INSTANUTE Immediate Release

Nutraceutical Products

INSTANUTE Immediate Release

Product Description

INSTANUTE IR is a ready-to-use film coating system in dry powder form for reconstitution in water, based on Hypromellose (HPMC) & dedicated to nutritional applications. It is supplied in a wide range of colours. Selection can be easily made from the INSTANUTE Colour Guide (available on request). INSTANUTE IR can be formulated with aluminium lake, iron oxide and natural pigments. Flavours can also be incorporated.

Resources

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
  • 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
INSTANUTE IR
  • HPMC is one of the most commonly used film coating polymers with a long history of use
  • Systems are widely understood from regulatory, development and production perspective thus facilitating progress from formulation, scale-up through to full production
  • HPMC is highly water soluble
  • Minimal impact on dissolution and disintegration.
  • Aqueous processing promotes a safe working environment and avoidance of atmospheric pollution
  • Special core stabilisation formulation
  • Enhanced stability, longer shelf-life, protection against physical damage
  • 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

  • Purified water at up to 11% w/w solids

Equipment / Accessories

  • Variable-speed mechanical stirrer

  • Mixing Vessel

Calculation of INSTANUTE IR and solvent quantities

  • Determine the quantities of INSTANUTE IR (11% 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 3% wt. gain, weigh 33 g Instanute IR and 267 g purified water at room temperature (includes 10% overage for losses).

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 INSTANUTE IR to the centre of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of Instanute has been added, reduce the stirrer speed to eliminate the vortex. 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 (%) 2.5
Number of guns 1-6 1
Liquid nozzle diameter (mm) 1.0-1.5
Atomising air pressure (bar) 2.0-3.0
Pattern air pressure To achieve maximum uniform bed coverage
Tablet bed temperature (⁰C) 38-42
Inlet air temperature (⁰C) Set to achieve required product bed temperature
Suspension spray rate Set to achieve required product bed temperature
Exhaust air 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; Plasticiser; Glidant; Titanium Dioxide; Edible Pigments.