Method of treating or preventing type-2 diabetes

• US 20070088012A1
• Filed: 04/06/2006
• Published: 04/19/2007
• Est. Priority Date: 04/08/2005
• Status: Abandoned Application

• Current Assignee: Unimed Pharmaceuticals LLC (Abbott Laboratories Incorporated)
• Original Assignee: Unimed Pharmaceuticals LLC (Abbott Laboratories Incorporated)
• Inventors: Seo, Woun
• Application Number:
  US11/399,642
• Publication Number:
  US 20070088012A1
• Time in Patent Office: Days
• US Class Current: 514/171
• CPC Class Codes: A61K 31/565 not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
• CPC Class Codes: A61K 31/568 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 5/00 Drugs for disorders of the endocrine system
• CPC Class Codes: A61P 5/50 for increasing or potentiating the activity of insulin

Abstract

The present invention is generally related to a method of treating, preventing, or reducing the risk of developing type-2 diabetes, and, more particularly, is related to a method of administering a transdermal hydroalcoholic gel composition to treat or prevent type-2 diabetes and a method of administering a transdermal hydroalcoholic gel composition to increase glycemic control in a subject in need thereof.

Claims

1. A method of treating, preventing or reducing the risk of developing type-2 diabetes in a subject in need thereof, comprising:

administering an amount of a hydroalcoholic gel pharmaceutical composition to an area of skin of the subject, which delivers a therapeutically-effective amount of the steroid in the testosterone synthetic pathway to the blood serum of the subject, wherein the composition comprises;

a. about 0.1% to about 10% (w/w) of the steroid in the testosterone synthetic pathway;

b. about 0.1% to about 5% (w/w) penetration enhancing agent;

c. about 0.1% to about 5% (w/w) thickening agent;

e. about 30% to about 98% (w/w) lower alcohol; and

f. the balance purified water;

wherein the composition is capable of releasing the steroid after applying the composition to the skin at a rate and duration that delivers at least about 10 μ

g per day of the steroid to the blood serum of the subject; and

the percentages are on a weight to weight basis of the composition.

2. The method of claim 1, wherein the steroid in the testosterone synthetic pathway comprises about 0.1% to about 10% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof.

3. The method of claim 1, wherein the steroid in the testosterone synthetic pathway comprises about 1% testosterone, or a salt, ester, amide, enantiomer, isomer, tautomer, prodrug, or derivative thereof.

4. The method of claim 2, wherein the penetration enhancing agent comprises about 0.1% to about 5% of a C8-C22 fatty acid, a C8-C22 fatty alcohol, a lower alkyl ester of a C8-C22 fatty acid, a di(lower)alkyl ester of a C6-C22 diacid, a monoglyceride of a C8-C22 fatty acid, a tetrahydrofurfuryl alcohol polyethylene glycol ether, a polyethylene glycol, a propylene glycol, a 2-(2-ethoxyethoxy)ethanol, a diethylene glycol monomethyl ether, an alkylaryl ether of polyethylene oxide, a polyethylene oxide monomethyl ether, a polyethylene oxide dimethyl ether, a dimethyl sulfoxide, a glycerol, an ethyl acetate, an acetoacetic ester, a N-alkylpyrrolidone, a terpene or combinations thereof.

5. The method of claim 4, wherein the penetration enhancing agent is isopropyl myristate.

6. The method of claim 2, wherein the thickening agent comprises about 0.1% to about 5% polyacrylic acid.

7. The method of claim 2, wherein the lower alcohol comprises about 45% to about 90% ethanol or isopropanol.

8. The method of claim 2, wherein the hydroalcoholic gel pharmaceutical composition comprises:

a. about 1% (w/w) testosterone;

b. about 0.9% (w/w) CARBOPOL®

;

c. about 0.5% (w/w) isopropyl myristate;

d. about 67% (w/w) ethanol; and

e. the balance purified water.

9. The method of claim 2, wherein the composition is capable of releasing the testosterone after applying the composition to the skin at a rate and duration that achieves circulating serum concentration of the testosterone greater than about 400 ng testosterone per dl serum during a time period beginning about 2 hours after administration and ending about 24 hours after administration.

10. The method of claim 9, wherein the serum testosterone concentration is maintained between about 400 ng testosterone per dl serum to about 1050 ng testosterone per dl serum.

11. The method of claim 2, wherein for each about 0.1 gram per day application of the composition to the skin, an increase of at least about 5 ng/dl in serum testosterone concentration results in the subject.

12. The method of claim 2, wherein the composition is provided to the subject for daily administration in about a 0.1 g to about a 10 g dose.

13. The method of claim 2, wherein the amount of the composition is a 5 g dose delivering about 50 mg of testosterone to the skin.

14. The method of claim 2, wherein the amount of the composition is a 7.5 g dose delivering about 75 mg of testosterone to the skin.

15. The method of claim 2, wherein the amount of the composition is a 10 g dose delivering about 100 mg of testosterone to the skin.

16. The method of claim 2, wherein the composition is provided to the subject in one or more packets.

17. The method of claim 16, wherein the packet comprises a polyethylene liner between the composition and inner surface of the packet.

18. The method of claim 2, wherein the subject has a pretreatment serum testosterone concentration less than about 300 ng/dl.

19. The method of claim 18, wherein after at least about 30 days of daily administration serum testosterone concentration in the subject is at least about 400 ng/dl to about 1050 ng/dl.

20. The method of claim 2, wherein the composition is administered once, twice, or three times daily for at least about 7 days.

21. A method for increasing glycemic control in a subject in need thereof, comprising:

administering an amount of a hydroalcoholic gel pharmaceutical composition to an area of skin of the subject, which delivers a therapeutically-effective amount of testosterone to the blood serum of the subject, wherein the composition comprises;

a. about 0.5% to about 10% (w/w) testosterone;

b. about 0.1% to about 5% (w/w) penetration enhancing agent;

c. about 0.1% to about 5% (w/w) thickening agent;

e. about 30% to about 98% (w/w) lower alcohol; and

f. the balance purified water;

wherein the composition is capable of releasing the steroid after applying the composition to the skin at a rate and duration that delivers at least about 10 μ

g per day of the steroid to the blood serum of the subject; and

the percentages are on a weight to weight basis of the composition.