Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- CAS No.
- 9004-65-3
- EC No.
- 618-389-6
- Technologies
- Typical Constituents
HPMC; Plasticiser; Titanium Dioxide; Edible Pigments, Glidant.
Features & Benefits
- Features
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Single polymer, HPMC with wide history of pharma/nutritional use.
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Formulated for lower viscosity than other HPMC systems.
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HPMC is highly water soluble.
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Can be applied in a wide range of equipment designs and sizes from most manufacturers.
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White or ready colored systems are available. Anti-counterfeiting and branding features can be built-in.
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- Benefits
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Facilitates product registration in multiple regulatory environments.
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Coatings are smooth, glossy and resilient to physical damage. Packaging speeds are enhanced.
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Solids levels up to 11% facilitate rapid coating.
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Rapid suspension preparation.
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Minimal impact on dissolution and disintegration.
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Avoids use of expensive super-disintegrants.
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Aqueous processing promotes a safe working environment and avoidance of atmospheric pollution.
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Easy scale-up and transfer to different equipment types or manufacturing sites.
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Meeting diverse marketing requirements is facilitated.
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Applications & Uses
- Markets
- Manufacturing Technology
- 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
Purified water at up to 11% w/w solids.
- Calculation of Instacoat™ Aqua and Solvent Quantities
Determine the quantities of Instacoat Aqua (11% 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 267 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 required quantity of Instacoat Aqua II 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.
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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 (%) 2.0-3.0% 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, Aqueous (°C) 40-42 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.