Wednesday , 19 June 2024

Pharmacokinetic Evaluation of Transdermal Drug Delivery of Diclofenac Potassium In Human Volunteers

P. Kiranmayee, B. Kumar*, G. Tharunasree
Department of Pharmacy Practice, Ratnam institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore District-524 346

Transdermal therapeutic systems are defined as self-contained discrete dosage forms which when applied to the intact skin, deliver the drugs through the skin, at a controlled rate to the systemic circulation.  To any drug moiety to elicit its pharmacological action, it has to reach the systemic circulation without change. The object of the present study was to formulate a transdermal drug delivery system using a natural polymer. Badam gum was selected as the polymer owing to its ideal film forming properties. Dicolfenac potassium was used as model drug.  The gum was subjected to preformulation tests such as pH, swelling index, ash values and microbial load. All the results were within acceptable limits. Compatibility studies were also conducted using FTIR studies, which showed that the drug and polymer were compatible.  The gum gave good films starting from a concentration of 2% w/w. Films were prepared using various concentrations of the polymer such as 2, 2.25, 2.5, 2.75 and 3% w/w. The prepared films were subjected to dissolution studies and based on the release profile, 2.5% was selected to be the ideal concentration. The bioavailability of the drug from ideal batch of the formulated films (containing 2.5% w/w of badam gum with 15% DMSO as penetration enhancer) was determined in healthy human volunteers and comparison was made with that of orally administered marketed tablets of diclofenac potassium. The retention time of diclofenac potassium was found to be 11.983 min for standard solution. The retention time for sample was found to be 11.900 minutes.

Key words: Transdermal delivery, pharmacokinetics, badam gum, Diclofenac sodium.

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