Composition and applicator for topical substance delivery

• US 6,592,860 B1
• Filed: 05/30/2000
• Issued: 07/15/2003
• Est. Priority Date: 05/30/2000
• Status: Expired due to Term

• Current Assignee: Solsys Medical LLC (Smith & Nephew PLC)
• Original Assignee: Soluble Systems LLC
• Inventors: Rancourt, James David, Levy, Guy Glickson, Williams, Carl Anthony, Gerdon, Christine June
• Primary Examiner(s): DEES, JOSE G
• Assistant Examiner(s): DeWitty, R
• Application Number:
  US09/580,679
• Time in Patent Office: 1,141 Days
• Field of Search: 424/422, 424/78.08, 424/484, 424/434, 525/116
• US Class Current: 424/78.08
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61L 26/0014 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 26/008 Hydrogels or hydrocolloids
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 17/16 Emollients or protectives, e.g. against radiation
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 21/02 Muscle relaxants, e.g. for tetanus or cramps
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 27/04 Artificial tears; Irrigation solutions
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 39/02 Antidotes
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: C08F 220/20 : of polyhydric alcohols or phenols , e.g. 2-hydroxyethyl (meth)acrylate or glycerol mono-(meth)acrylate
• CPC Class Codes: C08L 33/14 : of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen

Abstract

A polymerized hydrogel composition and applicator for hydrating or dehydrating a surface, particularly a dermatological surface, to which it is applied and a method for forming the composition. The composition is comprised of a mixture of two polymerizable materials, a two-part redox catalyst system and a two-part polymerization medium. The percentage by weight of each element in the composition may be varied within stated percentage ranges. The rate at which hydration or dehydration occurs may be controllably altered by varying the percentages of certain of the composition elements. The applicator includes a thermoplastic center section and two reservoir sections each having a reservoir storage area for holding moisture and/or medicaments. The composition is mechanically bonded onto each of the reservoir sections and then hydrated. The applicator is designed for insertion into a human mouth after hydration and is used for treating xerostomia.

Claims

1. A reusable, nonbioadhesive, microporous polymerized hydrogel composition for releasing moisture onto or absorbing moisture from a surface at a variable, controllable and customizable moisture release or moisture absorption rate having two polymerizable materials, a polymerization initiator and a two-part polymerization medium comprised of:

a first polymerizable material further comprised of a hydrophilic acrylate-based monomer representing between 26% and 35% by weight of composition;

a second polymerizable material further comprised of a crosslinking agent representing between 1% and 1.8% by weight of the composition;

a redox catalyst system functioning as a polymerization initiator for said first and said second polymerizable materials comprised of a mixture of between 0.3% and 0.5% by weight of AP and between 0.1% and 0.3% by weight of TEMED;

distilled water representing between 62% and 72% by weight of the composition; and

a low molecular weight aliphatic alcohol representing between 0% and 11% by weight of the composition,

wherein said distilled water and said low molecular weight aliphatic alcohol are the two-part polymerization medium and wherein the moisture release rate of the composition is controllably increased by, prior to formation of the composition, doing any one or more of increasing the percentage by weight of said distilled water used to form the composition within the stated range, decreasing the percentage by weight of said low molecular weight aliphatic alcohol used to form the composition within the stated range while mechanically deforming the composition and decreasing the percentage by weight of said first polymerizable material used to form the composition within the stated range and, further, wherein the moisture absorption rate of the composition is controllably increased by, prior to formation of the composition, doing any one or more of decreasing the percentage by weight of said distilled water used to form the composition within the stated range, decreasing the percentage by weight of said low molecular weight aliphatic alcohol used to form the composition within the stated range and increasing the percentage by weight of said first polymerizable material used to form the composition within the stated range.

2. The composition of claim 1 wherein said first polymerizable material is any one selected from the group consisting of HEMA, 2-hydroxy ethylacrylate, 2-hydroxy propylacrylate or 4-hydroxy butylacrylate.

3. The composition of claim 1 wherein said second polymerizable material is any one selected from the group consisting of EGDMA, diethylene glycol dimethacrylate, trimethylpropane triacrylate or trimethylpropane trimethacrylate.

4. The polymerized composition of claim 1 wherein said low molecular weight aliphatic alcohol is IPA.

5. The composition of claim 1 wherein the maximum amount of moisture which the polymerized composition is capable of absorbing from a surface is increased by decreasing the percentage by weight of said low molecular weight aliphatic alcohol used to form the composition.

6. The composition of claim 1 wherein the composition is elastic and monolithic.

7. A method for controllably increasing the moisture release rate of a reusable, nonbioadhesive, microporous polymerized hydrogel composition having a hydrophilic acrylate-based monomer with a range of between 26% and 35% by weight of the composition, a crosslinking agent with a range of between 1% and 1.8% by weight of the composition, AP with a range of between 0.3% and 0.5% by weight of the composition, TEMED with a range of between 0.1% and 0.3% by weight of the composition, distilled water with a range of between 62% and 72% by weight of the composition, and a low molecular weight aliphatic alcohol with a range of between 0% and 11% by weight of the composition, comprising any one or more of the following steps undertaken prior to formation of the composition:

increasing the percentage by weight of said distilled water used to form the composition within the stated range;

decreasing the percentage by weight of said low molecular weight aliphatic alcohol used to form the composition within the stated range and mechanically deforming the composition; and

decreasing the percentage by weight of said hydrophilic acrylate-based monomer used to form the composition within the stated range.

8. The method of claim 7 wherein the composition is elastic and monolithic.

9. A method for controllably increasing the moisture absorption rate of a reusable, nonbioadhesive, microporous polymerized hydrogel composition having a hydrophilic acrylate-based monomer with a range of between 26% and 35% by weight of the composition, a crosslinking agent with a range of between 1% and 1.8% by weight of the composition, AP with a range of between 0.3% and 0.5% by weight of the composition, TEMED with a range of between 0.1% and 0.3% by weight of the composition, distilled water with a range of between 62% and 72% by weight of the composition, and a low molecular weight aliphatic alcohol with a range of between 0% and 11% by weight of the composition, comprising any one or more of the following steps undertaken prior to formation of the composition:

decreasing the percentage by weight of said distilled water used to form the composition within the stated range;

decreasing the percentage by weight of said low molecular weight aliphatic alcohol used to form the composition within the stated range; and

increasing the percentage by weight of said hydrophilic acrylate-based monomer used to form the composition within the stated range.

10. The method of claim 9 wherein the composition is elastic and monolithic.

11. A reusable, nonbioadhesive, microporous polymerized hydrogel composition for hydrating or dehydrating a surface with which the composition is placed in contact at a variable, controllable and customizable moisture release or moisture absorption rate comprised of:

a hydrophilic acrylate-based monomer in the range of 26% to 35% by weight of the composition;

a crosslinking agent in the range of 1% to 1.8% by weight of the composition;

a polymerization initiator;

water in the range of 62% to 72% by weight of the composition; and

an aliphatic alcohol in the range between 0% and 11% by weight of the composition.

12. The composition of claim 11 wherein said hydrophilic acrylate-based monomer is any one selected from the group consisting of HEMA, 2-hydroxy ethylacrylate, 2-hydroxy propylacrylate or 4-hydroxy butylacrylatc.

13. The composition of claim 11 wherein said crosslinking agent is any one selected from the group consisting of EGDMA, diethylene glycol dimethacrylate, trimethylpropane triacrylate or trimethylpropane trimethacrylate.

14. The composition of claim 11 wherein said polymerization initiator is a redox catalyst system.

15. The composition of claim 14 wherein said redox catalyst system is comprised of AP in the range of 0.3% to 0.5% by weight of the composition and TEMED in the range of 0.1% to 0.3% by weight of the composition.

16. The composition of claim 11 wherein said polymerization initiator is thermally activated.

17. The composition of claim 16 wherein said polymerization initiator is AIBN.

18. The composition of claim 11 wherein said aliphatic alcohol is isopropyl alcohol.

19. The composition of claim 18 wherein use of isopropyl alcohol reduces the amount of residual monomer in the polymerized hydrogel by up to 80%.

20. The composition of claim 11 wherein significant growth of microscopic organisms is not supported.

21. The composition of claim 11 wherein the composition is monolithic and elastic.

22. A method for making a specified amount of a reusable, nonbioadhesive, microporous polymerized hydrogel composition useful for hydrating or dehydrating a surface to which it is applied at a variable, controllable and customizable moisture release or moisture absorption rate and for forming the composition into a desired, molded shape based on use of a two-part polymerization medium, two polymerizable materials and a two-part redox catalyst system for polymerization initiation comprising the steps of:

weighing out an amount of distilled water as the first part of the polymerization medium within the range of 62% and 72% by weight of the amount of composition desired to be made;

weighing out an amount of a low molecular weight aliphatic alcohol as the second part of the polymerization medium within the range of 0% and 11% by weight of the amount of composition desired to be made;

combining the resulting distilled water and the resulting low molecular weight aliphatic alcohol into a mixture;

weighing out an amount of a first, hydrophilic, acrylate-based polymerizable material within the range of 26% and 35% by weight of the amount of composition desired to be made;

weighing out an amount of a second polymerizable material within the range of 1% and 1.8% by weight of the amount of composition desired to be made;

adding the resulting first and second polymerizable materials to the mixture;

weighing out an amount of the first part of the redox catalyst system within the range of 0.3% and 0.5% by weight of the amount of composition desired to be made;

thoroughly dissolving the first part of the redox catalyst system in the mixture;

weighing out an amount of the second part of the redox catalyst system within the range of 0.1% and 0.3% by weight of the amount of composition desired to be made;

adding the resulting second part of the redox catalyst system to the mixture;

transferring the resultant mixture to a mold within approximately two minutes after adding the second part of the redox catalyst system to the mixture;

removing the composition from the mold within between twenty and twenty-five minutes after adding the second part of the redox catalyst system to the mixture; and

washing the molded composition in a concentrated water solution for a period of at least twenty-four hours.

23. The method of claim 22 wherein the low molecular weight aliphatic alcohol is IPA.

24. The method of claim 22 wherein the first polymerizable material is any one selected from the group consisting of HEMA, 2-hydroxy ethylacrylate, 2-hydroxy propylacrylate or 4-hydroxy butylacrylate.

25. The method of claim 22 wherein the second polymerizable material is any one selected from the group consisting of EGDMA, diethylene glycol dimethacrylate, trimethylpropane triacrylate or trimethylpropane trimethacrylate.

26. The method of claim 22 wherein the first part of the redox catalyst system is AP which comprises 0.4% by weight of the amount of composition desired to be made.

27. The method of claim 22 wherein the second part of the redox catalyst system is TEMED which comprises 0.2% by weight of the amount of composition desired to be made.

28. The method of claim 22 wherein the composition is elastic and monolithic.