Suresh Pareek, MD, Ideal Cures and Sanjay Negi, DGM Film Coatings, Ideal Cures, give an insight the coating performance of IDEAL CURES revolutionary product INSTACOAT 4G with high solids capability, in combination with different spray guns
The pharmaceutical industry is witnessing a transformation from conventional batch to automated continuous processing in response to changing requirements. There have also been many improvements in the design of spray guns with the aims of improving coating process efficiency and the quality of appearance of the finished product. With similar aims, there have been parallel developments in the coating formulations that enhance the coating efficiency and product quality.
The present study evaluates the coating performance of IDEAL CURES revolutionary product INSTACOAT 4G with high solids capability (35 per cent solids), in combination with different spray guns (Gansons GHPN-III, Spraying Systems, RAU & Schlick 930 ABC). High Solids and low viscosity capability of INSTACOAT 4G makes it the preferred choice for all types of spray guns and coating equipment.
In a coating process it is very important that the coating suspension must be distributed evenly on the tablet bed. Spraying guns are used to achieve the desired distribution. Most often these are atomisers that use compressed air to atomise the coating suspension. There are three common gun types: 2-port, 3-port and 4-port.
The simple 2-port spray gun has one port for the liquid coating suspension and the other is for the atomising air. In a 3-port spray gun, the atomisation and spray activation pressures can be controlled independently which allows the spray width to be controlled. In a 4-port spray gun, three ports are for air and one for liquid, and these allow for the independent control of activation pressure, atomisation pressure and spray width.
Process summary
INSTACOAT 4G was reconstituted at 35 per cent solids and applied at a target weight gain of 2.5 per cent w/w. High Solids and low viscosity capability of INSTACOAT 4G allows quick drying of the tablets without any gun blockage issues. Coating trials were performed using optimised coating conditions at the Ideal Cures laboratory facility in a Gansons Autocoater Model GAC-600 fitted with a 24-inch diameter pan. Refer Table No. 1 for process Parameters.
Spray Guns from Schlick, Spray Systems (RAU) and Gansons (GHPN-III) were used for the experiments. Spray patterns were visualised on paper surfaces using each nozzle at a distance of approximately 12 to 15 cm inches’ distance from the gun. Fine spray mist could be achieved with INSTACOAT 4G due to its low viscosity capabilities. (Ref. Figure No. 2).
Evaluation of coating process
An approximate 60 per cent reduction in the coating process time was seen, in comparison to traditional coating formulations. This time saving advantage can be attributed to the ability of INSTACOAT 4G of reconstituting at a high solid level of 35 per cent, while maintaining low viscosity value. (Ref. Figure No. 1) Coating suspension was agglomerate free and easily sprayable. No gun blockage was observed during the entire coating process. There were no coating defects, no color uniformity concerns (DE<1.5) and coated tablets exhibited good surface smoothness and logo clarity. (100 coated tablets samples were evaluated).
Conclusion
Coating trials were carried out successfully in a 24 inch Gansons Autocoater 600 using predetermined coating parameters with three spray gun/nozzle combinations at Ideal Cures Goregaon Laboratory using INSTACOAT 4G. It was found that the
INSTACOAT 4G – a high solid, low viscosity coating formulation could be rapidly applied at 35 per cent solids. The coating process time was significantly lowered and the suspension exhibited low viscosity in spite of very high solids (35 per cent). Fine spray mist was achieved during spraying with different gun designs. The coated tablets had a smooth surface at the end of the coating process.
About Ideal Cures
Ideal Cures (IC) is one of India’s leading manufacturer and exporter of pharma excipients and ready-to-use coating systems for solid oral dosage forms. IC provides tailor-made solutions and products for the pharma and allied industries, through a network of customers and partners across more than 40 countries around the world. Leveraging over three decades of coating experience, technical know-how and expertise Ideal Cures’ provides precise, simplified solutions uniquely shaped to meet a customer’s requirements.
IC provides its customers with a complete range of coating products and excipients complemented by technical and regulatory services. IC’s product portfolio includes INSTACOAT ready-to-use film coating systems, ECOPOL range of Pharma Acrylic Polymer’s, ECOCOOL brand of cooling compounds, ESPHERES range of microcrystalline cellulose, silicon dioxide, calcium carbonate, tartaric acid spheres, new generation of sugar spheres and INSTANUTE coating technology for nutraceuticals and dietary supplements.
IC is the first film coating company to have all its cGMP compliant manufacturing plants EXCiPACT certified. IC’s latest manufacturing facility in Sikkim will be certified in due course. An ISO 9001:2015 certified company with a US DMF for all its manufacturing facilities, IC is one of the most innovative film-coating companies. IC has 11 granted patents and 8 pending grants for its film-coating products, specialised excipients and R&D coating machines.
The above study was successfully presented at AAPS (American Associates of Pharmaceutical Scientists) 2017, Nov 12-15, San Diego
Experiment protocol designed by: Sanjay Negi
Experiments executed by: Sanjay Negi
Contact details
Email: [email protected]
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