Apex Labs launches advanced Supra Bioavailable Itraconazole 65 and 130 mg capsules

Apex Laboratories has launched an advanced form of Itraconazole Capsules Supra Bioavailable 65 and 130 mg, a potent therapeutic choice to effectively control fungal infections. Supra Bioavailable Itraconazole capsules deliver a higher percentage (90 per cent) 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, a statement from the company notified.

The statement also said Itraconazole capsule has become an oral treatment of choice for superficial fungal diseases. Itraconazole is widely considered even for the treatment of conditions such as blastomycosis, histoplasmosis and aspergillosis.

“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, in the statement.

The United States Food and Drug Administration (FDA) has approved the SUBA (Super Bio-Available) preparation of oral Itraconazole 65 mg and dosing regimen of 130 to 260 mg. In India, the Central Drugs Standard Control Organisation (CDSCO) also approved the similar formulation of Supra Bioavailable oral Itraconazole 65 and 130 mg capsules for the treatment of conditions like blastomycosis, histoplasmosis and aspergillosis, according to the statement.

Supra Bioavailable Itraconazole 65 mg and 130 mg capsules is 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 utilises a solid dispersion of drug in a polymer to improve the absorption in the gastrointestinal tract to achieve “super bioavailability” compared to conventional preparations, the statement concluded.