Efficacy of super bioavailable itraconazole in the management of dermatophytosis in India


  • Ramesh M. Oxford Medical College, Bangalore, Karnataka, India
  • Dinesh Hawelia AMRI Hospitals, Salt Lake, Kolkata, West Bengal, India
  • Gayatri Bharadwaj Dr. Gayatri’s Cosmetic Clinic, Dombivli, Thane, Maharashtra, India
  • Gautam Dethe Sparsh Skin Clinic, Seawoods, Navi Mumbai, Maharashtra, India
  • Biswajit Aich Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, India
  • Krishna C. Veligandla Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, India
  • Rahul Rathod Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, India
  • Bhavesh P. Kotak Department of Medical Affairs, Dr Reddy’s Laboratories Ltd, Hyderabad, Telangana, India




Mycoses, Antifungal agents, ITZ


Itraconazole (ITZ) is a commonly prescribed oral antifungal agent in India and has a low minimum inhibitory concentration when compared to other oral antifungals. However, clinicians have reported inconsistent clinical responses despite its high skin levels, which may be due to variations in pelletization parameters, which affect its bioavailability and serum levels. Conventional ITZ has a maximum bioavailability of 55%; however, this is unpredictable and inconsistent. In contrast, the novel ITZ formulation, super bioavailable ITZ (ITZ-SB), has targeted drug release in the small intestine, resulting in predictable serum levels with minimal interindividual variability. This makes it a potentially useful drug in treating recalcitrant dermatophytosis. This expert opinion highlights the benefits of novel ITZ-SB with the incorporation of SUBA® technology. The SUBA® technology improves the bioavailability of poorly soluble drugs by ‘solid dispersion’ in polymer to increase drug absorbency. This technology also has potential to reduce variability in absorption and adverse effects. Benefits of this technology include more predictable clinical response and lower drug quantities necessary to achieve therapeutic blood levels, making it a promising treatment option for recalcitrant dermatophytosis. Fixtral SB, which uses this technology, is a novel weapon in the arsenal of treatments for superficial mycoses.


Gnat S, Łagowski D, Nowakiewicz A. Major challenges and perspectives in the diagnostics and treatment of dermatophyte infections. J Appl Microbiol. 2020;129(2):212-32.

Dogra S, Uprety S. The menace of chronic and recurrent dermatophytosis in India: Is the problem deeper than we perceive? Indian Dermatol Online J. 2016;7(2):73-6.

Naglot A, Shrimali DD, Nath BK, Gogoi H.K, Veer. V, Chander J et al. Recent trends of dermatophytosis in Northeast India (Assam) and interpretation with published studies. Int J Curr Microbiol App Sci. 2015;4(11):111-20.

Sardana K, Khurana A, Singh A, Gautam RK. A Pilot Analysis of Morphometric Assessment of Itraconazole Brands Using Dermoscopy and its Relevance in the Current Scenario. Indian Dermatol Online J. 2018;9(6):426-31.

SUBATM Bioavailability Technology. www.maynepharma.com. Available at: https://www.maynepharma.com/innovation/specialty-technologies/suba-bioavailability-technology/. Accessed on 24 April, 2023.

Abuhelwa AY, Foster DJ, Mudge S, Hayes D, Upton RN. Population pharmacokinetic modelling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and sporanox capsule formulations in healthy subjects in fed and fasted states. Antimicrob Agents Chemother. 2015;59(9):5681-96.

Mahajan H, Dhoot D, Deshmukh G. Comparative clinical effectiveness and safety of super bioavailable itraconazole and conventional itraconazole in management of dermatophytosis: A retrospective data analysis. J Res Dermatol. 2021;7(3):388-94.

Thompson III GR, Lewis P, Mudge S. Open-label crossover oral bioequivalence pharmacokinetics comparison for a 3-day loading dose regimen and 15-day steady-state administration of SUBA-itraconazole and conventional itraconazole capsules in healthy adults. Antimicrob Agents Chemother. 2020;64(8):00400-20.

FDA Approves SUBA-Itraconazole for Treatment of Systemic Fungal Infections. Available at: https://www.contagionlive.com/view/fda-approves-subaitraconazole-for-treatment-of-systemic-fungal-infections. Accessed on 24 April, 2023.

Center for drug evaluation and research. Available at: https://www.accessdata.fda.gov/drugsatfda_ docs/nd/2018/208901Orig1s000Approv.pdf. Accessed on 24 April, 2023.

Drugs@CDSCO. Available at: https://cdscoonline.gov.in/CDSCO/Drugs. Accessed on 24 April, 2023.

Naqvi SM, Gala MY, Muchhala S, Arumugam A, Panigrahi D, Patil D et al. Pharmacokinetics/Pharmacodynamics study of Fixtral SB as compared to supra bioavailable itraconazole and conventional itraconazole. World J Pharmacol. 2023;12(1):1-11.

Lee JH, Park C, Weon KY, Kang CY, Lee BJ, Park JB. Improved Bioavailability of Poorly Water-Soluble Drug by Targeting Increased Absorption through Solubility Enhancement and Precipitation Inhibition. Pharmaceuticals (Basel). 2021;14(12):1255-70.

Sardana K, Mathachan SR. Super Bioavailable Itraconazole and Its Place and Relevance in Recalcitrant Dermatophytosis: Revisiting Skin Levels of Itraconazole and Minimum Inhibitory Concentration Data. Indian Dermatol Online J. 2021;12(1):1-5.

Kumar P, Ramachandran S, Das S. Insights into Changing Dermatophyte Spectrum in India Through Analysis of Cumulative 161,245 Cases Between 1939 and 2021. Mycopathologia. 2023;188,183-202.

Shen JJ, Arendrup MC, Verma S, Saunte DML. The emerging terbinafine-resistant trichophyton epidemic: what is the role of antifungal susceptibility testing? Dermatology. 2022;238(1):60-79.

Thomas M, Wong CC, Anderson P, Grills N. Magnitude, characteristics and consequences of topical steroid misuse in rural North India: an observational study among dermatology outpatients. BMJ Open. 2020;10(5):e032829.

Verma S, Madhu R. The Great Indian Epidemic of Superficial Dermatophytosis: An Appraisal. Indian J Dermatol. 2017;62(3):227-36.

Nenoff P, Verma SB, Vasani R, Burmester A, Hipler UC, Wittig F et al. The current Indian epidemic of superficial dermatophytosis due to Trichophyton mentagrophytes-A molecular study. Mycoses. 2019;62(4):336-56.

Khurana A, Sardana K, Chowdhary A. Antifungal resistance in dermatophytes: Recent trends and therapeutic implications. Fungal Genet Biol. 2019;132:103255.

Maurya VK, Kachhwaha D, Bora A, Khatri PK, Rathore L. Determination of antifungal minimum inhibitory concentration and its clinical correlation among treatment failure cases of dermatophytosis. J Family Med Prim Care. 2019;8(8):2577-81.

Bhatia A, Kanish B, Badyal DK, Kate P, Choudhary S. Efficacy of oral terbinafine versus itraconazole in treatment of dermatophytic infection of skin-A prospective, randomized comparative study. Indian J Pharmacol. 2019;51(2):116-9.

Rajagopalan M, Inamadar A, Mittal A, Miskeen AK, Srinivas CR, Godse K et al. Expert consensus on the management of dermatophytosis in India (ECTODERM India) BMC Dermatol. 2018;18:6-16.

Inamadar A, Rengasamy M, Charugulla SN. Treatment approach for superficial dermatophytosis infections and factors contributing for noncompliance to antifungal therapy in India: An epidemiological survey. Clin Dermatol Rev. 2022;6(1):15-21.

De Doncker P, Pande S, Richarz U, Garodia N. Itraconazole: What clinicians should know? Indian J drugs dermatol. 2017;3(1):4-10.

Dhoot DS, Mahadkar N, Jain G, Kesharwani P. Comparative analysis of serum and sebum concentration of super-bioavailable itraconazole 50 versus 65 mg in healthy adult volunteers. Int J Res Dermatol. 2023;9(1):59-60.

Dhoot D, Jain GK, Manjhi M, Kesharwani P, Mahadkar N, Barkate H. Pharmacokinetic and clinical comparison of super-bioavailable itraconazole and conventional itraconazole at different dosing in dermatophytosis. Drugs Context. 2022;11:8-18.

Ide N, Mochizuki A, Kagawa Y, Ito M. A case of complete atrioventricular block with extremely high blood concentration of azelnidipine. J Pharm Health Care Sci. 2021;7(1):48-53.

LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012. Itraconazole. Available at: https://www.ncbi.nlm.nih.gov/books/NBK547852. Accessed on 24 April, 2023.

Eljaaly K, Alshehri S. An updated review of interactions of statins with antibacterial and antifungal agents. J Transl Sci. 2017;3:1-4.






Review Articles