Delving into the Latest Updates on Betamethasone Dipropionate/Salicylic acid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DIPROSALIC

Target

COX x GR

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

Skin and Musculoskeletal Diseases

Active Indication

Keratosis

Inactive Indication-

Originator Organization-

Active Organization

Organon Canada, Inc.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CA (04 Oct 1982),

Keratosis

Regulation-

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Structure

Molecular FormulaC28H37FO7

InChIKeyCIWBQSYVNNPZIQ-XYWKZLDCSA-N

CAS Registry5593-20-4

View All Structures (2)

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.

01 Apr 2005·Journal of Pharmaceutical and Biomedical AnalysisQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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).

01 Jan 2004·American Journal of Clinical DermatologyQ2 · MEDICINE

Fixed-Dose Combination Therapy for Psoriasis

Q2 · MEDICINE

Review

Author: 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 Deals associated with Betamethasone Dipropionate/Salicylic acid

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