Knowde Enhanced TDS
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Typical Constituents
Methacrylic Acid Copolymer Type C; Plasticiser; Titanium Dioxide; Edible Pigments; Alkaliser; Glidant.
Features & Benefits
- Features
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Methacrylic Acid copolymers are the most widely used and accepted enteric polymers worldwide.
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Development and production staff are familiar with process requirements.
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Aqueous processing.
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Low viscosity coating system.
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Rapid dispersibility in water.
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Glidant is included.
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Can be applied in a wide range of equipment designs and sizes from most manufacturers.
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- Benefits
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Absence of regulatory problems and delays.
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Easy scale-up and production introduction.
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Safer working environment.
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Environmentally friendly.
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Low atomisation pressure required.
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Excellent tablet-to-tablet coating uniformity.
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Smooth & glossy appearance.
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Rapid suspension preparation.
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Overcomes polymer tack issues and contributes to productivity gains.
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Easy scale-up and transfer to different equipment types or manufacturing sites.
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Suitable for batch and continuous processes.
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Applications & Uses
- Markets
- Applications
- Equipment / Accessories
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Variable-speed mechanical stirrer (do not use high-shear equipment)
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Mixing Vessel
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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™ EN Super II and Solvent Quantities
Determine the quantities of Instacoat EN SUPER-II (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 8% wt. gain, weigh 88 g Instacoat and 352 gm purified water at room temperature (includes 10% overage for losses).
- Reconstitution Process
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Add the weighed quantity of water to a mixing vessel.
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Using a mechanical stirrer, stir the purified water to form a vortex.
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Add the required quantity of Instacoat EN SUPER-II to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex and completing powder dispersion within 5 minutes. Once this has been achieved, reduce the stirrer speed to eliminate the vortex and continue mixing for 45 minutes.
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- Recommended Process Conditions
Side-Vented
(Fully Perforated) PansConventional
(Non Perforated) PansPan Diameter (inch) 24-60 12-36 Tablet Load (kg) 10-300 0.5-50 Weight Gain (%) 8-9 % Number of Guns 1-6 1 Liquid Nozzle diameter (mm) 1.0-1.5 Atomising Air Pressure (bar) 1.5-2.5 Pattern Air Pressure To achieve maximum uniform bed coverage Tablet Bed Temperature (°C) 30-35 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.