The Effects of Coating Treatments on Enteric Coating of the Soft Capsules Containing Omega-3 Fatty Acids

오메가-3 연질캡슐의 코팅 조건에 따른 장용성 코팅품질에 미치는 영향

  • Received : 2011.10.18
  • Accepted : 2012.01.18
  • Published : 2012.04.30


This article presents an evaluation of the effects of coating conditions on the enteric coating quality of soft gelatin capsules containing Omega-3 fatty acids. Three conditions were controlled: concentration of hydroxypropyl methylcellulose phthalate (6, 8, and 10 wt% in solution), temperature of the inlet air (32, 35, and $38^{\circ}C$), and the coating solution feed rate (7.5, 11.25, and 15.0 g/min). The transparency of the enteric coated soft gelatin capsules was evaluated by measuring the degree of whiteness of the surface using a spectrophotometer. Results showed that the most important parameter in the enteric coating process was the coating solution feed rate. As the coating solution feed rate decreased and inlet air temperature increased, the degree of whiteness of coating surfaces decreased. We also evaluated the disintegration properties of the enteric coated capsules in accordance with the Korea Health Functional Food Code.


  1. KFDA. Health functional food code proclaim. 2011-68. Korea Food & Drug Administration. Seoul, Korea. pp.2-4 (2011)
  2. KFDA. Health functional food code proclaim. 2011-20. Korea Food & Drug Administration. Seoul, Korea. pp.6-7 (2011)
  3. Guo HX, Heinämäki J, Yliruusi J. Diffusion of a freely water-soluble drug in aqueous enteric-coated pellets. AAPS PharmSciTech 3: 97-104 (2002)
  4. Allen Jr. LV, Popovich NG, Ansel HC. Ansel's pharmaceutical dosage forms and drug delivery systems. Lippincott Williams & Wilkins, Philadelphia, PA, USA. p.222 (2009)
  5. Ehrhardt L, Patt L, Schindler E. Optimization of film coating systems. Pharma. Ind. 35: 719-722 (1973)
  6. Delporte JP, Jaminet F. Influence of formulation of enteric-coated tablets on the bioavailability of the drug. J. Pharm. Belg. 31: 263-276 (1976)
  7. Patt L, Hartmann V. Solvent residues film forming agents. Pharma. Ind. 38: 902-906 (1976)
  8. Stafford JW. Enteric film coating using completely aqueous dissolved hydroxypropyl methylcellulose phthalate spray solutions. Drug Dev. Ind. Pharm. 8: 513-530 (1982)
  9. Thoma K, Heckenmuller H, Oschmann R. Resistance and disintegration behavior of gastric juice resistant drugs. Pharmazie 42: 832-836 (1987)
  10. Thoma K, Heckenmuller H, Oschmann R. Impact of film formers and plasticizers on stability of resistance and disintegration behavior. Pharmazie 42: 837-841 (1987)
  11. Rowe RC. Molecular weight studies on hydroxypropyl methylcellulose phthalate (HP-55). Acta Pharm. Technol. 28:127-130 (1982)
  12. 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. 18: 1787-1797 (1992)
  13. Fetterman F, Hussain MM. Therapeutic potential of n-3 polyunsaturated fatty acids in disease. Am. J. Health- Syst. Ph. 66: 1169-1179 (2009)
  14. Belluzzi A, Brignola C, Campieri M, Camporesi EP, Gionchetti P, Rizzello F, Belloi C, De Simone G, Boschi S, Miglioli M. Effect of new fish oil derivative on fatty acid phospholipid-membrane pattern in a group of Crohn's disease patients. Digest. Dis. Sci. 39: 2589-2594 (1994)
  15. Belluzzi A, Brignola C, Campieri M, Pera A, Boschi S, Miglioli M. Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease. New Engl. J. Med. 334: 1557-1560 (1996)
  16. Haghes DB, Hoover DG. Viability and enzymatic activity of bifidobacteria in milk. J. Dairy Sci. 78: 268-276 (1995)
  17. Kailaspathy K, Rybka S. Lactobacillus acidophilus and Bifidobacteria spp.- their therapeutic potential and survival in yogurt. Aust. J. Dairy Technol. 52: 28-35 (1997)
  18. Klaver FAM, Kingma F, Weekamp AH. Growth and survival of bifidobacteria in milk. Neth. Milk Dairy J. 47: 151-164 (1993)
  19. McGinity JW. Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms. Vol. 79. Mercel Dekker, Inc., Piehurst, NC, USA. pp. 315-323 (1997)
  20. Lai X, Sun C, Tian H, Zhao W, Gao L. Evaluation of poly(styrene- alt-maleic anhydride)-ethanol as enteric coating material. Int. J. Pharm. 352: 66-73 (2008)

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