In the pharmaceutical industry, there is a common technical clarification regarding Nystatin: it is measured in International Units (IU) rather than milligrams (mg). When a client asks for “Nystatin 100,000,” they are referring to 100,000 IU, which is the standard concentration for this potent polyene antifungal agent.
Primary Clinical Uses
Nystatin is specifically indicated for the treatment of Candidiasis (fungal infections caused by Candida species). Because it is not absorbed into the systemic circulation from the skin or gastrointestinal tract, its use is strictly localized:
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Oral Candidiasis (Thrush): The 100,000 IU/ml oral suspension is used as a “swish and swallow” or “swish and spit” treatment for fungal infections of the mouth and throat.
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Intestinal Candidiasis: Used in tablet or liquid form to treat fungal overgrowth in the digestive tract.
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Vaginal Candidiasis: Formulated as vaginal inserts (pessaries) to treat yeast infections.
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Cutaneous Candidiasis: Formulated in creams or ointments for fungal skin infections, such as diaper rash or intertrigo.
Mechanism of Action: Membrane Pore Formation
Nystatin is fungistatic and fungicidal. It works by exploiting the structural differences between fungal and human cells.
Ergosterol Binding: Nystatin binds specifically to ergosterol, a vital component of the fungal cell membrane (human cells use cholesterol instead).
Pore Formation: This binding creates physical “pores” or channels in the fungal cell wall.
Leakage and Death: Intracellular components like potassium ($K^+$) and other ions leak out through these pores, causing the fungal cell to lose its structural integrity and die.
The Manufacturer’s Perspective: Technical & Export
From a manufacturing standpoint in our WHO-GMP environment, Nystatin 100,000 IU requires specialized handling:
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Non-Systemic Safety: A major USP for your digital platform is that Nystatin is “nontoxic” because it is not absorbed. This makes it exceptionally safe for infants (diaper rash/thrush) and pregnant women, a key selling point for B2B buyers in pediatrics and gynecology.
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Photosensitivity and Stability: Nystatin is sensitive to light, heat, and moisture. At our Mumbai facility, we utilize Amber-colored glass or opaque HDPE bottles for suspensions and Alu-Alu blisters for tablets to ensure a 24-month shelf life for export to Zone IVb regions.
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Potency Calculations: Since the API is measured in IU/mg, our QC laboratory performs rigorous biological assays to ensure the finished product accurately reflects the 100,000 IU label claim.
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B2B & Dossier Support: We provide full CTD/eCTD Dossiers to support international registration against the innovator (Mycostatin).