Subproducts

Instacoat EN SOL

Product Description

INSTACOATTM EN-SOL is a fully formulated enteric coating system based on Cellulose Acetate Phthalate. It requires organic solvent for reconstitution and can be used on highly moisture sensitive cores. It provides a consistent and reproducible delayed release profile.

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 EN-SOL

  • CAP polymer system is soluble above pH 6
  • Suitable for enteric formulations requiring higher pH solubility point than many other systems while avoiding use of acrylics.
  • Widely known & understood polymer with > 70-year history of use in enteric coating
  • Regulatory acceptability
  • Fully non-aqueous solvent system
  • Suitable for highly moisture sensitive formulations
  • 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.

Recommended Solvent System and Reconstitution Level

  • Methylene chloride (90%) + IPA (10%) at up to 5% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of Instacoat EN-SOL and solvent quantities

  • Determine the quantities of Instacoat EN-SOL (5% w/w solids) and methylene chloride/IPA mixture 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 g Instacoat, 1672 g of methylene chloride and and 88 gm of IPA at room temperature (includes 10% overage for losses)

Reconstitution Process

  • Mix together the weighed quantities of methylene chloride and IPA
  • Using a mechanical stirrer, stir the mixed solvents to form a vortex
  • Add the required quantity of Instacoat EN-SOL 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

  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 (%) 8.0-12.0
Number of guns 1-6 1
Liquid nozzle diameter (mm) 1.0-1.5
Atomising air pressure (bar) 2.0-3.5
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature (⁰C) 33-37
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

CAP, Plasticiser, Titanium Dioxide, Pigments.