Avoidance of specific commonly used polymers

Subproducts

Instacoat P4

Product Description

INSTACOATTM P4 is an alginate-based film coating system. This avoids the use of cellulose-based materials to avoid incompatibility or provide IP advantages. It is a dry blend of polymer, plasticizer and approved colours. It gives a glossy finish to tablets at weight gain values of around 2.0 to 3.0%. The system being robust can be handled with a variety of coating machines and processes without stringent processing conditions.

Resources
Features Benefits

INSTACOAT System

  • Dry powder system for reconstitution
  • Process time savings from rapid coating suspension manufacture
  • Complete coating formulation minus solvent
  • Cost savings in inventory and inventory management
  • Advanced colour control methods
  • Reproducible finished product appearance
  • Avoidance of customer complaints
  • White or ready coloured systems matched to your specification or sample are available. Anti-counterfeiting and branding features can be built-in
  • Meeting diverse marketing requirements is facilitated
  • Colours used are checked for compliance with appropriate regulations in target markets
  • Avoidance of regulatory issues

INSTACOAT P4

  • Absence of cellulosic materials
  • Stability improvement where API is incompatible with cellulosic polymers
  • Polymers used have low viscosity
  • Enables use of fast-drying, high solids coating systems with consequent process time savings
  • Polymers used are highly water soluble
  • Minimal impact on dissolution and disintegration.
  • Aqueous processing promotes a safe working environment and avoidance of atmospheric pollution
  • Polymers used have high adhesion and gloss
  • Excellent appearance including logo definition and gloss.
  • Reduces logo bridging and in most cases improves low temperature coating performance
  • Can be applied in a wide range of equipment designs and sizes from most manufacturers
  • Easy scale-up and transfer to different equipment types or manufacturing sites.

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.

Recommended Solvent System and Reconstitution Level

  • Purified water at up to 20% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of Instacoat P4 and solvent quantities

  • Determine the quantities of Instacoat P4 (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 3% wt. gain, weigh 33 g Instacoat and 132 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 Instacoat P4 to the centre 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

Parameters Side-vented (fully
perforated) pans
Conventional
(non perforated) pans
Pan 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) 3.0 - 4.0
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature (°C) 37 - 40
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.

Typical Constituents

Non-cellulosic water-soluble polymer(s); Plasticiser; Opacifier; Pigments; Glidant; Microbiological Preservative.