Apex Laboratories Pvt. Ltd., a pharmaceutical companies based in Chennai, on Tuesday announced the launched of an advanced form of Itraconazole Capsules Supra Bioavailable 65 and 130 mg, to control fungal infections.
According to the company’s Supra Bioavailable Itraconazole capsules deliver a higher percentage (90%) of active medicine to the biological system, at a lesser dose. This advanced preparation also ensures lesser inter-individual variability which might translate into enhanced efficacy in the management of fungal infections.
Superficial mycoses of skin, nails and hair are among the common fungal infections and World Health Organization (WHO) reported their prevalence rate as 25 percent and it varies for occupational groups, gender, and age groups. Itraconazole capsule has become an oral treatment of choice for superficial fungal diseases, the company claims. “Itraconazole is also considered a first-line in many countries for the treatment of infections such as sporotrichosis, histoplasmosis, blastomycosis and cryptococcosis that circulate throughout the body, it stated.
“Although Itraconazole is an effective agent for fungal infection, studies state that, it has limitations such as poor absorption and variability in its blood concentrations and for any medicine to produce a desired clinical effect, its absorption should be optimal with minimal inter-individual variability,” said Vishagan, Director, Apex Laboratories Pvt. Ltd in a statement.
The United States Food and Drug Administration (USFDA) has approved the SUBA (Super Bio-Available) preparation of Itraconazole 65 mg and 130 mg capsules. In India, the Central Drugs Standard Control Organisation (CDSCO), also approved the similar formulation of Supra Bioavailable Itraconazole 65 & 130 mg capsules for the treatment of Blastomycosis, Histoplasmosis & Aspergillosis.
“Supra Bioavailable Itraconazole 65 & 130 mg capsules are prepared by Top spray granulation technology which is used to improve the dissolution rate of Itraconazole. It contains a solid dispersion of Itraconazole in a uniform non-pellet formulation. This novel technology enhances the bioavailability of poorly soluble drugs. The Technology utilizes a solid dispersion of drug in a polymer to improve the absorption in the gastrointestinal tract to achieve super bioavailability compared to conventional preparations,” added Mr Vanangamudi .
The pharma company claims that Supra Bioavailable Itraconazole can be taken with or without food and can be co-administered with medicines that lowers stomach acidity without causing any reduction in the absorption of Itraconazole.