倍他米松二丙酸酯/水杨酸(Betamethasone Dipropionate/Salicylic acid) - 药物靶点：COX x GR_在研适应症：角化病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

DIPROSALIC

靶点

COX x GR

作用机制

COX抑制剂(环氧化酶抑制剂)、GR激动剂(糖皮质激素受体激动剂)

治疗领域

皮肤和肌肉骨骼疾病

在研适应症

角化病

非在研适应症-

原研机构-

在研机构

Organon Canada, Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

加拿大 (1982-10-04),

角化病

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C28H37FO7

InChIKeyCIWBQSYVNNPZIQ-XYWKZLDCSA-N

CAS号5593-20-4

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关联

2

项与倍他米松二丙酸酯/水杨酸相关的临床试验

EUCTR2020-004081-19-DE

/ Not yet recruiting临床3期

Double-blind, randomised clinical study comparing efficacy and safety of Betamethasone dipropionate 0.64 mg/g _ Salicylic acid 30 mg/g Ointment (Test) vs. Diprosalic(R) Ointment (Reference) vs. Vehicle in patients with chronic stable plaque psoriasis

开始日期2021-12-22

申办/合作机构

Dermapharm AG

NCT00845481

/ Completed临床2期

A Plaque Test Comparing 4 Steroids With Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris

The purpose of the study is to compare the anti-psoriatic effect of marketed products with Daivobet® ointment in a plaque test

开始日期2009-01-01

申办/合作机构

Leo Pharma, Inc.

100 项与倍他米松二丙酸酯/水杨酸相关的临床结果

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100 项与倍他米松二丙酸酯/水杨酸相关的转化医学

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100 项与倍他米松二丙酸酯/水杨酸相关的专利（医药）

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8

项与倍他米松二丙酸酯/水杨酸相关的文献（医药）

2009-10-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion®

3区 · 医学

Article

作者: Robert J. Markovich ; Minshan Shou ; Qinglin Tang ; Yu-Chien Wei ; Wilmer A. Galinada ; Abu M. Rustum

Diprosalic Lotion is an anti-inflammatory drug product that contains salicylic acid and betamethasone dipropionate as active pharmaceutical ingredients (APIs). A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous determination of salicylic acid, betamethasone dipropionate, and their related compounds in Diprosalic Lotion. A 150 mm x 4.6 mm I.D. YMC J'sphere ODS-H80 column at 35 degrees C and UV detection at 240 nm was used. A gradient elution was employed using 0.05% (v/v) methanesulfonic acid solution and acetonitrile as mobile phases. A total of thirty three compounds from Diprosalic Lotion samples were separated in 38 min. The stability-indicating capability of this method has been demonstrated by the adequate separation of all the impurities and degradation products in expired stability samples of Diprosalic Lotion. The method was validated as per the current ICH guidelines.

2005-04-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Automated system for release studies of salicylic acid based on a SIA method

3区 · 医学

Article

作者: H. Sklenářová ; J. Klimundová ; U.F. Schaefer ; P. Solich

The aim of this work was to describe a fully automated system for the in vitro release testing of semisolid dosage forms based on SIA technique. The system was tested for monitoring release profiles of different ointments containing 3% of salicylic acid (Belosalic, Diprosalic, Triamcinolone S). The native fluorescence of salicylic acid was used for fluorimetric detection. Phosphate buffer pH 7.4 was the receptor medium; samples were taken at 10 min intervals during 6 h of the release test; and each test was followed by calibration with five standard solutions. The linear calibration range was 0.05-10 microg ml(-1) (r = 0.9996, six standards); the maximal SIA sample throughput for this system was 120 h(-1), sample volume being 50 microl and flow rate 50 microl s(-1). The detection limit for salicylic acid was 0.01 microg ml(-1).

2004-01-01·American Journal of Clinical Dermatology2区 · 医学

Fixed-Dose Combination Therapy for Psoriasis

2区 · 医学

Review

作者: Guenther, Lyn C

Fixed-dose combination therapy offers stable products containing two or more medications with different mechanisms of action and safety profiles. It is also convenient for patients since only one product rather than two or more needs to be applied. Topical corticosteroids are often the mainstay of therapy in psoriasis. Diprosalic and Nerisalic contain a topical corticosteroid (betamethasone dipropionate and diflucortolone, respectively) and salicylic acid. A left/right study showed that both products have comparable efficacy. It has also been shown that betamethasone dipropionate + salicylic acid ointment has similar efficacy to clobetasol and calcipotriene (calcipotriol) ointments. Betamethasone dipropionate + salicylic acid lotion has similar efficacy to clobetasol lotion. Faster improvement of scaling, itching, and redness was noted with betamethasone dipropionate + salicylic acid lotion compared with betamethasone dipropionate alone. Dovobet (Daivobet) ointment is a fixed-dose combination product containing betamethasone dipropionate and calcipotriene. Clinical studies have shown that it has greater efficacy and a faster speed of onset than the individual components or tacalcitol. Once daily and twice daily treatments have similar efficacy. Psoriasis Area and Severity Index reductions of approximately 40% after 1 week and 70% after 4 weeks of therapy were consistently noted in six large international studies involving >6000 patients. Betamethasone dipropionate + calcipotriene treatment is associated with approximately 75% less adverse cutaneous events as compared with tacalcitol, 50% less compared with calcipotriene, and a similar number as treatment with betamethasone dipropionate.

100 项与倍他米松二丙酸酯/水杨酸相关的药物交易

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