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Abstract
The aim of the present study was to develop and characterize the physiochemical properties of transdermal patches of 6‐Mercaptopturine (6‐MP) and evaluate the cytotoxicity, antitumor activity in Balb/c mice using Dalton's lymphoma ascites (DLA) as model cell lines, skin irritation and sensitization in mice and human subjects. 6‐MP was loaded into the patches according to pharmacokinetics properties of 6‐MP. Cytotoxicity was measured by exposing cell suspension to an increased concentration of drug from 50‐1000 ng/ml and the viable cell count was measured by the tryphan blue exclusion method. Results confirmed that 1000 ng/ml of 6‐MP was cytotoxic, and there was an increase in the life span (%ILS) by 71.0% with maximum survival time of 36±1days for 6‐MP transdermal patches, results were statistically significant (p <0.05) compared to untreated control, and anti‐tumor activity was very effective compared to the oral route. Patches did not show any sign of erythema, vesiculations or bullaous reaction, the mean cumulative skin irritation and adherence scoring for both animals and humans proved no irritation sensitization reaction scores were 0 and less than 1, good adherence was seen with score=0, with complete adherence to skin, without leaving any adhesive on skin with score=0 in human subjects. Transdermal patches showed 100% flatness, thickness 150±0.03 mm, good content uniformity, folding endurance (>500 foldings), tensile strength was 2.1 to 7.2 Newton's, elongation was 3–5%, patches were stylish, smooth, transparent, and flexible in appearance. The thumb tack test showed good adhesion, Velcro® protection jackets were suitable for study and served our purpose for licking, scratched and rubbing of applied patches.
Acknowledgments
The authors would like to thank Professor B.G. Shivananda, Principal, and the management of Al‐Ameen College of Pharmacy for their continuous encouragement, one of the authors, N.S. Chandrashekar has received financial support in the form of a Senior Research Fellowship from the Indian Council of Medical Research (ICMR), Government of India, 3M India, Dr. Nirmala Balavalli of 3M, USA are greatly acknowledged for their support in research work. Dr. Ramadasan Kuttan, Dr. Girija Kuttan, and Theejas. P, of the Amala Cancer Research Center, Thrissur, Kerala, are thankfully acknowledged for their support in the work. We thank our research colleagues for their discussions and assistance. Mr. Anantha Padmanab and Balaji of Cranes Software Ltd. Bangalore is thankfully acknowledged for plotting the Kaplan‐Meier graph.