Itraconazole IR Pellets

Itraconazole Pellets 22%, 40% – Suitable for Capsules (Dose: 100 mg, 200 mg)

Itraconazole belongs to the family of medications called antifungals. It is used to treat certain types of fungal infections, both internally (inside the body) and externally (skin and nails).

  • Itraconazole is used for the treatment of fungal infections in both HIV- and non-HIV-infected individuals.
  • The objective of developing Itraconazole pellets by aqueous technology is to match the dissolution profile of Itraconazole Pellets with SPORANOX without use of organic solvent.
  • The product developed is comparable with innovator with respect to dissolution profile of the marketed product.
  • We do offer development services in case of a requirement for different formulation/dosage/strength
  • Offer complete technical package for registrations in all regulated/semi regulated markets
  • Products protected by ongoing Patents are not offered by MKPPL.

 

Itraconazole is used to treat fungal nail infections. Itraconazole goes into your bloodstream and travels to the source of the infection underneath the nail so that it can fight the infection there.

The mechanism of action of itraconazole is the same as the other azole antifungals: it inhibits cytochrome P450 oxidase mediated synthesis of ergosterol.

Itraconazole is used for the treatment of fungal infections in both HIV- and non-HIV-infected individuals. It is active against fungal infections such as aspergillosis, blastomycosis, histoplasmosis, and candidiasis, as well as fungal infection localized to the toenails and fingernails (onychomycosis). It also is used for treating patients with fever and low white blood cell counts who are likely to develop a fungal infection.

Ours is a 100% patent non-infringing process. We are the first in the world to employ Aqueous Layering Technique.

Additional Information

Percentage

22%, 44%

Mesh Size

14#18, 16#20, 20#24

Quality Standard

BP20, USP43

Documentation Available:

DMF in CTD Format

Release Type

Immediate Release

Target Formulations

Capsules

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