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Method of treating diabetes

A technology for diabetes, prediabetes, for use in the field of treatment of diabetes mellitus with at least one cardiovascular disease

Inactive Publication Date: 2010-03-24
GILEAD SCI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of these treatments is ideal

Method used

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  • Method of treating diabetes
  • Method of treating diabetes
  • Method of treating diabetes

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0255] A 20-mL Type 1 flint vial of ranolazine injection was filled for delivery of 20 mL (at 1, 5, or 25 mg / mL ranolazine concentrations).

[0256] composition:

[0257] Ranolazine 1.0, 5.0, 25.0mg / mL

[0258] Glucose monohydrate 55.0, 52.0, 36.0 mg / mL

[0259] Hydrochloric acid q.s.pH to 4.0±0.2

[0260] Sodium hydroxide q.s.pH to 4.0±0.2

[0261] Water for injection q.s.

[0262] Container / Closure System:

[0263] Vial: Type 1 vial (Flint), 20-cc, 20-mm mouth

[0264] Stopper: Rubber stopper, 20-mm, West 4432 / 50, gray butyl rubber (graybutyl), Teflon coating

[0265] Sealing: aluminum seal, 20-mm, clamshell outer seal

[0266] production method

[0267] Ranolazine intravenous formulations are manufactured via the following aseptic filling method. In a suitable container, the desired amount of dextrose monohydrate was dissolved in water for injection (WFI) at about 78% by weight of the final batch. With continuous stirring, the required amount of ranolazine was add...

Embodiment 2

[0269] Fill a 20-mL Type 1 Flintstone vial of ranolazine injection for delivery of 20 mL (25 mg / mL concentration).

[0270] composition:

[0271] Ranolazine 25.0mg / mL

[0272] Glucose monohydrate 36.0mg / mL

[0273] Hydrochloric acid Adjust the pH to 3.3-4.7

[0274] Water for injection q.s.

[0275] Container / Closure System:

[0276] Vial: Type 1 tube, untreated, 20-mL, 20-mm neck opening

[0277] Stopper: Rubber stopper, 20-mm, West 4432 / 50, gray butyl rubber,

[0278] Sealing: Aluminum seal, 20-mm, blue clamshell outer seal

[0279] production method

[0280] Water for injection (WFI) was injected into a suitable container at about 90% of the final batch weight. Add about 90% to 95% of the required amount of 5N HCl to the mixing vessel. With continuous stirring, the required amount of ranolazine was slowly added, followed by the addition of dextrose monohydrate to the ranolazine solution. To dissolve ranolazine, the pH of the solution was adjusted to a target value...

Embodiment 3

[0282] Patients with diabetes mellitus or metabolic syndrome presenting as non-ST-elevated acute coronary syndrome (NSTEACS)

[0283] background

[0284] Data from clinical trials of patients with confirmed non-ST-elevating acute coronary syndrome (NSTEACS) were evaluated to determine the prevalence and outcomes of those patients who also had diabetes and / or metabolic syndrome. Patients were treated with ranolazine, which was associated with improved glycemic parameters. See US Patent Application Serial No. 10 / 443,314, published as 2004 / 0063717, which is hereby incorporated by reference in its entirety.

[0285] method

[0286] MERLIN-TIMI 36 randomized 6560 patients presenting with NSTEACS to treatment with placebo or the anti-ischemic drug ranolazine, which was also associated with improved glycemic parameters. The median clinical follow-up was 12 months. Metabolic syndrome was defined as having any 3 of the following: 1) waist circumference ≥102 cm (men) and ≥88 cm (wom...

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PUM

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Abstract

Methods are provided for lowering plasma level of HbAIc in a diabetic, pre- diabetic, or non-diabetic patient suffering from at least one cardiovascular disease and slowing or delaying the developmentof or worsening of hyperglycemia in a diabetic, pre-diabetic, or non-diabetic patient.

Description

technical field [0001] The present invention provides a method for reducing plasma levels of HbA1c in diabetic, prediabetic or non-diabetic patients for treating diabetes with at least one cardiovascular disease comprising administering ranolazine to these patients. Background technique [0002] Diabetes mellitus is a disease characterized by hyperglycemia; altered lipid, carbohydrate, and protein metabolism; and increased risk of syndromes from vascular disease. Diabetes is an increasingly common health problem because of the disease's association with advancing age and obesity. [0003] Diabetes has two main types: 1) Type I, also known as insulin-dependent diabetes mellitus (IDDM), and 2) Type II, also known as insulin-independent or non-insulin-dependent diabetes mellitus (NIDDM). Both types of diabetes are caused by insufficient amounts of circulating insulin and a decreased response of peripheral tissues to insulin. [0004] Type 1 diabetes is caused by the body's in...

Claims

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Application Information

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IPC IPC(8): A61K31/495A61P9/10A61P3/10A61K9/22
CPCA61K31/495A61P9/00A61P9/10A61P3/10A61K31/496A61K9/20
Inventor 马库斯·耶林安德鲁·沃尔夫
Owner GILEAD SCI INC