药物固体制剂静电干粉包衣技术研究进展

袁凤, 杨庆良, 杨燕, 郭钫元, 周杭, 史楷岐, 杨根生

中国药学杂志 ›› 2018, Vol. 53 ›› Issue (20) : 1709-1713.

PDF(1082 KB)
PDF(1082 KB)
中国药学杂志 ›› 2018, Vol. 53 ›› Issue (20) : 1709-1713. DOI: 10.11669/cpj.2018.20.001
综述

药物固体制剂静电干粉包衣技术研究进展

  • 袁凤1, 杨庆良1, 杨燕1, 郭钫元1, 周杭2, 史楷岐3, 杨根生1*
作者信息 +

Electrostatic Dry Powder Coating for Pharmaceutical Solid Dosage Forms

  • YUAN Feng1, YANG Qing-liang1, YANG Yan1, GUO Fang-yuan1, ZHOU Hang2, SHI Kai-qi3, YANG Gen-sheng1*
Author information +
文章历史 +

摘要

药物固体制剂的静电干粉包衣起源于粉末喷涂技术,近年来发展迅速。该技术使用静电喷枪将细粉化的包衣材料直接喷洒在固体制剂片芯的表面,然后加热固化成包衣膜。该包衣过程不需要使用任何有机溶剂或水,属于典型的干法包衣技术。与传统的湿法包衣技术(溶剂包衣和水性包衣)相比,静电干粉包衣技术具有效率高、质量好、能耗低、耗时短的优点,属于绿色、环保、高效、节能的新型医药包衣技术。笔者将详细介绍固体制剂静电干粉包衣技术的发展背景、基本原理、技术优势等,总结讨论现有的主要研究成果,并对该技术在包衣工业领域中的应用前景做出展望。

Abstract

Derived from industrial dry powder coatings, electrostatic dry powder coating for pharmaceutics gained numbers of attentions in recent years. In this technology, powdered coating materials are directly sprayed onto the surface of the solid dosage through an electrostatic gun without using any solvent or water, followed by a curing step to allow those deposited coating particles to coalesce together and form a coating film. The electrostatic dry powder technology has many advantages compared with solvent or aqueous coating such as higher coating efficiency with better coating film, less energy consumption and shorter processing time, which is a promising alternative of liquid coatings used in the present pharmaceutical industry.The objective of this review is to introduce the development background, fundamental principles, technological superiority of the electrostatic powder coating for solid dosage forms,and to summarize and discuss those reported results, giving prospects for the future industrial applications.

关键词

静电干粉包衣技术 / 固体制剂 / 薄膜包衣 / 静电喷涂

Key words

electrostatic dry powder coating / solid dosage form / film coating / electrostatic coating

引用本文

导出引用
袁凤, 杨庆良, 杨燕, 郭钫元, 周杭, 史楷岐, 杨根生. 药物固体制剂静电干粉包衣技术研究进展[J]. 中国药学杂志, 2018, 53(20): 1709-1713 https://doi.org/10.11669/cpj.2018.20.001
YUAN Feng, YANG Qing-liang, YANG Yan, GUO Fang-yuan, ZHOU Hang, SHI Kai-qi, YANG Gen-sheng. Electrostatic Dry Powder Coating for Pharmaceutical Solid Dosage Forms[J]. Chinese Pharmaceutical Journal, 2018, 53(20): 1709-1713 https://doi.org/10.11669/cpj.2018.20.001
中图分类号: R944   

参考文献

[1] DOROTHEA S,MATTEO C,JAMES D,et al. Dry powder coating of pharmaceuticals: a review. Int J Pharm,2013,457(2):488-502.
[2] SIEPMANN J, BODMEIER R, MCGINITY J W, et al. Progress in film coating. Int J Pharm,2013,457(2-5):361-361.
[3] FELTON L A,SHAH N H,ZHANG G,et al. Physical-mechanical properties of film-coated soft gelatin capsules. Int J Pharm,1996,127(2):203-211.
[4] CUNNINGHAM C R,FEGELY K A. One-step aqueous enteric coating systems: scale-up evaluation. Pharm Technol Eur,2001,13(10):48-54.
[5] SIEPMANN J, SIEPMANN F. Stability of aqueous polymeric controlled release film coatings. Int J Pharm,2013,457(2):437-445.
[6] OBARA S,MARUYAMA N,NISHIYAMA Y,et al. Dry coating: an innovative enteric coating method using a cellulose derivative. Eur J Pharm Biopharm,1999,47(1):51-59.
[7] BEATRICE A, SERENA B, CECILIA M, et al. A novel approach for dry powder coating of pellets with ethylcellulose.Part I: evaluation of film formulation and process set up. Int J Pharm,2017,516(1-2):380-391.
[8] BOSE S, BOGNER R H. Solventless pharmaceutical coating processes: a review. Pharm Develop Technol, 2007, 12(2):115-131.
[9] RUJIVIPAT S,BODMEIER R. Moisture plasticization for enteric Eudragit® L30D-55-coated pellets prior to compression into tablets. Eur J Pharm Biopharm,2012,81(1):223-229.
[10] YING Y T,HUAN T,CUI F C,et al. Tablets of paliperidone using compression-coated technology for controlled ascending release. Asian J Pharm Sci,2018,13(2):143-154.
[11] BOSE S,BOGNER R H. Solventless visible light-curable coating:Ⅰ. Critical formulation and processing parameters. Int J Pharm,2010,393(1-2):32-40.
[12] BOSE S,BOGNER R H. Solventless visible light-curable coating:Ⅱ. Drug release, mechanical strength and photostability. Int J Pharm,2010, 393(1-2):41-47.
[13] YUE B,YANG J,WANG Y,et al. Particle encapsulation with polymers via in situ polymerization in supercritical CO2. Powder Technol,2004,146(1-2):32-45.
[14] NI M, XU Q, XU G, et al. Applications of supercritical fluid transport technology in preparation of controlled-release drug delivery systems. Prog Chem,2011,23(8):1611-1617.
[15] KNEZEVIC Z,GOSAK D,HRASTE M,et al. Application of hot-melt coating process for designing a lipid based controlled release drug delivery system for highly aqueous soluble drugs. Chem Pharm Bull,2009,57(5):464-471.
[16] MULLER M G, LINDNER J A, BRIESEN H,et al. On the properties and application of beeswax,carnauba wax and palmfat mixtures for hot melt coating in fluidized beds. Adv Powder Technol,2018,29(3):781-788.
[17] CEREA M,ZHENG W,YOUNG C R,et al. A novel powder coating process for attaining taste masking and moisture protective films applied to tablets. Int J Pharm,2004,279(1):127-139.
[18] PEARNCHOB N,BODMEIER R. Dry polymer powder coating and comparison with conventional liquid-based coatings for Eudragit® RS,ethylcellulose and shellac. Eur J Pharm Biopharm,2003,56(3):363-369.
[19] QIAO M,ZHANG L,MA Y,et al. A novel electrostatic dry powder coating process for pharmaceutical dosage forms: immediate release coatings for tablets. Eur J Pharm Biopharm, 2010,76(2):304-310.
[20] PU Y,MAZUMDER M,COONEY C. Effects of electrostatic charging on pharmaceutical powder blending homogeneity. J Pharm Sci,2009,98(7):2412-2421.
[21] BAILEY A G. The science and technology of electrostatic powder spraying,transport and coating 1. J Electrostat,1998,45(2):85-120.
[22] HOGAN J E,STANNFORTH J N,REEVES L,et al. Electrostatic coating:US,7070656B2. 2006-07-04.
[23] REEVES L A,FEATHER D H,NELSON D H,et al. Electrostatic application of powder material to solid dosage forms: US,6806017 B2. 2004-10-19.
[24] NEWMAN M,IMPEY B,HENLEY T,et al.Method and apparatus for the application of powder material to substrates:US,2012/0012055 A1. 2012-01-19.
[25] ZHU J X,LUO Y F,MA Y L,et al. Direct coating solid dosage forms using powdered materials:US,7862848B2. 2011-01-04.
[26] KHATRI P, DESAI D, MINKO T, et al. Role of plasticizer in membrane coated extended release oral drug delivery system. J Drug Deliv Sci Technol,2018,44:231-243.
[27] QIAO M,LUO Y,ZHANG L,et al. Sustained release coating of tablets with Eudragit® RS/RL using a novel electrostatic dry powder coating process. Int J Pharm,2010,399(1-2):37-43.
[28] QIAO M,ZHANG L,MA Y,et al. A novel electrostatic dry coating process for enteric coating of tablets with Eudragit® L100-55. Eur J Pharm Biopharm,2013,83(2):293-300.
[29] YANG Q,MA Y,ZHU J. Sustained drug release from electrostatic powder coated tablets with ultrafine ethylcellulose powders. Adv Powder Technol,2016,27(5):2145-2152.
[30] YANG Q,MA Y,ZHU J. Dry powder coated osmotic drug delivery system. Eur J Pharm Sci, 2018,111(1):383-392.
[31] YANG Q,MA Y,ZHU J,et al. Electrostatic coated controlled porosity osmotic pump withultrafine powders. Powder Technol,2018,333(15):71-77.
[32] YANG Y,SHEN L,SHAN W,et al. Preparation of sustained release capsules by electrostatic dry powder coating, using traditional dip coating as reference. Int J Pharm,2018,543(1-2):345-351.
[33] DREU R,LUŠTRIK M,PERPAR M,et al. Fluid-bed coater modifications and study of their influence on the coating process of pellets. Drug Develop Ind Pharm,2012,38(4):501-511.
[34] YANG Q,MA Y,ZHU J. Applying a novel electrostatic dry powder coating technology to pellets. Eur J Pharm Biopharm,2015,97(Pt A):118-124.
[35] BELDER E G, JRUTTEN H J, PERERA D Y. Cure characterization of powder coatings. Prog Organic Coatings,2001,42(3-4):142-149.
[36] MATSUSAKA S, MARUYAMA H, MATSUYAMA T,et al. Triboelectric charging of powders. Chem Eng Sci,2010,65(22):5781-5807.
[37] KABLITZ C D,URBANETZ N A. Characterization of the film formation of the dry coating process. Eur J Pharm Biopharm,2007,67(2):449-457.
[38] MISEV T A. Powder Coatings: Chemistry and Technology. Toronto: Wiley,1991:399.
[39] ZHU J,ZHANG H. Fluidization additives to fine powders:US,6833185B2. 2004-12-21.

基金

国家自然科学基金项目资助(21376223,21808206);宁波市科技合作项目资助(2015D10008)
PDF(1082 KB)

144

Accesses

0

Citation

Detail

段落导航
相关文章

/