Purpose: The pharmaceutical industry has always been focusing on improving manufacturing efficiency and product quality with adoption of innovative technology. In view to these trends, the tablet coating process has introduced the concept of continuous coating technology that improves efficiency and increase productivity. High solids coating systems are used to achieve significant savings in both process time and overall energy consumption. The present study evaluates the coating uniformity and appearance of Tramadol tablets coated with INSTACOAT 4G™a high solids ( 35%) capability using Autocoater.
Methods: Tramadol Tablets 225 mg( 10 mm round) were used as the substrate for the coating process. Coating trial was conducted in a 48” Autocoater), equipped with 4 spray guns (Walther Pilot 1.2 mm nozzle dia.) using recommended coating parameters of INSTACOAT 4G™. Coating suspension was reconstituted at 35% solids level.Tramadol Tablets were coated up to 2% weight gain. Critical Process Parameters i.e Product bed temperature, Spray Rate, Pan RPM , Atomizing Air Pressure were optimized during the coating process (Refer. Attached JPEG). Tramadol Tablets 225 mg were assessed for visual appearance, color difference, disintegration time and coating defects. Color difference of the coated tablets was measured using a reflectance spectrophotometer.
Results: The Instacoat 4G coating trial was successfully carried out at a batch size of 150 kg using a 48” Perforated Pan. Coated Tramadol tablets 225 mg were evaluated for appearance, color difference, DT and coating defects. All the results were well within the specifications. The appearance and color uniformity of coated tablets was good. No coating defects were observed. The coating process parameters of Instacoat 4G were optimized in the autocoater.
Conclusion: Instacoat 4G coating trial was successfully performed for Tramadol Tablets (Lot Size 150 Kg) using a 48” Autocoater. Coating process time was reduced by 50% which reduced the energy usage, eliminated organic solvents usage and enhanced the product stability (Due to Higher adhesion and Optimum Moisture Barrier Capabilities of Instacoat 4G). Coated tablets were evaluated for appearance, color difference and coating defects. All results were found acceptable. Coated tablets achieved good color uniformity within a short process time.