Methods and compositions for administration of oxybutynin

• US 9,119,777 B2
• Filed: 12/27/2012
• Issued: 09/01/2015
• Est. Priority Date: 05/30/2008
• Status: Expired due to Fees

• Current Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Original Assignee: MicroDose Therapeutx, Inc. (Teva Pharmaceutical Industries Limited)
• Inventors: Cook, Robert, Byron, David A., Fleming, Scott
• Primary Examiner(s): Kwon, Brian-Yong
• Assistant Examiner(s): Berrios, Jennifer A
• Application Number:
  US13/728,706
• Publication Number:
  US 20130189319A1
• Time in Patent Office: 978 Days
• Field of Search: 514/534, 424/489
• US Class Current: 1/1
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61K 9/008 comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
• CPC Class Codes: A61K 9/14 Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2202/064 Powder

Abstract

The present invention is directed to methods and compositions for treating pulmonary disease comprising delivering directly to a patient'"'"'s lungs a therapeutically effective amount of oxybutynin in combination with one or more pharmaceutically effective agents. Oxybutynin may be selected from the group consisting of, but not limited to, a xinafoate salt, a palmitate salt, a pamoic salt, a resonate salt, a laurate salt and other salts. The pharmaceutically effective agents comprise bronchodilators, antiinflammatories, corticosteroids, corticosteroid reversal agent or alveolar growth agents or other agents selected from proteinase or protease inhibitors.

Claims

1. A method for treating pulmonary disease comprising delivering directly to a patient'"'"'s lungs a therapeutically effective amount of a salt form of oxybutynin in combination with one or more pharmaceutically effective agents, wherein the salt form of oxybutynin is selected from the group consisting of a xinafoate salt and a laurate salt, and wherein, the oxybutynin and the pharmaceutically effective agents are delivered in dry powder form using a dry powder inhaler, wherein the dosage of the therapeutically effective amount of oxybutynin is within the range of 0.001 to 20 mg per day, 0.02 to 15 mg per day, or 0.05 to 10 mg per day administered as needed.

2. The method according to claim 1, wherein oxybutynin comprises oxybutynin xinafoate.

3. The method of claim 1, wherein the pulmonary disease comprises asthma, atelectasis, bronchitis, chronic obstructive pulmonary disease, emphysema, lung cancer, pneumonia or pulmonary edema.

4. The method according to claim 1, wherein the dry powder inhaler includes a piezo vibrator.

5. The method according to claim 1, wherein oxybutynin is delivered in dry powder form having a mass median aerodynamic particle size selected from the group consisting of 0.5-20 microns, 0.5-15 microns, 0.5-10 microns, or 0.5-5 microns.

6. A method for treating chronic obstructive pulmonary disease comprising delivering directly to a patient'"'"'s lungs a therapeutically effective amount of a salt form of oxybutynin in combination with one or more pharmaceutically effective agents, wherein the salt form of oxybutynin is selected from the group consisting of a xinafoate salt and a laurate salt, and wherein, the oxybutynin and the pharmaceutically effective agents are delivered in dry powder form using a dry powder inhaler.