Comparative analysis of serum and sebum concentration of super-bioavailable itraconazole 50 versus 65 mg in healthy adult volunteers

Dhoot, Dhiraj; Mahadkar, Namrata; Jain, Gaurav; Kesharwani, Prashant

doi:10.18203/issn.2455-4529.intjresdermatol20223279

Cited by 3 publications

(6 citation statements)

References 7 publications

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“…25 Thus, a higher serum concentration of drug can lead to high skin concentration resulting in extensive eradication of fungi from the lesions. This was supported by recently published study on serum and sebum analysis of SB 50 mg and SB 65 mg in which authors reported statistically significant serum and sebum concentration with SB 65 mg than SB 50 mg. 26 The improvement in the SB 65 group in our study may therefore be attributable to the potential for increased sebum content.…”

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confidence: 60%

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

Shah¹,

Mistry²,

Dharmender³

et al. 2023

IDR

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Owing to pharmacokinetic challenges of itraconazole, super-bioavailable itraconazole (SB) was developed and recently approved in strengths of 50mg and 65mg. But comparative study was lacking between these two strengths in glabrous tinea (dermatophytosis) management. Hence, this study was planned to compare the efficacy of both these strengths in dermatophytosis. Methods: One hundred eligible patients were enrolled in this prospective, randomized, clinical study during May-2022 to September-2022 at tertiary hospital in Ahmedabad in adults. Efficacy and safety assessments were done at week-3 and 6 with follow up at week-10 for relapse. Primary objective was to assess the proportion of patients achieving complete cure at week-6 following treatment in both the groups. Secondary outcomes compared safety, clinical and mycological cure rates. Results: Of the 100 patients enrolled, 98 patients (50 in SB-50mg and 48 in SB-65mg group) included in the final analysis. At week 6, 20 patients (40%) and 30 patients (62.5%) achieved complete cure (p < 0.05) in SB-50mg and SB-65mg groups, respectively. In completely cured patients, relapse was reported in 3 (15%) and 5 (17%) patients of SB-50mg and SB-65mg groups, respectively (p = 1). A significant difference was noted in clearance of symptoms and lesions in SB-65mg group (p < 0.05). Moreover, similar results were also obtained in sub-group analysis of recalcitrant dermatophytosis. Both the treatments were found to be safe and well tolerated with no discontinuation. Conclusion: Study result concluded the superiority of SB-65mg over SB-50mg in terms of cure rate and resolution of symptoms in dermatophytosis management.

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confidence: 60%

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

Shah¹,

Mistry²,

Dharmender³

et al. 2023

IDR

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“…This study aimed to reach a consensus on the suitability, dosage, duration of treatment, and advantages of SB ITZ in managing dermatophytosis in different clinical scenarios. A study comparing the usage of 65 mg BD SB ITZ with 50 mg BD SB ITZ found a statistically significant higher trough concentration with 65 mg SB ITZ than with 50 mg SB ITZ (p < 0.05) [33]. Sebum concentrations of SB ITZ at 7 and 14 days were also significantly higher in the 65 mg group than in the 50 mg group (p < 0.05).…”

Section: Discussionmentioning

confidence: 98%

“…Sebum concentrations of SB ITZ at 7 and 14 days were also significantly higher in the 65 mg group than in the 50 mg group (p < 0.05). A larger percentage of patients in the 65 mg group achieved therapeutic concentrations as compared to the 50 mg group [33]. A randomized, open-label, four-arm study comparing different dosing and strengths of SB ITZ and CITZ, reported that patients who received the SB ITZ (130 mg OD) treatment had 1.28 times higher serum concentrations of ITZ on day 1 as compared to those who received the SB ITZ (100 mg OD) treatment.…”

Section: Discussionmentioning

confidence: 99%

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Clinical Use of Super-Bioavailable Itraconazole for the Management of Dermatophytosis: Consensus Statement by Dermatologists from India via the Modified Delphi Technique

Saraswat,

Dogra,

Shenoy

et al. 2024

Dermatology

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Introduction: Super bioavailable itraconazole (SB ITZ) overcomes the limitations of conventional itraconazole (CITZ) such as inter-individual variability and reduced bioavailability. It has been approved for systemic mycoses in Australia and Europe as 50mg and the United States as 65mg and in India as 50mg, 65mg, 100mg, and 130mg. However, data on the ideal dose and duration of SB ITZ treatment in managing dermatophytosis is insufficient. This consensus discusses the suitability, dosage, duration of treatment, and relevance of using SB ITZ in managing dermatophytosis in different clinical scenarios. Methods: Sixteen dermatologists, (>15 years of experience in the field and ≥2 years clinical experience with SB ITZ) formed the expert panel. A modified Delphi technique was employed, and a consensus was reached if the concordance in response was >75%. Results: A total of 26 consensus statements were developed. The preferred dose of SB ITZ is 130mg once daily and if not tolerated, 65mg twice daily. The preferred duration for treating naïve dermatophytosis is 4–6 weeks and that for recalcitrant dermatophytosis is 6–8 weeks. Moreover, cure rates for dermatophytosis are a little better with SB ITZ than with CITZ with a similar safety profile as of CITZ. Better patient compliance and efficacy are associated with SB ITZ than with CITZ, even in patients with comorbidities and special needs such as patients with diabetes, extensive lesions, corticosteroid abuse, adolescents, and those on multiple drugs. Conclusion: Expert opinions indicate that overall clinical experience with SB ITZ is better than that with CITZ.

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“…25 A study comparing a 65 mg BD ITZ-SB course with a 50 mg BD ITZ-SB course found a statistically significant higher trough concentration of ITZ-SB with the 65 mg ITZ-SB course than with the 50 mg ITZ-SB course (p<0.05); there was also a higher sebum concentration of ITZ at 7 days and 14 days in the 65 mg ITZ-SB group (p<0.05). 26 Another randomized study compared the efficacies of ITZ-C (100 mg BD), ITZ-C (200 mg OD), ITZ-SB (130 mg OD), and ITZ-SB (100 mg OD) used for 4 weeks and reported that 130 mg ITZ-SB OD had 1.28 times greater serum concentration of ITZ than 100 mg ITZ-SB OD on day 1, which kept increasing till the 28th day. The ITZ concentrations in the sebum for ITZ-SB (130 mg OD) were 1.45, 1.38, and 1.07 times greater than those for ITZ-C (100 mg BD), ITZ-SB (100 mg OD), and ITZ-C (200 mg OD), respectively.…”

Section: Skin Kinetics Of Itzmentioning

confidence: 99%

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

M.,

Hawelia,

Bharadwaj

et al. 2023

Int J Res Dermatol

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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.

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Comparative analysis of serum and sebum concentration of super-bioavailable itraconazole 50 versus 65 mg in healthy adult volunteers

Cited by 3 publications

References 7 publications

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

Comparative Efficacy of Super Bioavailable Itraconazole Capsules 50 mg vs 65 mg Twice Daily in the Management of Glabrous Tinea

Clinical Use of Super-Bioavailable Itraconazole for the Management of Dermatophytosis: Consensus Statement by Dermatologists from India via the Modified Delphi Technique

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

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