Suresh Pareek, MD, Ideal Cures and Sanjay Negi, DGM Film Coatings, Ideal Cures, evaluates coating uniformity and appearance of tablets coated with Ideal Cures’ revolutionary product INSTACOAT 4G, a high solids aqueous coating system of 35 per cent solids capability, in a batch coater
The pharmaceutical industry is continuously improving manufacturing efficiency and product quality by adopting innovative technologies. Coating systems with high solids are used to significantly save both process time and overall energy consumption. Ideal Cures understands the needs of pharma companies and has developed a revolutionary coating formulation having high solids capability – INSTACOAT 4G.
Achieving good colour uniformity at higher reconstitution levels is a big challenge at commercial scale and it has been evaluated in our trial conducted using a batch coater.
The present study evaluates the coating uniformity and appearance of tablets coated with Ideal Cures’ revolutionary product INSTACOAT 4G, a high solids aqueous coating system of 35 per cent solids capability, in a batch coater.
Process summary
INSTACOAT 4G was reconstituted at 35 per cent solids concentration in water and applied at a target weight gain of 3 per cent. The coating dispersion was evaluated for appearance and viscosity.
Coating trials were performed in a batch coater using predetermined optimised coating conditions.
Round shaped placebo tablets were used for the coating trials.
The viscosity of the coating suspension was found to be 209 cps which is too low and very spray able considering 35 per cent solid. Coating process evaluation was carried out in terms of coating process time, finished tablet appearance, coating defects and disintegration time. Refer Table 1. for coating process parameters. Coated tablet samples were collected from the coating pan at different time intervals (15 minutes) until the completion of the coating process. Colour difference of the coated tablets was measured using a reflectance spectrophotometer. Coated tablets achieved very low colour difference values after 120 minutes of coating. (Figure No.1) which is remarkable.
Evaluation of coating process: Massive reduction in coating time with ability to triple production output!
Coating process could be completed very quickly as compared to traditional coating formulations (Ref. Figure No. 2) due to high solids and low viscosity capabilities of INSTACOAT 4G.
Coating of a batch (300 Kg) in a 60-inch pan generally takes around four hours and hence in one entire shift, an approximate of 1.5 batches is possible.
INSTACOAT 4G due to its high solids capabilities will reduce the process time by more than 60 per cent. It allows coating of three batches instead of 1.5 batches and almost triples production output.
Further, coating suspension was agglomerate free and easily sprayable. No gun blockage was observed during the entire coating process.
There were no coating defects and colour uniformity concerns. (DE<1.5) Coated tablets exhibited good surface smoothness and logo clarity (100 coated tablets samples were evaluated)
Reduce carbon emission, gain carbon credits
Reduced energy consumption by virtue of reduced coating time results in reduced carbon emissions and carbon footprint making INSTACOAT 4G a best-in-class eco-friendly coating system
There is an approximate reduction of 80 per cent in carbon emissions/ year with INSTACOAT 4G compared to traditional coating systems (11 per cent)
- *Batch size = 300 kg,
- ** 2 batches of 300 kg/day in a year (300 working days in a year)
- *** With respect to 11 per cent reconstitution levels
- # 0.5377(CO2 conversion factor used for calculations, Ref: Carbon Trust,
“Conversion factors: Energy and Carbon Conversions”2011)
Assumptions
All the parameters are based on assumptions. These assumptions were used to quantify both the aforementioned energy consumption and the production capacity of a single coater. These numbers may obviously vary from equipment to equipment, from company to company and by geographic location. Typical values are used and it is used as a representative analysis. Under the assumptions provided in this article, using INSTACOAT™ 4G may reduce energy consumption since it has shorter coating process time and may in turn reduce equivalent CO2 emissions by 79.2 per cent per year (compared to HPMC coating system).
Conclusion
A need for innovative technologies to improve product quality and process efficiency with retention or enhancement of product safety within commercially acceptable cost constraints was identified, leading to the development of the most advanced aqueous coating formulation – INSTACOAT 4G.
INSTACOAT 4G, innovated by Ideal Cures is the most advanced immediate release film coating system, designed for rapid film coating. It brings about large-scale reduction in the overall coating process time, reduces total cost of coating operations and most importantly, will save energy and help reduce carbon footprints. It offers excellent film adhesion properties, smooth product finish along with moisture barrier properties. Launched globally in 2016, this one-of-a-kind firm coating system offers 35 per cent reconstitution – seen in no other coating formulation.
The coating trial of INSTACOAT 4G was successfully performed in a 60-inch Batch Coater and coated tablets were evaluated for appearance, colour difference, coating defects and disintegration time at various intervals of the coating process. INSTACOAT 4G achieved acceptable results. The product under test was successfully applied and achieved good colour uniformity within a short coating process time.
Over 60 per cent coating process time savings can be achieved by using INSTACOAT 4G as compared with traditional film coating formulations. INSTACOAT 4G is well suited for all coating equipment i.e. conventional, batch coaters to the most advanced continuous coaters being used in the pharma industry
worldwide.
Ref:
(1) Coating Economics – How very low viscosity coatings reduce the total cost of ownership of coating operations, DOW WOLFF Celulosics
About Ideal Cures
Ideal Cures (IC) is one of India’s leading manufacturer and exporter of pharmaceutical 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 eight 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
(Note: All figures/graphs derived are based on the assumptions given in this article. The actual performance in a manufacturing operation may vary depending on various factors, but the fundamental efficiency advantage of using INSTACOAT 4G coating still holds)