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Instacoat™ 4G is a ready-mixed powder that can be rapidly reconstituted in water, for the film coating of solid oral dosage forms. It contains polymer, plasticizer, pigments, etc. in optimal ratios to achieve significant benefits in terms of processability and product quality. It is available in a wide range of shades to customer specifications.

Functions: Coating System, Detackifier

Technical Data Sheet
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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
Typical Constituents

PVA; Plasticiser; Titanium Dioxide; Edible Pigments, Anti-Tack & Adhesion Enhancing agents.

Features & Benefits

Features
  • PVA is a low viscosity polymer.

  • PVA is highly water soluble.

  • Anti-tack agent.

  • PVA is a highly adhesive polymer & is supplemented by an adhesive enhancing agent.

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

  • Single polymer and absence of soya lecithin.

Benefits
  • Coatings are smooth, glossy and resilient to physical damage. Packaging speeds are enhanced.

  • Solids levels up to 35% facilitate rapid coating thus major productivity gains.

  • Rapid suspension preparation

  • Minimal impact on dissolution and disintegration.

  • Avoids use of expensive super-disintegrants in tablet core.

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

  • Overcomes PVA tack issues and contributes to productivity gains.

  • Excellent logo definition and freedom from coating faults such as logo bridging despite high application rates.

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

  • Suitable for batch and continuous processes.

  • Facilitates product registration in multiple regulatory environments.

Applications & Uses

Manufacturing Technology
Equipment / Accessories
  • Variable-speed mechanical stirrer

  • Mixing Vessel

Properties

Physical Form

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 35% w/w solids.

Calculation of Instacoat™ 4G and Solvent Quantities

Determine the quantities of InstacoatTM 4G (35% 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 3 g Instacoat and 61.3 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 InstacoatTM 4G 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
Continuous Coaters
Pan Diameter (inch) 24-60 12 24-30
Tablet Load (kg) 10-350 0.5-1.0 150-430 static
Tablet Throughput (kg/hr) N/A N/A 500-635
Weight Gain (%) 2.5-3.0
Number of Guns 1-6 1-2 14-22
Liquid Nozzle diameter (mm) 1.0-1.2
Atomising Air Pressure (bar) 3.0-4.0
Pattern Air Pressure Set to achieve maximum uniform bed coverage
Tablet Bed Temperature (°C) 42-46
Inlet Air Temperature (°C) Set to achieve required bed temperature & process time
Suspension Spray Rate (g/min) Set to achieve required product bed temperature
Exhaust Air Volume To maintain slight negative pressure in pan
Pan Speed To achieve steady tablet flow through spray zone

Table 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.