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    Ophtalmicpreparations 230708103652 6ce546e8

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    Ophtalmicpreparations 230708103652 6ce546e8

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    of 13

    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
    Introduction

    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.
    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
    Formulation Considerations
    • Clarity
    • Stability
    • Buffer and pH
    • Tonicity
    • Viscosity
    • Additives
    • Microbiological preservatives
    • Antioxidants
    • Surfactants
    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.
    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
    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.
    Methods of Preparation

    • Preparation of Eye Drops


    • Preparation of the Solution
    • Clarification
    • Sterilisation:
    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
    Containers
    • Single-Dose Containers
    • Plastic Bottles
    • Glass Bottles
    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
    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

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