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Year : 2022  |  Volume : 8  |  Issue : 1  |  Page : 7-14

Serum and sebum pharmacokinetics evaluation of a novel formulation of itraconazole in healthy volunteers

1 Department of Global Medical Affairs (India Formulations), Glenmark Pharmaceuticals Ltd, Mumbai, India
2 Department of Pharmaceutics, Delhi Pharmaceutical Science and Research University, New Delhi, India
3 Department of Global Medical Affairs (India Formulations, Middle East & Africa, Asia Pacific), Glenmark Pharmaceuticals Ltd, Mumbai, India

Correspondence Address:
Dhiraj Dhoot
Department of Global Medical Affairs (India Formulations), Glenmark Pharmaceuticals Ltd, Glenmark Enclave, B D Sawant road, Andheri (East), Mumbai 400099,
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijdd.ijdd_23_21

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Background and Objective: Super bioavailable itraconazole is a newer formulation of itraconazole, which overcomes challenges encountered with the use of conventional itraconazole like interpatient variability, limited absorption, reduction in its absorption with co-administered gastric acid lowering agents, etc. The present study was done to evaluate the plasma pharmacokinetics, sebum concentrations of super bioavailable itraconazole in comparison with conventional itraconazole. Materials and Methods: Twelve healthy Asian Indian male healthy volunteers were enrolled in single-center, open-labeled, two treatments, multi-dose, parallel pharmacokinetic study. Test drug (T), i.e. super bioavailable itraconazole 50 mg, was given to six volunteers twice daily after meals for 7 continuous days. Reference drug (R), i.e. conventional itraconazole 100 mg, was given in similar way to the remaining six volunteers. Concentration of the itraconazole in plasma in both the groups was quantified by using high performance liquid chromatography. Concentration of the itraconazole in sebum was measured by paper absorption method. Results: The plasma concentration of itraconazole in both the groups was comparable at all-time points. The maximum concentration (Cmax) and area under curve in test group was higher as compared to reference group. The relative bioavailability of test drug was 107% as compared to the reference drug. The intersubject variability was less in test group (8.37%) as compared to reference drug (19.82%). At day 7, the mean sebum concentration of itraconazole in test drug group was 11.6% higher as compared to reference drug (P = 0.01). Conclusion: It is apparent from the study outcomes that super bioavailable itraconazole (50 mg) is bioequivalent to the conventional itraconazole (100 mg) along with less intersubject variability, and most importantly higher sebum concentration as compared to conventional itraconazole.

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