General Purpose Coatings

Subproducts

Instacoat Sol

Product Description

INSTACOATTM SOL is a unique film coating system consisting of a dry blend of polymers, plasticizers, pigments, opacifiers and other excipients, for organic solvent use. It is a user-friendly system which is simple and easy to prepare.

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 with guaranteed batch-to-batch colour uniformity
  • 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 SOL

  • Polymer system employs cellulosic materials which have been widely used in film coating over many years
  • Systems are widely understood from regulatory, development and production perspective thus facilitating progress from formulation, scale-up through to full production
  • Polymers used are soluble in most of the commonly used organic & hydro-alcoholic solvents found in pharmaceutical film coating
  • Coatings are fast drying leading to short and economic process times.
  • Multiple use system.
  • Can be used as sub-coating & top-coating sealcoats, for regular colour coating and as the vehicle in drug loading processes.
  • 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..

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

  • Organic:
    I. IPA 35% + MDC 65% w/w at up to 5% solids
    II. Ethanol 35% + Chloroform 65% w/w at up to 5% solids

Equipment / Accessories

  • Variable-speed mechanical stirrer
  • Mixing Vessel

Calculation of Instacoat Sol and solvent quantities

  • • Determine the quantities of Instacoat Sol (5% w/w solids) and IPA 35% + MDC 65% or Ethanol 35% + Chloroform 65% 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 3% wt. gain, weigh 33 g Instacoat and 627 gm IPA 35%+ MDC 65% or Ethanol 35% + Chloroform 65% at room temperature (includes 10% overage for losses).

Reconstitution Process

  • Instacoat Sol (Organic): the weighed quantity of organic solvent to a mixing vessel.
  • Using a mechanical stirrer, stir the organic solvent to form a vortex.
  • Add required quantity of Instacoat Sol 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. (Fig. 3) Continue mixing for 45 minutes.

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 (%) 2.0-3.0%
Number of guns 1-6 1
Liquid nozzle diameter (mm) 1.0-1.2
Atomising air pressure (bar) 2.5-3.0
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature, Aqueous (⁰C) 40-42
Tablet bed temperature, Organic (⁰C) 36-38
Tablet bed temperature, Hydro-alcoholic (⁰C) 38-40
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; Plasticisers; Titanium Dioxide; Edible Pigments, Glidant.