Methods of Preparation of Ophthalmic

• Methods of Preparation of Ophthalmic involve aseptic compounding under sterile conditions to prevent contamination and ensure patient safety.
• Methods of Preparation of Ophthalmic vary for drops, ointments, and gels, requiring precise formulation, pH adjustment, and isotonicity.

1. Aseptic Filtration:

   • The formulation (solution) is passed through a sterile 0.22 μm membrane filter, removing bacteria and other particulates.
   • The filtered solution is then filled into previously sterilized containers under laminar airflow conditions.

2. Terminal Sterilization:

   • If the formulation and container can withstand heat, autoclaving at 121°C for 15–20 minutes is often employed.
   • Advantages: higher sterility assurance level.
   • Disadvantages: not suitable for heat-labile drugs.

3. Dry Heat Sterilization (for Ointments):

   1. The base can be sterilized by heating in an oven at 160–170°C for a specific time.
   2. Drug powders might be sterilized separately if stable to heat, then mixed under aseptic conditions.

4. Gamma Irradiation or Ethylene Oxide:

   • Used in specialized cases (e.g., certain packaging materials).
   • Less common for routine ophthalmic solutions due to potential effects on drug stability and safety.

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