Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Pharma & Nutraceuticals Functions
- Technologies
- Product Families
- Typical Constituents
Cellulosic Polymers; Plasticiser; Titanium Dioxide; Edible Pigments, Glidant.
Features & Benefits
- Features
-
Cellulosic polymer system.
-
Correct balance of water soluble and insoluble elements in coating formulation.
-
Glidant
-
Can be applied in a wide range of equipment designs and sizes from most manufacturers.
-
Organic or hydro-alcoholic systems.
-
All ingredients widely recognized with long history of pharmaceutical use.
-
- Benefits
-
Coatings are smooth, glossy and resistant to physical damage. Packaging speeds are enhanced.
-
Solids levels up to 9% (hydro-alcoholic) or 5% (organic) facilitate rapid coating.
-
Rapid suspension preparation.
-
Minimal impact on dissolution and disintegration.
-
Overcomes polymer tack issues and contributes to coating speed.
-
Reduction or complete elimination of water in solvent system for products with such high moisture sensitivity that fully aqueous systems cannot be used.
-
Easy scale-up and transfer to different equipment types or manufacturing sites.
-
Suitable for batch and continuous processes.
-
Facilitates product registration in multiple regulatory environments.
-
Applications & Uses
- Markets
- Applications
- Equipment / Accessories
-
Variable-speed mechanical stirrer
-
Mixing Vessel
-
Properties
Regulatory & Compliance
- 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.
Technical Details & Test Data
- Recommended Solvent System and Reconstitution Level
-
75% IPA + 25% Purified Water at up to 9% solids
-
35% IPA + 65% MDC at up to 5% solids
-
- Calculation of Instamoistshield and Solvent Quantities
-
Instamoistshield (Organic): Determine the quantities of Instamoistshield (5% w/w solids) and 35% IPA + 65% MDC 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 35% IPA + 65% MDC at room temperature (includes 10% overage for losses).
-
Instamoistshield (Hydro-alcoholic): Determine the quantities of Instamoistshield (9% w/w solids) and 75% IPA + 25% Purified 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 gm Instacoat and 334 gm 75% IPA + 25% Purified Water at room temperature (includes 10% overage for losses).
-
- Reconstitution Process
-
Instamoistshield (Organic or Hydro-alcoholic): Add the weighed quantity of solvent to a mixing vessel.
-
Using a mechanical stirrer, stir the solvent to form a vortex.
-
Add the required quantity of Instamoistshield to the center of the liquid vortex in a slow steady stream, avoiding clumping while maintaining a vortex. Once the entire quantity of powder has been added, reduce the stirrer speed to eliminate the vortex. Continue mixing for 45 minutes.
-
- Recommended Process Conditions
Side-Vented
(Fully Perforated) PansConventional
(Non Perforated) PansPan Diameter (inch) 24-60 12-36 Tablet Load (kg) 10-300 0.5-50 Weight Gain (%) 3.5-4.0% Number of Guns 1-6 1 Liquid Nozzle diameter (mm) 1.0-1.2 Atomising Air Pressure (bar) 2.5-3.5 Pattern Air Pressure To achieve maximum uniform bed coverage Tablet Bed Temperature (°C) 36-38 Tablet Bed Temperature, Hydro- Alcoholic (°C) 38-40 Inlet Air Temperature (°C) 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.