Subproducts

Instacoat EN-HPMC-P

Product Description

INSTACOATTM EN-HPMC-P is a fully formulated enteric coating system based on Hydroxypropyl Methyl Cellulose Phthalate. It is presented as a dry powder for reconstitution in organic or hydroalcoholic solvent systems prior to application.

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 EN HPMC-P

  • HPMC-P has more than 40 years history of use as an enteric polymer with properties and application technology well understood within the pharma industry
  • Safe & reliable enteric protection for oral solid dosage forms
  • Product registration, scale-up and manufacturing are facilitated
  • Greater stability than cellulose acetate phthalate systems and employs a less hazardous and less toxic solvent system
  • Can be used with fully non-aqueous solvent systems
  • Can be used in moisture sensitive products where aqueous processing is not feasible
  • Non-acrylic system
  • Good option where use of acrylics is precluded for compatibility or IP reasons
  • 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
  • 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 EN HPMC-P is an HPMC-P based ready-to-use enteric coating system for organic solvent use, which provides excellent enteric protection to solid oral dosage forms. Use of a seal coat to prevent interaction between active and polymer and to provide a uniform substrate is recommended.

Recommended Solvent System and Reconstitution Level

  • Hydroalcoholic: IPA 75% + Water 25% at up to 10% w/w solids.
  • Organic: Methylene Chloride 65% + IPA 35% w/w at up to 5% w/w solids.

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of Instacoat EN HPMC-P solvent quantities

  • Determine the quantities of Instacoat EN HPMC-P (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 EN HPMC-P and 594 gm IPA + 198 gm purified water at room temperature (including 10% overage for losses)
  • Determine the quantities of Instacoat EN HPMC-P (5% w/w solids) and Methylene Chloride + IPA 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 EN HPMC-P and 1087 gm Methylene Chloride + 585 gm IPA at room temperature (including 10% overage for losses)

Reconstitution Process

  • Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.
  • Using the mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.
  • Add required quantity of Instacoat EN-HPMCP 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 weighed quantity of methylene chloride.
  • Once the entire quantity of Instacoat EN HPMCP 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 throughout the coating process.

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) 1.0–3.5
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature, hydro-alcoholic (⁰C) 36-40
Tablet bed temperature, organic (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

HPMC Phthalate; Plasticiser; Titanium Dioxide; Edible Pigments.