ADVERSE EVENT REPORTING FOR A DERMATOPHARMACOKINETIC STUDY OF DICLOFENAC SODIUM TOPICAL FORMULATIONS
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 9
Abstract
In this single-dose-one arm, open label three way parallel design, pharmacokinetic study of three marketed formulations of Diclofenac Sodium using 12 healthy Indian male subjects, the pharmacokinetic parameters of three marketed Diclofenac Sodium topical formulations were compared. Marketed Diclofenac Sodium topical formulations (A, B & C) were applied on the pre-marked forearms of the subjects as per the dosing schedule. Treatment sample C was used as a reference sample. Subjects received treatment A, treatment B & treatment C on both the arms simultaneously, following open label three way parallel design. Skin Stratum Corneum samples were collected in sterile glass test tubes during the study period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, & 6.0 hours post-dose application. Diclofenac Sodium was estimated in Stratum Corneum using a validated Spectroscopic method and the treatments were claimed to be bio-equivalent. The aim of this article was to report the occurrence of adverse events during this study. It was observed that only a single incidence of mild adverse event was reported in two volunteers, and it involved mild laceration on the right forearm. But, the event was found to be self resolving & with the relationship of the adverse event to study medication was “unlikely” but it could be due to the ‘tape stripping method’ employed for DPK analysis.
Authors and Affiliations
Rahul Mayee , Swati Rawat , Ambrish Thosar , Kavita Atre , Prafulla Mane
Keywords
Related Articles
- EP ID EP119519
- DOI -
- Views 113
- Downloads 0
NANOTECHNOLOGY: THE COMING REVOLUTION IN MODERN BIOLOGY AND MEDICINE
Nanotechnology is a wide field that covers a variety of devices derived from engineering, physics, chemistry, and biology. The promising new field of nanotechnology, created up by rapid advances in life science and techn...
PRODUCTION AND CHARACTERIZATION OF ANTIBIOTICS FROM SOIL-ISOLATED ACTINOMYCETES
In the present study, the soil samples were collected from various places in the Coimbatore, near drainage, mud and coloured soil where there were no plants around. Actinomycetes strains were isolated in specific medium...
CONCEPT OF DRUG INTERACTION
Drug interaction is an increasingly important cause of adverse reactions (ADR), and is the modification of the effect of one drug (object) by the prior or concomitant administration of another drug (precipitant drug). Dr...
PREPARATION AND PHYSICOCHEMICAL ANALYSIS OF MANDOOR PARPATI
The name of Ahcarya Chakradatta will always be remembered with gratefulness by all physicians as he started using amalgamation of Metallic medicines with herbal medicines for e.g. Parpati. Parapati is an important prepar...
ANALYSIS OF PRESCRIPTION PATTERN AND DRUG UTILIZATION IN ASTHMA THERAPY
This drug utilization or prescription-monitoring study was conducted to evaluate the drug-prescribing trend of anti-asthmatic drugs in retailed pharmacy outlets during 2009 and 2011 in urban and rural area of Saurashtra...