DELAYED RELEASE FORMULATION FOR REDUCING THE FREQUENCY OF URINATION AND METHOD OF USE THEREOF

• US 20120141554A1
• Filed: 01/04/2012
• Published: 06/07/2012
• Est. Priority Date: 07/08/2010
• Status: Abandoned Application

• Current Assignee: Wellesley Pharmaceuticals, LLC
• Original Assignee: Wellesley Pharmaceuticals, LLC
• Inventors: Dill, David A.
• Application Number:
  US13/343,349
• Publication Number:
  US 20120141554A1
• Time in Patent Office: Days
• US Class Current: 424/400
• 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 31/122 having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
• 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 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/216 of acids having aromatic rings, e.g. benactizyne, clofibrate
• CPC Class Codes: A61K 31/4025 not condensed and containing further heterocyclic rings, e.g. cromakalim
• CPC Class Codes: A61K 31/405 Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
• CPC Class Codes: A61K 31/46 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
• CPC Class Codes: A61K 31/4725 containing further heterocyclic rings
• CPC Class Codes: A61K 31/616 by carboxylic acids, e.g. acetylsalicylic acid
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/5073 having two or more different coatings optionally including drug-containing subcoatings
• CPC Class Codes: A61K 9/5089 Processes
• CPC Class Codes: A61P 13/00 Drugs for disorders of the urinary system

Abstract

Methods and compositions for reducing the frequency of urination are disclosed. One method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising an analgesic agent formulated in a delayed-release formulation. Another method comprises administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising multiple active ingredients. Yet another method comprises administering to a subject in need thereof an effective amount of a diuretic followed with another administration of an pharmaceutical composition comprising an analgesic agent.

Claims

1. A method for reducing the frequency of urination, comprising:

administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a first analgesic agent,

wherein said pharmaceutical composition is formulated in delayed-release formulation.

2. The method of claim 1, wherein said delayed-release formulation comprises an enteric coating.

3. The method of claim 1, wherein said first analgesic agent is selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and wherein said first analgesic agent is administered at a daily dose of 0.1-100 μ

g.

4. The method of claim 1, wherein said first analgesic agent is selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and wherein said first analgesic agent is administered at a daily dose of 0.1-10 mg.

5. The method of claim 1, wherein said pharmaceutical composition is administered 1-3 hours before bedtime.

6. The method of claim 1, wherein said pharmaceutical composition further comprises a second analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, wherein said second analgesic agent is different from said first analgesic agent.

7. The method of claim 1, wherein said pharmaceutical composition further comprises a first antimuscurinic agent selected from the group consisting of oxybutynin, solifenacin, darifenacin and atropine.

8. A method for reducing the frequency of urination, comprising:

administering to a subject in need thereof an effective amount of a pharmaceutical composition comprising a plurality of active ingredients, wherein said plurality of active ingredients comprises (1) one or more analgesic agents and/or (2) one or more antimuscurinic agents.

9. The method of claim 8, wherein said pharmaceutical composition is formulated for immediate-release of said plurality of active ingredients.

10. The method of claim 8, wherein said pharmaceutical composition contains two active ingredients, one is formulated for immediate-release and the other one is formulated for delayed-release.

11. The method of claim 8, wherein said pharmaceutical composition contains two active ingredients, one is for delayed-release at a first time point and the other one is formulated for delayed-release at a second time point.

12. The method of claim 8, wherein said one or more analgesic agents are selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and wherein said one or more antimuscurinic agents are selected from the group consisting of oxybutynin, solifenacin, darifenacin and atropine.

13. The method of claim 8, wherein said plurality of active ingredients consists of two analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen.

14. The method of claim 8, wherein said plurality of active ingredients consists of one analgesic agent selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen, and one antimuscurinic agent selected from the group consisting of oxybutynin, solifenacin, darifenacin and atropine.

15. A method for reducing the frequency of urination, comprising:

administering to a person in need thereof a first pharmaceutical composition comprising a diuretic; and

administering to said person a second pharmaceutical composition comprising one or more analgesic agents,

wherein said first pharmaceutical composition is dosed and formulated to have a diuretic effect within 6 hours of administration and is administered at least 8 hours prior to bedtime, and wherein said second pharmaceutical composition is administered within 2 hours prior to bedtime.

16. The method of claim 15, wherein said second pharmaceutical composition further comprises one or more antimuscurinic agents.

17. The method of claim 15, wherein said first pharmaceutical composition is formulated for immediate-release and wherein said second pharmaceutical composition is formulated for delayed-release.

18. A pharmaceutical composition, comprising:

two or more analgesic agents selected from the group consisting of aspirin, ibuprofen, naproxen sodium, indomethacin, nabumetone, and acetaminophen; and

a pharmaceutically acceptable carrier.

19. The pharmaceutical composition of claim 18, wherein at least one of said two or more analgesic agents is formulated for delayed-release.

20. A method for treating nocturia, comprising:

administering to a subject in need thereof one or more analgesic agent and one or more antidiuretic agents.

21. The method of claim 20, wherein said one or more analgesic agent and one or more antidiuretic agents are formulated for delayed-release.

22. A pharmaceutical composition, comprising:

a plurality of active ingredients comprising one or more analgesic agents and one or more antimuscurinic agents; and

a pharmaceutically acceptable carrier.

23. The pharmaceutical composition of claim 22, wherein at least one of said plurality of active ingredients is formulated for delayed-release.