Knowde Enhanced TDS
Identification & Functionality
- Pharma & Nutraceuticals Functions
- Technologies
- Typical Constituents
Methacrylic Acid Copolymer Type A &/or Type B, Plasticisers; Titanium Dioxide; Edible Pigments; Glidant; Surfactant.
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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Good solubility in the recommended solvent systems.
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Enteric protection achieved at low weight gain.
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Glidant is included.
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Surfactant included.
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High gloss levels.
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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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Rapid suspension preparation.
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Raw material and process cost and time savings.
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Overcomes polymer tack issues and contributes to productivity gains.
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Excellent spreadability resulting in enhanced tablet-to-tablet coating uniformity.
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High level of patient acceptability from elegant appearance.
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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
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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
IPA 90% + Purified Water 10% at up to 10% w/w solids.
- Calculation of Instacoat™ EEN and Solvent Quantities
Determine the quantities of Instacoat EEN (10% w/w solids) and IPA + 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 gm Instacoat EEN and 792 gm IPA + 88 gm purified water at room temperature (including 10% overage for losses).
- Reconstitution Process
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Add the weighed quantity of Isopropyl Alcohol in a mixing vessel.
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Using a propeller stirrer, stir the Isopropyl Alcohol to form a vortex.
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Add the required quantity of Instacoat EEN to the center of the solvent vortex in a slow steady stream, avoiding clumping. Maintaining the vortex, stir for 5 minutes, and then add the weighed quantity of water.
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Once the entire quantity of Instacoat EEN has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
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Filter the coating suspension through a 60 mesh screen.
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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 (%) 8.0 Number of Guns 1-6 1 Liquid Nozzle diameter (mm) 1.0-1.5 Atomising Air Pressure (bar) 1.0–2.0 Pattern Air Pressure To achieve maximum uniform bed coverage Tablet Bed Temperature (°C) 31-35 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.