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%.
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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.
IPA 90% + Purified Water 10% at up to 10% w/w solids
Variable-speed mechanical stirrer
Mixing Vessel
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).
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.
| Side-vented (fully perforated) pans | Conventional (non perforated) pans | |
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| 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.
Methacrylic Acid Copolymer Type A &/or Type B, Plasticisers; Titanium Dioxide; Edible Pigments; Glidant; Surfactant.