Instacoat EN SOL
Instacoat™ 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.
Properties
- Pharma and Nutraceuticals Functions
- Coating System
Product families
Applications
- Oral
- Excipients & Coatings
Product Families
- Pharmaceutical Coatings
Other characteristics
- Brand
- Instacoat
- Functions
- Coating System
- Markets
- Healthcare & Pharma
- Benefits
Suitable for enteric formulations requiring higher pH solubility point than many other systems while avoiding use of acrylics.; Regulatory acceptability.; Suitable for highly moisture sensitive formulations.; Easy scale-up and transfer to different equipment types or manufacturing sites.; Suitable for batch and continuous processes.
- Features
CAP polymer system is soluble above pH 6.; Widely known & understood polymer with > 70-year history of use in enteric coating.; Fully non-aqueous solvent system.; Can be applied in a wide range of equipment designs and sizes from most manufacturers.
- Technology
- Pharmaceuticals & Nutraceuticals
- Typical Constituents
- CAP, Plasticiser, Titanium Dioxide, Pigments.
- 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 center 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.
- 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.
- Equipment / Accessories
- Variable-speed mechanical stirrer
- Mixing Vessel
- Recommended Process Conditions
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.
- Recommended Solvent System and Reconstitution Level
Methylene chloride (90%) + IPA (10%) at up to 5% w/w solids.
- Calculation of Instacoat™ 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)
