INSTACOATTM EN SUPER-IV is a fully formulated enteric coating system based on Methacrylic Acid and Ethyl Acrylate Co-polymer. It is recommended in the cases where phthalate esters such as CAP or HPMCP are not compatible or pose other problems. Typically, a weight gain of around 8% provides reproducible delayed release profiles.
Three separate formulations are available which are suitable for either fully aqueous, hydro-alcoholic, or fully organic solvent seems. With respect to solvent systems, the formulations are not interchangeable
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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.
Purified Water at up to 20% w/w solids
IPA at up to 10% w/w solids
90% IPA + 10% Purified Water at up to 10% solids
Please note that different formulations are provided according to the chosen solvent system. The individual formulations are not interchangeable between solvents.
Variable-speed mechanical stirrer
Mixing Vessel
INSTACOAT EN-SUPER IV (Aqueous): Determine the quantities of INSTACOAT EN-SUPER IV (20% w/w solids) and 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 g Instacoat and 352 g purified water at room temperature (includes 10% overage for losses)
INSTACOAT EN-SUPER IV (Organic): Determine the quantities of INSTACOAT EN- SUPER IV (10% w/w solids) and 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 g Instacoat and 792 g IPA at room temperature (includes 10% overage for losses).
INSTACOAT EN-SUPER IV (Hydro-alcoholic): Determine the quantities of INSTACOAT EN-SUPER IV (10% w/w solids) and 90% IPA + 10% 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 8% wt. gain, weigh 88 g Instacoat and 713 g IPA + 79 g Purified Water at room temperature (includes 10% overage for losses).
INSTACOAT EN-SUPER IV (Aqueous)
Add the weighed quantity of water to a mixing vessel.
Using a mechanical stirrer, stir the purified water to form a vortex.
Add required quantity of Instacoat EN–Super IV 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.
INSTACOAT EN-SUPER IV (Organic)
Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.
Using a mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.
Add required quantity of Instacoat EN–Super IV 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.
INSTACOAT EN-SUPER IV (Hydro alcoholic)
Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.
Using a mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.
Add required quantity of Instacoat EN–Super IV to the centre of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Stir for 5 minutes and add the weighed quantity of Purified water. Reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
| Side-vented (fully perforated) pans | Conventional (non perforated) pans | |
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| Aqueous Organic Hydro-alcoholic | Aqueous Organic Hydro-alcoholic | |
| Pan diameter (inch) | 24-60 | 12-36 |
| Tablet load (kg) | 10-300 | 0.5-50 |
| Weight gain (%) | 8-0 % | |
| Number of guns | 1-6 | 1 |
| Liquid nozzle diameter (mm) | 1.0-1.2 | |
| Atomising air pressure (bar) | 1.5-2.5 | |
| Pattern air pressure | To achieve maximum uniform bed coverage | |
| Tablet bed temperature (⁰C) | 33-36 30-33 32-35 | 33-36 30-33 32-35 |
| Inlet air temperature (⁰C) | Set to achieve required product bed temperature | |
| Suspension spray rate | Set to achieve required product bed temperature | |
| Inlet air volume | Set to achieve required 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.
Aqueous solvent: Methacrylic Acid Co-polymer Type C; Plasticiser; Titanium Dioxide; Edible Pigments; Glidant, Alkaliser, Surfactant