Ophthalmic Preparation

ophthalmic preparations

1. Class- B-pharm- III Sem V Subject - Industrial Pharmacy-I Topic Name : Ophthalmic Preparations Mr Nandakishor B Deshmukh. Assistant Professor Department Of Pharmaceutics Shraddha Institute Of Pharmacy, Kondala Zambre , Washim

2. Int roduction Ophthalmic or eye preparations are sterile liquid,semi -solid, or solid preparations containing one or more active pharmaceutical ingredient and meant to be applied on the eye.

3. Advantages They can be easily administered by the nurse. They can be easily administered by the patients themselves. They undergo quick absorption and thus produce a quick effect. They produce less systemic side effects. They have increased shelf-life. They show better patient compliance.   Disadvantages They stay for a very short time at the eye surface. They have poor bioavailability. The dissolved drug shows instability. They need a preservative

4. Formulation Considerations Clarity Stability Buffer and pH Tonicity Viscosity Additives Microbiological preservatives Antioxidants Surfactants

5. Formulation of Eye Drops An eye drop formulation comprises of the following: Active ingredient Vehicle (aqueous or oily). preservatives Inert adjuvants for adjusting tonicity viscosity pH to increase the stability of active ingredient(s). Suitable container to maintain the preparation in a stable form and provide protection against contamination during preparation, storage, and use.

6. Formulation of Eye Ointments The following bases can be used for the preparation of eye ointments : . Yellow soft paraffin (80gm), Liquid paraffin (10gm), or Wool fat (10gm

7. Formulation of Eye Lotions Eye lotions are undiluted aqueous solutions used for first aid purposes. They allow a large volume of fluid to quickly flow over the eyes. They are iso -osmotic to tears as they make the lachrymal fluid much more dilute than the eye drops. However, they may cause discomfort if not adjusted. An ideal eye lotion should have the following properties : It should be sterile and should contain no preservative. It should be iso -osmotic to lachrymal fluid. It should have a neutral pH. It should be of large volume but not greater than 200ml. It should be non-irritant to ocular tissue.

8. Methods of Preparation Preparation of Eye Drops Preparation of the Solution Clarification Sterilisation :

9. Preparation of Eye Ointments Preparation of Eye Ointments Wool fat and yellow soft paraffin are melted on a heated water bath. Liquid paraffin is added to the melted mixture and filtered through a coarse filter paper ( e.g., Whatman 54) placed in a heated funnel

10. Containers Single-Dose Containers Plastic Bottles Glass Bottles

11. Labelling The product name, The name(s) of active ingredient(s) and their concentration, The name(s) and concentration(s) of antimicrobial agent(s) and/or antioxidant(s) added, The amount or volume of preparation in the container, The batch (lot) number as assigned by the manufacturer, The expiry date, Special storage conditions or handling precautions (if any), The period of use after opening the container, Directions for use, warnings, and precautions, The manufacturer’s name and address, and The statement “This preparation is sterile

12. Evaluation of Ophthalmic Preparations Sterility Antimicrobial Preservatives: Uniformity of Dosage Units: Uniformity in Containers: Leachables and Extractables : Container Closure Integrity: Container Closure Integrity: Antioxidant Content Particle Size and Particle Size Distribution