Subproducts

Instacoat EEN SF

Product Description

INSTACOATTM EEN-SF is a ready-to-use acrylic-based enteric coating formulation in dry powder form for reconstitution. It is used to coat oral solid dosage forms, providing enteric protection at weight gain levels as low as 5%, thus providing cost savings in raw materials, with the shorter process times offering further economies from reduced energy usage.

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-SF

  • 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 very low weight gain
  • Raw material and process cost and time savings
  • 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 SF is an acrylic based high-speed optimized enteric film coating material suitable for use with hydro-alcoholic solvent systems. It offers enteric protection at low weight gain and is suitable for all coating machine designs and sizes. Use of a seal coat to prevent interaction between active ingredient and polymer and to provide a uniform substrate surface is recommended.

Recommended Solvent System and Reconstitution Level

  • Hydroalcoholic: IPA 85% + Water 15% at up to 8% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of Instacoat EEN SF and solvent quantities

  • Determine the quantities of Instacoat EEN SF (8% w/w solids), IPA & purified 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 5% wt. gain, weigh 55 gm Instacoat EEN SF, 538 g IPA & 95 g water at room temperature (including 10% overage for losses).

Reconstitution Process

  • Add the weighed quantity of Iso Propyl Alcohol to the mixing vessel.
  • Using the mechanical stirrer, stir the Iso Propyl Alcohol to form a vortex.
  • Add the required quantity of Instacoat EEN SF to the centre of the solvent vortex in a slow steady stream, avoiding clumping and maintaining a vortex. Stir for 5 minutes, then add the water.
  • Once the entire quantit0. of Instacoat EEN SF has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
  • It is recommended to continuously stir the coating suspension during the entire coating process.
  • 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 (%) 5.0
Number of guns 1-6 1-2
Liquid nozzle diameter (mm) 1.0-1.2
Atomising air pressure (bar) 1.0–2.0
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature (⁰C) 33-35
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 Copolymer Type A, Type B; Plasticisers; Titanium Dioxide; Edible Pigments; Surfactant; Glidant.