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Niacin and NSAID combination therapy

A technology of niacin and therapy, which is applied in drug combinations, medical preparations containing active ingredients, metabolic diseases, etc., and can solve problems such as lowering and increasing expected tolerance and safety, and limiting doses

Inactive Publication Date: 2011-06-01
科莱尼斯医疗控股公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, when choosing an appropriate dose, we need to consider the tolerability and safety of the drug, which is expected to decrease with increasing dose
In most cases, these factors will limit the dose

Method used

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  • Niacin and NSAID combination therapy
  • Niacin and NSAID combination therapy
  • Niacin and NSAID combination therapy

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0387] A clinical study is provided to establish the antiflush effect of an aspirin regimen on immediate-release niacin.

[0388] The product used is a niacin / aspirin oral dosage form.

[0389] Test design

[0390] The primary endpoint of the study was to compare the incidence, duration and severity of flushing after administration of niacin between treatment groups; adverse events were routinely monitored.

[0391] Subjects were screened once up to 4 weeks prior to the first dispensing visit. All eligible subjects received two single doses of niacin each week. Subjects were randomly assigned to receive either an aspirin regimen or a placebo regimen on Day 1 prior to their niacin dose and the opposite regimen prior to their niacin dose on Day 8. Subjects were randomly selected for blind testing on the morning and evening of Days -4, -3, -2, and -1. Subject was admitted to the hospital on Day -1 and remained under observation for approximately 24 hours after administration ...

Embodiment 2

[0441] Research

[0442] A randomized, double-blind, three-way cross-over study was provided to investigate the antiflush effect of two aspirin regimens compared with placebo on extended-release niacin.

[0443] product

[0444] The product used is a niacin / aspirin oral dosage form.

[0445] Research purposes

[0446] Evaluation of two aspirin regimens for relief versus single-dose administration of extended-release niacin (Niaspan ) related flushing abilities.

[0447] method

[0448] Extended-release niacin (2 g) and one of two aspirin regimens or placebo were administered as a single oral dose. Subjects remained overnight at the Clinical Research Center following niacin administration to carefully monitor for flushing reactions and other adverse events. Each subject received all three dosage regimens in a randomized, three-way spanning fashion.

[0449] primary endpoint

[0450] The incidence, duration, and severity of flushing after niacin administration were comp...

Embodiment 3

[0535] Aspirin extended-release and niacin-modified-release have been manufactured at the French company FT (Flamel Technologies) by the methods described in US 5,846,566, US 5,603,957 and WO 03 / 030878.

[0536] Aspirin SR (ASA) is an extended release product in the form of white / white oral capsules containing 81 mg of aspirin as aspirin microparticles. ASA is available in three extended release formulations that release 80% of aspirin in approximately 4-5 hours (prototype A1), 6-7 hours (prototype A2) and 9-10 hours (prototype A3) SR capsules. The A1, A2 and A3 prototypes were made with the same coating composition with different coating ratios. The coating composition is not pH sensitive and its dissolution is not affected by its location within the gastrointestinal tract.

[0537] The manufacturing method of Aspirin SR is based on the coating of aspirin crystals of suitable shape and size as 300 / 500 grade refined acetylsalicylic acid supplied by Shandong. The quantitativ...

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Abstract

Provided are pharmaceutical compositions and methods for preventing or reducing niacin-induced flushing, where the pharmaceutical compositions comprise an aspirin component and a niacin component having different release profiles. Also provided are methods and compositions for preventing or reducing niacin-induced flushing, where the compositions comprise niacin, aspirin and a lipid-lowering drug other than niacin.

Description

technical field [0001] Pharmaceutical compositions and formulations of one or more lipid-lowering drugs, especially niacin, and NSAID with or without a second lipid-lowering agent are provided. In one embodiment, the pharmaceutical composition and preparation can reduce adverse reactions caused by these lipid-lowering drugs. In other embodiments, specific dosage regimens of niacin and aspirin that reduce niacin-mediated flushing are provided. In yet other embodiments, specific dosage regimens of niacin, aspirin, and lipid modulators that reduce niacin-mediated flushing are provided. In yet other embodiments, methods of administering a combination formulation are provided. Background technique [0002] Niacin, one of the earliest drugs used to treat dyslipidemia and atherosclerosis, is most miraculous in its beneficial effects on all lipid parameters (Altschul et al., Arch Biochem Biophys 54:558-559, 1955; Knopp , Am J Cardiol 82:24U-28U, 1998). Niacin is known to increas...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06
CPCA61K31/455A61K31/616A61P1/18A61P13/12A61P15/10A61P25/16A61P25/28A61P25/34A61P27/02A61P29/00A61P3/04A61P31/04A61P35/00A61P3/06A61P43/00A61P7/02A61P9/04A61P9/06A61P9/10A61P9/12A61P3/10A61K2300/00
Inventor 约翰·R·韦特劳凌宇·朱罗伯特·A·斯科特康斯坦斯·H·凯泽林吉恩-路易斯·达瑟优克斯丹妮拉·卡门·奥尼丘皮埃尔·奥唐罗杰·克拉维索夫凯瑟琳·卡斯唐埃尔韦·吉亚尔
Owner 科莱尼斯医疗控股公司
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