In the pharmaceutical industry, Griseofulvin 250 mg is a fungistatic antibiotic derived from Penicillium griseofulvum. As a pharmacist, I characterize it as a “legacy” antifungal that remains highly effective for specific infections where newer azoles might fail, particularly because of its unique affinity for keratinized tissues (skin, hair, and nails).

Primary Clinical Uses

• Tinea Capitis (Scalp Ringworm): Griseofulvin is still considered a first-line treatment for scalp ringworm in children, especially infections caused by Microsporum species.

• Tinea Corporis and Tinea Cruris: Used for fungal infections of the body and groin when topical therapies are ineffective.

• Tinea Pedis (Athlete’s Foot): Indicated for stubborn infections of the feet.

• Onychomycosis: Used for fungal infections of the fingernails and toenails, though treatment must be continued for several months until the infected nail is completely replaced by healthy growth.

Mechanism of Action

Griseofulvin has a distinct mechanism that sets it apart from the azole family. It is a spindle poison.

Inhibition of Mitosis: It binds to the fungal microtubules (tubulin), which disrupts the formation of the mitotic spindle. This prevents the fungal cell from dividing (metaphase arrest).

Keratin Binding: After oral administration, the drug is deposited in the precursor cells of keratin. As these cells migrate to the surface, the Griseofulvin remains tightly bound to the keratin, making the tissue “resistant” to fungal invasion.

Fungistatic Effect: It does not kill the fungus instantly but prevents it from infecting new hair or skin. The infection is cured only as the old, infected keratin is shed and replaced by new, drug-protected keratin.

The Manufacturer’s Perspective: Formulation & Export

From a production and global trade standpoint, Griseofulvin 250 mg presents specific technical challenges:

• Micronization (Critical): Griseofulvin has extremely low solubility. As a WHO-GMP manufacturer, we utilize micronized (or ultra-micronized) API. Reducing the particle size increases the surface area, which significantly enhances absorption and bioavailability.

• Fat-Enhanced Absorption: As a pharmacist, you know that Griseofulvin is highly lipophilic. We include instructions in our Product Information Leaflets (PIL) advising patients to take the medication with a high-fat meal to maximize absorption.

• Stability for Export: Griseofulvin is relatively stable but must be protected from light. We utilize Alu-Alu or opaque PVC/PVDC blister packaging to ensure a 36-month shelf life for export to Zone IVb regions (Africa and SE Asia).

• B2B & Public Health Tenders: This product is a staple in pediatric hospital tenders and dermatology clinics. Our Mumbai-based facility provides the CTD/eCTD Dossiers and stability data required for international registration.