Fluconazole 150 mg Capsule | Formulation & Manufacturing Process

Fluconazole is an antifungal medication used for several fungal infections. This includes candidiasis, blastomycosis, coccidioidomycosis, cryptococcosis, histoplasmosis, dermatophytosis, and pityriasis versicolor. It is also used to prevent candidiasis in those who are at high risk such as following organ transplantation, low birth weight babies, and those with low blood neutrophil counts. It is given either by mouth or by injection into a vein.

Fluconazole was patented in 1981 and came into commercial use in 1988. It is on the World Health Organization’s List of Essential Medicines. Fluconazole is available as a generic medication. In 2020, it was the 174th most commonly prescribed medication in the United States, with more than 3 million prescriptions.

There are several dosage forms and strengths available with Fluconazole. The most common of which is Fluconazole 150 mg Capsule.

Each capsule contains Fluconazole USP 150 mg. The formulation & manufacturing process of Fluconazole 150 mg Capsule is as below:

Formulation:

Each capsule contains:

Manufacturing Process:

1. Pass Fluconazole and Lactose Monohydrate through a 20-mesh and Purified Talc, Colloidal Anhydrous Silica 200, and Magnesium Stearate through a 40-mesh sieve.
2. Blend Fluconazole, Lactose Monohydrate, Colloidal Anhydrous Silica, Purified Talc, and Magnesium Stearate in a Drum/Double Cone Blender for 30 minutes.
3. Fill the blended mix into an Empty Hard Gelatin Capsule Shell of Size # 2.
4. Send the sample of capsules to the Quality Control Department by an Analytical Test Request Sheet for necessary analysis & release for blistering.