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Inventi Rapid - Pharmacokinetics & Pharmacodynamics

Articles

  • Inventi:pkd/116/13
    A SIMPLE NON-INVASIVE METHYL NICOTINATE MODEL WAS STANDARDIZED AND ITS APPLICATION TO A RANDOMIZED, COMPARATIVE CONTROLLED STUDY OF DEXIBUPROFEN TABLETS IN HEALTHY HUMAN MALE VOLUNTEERS
    Punnamchand Loya, Madhusudan N Saraf

    In the present study, a non-invasive, methyl nicotinate (MN) induced erythema model using Laser Doppler Flowmeter was standardized and successfully validated to perform the effect-time study on healthy human male volunteers after oral administration of 400 mg tablets of dexibuprofen. MN was applied on the volar region of forearm (20 µl) for 6 min to produce a visible vasodilation i.e. increase in mean cutaneous blood flow. It remained constant for 10 minutes after which it declined gradually. The effect of dexibuprofen was determined from the response of LDF to the MN challenge by calculating the percent inhibition of MN induced inflammation by dexibuprofen for each time point. It was observed that dexibuprofen inhibited the inflammation by approximately 35 % in the 0.5 h of dosing of dexibuprofen formulation. The observed mean maximum inhibition (Emax) was 93.64±4.57 % and 95.22±3.61 %; and the corresponding mean time to maximum effect was found to be 2.08±0.36 h and 2.17±0.33 h for the test and comparator formulations, respectively. Therefore, It is suggested that this non-invasive technique can be adopted in various fields of research, where, efficacy of NSAIDs to be quantified in terms of their effect on a cutaneous challenge by nicotinic ester.

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