Pharmaceutical combination comprising either (s)-2-ethoxy-3-[4-(2-{4-methane sulfonyl oxyphenyl} ethoxy) phenyl] propanoic acid or 3-{-4-[2-(4-tert-butoxy carbonyl aminophenyl) ethoxy] phenyl}-(s)-2-ethoxy propanoic acid and a sulonylurea

• US 20040157927A1
• Filed: 11/26/2003
• Published: 08/12/2004
• Est. Priority Date: 06/01/2001
• Status: Abandoned Application

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Astrazeneca AB (Astrazeneca PLC)
• Inventors: Ohman, Peter
• Application Number:
  US10/479,205
• Publication Number:
  US 20040157927A1
• Time in Patent Office: Days
• US Class Current: 514/562
• 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 31/64 Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

A pharmaceutical combination comprising either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[4-tert-butoxycarbonylaminophenyl)ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically-acceptable salt thereof and any solvates of either thereof and a sulfonylurea.

Claims

1. A pharmaceutical combination comprising either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof or a solvate of either thereof and a sulfonylurea.

2. A pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable carrier and/or diluent.

3. A method of treating or preventing diabetes, which comprises administering to a patient in need thereof an effective amount of a pharmaceutical combination of claim 1.

4. A method of treating insulin resistance syndrome, which comprises administering to a patient in need thereof an effective amount of a pharmaceutical combination of claim 1.

12. A pharmaceutical combination according to claim 1 or a kit according to any one of claims 5, 6, or 10, wherein the sulfonylurea comprises one or more of glyburide, glimepiride, glibenclamide, gliclazide, glipizide, gliquidone, chloropropamide, tolbutamide, acetohexamide, glycopyramide, carbutamide, glibonuride, glisoxepid, glybuthiazole, glibuzole, glyhexamide, glymidine, glypinamide, phenbutamide, tolcylamide and tolazamide.

13. A pharmaceutical combination according to claim 1 or a kit according to any one of claims 5, 6, or 10, which further comprises one or more additional existing therapies for the treatment of type 2 diabetes and its associated complications.

5. A kit comprising:

(i) a vessel containing either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)-ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically[[-]]acceptable salt thereof; and

(ii) a vessel containing a sulfonylurea; and

(iii) instructions for the sequential, separate or simultaneous administration of (i) and (ii) to a patient.

6. A kit comprising:

(i) a pharmaceutical formulation containing either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)-ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier; and

(ii) a pharmaceutical formulation containing a sulfonylurea, in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier;

wherein (i) and (ii) are each provided in a form that is suitable for administration in conjunction with the other.

7. A combined preparation comprising:

(i) a pharmaceutical formulation including either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)-ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof and a sulfonylurea, in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier; and

(ii) a kit comprising components

(a) a pharmaceutical formulation including either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)-ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier; and

(b) a pharmaceutical formulation including a sulfonyl urea in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier,

wherein (a) and (b) are each provided in a form that is suitable for administration in conjunction with the other.

8. A method of making a kit of claim 7, which method comprises bringing (a into association with (b).

9. A method according to claim 8, wherein (a) and (b) of the kit may be:

(i) provided as separate formulations, independently of one another, which are subsequently brought together for use in conjunction with each other in combination therapy;

or

(ii) packaged and presented together as separate components of a combination pack for use in conjunction with each other in combination therapy.

10. A kit comprising:

(i) a pharmaceutical formulation including either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)-ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier;

or

(ii) a pharmaceutical formulation including a sulfonyl urea in admixture with a pharmaceutically acceptable adjuvant, diluent or carrier; and

(iii) instructions to use that component in conjunction with the other of the two components.

11. A kit according to any one of claims 5, 6 or 10, which comprises more than one formulation including either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl]propanoic acid or 3-{4-[2-(4-tert-butoxycarbonylaminophenyl)ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically acceptable salt thereof, and/or more than one formulation including an appropriate quantity/dose of a sulfonylurea in order to provide for repeat dosing.