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 car4bonyl aminophenyl) ethoxy] phenyl} -(s)-2-ethoxy propanoic acid and biguanide drug

• US 20040152771A1
• Filed: 11/25/2003
• Published: 08/05/2004
• 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:
  US10/478,798
• Publication Number:
  US 20040152771A1
• Time in Patent Office: Days
• US Class Current: 514/517
• 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 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 31/325 Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof thiurams A61K31/145
• 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-[2-(4-tert-butoxycarbonylaminophenyl)ethoxy]phenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically-acceptable salt thereof and any solvates of either thereof and a biguanide drug.

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 biguanide drug.

2. A pharmaceutical combination according to claim 1, comprising (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxyphenyl}ethoxy)phenyl] propanoic acid or a pharmaceutically acceptable salt thereof or a solvate of either thereof, wherein the biguanide drug is metformin.

3. A pharmaceutical combination according to claim 1, comprising 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, wherein the biguanide drug is metformin.

4. A pharmaceutical composition of claims 2 or 3, further comprising a pharmaceutically acceptable carrier and/or diluent.

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

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

14. A pharmaceutical combination according to claim 1, or a kit according to any one of claims 7, 8, or 12, which further comprises one or more additional existing therapies for the treatment of type 2 diabetes and its associated complications.

7. 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) ethoxyphenyl}-(S)-2-ethoxy propanoic acid, or a pharmaceutically[[-]]acceptable salt thereof;

(ii) a vessel containing a biguanide drug; and

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

8. A kit comprising

(i) a pharmaceutical formulation containing either (S)-2-ethoxy-3-[4-(2-{4-methanesulfonyloxy phenyl}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 biguanide drug 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.

9. 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 and a biguanide drug 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 biguanide drug 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.

10. A method of making a kit of claim 9, which method comprises bringing (a) into association with (b).

11. A method according to claim 10, wherein (a) and (b) are:

(i) provided as separate formulations independently of one another, and 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.

12. 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 biguanide drug 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.

13. A kit according to any one of claims 7, 8 or 12, 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 biguanide drug in order to provide for repeat dosing.

15. A pharmaceutical combination according to claim 5, or 6 or a kit according to any one of claims 7, 8, or 12, wherein the biguanide drug is metformin.