Instacoat P4
Instacoat™ P4 is an alginate-based film coating system. This provides avoids the use of cellulose-based materials to avoid incompatibility or provide IP advantages. It is a dry blend of polymer, plasticizer and approved colors. It gives a glossy finish to tablets at weight gain values of around 2.0 to 3.0%. The system being robust can be handled with a variety of coating machines and processes without stringent processing conditions.
Properties
- Pharma and Nutraceuticals Functions
- Coating System
Product families
Applications
- Oral
- Excipients & Coatings
Product Families
- Pharmaceutical Coatings
Other characteristics
- Brand
- Instacoat
- Functions
- Coating System
- Markets
- Healthcare & Pharma
- Benefits
Stability improvement where API is incompatible with cellulosic polymers.; Enables use of fast-drying, high solids coating systems with consequent process time savings.; Minimal impact on dissolution and disintegration.; Aqueous processing promotes a safe working environment and avoidance of atmospheric pollution.; Excellent appearance including logo definition and gloss.; Reduces logo bridging and in most cases improves low temperature coating performance.; Easy scale-up and transfer to different equipment types or manufacturing sites.
- Features
Absence of cellulosic materials.; Polymers used have low viscosity.; Polymers used are highly water soluble; Polymers used have high adhesion and gloss.; Can be applied in a wide range of equipment designs and sizes from most manufacturers.
- Technology
- Pharmaceuticals & Nutraceuticals
- Typical Constituents
Non-cellulosic water-soluble polymer(s); Plasticiser; Opacifier; Pigments; Glidant; Microbiological Preservative.
- 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 P4 to the center 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.
- 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.
- Equipment / Accessories
- Variable-speed mechanical stirrer
- Mixing Vessel
- Recommended Process Conditions
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.
- Recommended Solvent System and Reconstitution Level
- Purified water at up to 20% w/w solids.
- Calculation of Instacoat™ P4 and Solvent Quantities
Determine the quantities of Instacoat P4 (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 3% wt. gain, weigh 33 g Instacoat and 132 gm purified water at room temperature (includes 10% overage for losses)
