Startseite Naturwissenschaften Optimization and In-vitro Evaluation of Coating Process for Film-Coated Tablets
Artikel
Lizenziert
Nicht lizenziert Erfordert eine Authentifizierung

Optimization and In-vitro Evaluation of Coating Process for Film-Coated Tablets

  • Marwan Abdelmahmoud Abdelkarim Maki , Palanirajan Vijayaraj kumar ORCID logo EMAIL logo und Yeong Siew Wei
Veröffentlicht/Copyright: 5. August 2017
Veröffentlichen auch Sie bei De Gruyter Brill

Abstract

The 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.

Funding statement: Pioneer Scientists Incentive Fund (PSIF) under Center of Excellence in Research, Value Innovation and Entrepreneurship (CERVIE), UCSI University, Malaysia (Grant/Award Number: ‘prg-In-FPS-008’).

Acknowledgement

This project (project code: prg-In-FPS-008) was supported by the Centre of Excellence in Research, Value Innovation and Entrepreneurship (CERVIE), UCSI University Malaysia, under the Pioneer Scientists Incentive Fund (PSIF). This project has been facilitated by the access to the pharmaceutical manufacturing plant of Hovid Berhad, Ipoh, Perak, Malaysia.

References

[1] Felton LA, McGinity JW. Aqueous polymeric coatings for pharmaceutical dosage forms. United States: CRC Press, 2008 .10.3109/9780849387883Suche in Google Scholar

[2] Teckoe J, Mascaro T, Farrell TP, Rajabi-Siahboomi AR. Process optimization of a novel immediate release film coating system using QbD principles. AAPS Pharm SciTech. 2013;14(2):531–540.10.1208/s12249-013-9935-3Suche in Google Scholar

[3] Peng T, Huang Y, Mei L, Wu L, Chen L, Pan X, et al. Study progression in application of process analytical technologies on film coating. Asian J Pharm Sci. 2015;10(3):176–185.10.1016/j.ajps.2014.10.002Suche in Google Scholar

[4] Schick RJ, Knasiak KF.. Characterization of spray guns for the tablet coating industry. 14th Annual Conference on Liquid Atomization and Spray Systems, Dearborn, Michigan; 2001.Suche in Google Scholar

[5] Ho L, Müller R, Gordon KC, Kleinebudde P, Pepper M, Rades T, et al. Applications of terahertz pulsed imaging to sustained-release tablet film coating quality assessment and dissolution performance. J Controlled Release. 2008;127(1):79–87.10.1016/j.jconrel.2008.01.002Suche in Google Scholar

[6] Suzzi D, Radl S, Khinast JG. Local analysis of the tablet coating process: Impact of operation conditions on film quality. Chem Eng Sci. 2010 ;65(21):5699–5715.10.1016/j.ces.2010.07.007Suche in Google Scholar

[7] Khan H, Fell JT, Macleod GS. The influence of additives on the spreading coefficient and adhesion of a film coating formulation to a model tablet surface. Int J Pharm. 2001 ;227(1):113–119.10.1016/S0378-5173(01)00789-XSuche in Google Scholar PubMed

[8] Sahni E, Chaudhuri B. Experiments and numerical modeling to estimate the coating variability in a pan coater. Int J Pharm. 2011 ;418(2):286–296.10.1016/j.ijpharm.2011.05.041Suche in Google Scholar PubMed

[9] Dennison TJ, Smith J, Hofmann MP, Bland CE, Badhan RK, Al-Khattawi A, et al. Design of experiments to study the impact of process parameters on droplet size and development of non-invasive imaging techniques in tablet coating. PLoS One. 2016 ;11(8):0157267.10.1371/journal.pone.0157267Suche in Google Scholar PubMed PubMed Central

[10] Agrawal AM, Pandey P. Scale up of pan coating process using quality by design principles. J Pharm Sci. 2015 ;104(11):3589–3611.10.1002/jps.24582Suche in Google Scholar PubMed

[11] Phadtare D, Ganesh Phadtare NB, Asawat M. Hypromellose—A choice of polymer in extended release tablet formulation. World J Pharm Sci. 2014 ;3:551–566.Suche in Google Scholar

[12] Cahyadi C, Tan BX, Chan LW, Heng PW. A study on in-line tablet coating—The influence of compaction and coating on tablet dimensional changes. AAPS Pharm Sci Tech. 2012 ;13(3):785–792.10.1208/s12249-012-9799-ySuche in Google Scholar PubMed PubMed Central

[13] Lachman L, Lieberman HA, Kanig JL. The theory and practice of industrial pharmacy. United States: Lea & Febiger, 1986 .Suche in Google Scholar

[14] Willig SH, Stoker JR. Good manufacturing practices for pharmaceuticals. A plan for total quality control. Drugs Pharm Sci. 1992;52:1–258.Suche in Google Scholar

[15] Zaman H. Quality evaluation of different salbutamol tablets. United States: Lulu Publisher, 2014 .Suche in Google Scholar

[16] Pharmacopoeia B. Appendix XVII G; Friability of Uncoated Tablets. Ph. Eur. method (2.9.7) 2011.Suche in Google Scholar

[17] Ruotsalainen M. Studies on aqueous film coating of tablets performed in a side-vented pan coater. Finland: University of Helsinki, 2003 .Suche in Google Scholar

[18] US FDA. The Code of Federal Regulations of the United States of America, § 436.200. United States: U.S. Government Printing Office, 1982 .Suche in Google Scholar

[19] XXII UP, XVII N. USP. Rockville, MD: United States Pharmacopeial Convention, 1990:1788–1789. .Suche in Google Scholar

[20] Mueller R, Kleinebudde P. Influence of scale-up on the abrasion of tablets in a pan coater. Eur J Pharm Biopharm. 2006 ;64(3):388–392.10.1016/j.ejpb.2006.05.016Suche in Google Scholar PubMed

[21] Qiu Y, Chen Y, Zhang GG, Liu L, Porter W. Developing solid oral dosage forms: Pharmaceutical theory & practice. United States: Academic Press, 2009 .Suche in Google Scholar

[22] Lin H, May RK, Evans MJ, Zhong S, Gladden LF, Shen Y, et al. Impact of processing conditions on inter‐tablet coating thickness variations measured by terahertz in‐line sensing. J Pharm Sci. 2015 ;104(8):2513–2522.10.1002/jps.24503Suche in Google Scholar PubMed PubMed Central

[23] Just S, Toschkoff G, Funke A, Djuric D, Scharrer G, Khinast J, et al. Optimization of the inter-tablet coating uniformity for an active coating process at lab and pilot scale. Int J Pharm. 2013 ;457(1):1–8.10.1016/j.ijpharm.2013.09.010Suche in Google Scholar PubMed

[24] Porter SC, Verseput RP, Cunningham CR. Process optimization using design of experiments. Pharm Technol. 1997 ;21(10):60–71.Suche in Google Scholar

[25] Suzuki Y, Suzuki T, Minami H, Terada K. A novel scale up model for prediction of pharmaceutical film coating process parameters. Chem Pharm Bull. 2016 64(3):215–221.10.1248/cpb.c15-00644Suche in Google Scholar PubMed

Published Online: 2017-8-5

© 2017 Walter de Gruyter GmbH, Berlin/Boston

Heruntergeladen am 30.12.2025 von https://www.degruyterbrill.com/document/doi/10.1515/ijfe-2017-0016/pdf
Button zum nach oben scrollen