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Clotrimazole Ointment Manufacturing Process (1%, 2% w/w) by Den Mark Pharmaceuticals Pvt. Ltd.

Introduction:

Cetostearyl alcohol, an ingredient in this lotion, may irritate or produce rashes on the skin. Benzyl alcohol, a component of clotrimazole, has the potential to produce minor local irritation. For those who have recently received an organ transplant, clotrimazole treatment may raise tacrolimus levels, potentially resulting in toxicities related to tacrolimus.

Den Mark Pharmaceuticals Pvt. Ltd. manufactures Clotrimazole Ointment (1%, 2% w/w) following WHO GMP guidelines to ensure consistent quality and efficacy. This document outlines the production process for both concentrations.

1. Materials :

  • Active Pharmaceutical Ingredient (API): Clotrimazole powder (100% w/w)
  • Ointment Base: Suitable bases like white petrolatum, white soft paraffin, or a combination (meeting pharmacopoeial specifications)
  • Antioxidants (optional): BHA, BHT (if required by formulation)
  • Preservatives (optional): Suitable preservatives as per regulations (if required by formulation)
  • Purified Water

2. Process Steps

Preparation:

  • Clean and disinfect the manufacturing area according to GMP protocols.
  • Pre-weigh required quantities of Clotrimazole API for 1% and 2% ointments based on production batch size.
  • Weigh the ointment base according to the formulation for each concentration.

3. Mixing:

  • Transfer the ointment base into a sanitized mixing vessel.
  • Add the pre-weighed Clotrimazole API for the desired concentration (1% or 2%).
  • Mix using a high-shear mixer until uniformly dispersed.
  • Consider using a homogenizer for improved particle size distribution (optional).

Milling:

  • Pass the mixed ointment through an ointment milling machine to achieve a smooth and homogenous consistency.

4. Filling and Packaging:

  • Ensure filling equipment is sterilized.
  • Load the prepared ointment into the filling machine.
  • Fill appropriate containers with the desired ointment amount (e.g., tubes, jars).
  • Seal the containers.

5. Labeling and Packaging:

  • Apply product labels with all necessary information (brand name, concentration, expiry date, batch number, etc.).
  • Pack the labelled containers into secondary packaging materials (cartons, boxes).

Quality Control

  • Samples of Clotrimazole Ointment (1%, 2% w/w) from each batch will undergo testing to ensure they meet specifications, including:
    • Clotrimazole content assay
    • Physical characteristics (appearance, consistency, pH)
    • Microbiological evaluation (if applicable)

Documentation

  • Maintain complete batch records for each production run, including:
    • Raw material certificates of analysis
    • Production weighing records
    • Mixing and milling parameters
    • Quality control test results

Storage

  • Following recommended storage conditions, store the finished Clotrimazole Ointment (1%, 2% w/w) in a cool, dry place protected from light and heat.

Additional Notes

  • This is a high-level process overview. Specific details, such as mixing time, milling parameters, and additional ingredients, may vary depending on the chosen formulation and equipment.
  • Den Mark Pharmaceuticals Pvt. Ltd. complies with all relevant regulatory requirements for manufacturing Clotrimazole Ointment in its region.

By following these steps and adhering to WHO GMP guidelines, Den Mark Pharmaceuticals Pvt. Ltd., a Leading Pharmaceutical Manufacturing Company, can ensure the production of high-quality Clotrimazole Ointment (1%, 2% w/w) for patient use.