Aqueous polymeric film coating

Pharmaceutical Dosage Forms: Tablets, Third Edition: Volume 1: Unit Operations and Mechanical Properties

Volumn , Issue , 2008, Pages 399-438

  Miller, Dave A ^a   McGinity, James W ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 85057238894     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (112)

1. Porter SC. Coating of pharmaceutical dosage forms. In: Gennaro AR, ed. Remington: The Science and Practice of Pharmacy. 20th ed. Baltimore, MD: Lippincott Williams & Wilkins, 2000.
2. Kremmers E, Urdang G. History of Pharmacy. Philadelphia: Lippincott, 1940.
3. Urdang G. What’s new. J Am Pharm Assoc 1943; 34(135): 5-14.
4. White RC. J Am Pharm Assoc 1922; 11: 345.
5. Weigand TS. Am J Pharm 1902; 74: 33.
6. Warner WR. The sugar coated pill. Am J Pharm 1902; 74: 32.
7. Wheatley TA, Steuernagel CR. Latex emulsions for controlled drug delivery. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, 1997: 15.
8. Sohi H, Sultana Y, Khar R. Taste masking technologies in oral pharmaceuticals: Recent developments and approaches. Drug Dev Ind Pharm 2004; 30(5): 429-48.
9. Jones BE. Colours for pharmaceutical products. Pharm Technol Int 1993; 5: 14-20.
10. Cheiken AH, Bavitz JF, inventors; Merck & Co., Inc., assignee. Method for Applying High Luster Coating to Tablets. US Patent No. 3,576,665. 1971.
11. Perkins AC, Wilson CG, Frier M, et al. Oesophageal transit, disintegration and gastric emptying of a film-coated risedronate placebo tablet in gastro-oesophageal reflux disease and normal control subjects. Aliment Pharmacol Ther 2001; 15(1): 115-21.
12. Anonymous. Tablets and capsules that stick in the oesophagus. Drug Ther Bull 1981; 19(9): 33-4.
13. Wallace JW. Cellulose derivatives and natural products utilized in pharmaceutics In: Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker, Inc., 1990: 319-37.
14. Doerr DW, Serles ER, Deardorff DL, inventors; University of Illinois Foundation, assignee. Hydroxyethyl cellulose tablet coating. US Patent No. 2,816,062. 1957.
15. Lehmann K, Brogmann B. Tablet coating. In: Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker, Inc., 1996.
16. Singiser RE, inventor Abbott Laboratories, assignee. Japanese Patent 37-12294. 1962.
17. Nagai T, Obara S, Kokubo H, Hoshi N. Application of HPMC and HPMCAS to aqueous film coating of pharmaceutical dosage forms. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, Inc., 1997; 177-225.
18. Hogan JE. Film-coating materials and their properties. In: Cole G, ed. Pharmaceutical Coating Technology. Bristol, PA: Taylor & Francis Inc., 1995.
19. Li SP, Martellucci SA, Bruce RD, Kinyon AC, Hay MB, Higgins JD. Evaluation of the filmcoating properties of a hydroxyethyl cellulose/hydroxypropyl methylcellulose polymer system. Drug Dev Ind Pharm 2002; 28(4): 389.
20. Technical literature: Klucel EF Pharm Hydroxypropylcellulose. Aqualon, 2000. (Accessed February 27, 2007, at http://www.herc.com/aqualon/product_data/brochures/250_49.pdf#hpc.)
21. Specifications and test methods for Eudragit® E 100, Eudragit® E PO and Eudragit® E 12,5. degussa, 2004. (Accessed February 27, 2007, at http://www.eudragit.com/pharmapolymers/en/downloads/.)
22. Lehmann K. Acrylic resin coatings for drugs: relation between their chemical structure, properties and application possibilities. Drug Made Germany 1968; 11: 34-41.
23. Ishikawa T, Watanabe Y, Utoguchi N, Matsumoto M. Preparation and evaluation of tablets rapidly disintegrating in saliva containing bitter-taste-masked granules by the compression method. Chem Pharm Bull 1999; 47: 1451-4.
24. Chowhan ZT, Amaro AA, Chi LH. Comparative evaluation of aqueous film coated tablet formulations by high humidity aging. Drug Dev Ind Pharm 1982; 8: 713-37.
25. Thoennes CJ, McCurdy VE. Evaluation of a rapidly disintegrating, moisture resistant laquer film coating. Drug Dev Ind Pharm 1989; 15: 165-85.
26. Guidelines for Formulation Development and Process Technology for Protective Coatings. degussa, 2006. (Accessed February 27, 2007, at http://www.eudragit.com/pharmapolymers/en/downloads/.)
27. Kollicoat IR Technical Information. BASF, 2004. (Accessed February 27, 2007, at http:// www.pharma-solutions.basf.com/.)
28. Babb RR, Wilbur RS. Asprin and Gastrointestianl Bleeding. Calif Med 1969; 110(5): 440-1.
29. Strom JG, Jun HW. Gastric irritation and bleeding after drug administration. J Pharm Sci 1974; 63(11): 1812-3.
30. Overhoff KA, Moreno A, Miller DA, Johnston KP, Williams Iii RO. Solid dispersions of itraconazole and enteric polymers made by ultra-rapid freezing. Int J Pharm 2007; 330(1-2): 61-72.
31. Kohri N, Yamayoshi Y, Xin H, et al. Improving the oral bioavailability of albendazole in rabbits by the solid dispersion technique. J Pharm Pharmacol 1999; 51: 159-64.
32. Miller DA, McConville JT, Yang W, Williams III RO, McGinity JW. Hot-melt extrusion for enhanced delivery of drug particles. J Pharm Sci 2007; 96(2): 361-76.
33. Chambliss WG. Enteric coatings. In: Swarbrick J, Boylan JC, eds. Encyclopedia of Pharmaceutical Technology. New York: Marcel Dekker, Inc., 1992; 189-200.
34. Hiatt GD, inventor Eastman Kodak Company, assignee. Enteric Coating. US Patent No. 2,196,768. 1940.
35. Miller LA. Cellulose acetate phthalate. In: Rowe RC, Sheskey PJ, Owen SC, eds. Pharmaceutical Excipients. Pharmaceutical Press and American Pharmacists Association, 2006.
36. Edgar KJ. Cellulose esters in drug delivery. Cellulose 2006; 14: 49-64.
37. Wu SHW, Wyatt DM, Adams MW. Chemistry and applications of cellulosic polymers for enteric coatings of solid dosage forms. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. New York: Marcel Dekker, Inc., 1997.
38. Sakellariou P, Rowe RC, White EFT. The thermomechanical properties and glass transition temperatures of some cellulose derivatives used in film coating. Int J Pharm 1985; 27: 267-77.
39. Obara S, McGinity JW. Influence of processing variables on the properties of free films prepared from aqueous polymeric dispersions by a spray technique. Int J Pharm 1995; 126(1-2): 1-10.
40. Williams RO, Liu J. The influence of plasticizer on heat-humidity curing of cellulose acetate phthalate coated beads. Pharm Dev Technol 2001; 6(4): 607.
41. Anonymous. Hypromellose phthalate NF enteric coating material. Shin Etsu Chemical Company Technical Literature
42. Gaskonda S, Lee J. Hypromellose phthalate. In: Rowe RC, Sheskey PJ, Owen SC, eds. Pharmaceutical Excipients 5. Pharmaceutical Press and American Pharmacists Association 2005.
43. Muhammad NA, Boisvert W, Harris MR, Weiss J. Evaluation of hydroxypropyl methylcellulose phthalate-50 as film forming polymer from aqueous dispersion-systems. Drug Dev Ind Pharm 1992; 18(16): 1787-97.
44. Rafati H, Ghassempour A, Barzegar-Jalali M. A new solution for a chronic problem; Aqueous enteric coating. J Pharm Sci 2006; 95(11): 2432-7.
45. Thoma K, Bechtold K. Influence of aqueous coatings on the stability of enteric coated pellets and tablets. Eur J Pharm Biopharm 1999; 47(1): 39-50.
46. Felton L, McGinity J. Enteric film coating of soft gelatin capsules. Drug Deliv Technol 2003; 3(6): 34-9.
47. Siepmann F, Siepmann J, Walther M, MacRae R, Bodmeier R. Aqueous HPMCAS coatings: Effects of formulation and processing parameters on drug release and mass transport mechanisms. Eur J Pharm Biopharm 2006; 63(3): 262-9.
48. Lehmann K, Dreher D. Permeable acrylic resin coatings for the manufacture of depot preparation of drug. Pharm Ind 1969; 31: 319-22.
49. Anonymous. Specifications and test methods for Eudragit L 100-55. In: Degussa Pharma Polymers; 2004, www.eudragit.com.
50. Lehmann KOR. Chemistry and application properties of polymethacrylate coating systems. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, Inc., 1997: 101-76.
51. Schmidt PC, Niemann F. The miniwid-coater 2. Comparison of acid resistance of entericcoated bisacodyl pellets coated with different polymers. Drug Dev Ind Pharm 1992; 18(18): 1969-79.
52. Anonymous. Specifications and test methods for Eudragit L 100 and Eudragit S 100. In: Degussa Pharma Polymers; 2004, www.eudragit.com.
53. Lehmann K, Petereit H-U. Film coats based on polymethacrylate dispersions with retarded decay within the intestinal tract. Drug Made Germany 1993; 55: 615-8.
54. Gupta VK, Assmus MW, Beckert TE, Price JC. A novel pH- and time-based multi-unit potential colonic drug delivery system. II. Optimization of multiple response variables. Int J Pharm 2001; 213(1-2): 93-102.
55. Gupta VK, Beckert TE, Price JC. A novel pH- and time-based multi-unit potential colonic drug delivery system. I. Development. Int J Pharm 2001; 213(1-2): 83-91.
56. Rudolph MW, Klein S, Beckert TE, Petereit H-U, Dressman JB. A new 5-aminosalicylic acid multi-unit dosage form for the therapy of ulcerative colitis. Eur J Pharm Biopharm 2001; 51(3): 183-90.
57. Porter SC, Ridgway K. An evalutation of the properties of enteric coating polymers: measurement of glass transition temperature. J Pharm Pharmacol 1983; 35: 341-4.
58. Mehuys E, Remon J-P, Vervaet C. Production of enteric capsules by means of hot-melt extrusion. Eur J Pharm Sci 2005; 24(2-3): 207-12.
59. Cable C. Polyvinyl acetate phthalate. In: Rowe RC, Sheskey PJ, Owen SC, eds. Pharmaceutical Excipients 5. Pharmaceutical Press and American Pharmacists Association, 2005.
60. Hogan JE. Coating of tablets and multiparticulates In: Aulton ME, ed. Pharmaceutics: The Science of Dosage Form Design. New York: Churchill Livingstone; 2001: 441-8.
61. Collett J, Moreton C. Modified release peroral dosage forms In: Aulton ME, ed. Pharmaceutics: The Science of Dosage Form Design. New York: Churchill Livingstone; 2001: 289-305.
62. Abrahamsson B, Alpsten M, Jonsson UE, et al. Gastro-intestinal transit of a multiple-unit formulation (metoprolol CR/ZOK) and a non-disintegrating tablet with the emphasis on colon. Int J Pharm 1996; 140(2): 229-35.
63. Anonymous. Ethoc. In: Ethylcellulose Polymers Technical Handbook. The Dow Chemical Company: Dow Cellulosics; 2005, www.ethocel.com
64. Onions A. Films from water-based colloidal dispersions. Manufact Chem 1986; 57(4): 66-7.
65. Bodmeier R, Paeratakul O. Process and formulation variables affecting the drug release from chlorpheniramine maleate-loaded beads coated with commercial and self-prepared aqueous ethyl cellulose pseudolatexes. Int J Pharm 1991; 70(1-2): 59-68.
66. Iyer U, Hong WH, Das N, Gherbre-Sellassie I. Comparative evaluation fo three organic solvent and dispersion-based ethylcellulose coating formulations. Pharm Technol 1990; September: 68-86.
67. Leng DE, Sigelko WL, Saunders FL, inventors; The Dow Chemical Company, assignee. Aqueous dispersions of plasticized polymer particles US Patent No. 4,502,888. 1985.
68. Bodmeier R, Guo X, Paeratakul O. Process and formulational factors affecting the drug release from pellets coated with the ethylcellulose-pseudolatex aquacoat. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, Inc., 1997: 55-80.
69. Ozturk AG, Ozturk SS, Palsson BO, Wheatley TA, Dressman JB. Mechanism of release from pellets coated with an ethylcellulose-based film. J Control Release 1990; 14(3): 203-13.
70. Goodhart FW, Harris MR, Murthy KS, Nesbitt RU. An evaluation of aqueous film-forming dispersions for controlled release. Pharm Technol 1984; 8: 64-71.
71. Porter SC. Use of opadry, sureteric, and surelease for the aqueous film coating of pharmaceutical oral dosage forms. In: McGinity JW, ed. Aqueous Polymeric Coatings For Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, Inc., 1997: 327-83.
72. Bodmeier R, Paeratakul O. The effect of curing on drug-release and morphological properties of ethylcellulose pseudolatex-coated beads. Drug Devel Indl Pharm 1994; 20(9): 1517-33.
73. Amighi K, Moes A. Influence of plasticizer concentration and storage conditions on the drug release rate from Eudragit® RS30D film-coated sustained-release theophylline pellets. Eur J Pharm Biopharm 1996; 42(1): 29-35.
74. Zhang Y, Zhang ZR, Wu F. A novel pulsed-release system based on swelling and osmotic pumping mechanism. J Control Release 2003; 89(1): 47-55.
75. Chang CM, Bodmeier R. Organic solvent-free polymeric microspheres prepared from aqueous colloidal polymer dispersions by a w/o-emulsion technique. Int J Pharm 1996; 130(2): 187-94.
76. Lin AY, Muhammad NA, Pope D, Augsburger LL. Study of the effects of curing and storage conditions on controlled release diphenhydramine HCl pellets coated with Eudragit® NE30D. Pharm Develop Technol 2003; 8(3): 277-87.
77. Anonymous. Technical information: Kollicoat SR 30 D. In: BASF Pharma Solutions; 2006, www.pharma-solutions.basf.com.
78. Dashevsky A, Wagner K, Kolter K, Bodmeier R. Physicochemical and release properties of pellets coated with Kollicoat® SR 30 D, a new aqueous polyvinyl acetate dispersion for extended release. Int J Pharm 2005; 290(1-2): 15-23.
79. Shao ZJ, Morales L, Diaz S, Muhammad NA. Drug release from Kollicoat SR 30D-coated nonpareil beads: Evaluation of coating level, plasticizer type, and curing condition. AAPS PharmSciTech 2002; 3(2): 87-96.
80. Anonymous. Package insert. Avinza (morphine sulfate). San Diego: Ligand Pharmaceuticals, February 2003.
81. Anonymous. Package insert: Ritalin LA (methylphenidate hydrochloride). East Hanover, NJ: Novartis Pharmaceuticals Corporation 2006.
82. Bettman MJ, Percel PJ, Hensley DL, Vishnupad KS, Venkatesh GM, inventors; Eurand America, Inc., assignee. Methylphenidate modified release formulations US patent 6,344,215. 2002.
83. Gutierrez-Rocca JC, McGinity JW. Influence of water-soluble and insoluble plasticizers on the physical and mechanical properties of acrylic resin copolymers. Int J Pharm 1994; 103: 293-301.
84. Honary S, Orafai H. The effect of different plasticizer molecular weights and concentrations on mechanical and thermomechanical properties of free films. Drug Develop Ind Pharm 2002; 28(6): 711-5.
85. Hutchings D, Clarson S, Sakr A. Studies of the mechanical properties of free films prepared using an ethylcellulose pseudolatex coating system. Int J Pharm 1994; 104(3): 203-13.
86. Lin S, Chen K, Run-Chu L. Organic esters of plasticizers affecting the water absorption, adhesive property, glass transition temperature, and plasticizer permanence of Eudragit acrylic films. J Control Release 2000; 68: 343-50.
87. Al-Omran MF, Al-Suwayeh SA, El-Helw AM, Saleh SI. Taste masking of diclofenac sodium using microencapsulation. J Microencapsul 2002; 19(1): 45-52.
88. Raffin F, Duru C, Jacob M, et al. Physico-chemical characterization of the ionic permeability of an enteric coating polymer. Int J Pharm 1995; 120(2): 205-14.
89. Bechard SR, Levy L, Clas S-D. Thermal, mechanical and functional properties of cellulose acetate phthalate (CAP) coatings obtained from neutralized aqueous solutions. Int J Pharms 1995; 114(2): 205-13.
90. Bussemer T, Peppas NA, Bodmeier R. Time-dependent mechanical properties of polymeric coatings used in rupturable pulsatile release dosage forms. Drug Develop Ind Pharm 2003; 29(6): 623-30.
91. Appel LE, Zentner GM. Use of modified ethylcellulose lattices for microporous coating of osmotic tablets. Pharm Res 1991; 8(5): 600-4.
92. Appel LE, Clair JH, Zentner GM. Formulation and optimization of a modified microporous cellulose-acetate latex coating for osmotic pumps. Pharm Res 1992; 9(12): 1664-7.
93. Bodmeier R, Paeratakul O. Constant potassium-chloride release from microporous membrane- coated tablets prepared with aqueous colloidal polymer dispersions. Pharm Res 1991; 8(3): 355-9.
94. Wesseling M, Kuppler F, Bodmeier R. Tackiness of acrylic and cellulosic polymer films used in the coating of solid dosage forms. Eur J Pharm Biopharm 1999; 47(1): 73-8.
95. Anand JN. Contact theory of adhesion. Reply to comments. J Adhesion 1973; 5: 265-7.
96. Felton LA, McGinity JW. Influence of insoluble excipients on film coating systems. Drug Develop Ind Pharm 2002; 28(3): 225-43.
97. Vecchio C, Fabiani F, Gazzaniga A. Use of colloidal silica as a separating agent in film forming processed performed with aqueous dispersion of acrylic resins. Drug Dev Ind Pharm 1995; 21: 1781-7.
98. Petereit HU, Abmus M, Lehmann K. Glyceryl monostearate as a glidant in aqueous filmcoating formulation. Eur J Pharm Biopharm 1995; 41: 219-28.
99. Nimkulrat S, Suchiva K, Phinyocheep P, Puttipipatkhachorn S. Influence of selected surfactants on the tackiness of acrylic polymer films. Int J Pharm 2004; 287(1-2): 27-37.
100. Okhamafe AO, York P. Effect of Solids polymer interactions on the properties of some aqueous-based tablet film coating formulations 2. Mechanical characteristics. Int J Pharm 1984; 22(2-3): 273-81.
101. Chatfield HW. The science of surface coatings. New York: Van Nostrand, 1962.
102. Jordan MP, Easterbrook MG, Hogan JE. In: Proceedings in 11th International Pharmaceutical Technology Conference, Manchester, 1992.
103. Guo JH. Aging processes in pharmaceutical polymers. Pharm Sci Technol Today 1999; 2(12): 478-83.
104. Amighi K, Moes AJ. Influence of plasticizer concentration and storage conditions on the drug release rate from Eudragit RS 30 D film-coated sustained-release theophylline pellets. Eur J Pharm Biopharm 1996; 42(1): 29-35.
105. Maejima T, McGinity JW. Influence of film additives on stabilizing drug release rates from pellets coated with acrylic polymers. Pharm Develop Technol 2001; 6(2): 211-21.
106. Zheng W, Sauer D, McGinity JW. Influence of hydroxyethylcellulose on the drug release properties of theophylline pellets coated with Eudragit® RS 30 D. Eur J Pharm Biopharm 2005; 59(1): 147-54.
107. Zheng WJ, McGinity JW. Influence of Eudragit® NE 30 D blended with Eudragit® L 30 D-55 on the release of phenylpropanolamine hydrochloride from coated pellets. Drug Develop Ind Pharm 2003; 29(3): 357-66.
108. Wu CB, McGinity JW. Influence of an enteric polymer on drug release rates of theophylline from pellets coated with Eudragit® RS 30D. Pharm Develop Technol 2003; 8(1): 103-10.
109. Rowe RC. Defects in aqueous film-coated tablets. In: McGinity JW, ed. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. 2nd ed. New York: Marcel Dekker, Inc., 1997: 419-40.
110. Rowe RC. The effect of molecular weight on the properties of films prepared from hydroxypropyl methylcellulose. Pharm Acta Helv 1976; 51(11): 330-4.
111. Rowe RC, Forse SF. Pitting-a defect on film coated tablets. Int J Pharm 1983; 13: 347.
112. Proter SC. Tablet coating-problems with film coating Drug Cosmet Ind 1981; 129(9): 50.