Thai Journal of Dermatology

Bioequivalence Studies of Itraconazole Capsules

Sayam Kaewvichit — 2026-07-27

Objectives: To compare pharmaceutical properties and perform bioequivalence studies of two generic products with the innovative product, Sporal®.

Methods: The pharmaceutical properties ; weight variation, content uniformity, percent labeled amount, and dissolution profile, of two itraconazole generic products (Product A and Product B) were

investigated and compared with those of the innovative itraconazole capsule, Sporal®. Two bioequivalence

studies between product A or B with Sporal® were performed using 12 healthy Thai male volunteers for each study. A 200-mg single oral dose of itraconazole was administered immediately after breakfast. The study followed a double blind , two treatment, two period, two sequence randomized crossover design with at least a one-week wash out period between each formulation . Plasma concentrations of itraconazole were determined up to 36 hours after each dose using a validated high-performance liquid chromatography method.

Results: The itraconazole content of Product A was not uniform but no difference in dissolution profiles between Product A and Sporal® were shown. The dissolution profile of Product B was not similar to that of Sporal®. Statistical tests were carried out as stated in the USP 25 guidelines for bioequivalence studies

and 90% confidence intervals of the log of the ratios of either Cmax or AUC<f->last between product A and Sporal ®, and product B and Sporal®were outside the standard range 0.80 - 1.25.

Conclusion: In term of unchanged itraconazole , product A and B used in the studies was not bioequivalent to Sporal ®. Bioequivalence studies with hydroxy-itraconazole, an active metabolite of itraconazole, should be performed to determine the overall therapeutic effects. Long term use in patients should also be determined to evaluate the therapeutic effects.

Life Satisfaction in Patients with leprosy

Siramas Rodchan — 2026-07-27

The purpose of the research is to determine level of life satisfaction and to examine factors influencing life satisfaction in patients with leprosy at Rajprachasamasai Institute. Using a stratified random sampling technique by gender,300 patients with leprosy were recruited from a total population of 947 .Life satisfaction questionnaire for leprosy, adapted from neugarten was used.

When using logistic regression and controlling for confounding factors,the result indicated only 3 factors influencing life satisfaction, namely, ability to read(Adjusted OR=2.2,p=0.02), sufficience of income(Adjusted OR=4.7,p<0.001) and problem in social relationship(Adjusted OR=0.3,p<0.001).

Socio - economic rehabilitation and increase reading ability may therefore be strategies to improve life satisfaction in patients with leprosy.

Oral antifungal agents

Nucha Niumpradit — 2026-07-27

Oral antifungals advanced greatly since the introduction of griseofulvin, a drug with narrow-spectrum of activity against derrnatophytes. The following era is the discovery of the azole antifungals including ketoconazole, itraconazole and fluconazole that have broard-spectrum of activities. Terbinafine is the first oral antifungal that has fungicidal effect and enables ul; to treat many kinds of fungal infections successfully. However, there is still no " ideal" drug that could cover all kinds of fungal infections. At present, there are many drug-resistance organisms, various side effects of the drugs as well as drug interactions. Antifungals such as voriconazole, ravuconazole and posaconazole are new members of the azoles. A new group of antifungal with unique mechanism of action such as the echinocandins were developed in attempt to "fix" all the antifungal pitfalls. The mode of action, pharrnacokinetics, clinical use, side effects and drug interactions of these drugs were reviewed in this article.

Itraconazole (Sporlab®) in the treatment of Penicillium marneffei infection in HIV-infected patients

Kritut Dachavaranupat — 2026-07-27

Penicillium marne.ffei is the most common cause of systemic fungal infection in HIV-infected patients in Thailand. Amphotericin B and itraconazole are the treatment of choice. Afterwards the patients must continue itraconazole for life to prevent a relapse. This research was a preliminary, opened-trial study to ® evaluate the effectiveness of itraconazole (Sporlab ) in the treatment of moderately severe Penicillium marneffei infection in HIV-infected patients. The patients received Sporlab®( 100 mg) at a dose of 2 capsules 2 times daily after a meal for 8 weeks. Of 11 volunteers (5 male and 6 female), one female patient was excluded from the study in the 3rd week because of severe diarrhea. Of the IO volunteers, 9 had skin lesions that disappeared within an average of 18 days (10-28 days), 6 had fever that vanished within an average of 9 days (4-14 days), and in I patient presenting with abdominal pain, the investigation revealed hepatosplenomegaly and intraabdominal lymphadenopathy. The severity of the abdominal pain decreased after 2 weeks of treatment and the discomfort had gone completely within 1 month, although abdominal ultrasonography showed no significant change. After the treatment, all 10 patients gained weight at an average of 2.56 kg/month (1-5 kg/month). No other adverse side effects were found, except in 1 patient, who had elevated liver enzymes that became normal in the follow up of the secondary prophylaxis.

In conclusion, this preliminary, opened-trial study found that Sporlab®is effective in the treatment of moderately severe Penicillium marneffei infection in HIV-infected patients . The treatment does not warrant hospitalization and the cost is much lower than that for standard remedies.