Instacoat EN-HPMC-P
Instacoat™ EN-HPMC-P is a fully formulated enteric coating system based on Hydroxypropyl Methyl Cellulose Phthalate. It is presented as a dry powder for reconstitution in organic solvent prior to application.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Coating System
Product families
- Pharmaceutical Coatings
Other characteristics
- Brand
- Instacoat
- Functions
- Coating System
- Markets
- Healthcare & Pharma
- Benefits
Safe & reliable enteric protection for oral solid dosage forms.; Product registration, scale-up and manufacturing are facilitated.; Greater stability than cellulose acetate phthalate systems and employs a less hazardous and less toxic solvent system.; Can be used in moisture sensitive products where aqueous processing is not feasible.; Good option where use of acrylics is precluded for compatibility or IP reasons.; Rapid suspension preparation.; Raw material and process cost and time savings.; Easy scale-up and transfer to different equipment types or manufacturing sites.; Suitable for batch and continuous processes.
- Features
HPMC-P has more than 40 years history of use as an enteric polymer with properties and application technology well understood within the pharma industry.; Suitable for use with organic solvents.; Non-acrylic system.; Good solubility in the recommended solvent systems.; Can be applied in a wide range of equipment designs and sizes from most manufacturers.; Enteric protection achieved at low weight gain.
- Technology
- Pharmaceuticals & Nutraceuticals
- Typical Constituents
HPMC Phthalate; Plasticiser; Titanium Dioxide; Edible Pigments.
- Reconstitution Process
Add the weighed quantity of Isopropyl Alcohol to a mixing vessel.; Using the mechanical stirrer, stir the Isopropyl Alcohol to form a vortex.; Add required quantity of Instacoat EN-HPMCP to the center of the solvent vortex in a slow steady stream, avoiding clumping and maintaining a vortex. Stir for 5 minutes, then add the weighed quantity of methylene chloride.; Once the entire quantity of Instacoat EN HPMCP has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes; It is recommended to continuously stir the coating suspension throughout the coating process.
- 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.
