Subproducts

Instacoat EEN

Product Description

INSTACOATTM EEN is an optimized dry powder product for reconstitution in a hydro-alcoholic solvent system. It is based on methacrylic acid co-polymer type A &/or type B and provides enteric protection at minimum weight gain, typically between 6.5 and 8.0%.

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 EEN

  • Methacrylic Acid copolymers are the most widely used and accepted enteric polymers worldwide
  • Absence of regulatory problems and delays
  • Development and production staff are familiar with process requirements
  • Easy scale-up and production introduction
  • Good solubility in the recommended solvent systems
  • Rapid suspension preparation
  • Enteric protection achieved at low weight gain
  • Raw material and process cost and time savings
  • Glidant is included
  • Overcomes polymer tack issues and contributes to productivity gains
  • Surfactant included
  • Excellent spreadability resulting in enhanced tablet-to-tablet coating uniformity
  • High gloss levels
  • High level of patient acceptability from elegant appearance
  • 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
  • Suitable for batch and continuous processes

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.

INSTACOATTM EEN is an acrylic based ready-to-use enteric coating system for hydro-alcoholic solvent use, which provides excellent enteric protection to solid oral dosage forms. It is suitable for all coating machine designs and sizes. Use of a seal coat to prevent interaction between active and polymer and to provide a uniform substrate surface is recommended.

Recommended Solvent System and Reconstitution Level

  • IPA 90% + Purified Water 10% at up to 10% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

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

  • Add the weighed quantity of Isopropyl Alcohol in a mixing vessel.
  • Using a propeller stirrer, stir the Isopropyl Alcohol to form a vortex.
  • Add the required quantity of Instacoat EEN to the centre 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.
  • Once the entire quantity of Instacoat EEN has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
  • Filter the coating suspension through a 60 mesh screen.

Recommended Process Conditions

  Side-vented
(fully perforated) pans
Conventional
(non perforated) pans
Pan diameter (inch) 24-60 12-36
Tablet load (kg) 10-350 0.5-50
Weight gain (%) 8.0
Number of guns 1-6 1-2
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 (⁰C) 31-35
Inlet air temperature (⁰C) 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

Methacrylic Acid Copolymer Type A &/or Type B, Plasticisers; Titanium Dioxide; Edible Pigments; Glidant; Surfactant.