Anesthetizing plastics, drug delivery plastics, and related medical products, systems and methods

• US 6,461,644 B1
• Filed: 04/30/1998
• Issued: 10/08/2002
• Est. Priority Date: 03/25/1996
• Status: Expired due to Fees

• Current Assignee: Richard R. Jackson
• Original Assignee: Richard R. Jackson
• Inventors: Williams, John N., Jackson, Richard R.
• Primary Examiner(s): Williamson, Michael A.
• Application Number:
  US09/070,940
• Time in Patent Office: 1,622 Days
• Field of Search: 424/449, 514/277, 514/408, 514/529, 514/532, 514/534
• US Class Current: 424/499
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 2013/0296 for making transdermal patches (chemical processes excluded)
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• 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: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 29/141 Plasticizers
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 16/04 Tracheal tubes catheters in general A61M25/00
• CPC Class Codes: A61M 16/0443 Special cuff-wall materials A61M16/0481, A61M16/0422 take precedence
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 16/18 Vaporising devices for anaesthetic preparations
• CPC Class Codes: A61M 2205/0205 Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 35/00 : Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

Anesthetizing plastic or other drug delivery polymer system including a hydrophobic polymer and a drug that has an aromatic ring.

Claims

1. A transdermal drug delivery system including a drug delivery polymer in which a drug in the polymer has an aromatic ring, the drug incorporating at least one free amide or amine hydrogen in its structure, the polymer being hydrophobic and thermoplastic, the drug being soluble in the polymer in a concentration of at least 20% by weight, and the drug being in solution in the polymer in an effective concentration in excess of 20% by weight, the polymer being in the form of a layer adhered to a carrier sheet, the layer comprising pressure-sensitive adhesive adapted to adhere to skin.

3. The transdermal drug delivery system of claim 1 or 2 in which the drug is a topical anesthetic drug in base form.

4. The transdermal drug delivery system of claim 1 or 2 wherein the drug has the structure

5. The transdermal drug delivery system of claim 1 or 2 in the form of a transdermal patch in which the drug comprises a topical anesthetic compound in base form, which is more soluble in the polymer than in water, the amount of the anesthetic compound incorporated in the polymer rendering the composition suitable as a topical anesthetic agent.

6. The transdermal patch of claim 5 in which the anesthetic compound is selected from the group consisting procaine, mepivacaine, bupivicane, lidocaine, chloroprocaine, tetracaine, etidocaine, prilocaine, etidocaine, replivicaine, diphenhydramine and benzocaine.

7. The transdermal patch of claim 5 in which the polymer and anesthetic compound are present as a transparent layer.

8. The transdermal drug delivery system of claim 1 in which the drug is an anesthetic base selected from the group consisting of procaine, mepivacaine, bupivicane, lidocaine, chloroprocaine, tetracaine, etidocaine, prilocaine, etidocaine, replivicaine, diphenhydramine and benzocaine.

9. The composition of claim 1 or 2 wherein the drug comprises propafenone.

10. The transdermal drug delivery system of claim 1 in which the layer comprising pressure sensitive adhesive has solids in which the drug is substantially soluble, a non-adhesive polymeric resin distributed uniformly in non-particulate manner through the adhesive, and said drug.

11. The transdermal drug delivery system of claims 1, 10 or 2 in which the layer is sufficiently thin that there is no more than about 30 mg per inch square of drug present in the layer.

13. The transdermal drug delivery system of claims 1, 10 or 2 in which the layer is transparent.

14. The transdermal drug delivery system of claim 13 in which the layer is disposed on a transparent carrier sheet.

15. The transdermal drug delivery system of claims 1, 10, or 2 in which the drug is active upon nerves or an aspect of the nervous system.

16. The transdermal drug delivery system of claims 1, 10, or 2 in which the drug is an anesthetic, topical anesthetic, analgesic, a narcotic or opiate, or a stimulant of the nervous system.

17. The transdermal drug delivery system of claims 1, 10, or 2 in which the drug has local anesthetic properties, or is an antiarrhythmic or antiseizure drug, an adrenergic blocking drug, a sympathomimetic drug, an analgesic or antipyretic drug or a drug that stimulates the nervous system.

18. The transdermal drug delivery system of claims 1, 10 or 2 in which the drug comprises at least two drugs, one of which is soluble in the other, a solution of at least two drugs in the relative quantities present in the layer having a melting temperature below room temperature, and lower than the melting temperature of either drug alone.

19. The transdermal drug delivery system of claim 18 in which one of the drugs is an ester and one of the drugs is an amide.

20. The transdermal drug delivery system of claim 18 in which one of the drugs is tetracaine and one of the drugs is lidocaine.

21. The transdermal drug delivery system of claim 1 or 10 in which the adhesive is an acrylic adhesive of methacrylate resin.

22. The transdermal drug delivery system of claims 1, 10, or 2 in which the polymer or polymeric resin comprises PVC polymer.

23. The transdermal drug delivery system of claims 1, 10, or 2 in which the polymer or polymeric resin is selected from the group consisting polymers and copolymers of polyvinylchloride, other polymerized vinyl halides, chlorinated polyethylene, other halogenated polyolefins, ethylene propylene, cellulose resins such as cellulose nitrate, ethyl cellulose, and cellulose acetate, polystyrene, polyvinyl butyryl, acrylic resins, alkyl alkylacrylates, alkyl acrylates, acrylonitrile rubbers and chlorinated rubbers, polyesters, polyamides and polyformaldehyde.

24. The transdermal drug delivery system of claims 1, 10, or 2 in which the drug is selected from the group consisting of procaine, mepivacaine, bupivicane, lidocaine, chloroprocaine, cocaine, tetracaine, etidoncaine, prilocaine, etidocaine, replivicaine, diphenhydramine, and benzocaine.

25. The transdermal drug delivery system of claims 1, 10, or 2 in which the drug is fentanyl.

2. A transdermal drug delivery system including a drug delivery polymer in which a drug in the polymer has an aromatic ring, the drug incorporating at least one free amide or amine hydrogen in its structure, the polymer being hydrophobic and thermoplastic, the polymer being in the form of a non-adhesive layer of polymeric resin in which the drug is in substantial solution, and an adjoining adhesive band arranged to hold the non-adhesive layer against the skin, the drug being soluble in the polymer in a concentration of at least 20% by weight, and the drug being in solution in the polymer in an effective concentration in excess of 20% by weight.

12. The transdermal drug delivery system of claim 2 in which the polymeric resin and the drug comprise a congealed plastisol.

26. The transdermal drug delivery system of claim 2 in combination with a cushion arranged to press the drug-containing layer against the skin.

27. A transdermal drug delivery system including a drug delivery polymer in which a drug in the polymer has an aromatic ring, the drug incorporating at least one free amide or amine hydrogen in its structure, the polymer being hydrophobic and thermoplastic, the drug being soluble in the polymer in a concentration of at least 20% by weight, and the drug being in solution in the polymer in an effective concentration in excess of 20% by weight, the polymer being in the form of a pressure sensitive adhesive comprising medical grade pressure sensitive acrylic adhesive and polyvinyl chloride, the drug being in the form of one or more topical anesthetics in base form.

29. The transdermal drug delivery component of claim 27 in which the polyvinylchoride is distributed in the adhesive uniformly in a non-particulate manner.

30. The transdermal drug delivery system of claim 27, 29, or 28 in combination with a volatile alcohol as a paintable, coatable or sprayable composition onto the skin.

31. The transdermal drug delivery system of claim 27, 29, or 28 containing at least two miscible anesthetic bases, as drugs, in which the ratio of the weight of the two drugs, combined, to the weight of the combined adhesive solids and polyvinylchloride, or the polyvinylchloride when it appears alone, is greater than 50%.

28. A transdermal drug delivery system including a drug delivery polymer in which a drug in the polymer has an aromatic ring, the drug incorporating at least one free amide or amine hydrogen in its structure, and comprising one or more topical anesthetics in base form, the polymer being hydrophobic and thermoplastic, the drug being soluble in the polymer in a concentration of at least 20% by weight, and the drug being in solution in the polymer in an effective concentration in excess of 20% by weight, the polymer being polyvinyl chloride and the drug delivery system being in the form of a plastisol comprising said one or more topical anesthetics in base form and said polyvinyl chloride.

32. A transdermal drug delivery system including a drug delivery polymer in which a drug in the polymer has an aromatic ring, the drug incorporating at least one free amide or amine hydrogen in its structure, and comprising one or more topical anesthetics, the polymer being hydrophobic and thermoplastic, the drug being soluble in the polymer in a concentration of at least 20% by weight, and the drug being in solution in the polymer in an effective concentration in excess of 20% by weight, the drug delivery system being in the form of a congealed plastisol layer comprising said one or more topical anesthetics in base form and said polyvinyl chloride.