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Instacoat™ EHAis a complete film coating system consisting of a dry blend of HPMC, plasticizer, pigments, opacifiers and other excipients. The system is optimized to give superior tablet adhesion and finish using water as the solvent system.

Functions: Coating System

    Knowde Enhanced TDS

    Identification & Functionality

    Pharma & Nutraceuticals Functions
    CAS No.
    9004-65-3
    EC No.
    618-389-6
    Typical Constituents

    PVA; Plasticiser; Titanium Dioxide; Edible Pigments, Glidant; Adhesion Enhancing agent.

    Features & Benefits

    Features
    • HPMC is one of the most commonly used film coating polymers with a long history of use.

    • HPMC is highly water soluble.

    • Adhesion enhancing agent .

    • Can be applied in a wide range of equipment designs and sizes from most manufacturers.

    Benefits
    • Systems are widely understood from regulatory, development and production perspective thus facilitating progress from formulation, scale-up through to full production.

    • Minimal impact on dissolution and disintegration.

    • Aqueous processing promotes a safe working environment and avoidance of atmospheric pollution.

    • Provides excellent logo definition, reduces logo bridging and improves low temperature coating performance.

    • Suitable for waxy, low melting point substrates.

    • Easy scale-up and transfer to different equipment types or manufacturing sites.

    Applications & Uses

    Equipment / Accessories
    • Variable-speed mechanical stirrer

    • Mixing Vessel

    Regulatory & Compliance

    Regulatory Information

    All products are checked for the regulatory compliance of all ingredients in the target countries and market segments of sale. This determination is made at the time the initial formulation is established, based on customer-supplied information. If market countries and/or segments are extended once the formulation has been established, customers are encouraged to contact us to ensure that regulatory compliance is not compromised.

    Technical Details & Test Data

    Recommended Solvent System and Reconstitution Level

    Purified water at up to 20% w/w solids.

    Calculation of Instacoat™ EHA and Solvent Quantities

    Determine the quantities of Instacoat EHP (20% w/w solids) and water required based on the quantity of tablets to be coated and the target coating weight gain. e.g.: For coating 1.0 kg of tablets to 3% wt. gain, weigh 33 g Instacoat and 132 gm purified water at room temperature (includes 10% overage for losses)

    Reconstitution Process
    • Add the weighed quantity of water to a mixing vessel.

    • Using a mechanical stirrer, stir the purified water to form a vortex.

    • Add required quantity of Instacoat EHP 250 to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instacoat has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.

    Recommended Process Conditions
      Side-Vented
    (Fully Perforated) Pans
    Conventional
    (Non Perforated) Pans
    Pan Diameter (inch) 24-60 12-36
    Tablet Load (kg) 10-300 0.5-50
    Weight Gain (%) 3.5-4.0%
    Number of Guns 1-6 1
    Liquid Nozzle diameter (mm) 1.0-1.2
    Atomising Air Pressure (bar) 2.5-3.5
    Pattern Air Pressure To achieve maximum uniform bed coverage
    Tablet Bed Temperature (°C) 37-40
    Inlet Air Temperature (°C) Set to achieve required product bed temperature
    Suspension Spray Rate Set to achieve required product bed temperature
    Exhaust Air Volume To maintain slight negative pressure in pan
    Pan Speed Minimum for steady tablet flow through spray zone

    Tablet bed temperature offers the most effective way of controlling the coating process. Where this measurement is unavailable, exhaust temperature may be substituted. However, the relationship between the two measurements is complex and depends on several factors such as pan load, pan depression, pan design and airflow rate. Indicated exhaust temperature may be above or below the true bed temperature. It is recommended that the relationship between the two measurements is calibrated.