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Instacoat 4G

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.

Properties

Physical Form
  • Powder
  • Solid
Pharma and Nutraceuticals Functions
  • Coating System
  • Detackifier

Product families

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
  • Excipients & Coatings

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • Formulation & Processing Aids
  • Pharmaceutical Coatings

Other characteristics

Brand
Instacoat
Functions
Coating System, Detackifier
Markets
Healthcare & Pharma
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.

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.

Technology
Pharmaceuticals & Nutraceuticals
Typical Constituents

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

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.

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.

Equipment / Accessories
  • Variable-speed mechanical stirrer
  • Mixing Vessel
Manufacturing Technology
Tablet Coating
Recommended Process Conditions

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.

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).

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