A Scale-up Approach for Film Coating Process Based on Surface Roughness as the Critical Quality Attribute

2018 ◽  
Vol 19 (3) ◽  
pp. 1243-1253 ◽  
Author(s):  
Hiroyuki Yoshino ◽  
Yuko Hara ◽  
Masafumi Dohi ◽  
Kazunari Yamashita ◽  
Tadashi Hakomori ◽  
...  
2006 ◽  
Vol 7 (2) ◽  
pp. E1-E6 ◽  
Author(s):  
Paulus Seitavuopio ◽  
Jyrki Heinämäki ◽  
Jukka Rantanen ◽  
Jouko Yliruusi

2016 ◽  
Vol 64 (3) ◽  
pp. 215-221 ◽  
Author(s):  
Yasuhiro Suzuki ◽  
Tatsuya Suzuki ◽  
Hidemi Minami ◽  
Katsuhide Terada

2017 ◽  
Vol 13 (11) ◽  
Author(s):  
Marwan Abdelmahmoud Abdelkarim Maki ◽  
Palanirajan Vijayaraj kumar ◽  
Yeong Siew Wei

AbstractThe proper efficiency of the tablet-coating process often results in a coating within adequate quality, which might avoid the rejection of the film-coated tablets, minimize the operating expenses and production time. In general, the optimum coating system performance and coating conditions are important for achieving the desirable tablet-coating uniformity and manufacturing reproducibility. In this study, HPMC-aqueous-based tablet film coating successfully conducted in a perforated pan coater for process scale-up using the spray-coating technique. Certain process parameters such as spray rate, inlet air temperature, pan temperature, atomizing pressure as well as pan speed were maintained carefully and the optimum coating quality was achieved with acceptable film performance. At lower initial pan speed, the strength of the coated tablets was remarkably improved and the highest weight gain obtained. The smoothest and uniform film obtained at high spray rate, high pan speed, and low atomizing pressure. The results revealed that the optimum film-coating quality and uniformity achieved at a spray rate of 480 ml/min, atomizing pressure at 5 bar, inlet temperature at 85 to 90 °C, pan temperature at 58 °C, initial pan speed at 1.5 rpm and final pan speed at 4.0 rpm using side-vented pan coater. At initial pan speed of 1.5 rpm, the strength of the coated tablets remarkably improved with minimum edges erosion, which increases the weight gain up to 3.3%w/w.


Pharmaceutics ◽  
2020 ◽  
Vol 12 (9) ◽  
pp. 853
Author(s):  
Ki-Soo Seo ◽  
Rajiv Bajracharya ◽  
Sang Hoon Lee ◽  
Hyo-Kyung Han

Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.


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