We have reached a new contract for manufacturing a 100L OPTIMA Tablet Coater and a 200L Granulation Line for a well-known Argentine pharmaceutical laboratory.
The client is a pharmaceutical company specialized in the production of solid oral cancer drugs, in tablets, coated tablets, and capsules. It is in constant national and international growth, so they need to expand their production lines for coated tablets, and STE’s granulation and coating equipment is the best solution for this.
The piece of equipment to be delivered is a 100L OPTIMA Tablet Coating Machine. It is a perforated coating pan designed for the film coating of tablets or pellets, suitable in aqueous and organic coatings.
With our proprietary technology (patent pending), this coater is the only one that allows batches between 10% and 100% of its capacity with fully automatic adjustment.
Using an advanced sonar system the machine detects the tablet bed volume and automatically adjusts all the coating process parameters from a recipe: distance and angle of the spray nozzles, the flow and path of the inlet and exhaust air, turning speed of the drum, coating suspension dosage, etc. All in the same single drum and without any manual operation.
Tablet coating is a covering (film coating) that is applied to the surface of a particle or a tablet for different purposes.
The motivation for coating dosage forms range goes from:
■ Colour and gloss.
■ Improving stability (light protection, moisture, and gas barrier).
■ Making it easier to swallow the tablet.
Also, functional coatings can be used to modify the drug release behavior from the dosage form. Depending on the polymers used it is possible to either delay the release of the drug or use the coating to sustain the release of the drug from the dosage form over extended periods.
WET GRANULATION LINE
The customer has also requested a 200l complete granulation line for the preparation of the granulated product before tableting and coating.
STE Tecpharm’s granulation line integrates all the granulation process options in a single framework, reducing the risks of cross-contamination and minimizing the requested space in the cleanroom.
The equipment consists of:
– High Shear Mixer Granulator.
– Fluidized Bed Dryer.
– Integrated mill calibrators.
– Vacuum systems for product transfer.
– WIP Cleaning System.
Granulation refers to the process in which primary dust particles are made to adhere to form larger entities of multiple particles called granules.
In this process of wet granulation, the granules are formed by adding an agglutinative solution.
The granulation solution contains a solvent or carrier material that must be volatile so that it can be removed by drying and not being toxic.
Typical fluids include water, ethanol, and isopropanol alone or in combination. The liquid solution can be aqueous or solvent-based. Aqueous solutions have the advantage of being safer to treat than other solvents.