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Hydroquinone + Tretinoin + Mometasone Furoate Cream (2% + 0.025% + 0.1% w/w) Manufacturing Process by Den Mark Pharmaceuticals Pvt. Ltd.

Introduction

Den Mark Pharmaceuticals Pvt., a Pharmaceutical Formulation Company, produces a potent combination cream, blending Hydroquinone, Tretinoin, and Mometasone Furoate in precise ratios (2% + 0.025% + 0.1% w/w). This top-quality formulation effectively targets various skin concerns. Hydroquinone acts as a skin-lightening agent, combating hyperpigmentation.

Tretinoin enhances skin cell turnover, reducing acne and fine lines. Mometasone Furoate, a corticosteroid, alleviates inflammation and itching. Together, these ingredients synergize to deliver remarkable results in treating melasma, acne scars, and other dermatological conditions. Den Mark's cream promises both efficacy and safety, ensuring a comprehensive solution for diverse skincare needs.

Process:

1. Preparation:

  • All materials and equipment will be verified against specifications before use.
  • Production personnel will be appropriately trained and garbed.
  • The manufacturing area will be cleaned and disinfected according to GMP guidelines.

2. Weighing and Milling:

  • Individually weigh each raw material according to the pre-determined production batch size and documented master formula.
  • Mill the Hydroquinone, Tretinoin, and Mometasone Furoate to ensure proper particle size and dispersion within the cream.

3. Oil Phase Preparation:

  • In the jacketed mixing vessel, heat Isopropyl Myristate, Stearyl Alcohol, Cetearyl Alcohol, White Petrolatum, and Light Liquid Paraffin to a pre-determined temperature (around 75°C) under constant stirring.

4. Aqueous Phase Preparation:

  • Heat purified water, propylene glycol, disodium EDTA, and citric acid in a separate vessel at the same temperature (around 75°C) while stirring.

5. Emulsification:

  • Slowly add the aqueous phase to the oil phase while maintaining constant high-shear homogenization. This ensures the proper droplet size and cream stability.

6. Cooling and Maturation:

  • Gradually cool the emulsion to room temperature under gentle stirring. This allows for proper crystal formation and consistency development.

7. Active Ingredient Incorporation:

  • Once cooled, slowly incorporate the milled Hydroquinone, Tretinoin, and Mometasone Furoate under aseptic conditions. Ensure proper mixing to obtain a uniform distribution.

8. pH Adjustment:

  • Measure the cream's pH. If necessary, adjust the pH to a slightly acidic range (around 5.0-5.5) using small additions of Sodium Hydroxide solution.

9. Preservative Addition:

  • Add pre-determined preservatives (e.g., Methylparaben, Propylparaben) under aseptic conditions.

10. Filling and Packaging:

  • Transfer the finished Hydroquinone + Tretinoin + Mometasone Furoate Cream (2% + 0.025% + 0.1% w/w) to a designated quarantine area. Before use, the filling line will be thoroughly cleaned and sanitized.
  • Fill the sterilized containers with the cream using an automated filling machine.

11. Labelling and Packing:

  • Label each container with product name, ingredients, batch number, expiry date, and usage instructions according to pre-approved labeling designs.

12. Quarantine and Release:

  • The batch's samples of Hydroquinone + Tretinoin + Mometasone Furoate Cream (2% + 0.025% + 0.1% w/w) will be subjected to a battery of tests per specifications, including physical appearance, pH, microbial count, and an assay of active ingredients.
  • The batch will be released only after all tests meet the defined acceptance criteria.

13. Documentation:

  • Batch production records will comprehensively document all production activities, including raw material reconciliation, process parameters, and quality control results.