General Purpose Coatings

Subproducts

Instacoat QD

Product Description

INSTACOATTM QD is an innovative novel quick disintegrating ready-to-use aqueous film coating system. It is a dry blend of polymers, plasticizers, pigments, opacifiers and other excipients.

Resources
Features Benefits

INSTACOAT System
  • Polymer system employs materials which have been widely used in pharmaceutical film coating over many years
  • Systems are widely understood from regulatory, development and production perspective thus facilitating progress from formulation, scale-up to production.
  • Coating formulation optimized for rapid disintegration
  • Quick disintegration of the coating film allows early exposure of the core to the dissolution medium and leads to reduction in the time duration between administration and onset of action of the API.
  • High Solids Capability
  • Coating suspension can be reconstituted up to 35% solids thus providing reductions in energy consumption and production costs.
  • Can be applied in a wide range of equipment designs and sizes
  • Easy scale-up and transfer to different equipment types or manufacturing sites.

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.

Recommended Solvent System and Reconstitution Level

  • Purified water at up to 35% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of InstacoatTMQD and solvent quantities

  • Determine the quantities of Instacoat QD (35% 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 kgof tablets to 3% wt. gain, weigh 30gm Instacoat QD and 55.71 gm purified water at room temperature .

Reconstitution Process

  • 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 QD to the centre of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instacoat QD has been added, reduce the stirrer speed to eliminate the vortex. (Fig. 2) Continue mixing for 45 minutes.

Recommended Process Conditions

  Conventional
(non perforated) pans		 Perforated Pan
Pan diameter (inch) 12 15
Tablet load (kg) 0.5 to 1 2.0 to 3
Weight gain (%) 2.0-3.0 2.0-3.0
Number of guns 1 1
Liquid nozzle diameter (mm) 1.0 1.0
Atomising air pressure (bar) 1-2 2-3
Pattern air pressure To achieve maximum uniform bed coverage To achieve maximum uniform bed coverage
Tablet bed temperature (⁰C)* 38-42 38-42
Inlet air temperature (⁰C) Set to achieve required product bed temperature Set to achieve required product bed temperature
Suspension spray rate (g/min) Set to achieve required product bed temperature Set to achieve required product bed temperature
Pan speed Minimum for steady tablet flow through spray zone 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.