International, Inc.
• Inventors: Singh, Parminder, Faasse, Adrian, Cleary, Gary W., Mudumba, Sri, Feldstein, Mikhail M., Bayramov, Danir F.
• Primary Examiner(s): GHALI, ISIS A D
• Application Number:
  US14/293,703
• Publication Number:
  US 20140271781A1
• Time in Patent Office: 414 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61C 19/066 Bleaching devices; Whitening agent applicators for teeth, e.g. trays or strips
• CPC Class Codes: A61K 2800/262 Transparent; Translucent
• CPC Class Codes: A61K 2800/54 Polymers characterized by specific structures/properties
• CPC Class Codes: A61K 2800/5422 nonionic
• CPC Class Codes: A61K 8/0204 Specific forms not provided for by any of groups A61K8/0208 - A61K8/14
• CPC Class Codes: A61K 8/0208 Tissues; Wipes; Patches
• CPC Class Codes: A61K 8/042 Gels
• CPC Class Codes: A61K 8/22 Peroxides; Oxygen; Ozone
• CPC Class Codes: A61K 8/42 Amides
• CPC Class Codes: A61K 8/731 Cellulose; Quaternized cellulose derivatives
• CPC Class Codes: A61K 8/733 Alginic acid; Salts thereof
• CPC Class Codes: A61K 8/8147 Homopolymers or copolymers of acids; Metal or ammonium salts thereof, e.g. crotonic acid, (meth)acrylic acid; Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/8152 Homopolymers or copolymers of esters, e.g. (meth)acrylic acid esters; Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/817 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions or derivatives of such polymers, e.g. vinylimidazol, vinylcaprolactame, allylamines (Polyquaternium 6)
• CPC Class Codes: A61K 8/8176 Homopolymers of N-vinyl-pyrrolidones. Compositions of derivatives of such polymers
• CPC Class Codes: A61K 8/86 Polyethers
• CPC Class Codes: A61L 15/60 Liquid-swellable gel-forming materials, e.g. super-absorbents
• CPC Class Codes: A61L 15/64 specially adapted to be resorbable inside the body
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: C08L 2312/00 Crosslinking

Abstract

A composition is provided, wherein the composition comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer capable of hydrogen or electrostatic bonding to the hydrophilic polymer. The composition also includes a backing member. Active ingredients, such as a whitening agent, may be included. The composition finds utility as an oral dressing, for example, a tooth whitening composition that is applied to the teeth in need of whitening. The composition can be designed to be removed when the degree of whitening has been achieved or left in place and allowed to erode entirely. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Claims

1. A system comprising,

(i) an outer erodible backing member that serves as an external surface following application to a mucosal body surface or oral cavity,

(ii) a surface contact adhesive layer adhered to the backing member, the surface contact adhesive layer comprised of a hydrogel comprising a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer capable of hydrogen or electrostatic bonding to the hydrophilic polymer, and an active agent,

wherein the outer erodible backing member comprises a polymer selected from the group consisting of acrylate polymers, cellulosic polymers, starches, alginates, polyamino acids and combinations thereof, and erodes in a moist environment at a slower rate than the surface contact adhesive layer.

2. The system of claim 1, wherein the water-swellable, water-insoluble polymer is selected from the group consisting of a cellulose ester, alginic acid, and an acrylate polymer.

3. The system of claim 2, wherein the water-swellable, water-insoluble polymer is a cellulose ester selected from the group consisting of cellulose acetate, cellulose acetate propionate, cellulose acetate butyrate, cellulose propionate, cellulose butyrate, cellulose propionate butyrate, cellulose diacetate, and cellulose triacetate.

4. The system of claim 2, wherein the water-swellable, water-insoluble polymer is a cellulose ester comprised of a mixture of cellulose and cellulose ester monomer subunits.

5. The system of claim 2, wherein the water-swellable, water-insoluble polymer is an acrylate polymer selected from the group consisting of acrylate polymers and copolymers.

6. The system of claim 5, wherein the acrylate polymer is an acrylic acid or an acrylic acid ester polymer.

7. The system of claim 5, wherein the acrylate polymer is selected from polymers and copolymers of acrylic acid, methacrylic acid, methyl acrylate, ethyl acrylate, methyl methacrylate, and ethyl methacrylate.

8. The system of claim 5, wherein the acrylate polymer is a copolymer of methacrylic acid and ethyl acrylate.

9. The system of claim 1, wherein the water-swellable, water-insoluble polymer is insoluble in aqueous liquids at a pH of less than 5.5.

10. The system of claim 1, wherein the hydrophilic polymer is selected from the group consisting of poly(N-vinyl lactams), poly(N-vinyl acrylamides), poly(N-alkylacrylamides), polyacrylic acids and polymethacrylic acids, poly(vinyl alcohol), polyvinylamine, and copolymers thereof.

11. The system of claim 10, wherein the hydrophilic polymer is a poly(N-vinyl lactam).

12. The system of claim 1, wherein the complementary oligomer is selected from the group consisting of polyhydridic alcohols, monomeric and oligomeric alkylene glycols, polyalkylene glycols, alkane diols and carbonic diacids.

13. The system of claim 12, wherein the complimentary oligomer is a polyethylene glycol having a molecular weight in a range from 200 to 600 daltons.

14. The system of claim 1, wherein the system is a tooth whitening system and the active agent is a tooth whitening agent.

15. The system of claim 14, wherein the tooth whitening agent is a peroxide.

16. The system of claim 1, wherein the erodible backing member is substantially non-tacky.

17. The system of claim 1, wherein the erodible backing member comprises a cellulosic polymer.

18. The system of claim 1, further comprising a removable release liner, which upon removal, exposes the surface contact adhesive layer.

19. The system of claim 1, wherein the outer erodible backing member further comprises a substrate layer.

20. The system of claim 19, wherein the substrate layer is occlusive.

21. The system of claim 1, wherein the hydrogel comprises a single phase.

22. The system of claim 15, wherein the water-swellable, water-insoluble polymer is an acrylate polymer, the hydrophilic polymer is a poly(N-vinyl lactam) and the complementary oligomer is a polyalkylene glycol.

23. A method for whitening teeth of a human subject, the method comprising applying the surface contact adhesive layer of the teeth whitening system of claim 22 to one or more teeth of the subject.

24. The method of claim 23, wherein the teeth whitening system comprises a removable release liner, which is released prior to the applying step, to thereby expose the surface of the contact adhesive layer.

25. The method of claim 23, further comprising maintaining the teeth whitening system on the one or more teeth for a period of time ranging from a few minutes to several hours.

26. The method of claim 25, further comprising removing the system from the one or more teeth following the maintaining step.