Decomposer film for transdermal patches

• US 20070014839A1
• Filed: 01/06/2006
• Published: 01/18/2007
• Est. Priority Date: 07/18/2005
• Status: Abandoned Application

• Current Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Original Assignee: Bayer Intellectual Property GmbH (Bayer AG)
• Inventors: Bracht, Stefan
• Application Number:
  US11/327,823
• Publication Number:
  US 20070014839A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/18 Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
• 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 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61P 15/18 Feminine contraceptives
• 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: B09B 2101/68 Transdermal patches
• CPC Class Codes: B09B 3/0075 Disposal of medical waste casings for used articles, e.g. sharps A61B50/362; sterilisation of refuse A61L11/00; disposal of used needles or syringes A61M5/3205; disintegrating medical waste B02C19/0075

Abstract

The decomposer film product has a polymeric decomposer layer, a cover layer for protecting the decomposer film from the surroundings and a releasable support liner, which is removed prior to use. The polymeric decomposer film contains a water-soluble or water-insoluble polymeric adhesive material and a decomposition accelerator, which acts to decompose an effective ingredient, such as a steroid hormone, of a worn or unused transderamal patch, when the effective ingredient releasing layer of the patch adheres to the polymer film, so that the pharmaceutical effective ingredient comes into contact with the decomposition accelerator by diffusion. The decomposition accelerator includes a chemically oxidizing substance, preferably urea peroxide, manganese (III) acetate or iron (III) citrate. The water-insoluble polymeric adhesive material is preferably an acrylates adhesive. The water-soluble polymeric adhesive material is preferably polyvinyl alcohol, polyvinyl pyrrolidone, a cellulose derivative or a polyacrylic acid.

Claims

1. A polymer film comprising at least one decomposer layer, wherein said at least one decomposer layer contains at least one decomposition accelerator, said decomposition accelerator being effective to decompose at least one pharmaceutical effective ingredient contained in a worn or unused transderamal patch, when an effective ingredient releasing layer of said patch adheres to the polymer film so that the pharmaceutical effective ingredient comes into contact with the decomposition accelerator by diffusion.

2. The polymer film as defined in claim 1, wherein at least 50 percent by weight of the at least one pharmaceutical effective ingredient in the transdermal patch has decomposed chemically one month after adherence of the effective ingredient releasing layer to the polymer film and at least 90 percent by weight of the at least one pharmaceutical effective ingredient has decomposed chemically six months after adherence of the effective ingredient releasing layer to the polymer film.

3. The polymer film as defined in claim 1, in which the at least one pharmaceutical effective ingredient has a solubility in said at least one decomposer layer that is greater than a solubility of the at least one pharmaceutical effective ingredient in the effective ingredient releasing layer of the transdermal patch.

4. The polymer film as defined in claim 3, wherein said solubility in said decomposer layer is at least twice as great as said solubility in said releasing layer of the transdermal patch.

5. The polymer film as defined in claim 1, wherein said at least one decomposition accelerator comprises a chemically oxidizing substance.

6. The polymer film as defined in claim 5, wherein said chemically oxidizing substrate is selected from the group consisting of iron (III) citrate, manganese dioxide, manganese (III) acetate, copper (II) acetate, urea peroxide, carbamide peroxide, potassium persulfate, sodium persulfate, potassium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium polyphosphate peroxide, zinc peroxide and peroxy acetic acid.

7. The polymer film as defined in claim 5, wherein said chemically oxidizing substrate is selected from the group consisting of urea peroxide, manganese (III) acetate and iron (III) citrate.

8. The polymer film as defined in claim 5, wherein said at least one decomposition accelerator comprises an alkaline reacting substance.

9. The polymer film as defined in claim 8, wherein said alkaline reacting substance is potassium hydroxide, sodium hydroxide, triethanolamine, diethanolamine, 2-amino-2-methyl-1-propanol, hydrotalcide, arginine, lysine, Eudragit E100, sodium trisilicate, sodium metasilicate, disodium hydrogen phosphate, trisodium phosphate or sodium polyphosphate ((NaPO₃)₆.

10. The polymer film as defined in claim 8, wherein said alkaline reacting substance is selected from the group consisting of 2-amino-2-methyl-1-propanol, sodium trisilicate and sodium metasilicate.

11. The polymer film as defined in claim 1, wherein said at least one decomposition accelerator comprises at least one catalytically acting metal ion.

12. The polymer film as defined in claim 11, wherein said at least one catalytically acting metal ion is selected from the group consisting of iron (III), copper (II) and Manganese (III) and said at least one catalytically acting metal ion is present in the polymer film in the form of at least one organic or inorganic salt.

13. The polymer film as defined in claim 12, wherein said at least one organic or inorganic salt is present in dissolved form.

14. The polymer film as defined in claim 1, wherein said at least one decomposition accelerator comprises at least one chemically acid reacting substance.

15. The polymer film as defined in claim 14, wherein said at least one chemically acid reacting substance is at least one organic acid with a pK_a value under 4.0.

16. The polymer film as defined in claim 15, wherein said at least one organic acid is selected from the group consisting of lactic acid, ethylenediamine tetracetic acid, tartaric acid, succinic acid and citric acid.

17. The polymer film as defined in claim 1, wherein said at least one decomposition accelerator comprises a plurality of decomposition accelerating agents.

18. The polymer film as defined in claim 1, having adhesive properties and based on a water-insoluble adhesive.

19. The polymer film as defined in claim 18, wherein said water-insoluble adhesive is a hydrocarbon material or an acrylate adhesive.

20. The polymer film as defined in claim 1, wherein said at least one pharmaceutical effective ingredient is at least one steroid hormone selected from the group consisting of gestagens, estrogens and androgens.

21. The polymer film as defined in claim 20, wherein said at least one steroid hormone is ethinyl estradiol, levonorgestrel or gestoden.

22. The polymer film as defined in claim 1, further comprising a flat support liner and a releasable protective film for covering the polymer prior to use.

23. The polymer film as defined in claim 22, wherein said releasable protective film is on a side opposite to that of said flat support liner.

24. The polymer film as defined in claim 22, wherein said flat support linear is part of a primary or secondary package of the transdermal patch.

25. The polymer film as defined in claim 19, wherein said hydrocarbon material is selected from the group consisting of polyisobutylene, polyisoprene and polybutene.

26. The polymer film as defined in claim 1, having no adhesive properties and based on a water-soluble adhesive.

27. The polymer film as defined in claim 26, wherein said water-soluble adhesive is selected from the group consisting of polyvinyl alcohol, polyvinyl pyrrolidone, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethyl cellulose and polyacrylic acids.

28. The polymer film as defined in claim 1, wherein the at least one decomposition accelerator is completely dissolved in said at least one decomposer layer.

29. The polymer film as defined in claim 1, comprising a highly dispersed filling material for increasing interior surface area.

30. The polymer film as defined in claim 29, containing from 0.1 to 5.0 percent by weight of said highly dispersed filling material and said highly dispersed filling material is selected from the group consisting of silicon dioxide, titanium dioxide, zinc oxide, talcum powder and activated charcoal.