Treatment of asthma and chronic obstructive pulmonary disease with anti-proliferate and anti-inflammatory drugs

• US 9,937,159 B2
• Filed: 06/27/2016
• Issued: 04/10/2018
• Est. Priority Date: 11/20/2006
• Status: Active Grant

• Current Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Lutonix, Inc. (Becton, Dickinson & Co)
• Inventors: Wang, Lixiao
• Primary Examiner(s): Parad, Dennis J
• Assistant Examiner(s): BECKHARDT, LYNDSEY MARIE
• Application Number:
  US15/193,866
• Publication Number:
  US 20160303091A1
• Time in Patent Office: 652 Days
• Field of Search: None
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61L 2300/41 Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/06 Coatings containing a mixture of two or more compounds
• CPC Class Codes: A61L 29/08 Materials for coatings
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2210/0618 Nose
• 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

Abstract

Embodiments of the present invention provide a method for treatment of respiratory disorders such as asthma, chronic obstructive pulmonary disease, and chronic sinusitis, including cystic fibrosis, interstitial fibrosis, chronic bronchitis, emphysema, bronchopulmonary dysplasia and neoplasia. The method involves administration, preferably oral, nasal or pulmonary administration, of anti-inflammatory and anti-proliferative drugs (rapamycin or paclitaxel and their analogs) and an additive.

Claims

1. A balloon catheter comprising a coating layer overlying an exterior surface of the balloon catheter, wherein:

the balloon catheter is sized and configured for insertion into a passage of a respiratory system;

the coating layer comprises a water insoluble drug and a combination of a first additive and a second additive;

the water insoluble drug is chosen from paclitaxel and rapamycin;

the first additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or N-octanoyl N-methylglucamine; and

the second additive is chosen from sorbitol, glucose, sucrose, lactobionic acid, gluconolactone, meglumine, lactic acid, gentisic acid, or combinations thereof.

2. The balloon catheter of claim 1, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is sorbitol.

3. The balloon catheter of claim 1, wherein:

the drug is paclitaxel;

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is sorbitol.

4. The balloon catheter of claim 1, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is gluconolactone.

5. The balloon catheter of claim 1, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is lactobionic acid.

6. The balloon catheter of claim 1, wherein:

the drug is paclitaxel;

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is gluconolactone.

7. The balloon catheter of claim 1, further comprising a top layer over the coating layer.

8. The balloon catheter of claim 1, further comprising an adherent layer between the exterior surface and the coating layer.

9. The balloon catheter of claim 8, wherein the adherent layer is chosen from polyolefins, polyisobutylene, ethylene-α

-olefin copolymers, acrylic polymers and copolymers, polyvinyl chloride, polyvinyl methyl ether, polyvinylidene fluoride and polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polystyrene, polyvinyl acetate, ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, Nylon 12, polycaprolactone, polyoxymethylenes, polyethers, epoxy resins, polyurethanes, rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, chitins, polylactic acid, polyglycolic acid, polylactic acid-polyethylene oxide copolymers, polyethylene glycol, polypropylene glycol, polyvinyl alcohol, and mixtures thereof.

10. The balloon catheter of claim 9, further comprising a top layer over the coating layer.

11. A method for treating a respiratory system, the method comprising:

inserting into an airway a balloon catheter comprising a coating layer overlying an exterior surface of the balloon catheter, wherein;

the coating layer comprises a drug, a first additive, and a second additive;

the drug is chosen from paclitaxel and rapamycin,

the first additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or N-octanoyl N-methylglucamine; and

the second additive is chosen from sorbitol, glucose, sucrose, lactobionic acid, gluconolactone, meglumine, lactic acid, gentisic acid, or combinations thereof;

inflating the balloon catheter and releasing the drug to a wall of the airway;

deflating the balloon; and

withdrawing the balloon catheter from the airway.

12. The method according to claim 11, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is sorbitol.

13. The method according to claim 11, wherein:

the drug is paclitaxel;

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is sorbitol.

14. The method according to claim 11, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is gluconolactone.

15. The method according to claim 11, wherein:

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is lactobionic acid.

16. The method according to claim 11, wherein:

the drug is paclitaxel;

the first additive is PEG-20 sorbitan monolaurate; and

the second additive is gluconolactone.

17. The method according to claim 11, wherein the balloon catheter further comprises a top layer over the coating layer.

18. The method according to claim 11, wherein the balloon catheter further comprises an adherent layer between the exterior surface and the coating layer.

19. The method according to claim 18, wherein the adherent layer is chosen from polyolefins, polyisobutylene, ethylene-α

-olefin copolymers, acrylic polymers and copolymers, polyvinyl chloride, polyvinyl methyl ether, polyvinylidene fluoride and polyvinylidene chloride, polyacrylonitrile, polyvinyl ketones, polystyrene, polyvinyl acetate, ethylene-methyl methacrylate copolymers, acrylonitrile-styrene copolymers, Nylon 12, polycaprolactone, polyoxymethylenes, polyethers, epoxy resins, polyurethanes, rayon-triacetate, cellulose, cellulose acetate, cellulose butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, chitins, polylactic acid, polyglycolic acid, polylactic acid-polyethylene oxide copolymers, polyethylene glycol, polypropylene glycol, polyvinyl alcohol, and mixtures thereof.

20. A balloon catheter comprising a coating layer overlying an exterior surface of the balloon catheter, wherein:

the balloon catheter is sized and configured for insertion into a passage of a respiratory system;

the coating layer comprises a water insoluble drug and a combination of a first additive and a second additive;

the water insoluble drug is chosen from paclitaxel and rapamycin;

the first additive is chosen from PEG-20 sorbitan monolaurate, PEG-20 sorbitan monooleate, or N-octanoyl N-methylglucamine; and

the second additive is chosen from sorbitol, glucose, sucrose, lactic acid, or combinations thereof.