Preview

Разработка и регистрация лекарственных средств

Расширенный поиск

ЛЕКАРСТВЕННЫЕ ФОРМЫ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ СРЕДСТВ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ

Полный текст:

Аннотация

В обзоре литературы представлены сведения о нестероидных противовоспалительных препаратах и различных подходах к созданию лекарственных форм с модифицированным высвобождением нестероидных противовоспалительных средств. Рассмотрены биологически совместимые полимеры синтетического и природного происхождения, применяемые в качестве носителей лекарственных средств. Обсуждены различные методы, используемые для получения полимерных микрочастиц и лекарственных форм нестероидных противовоспалительных средств на их основе. Приведена характеристика готовых микрочастиц с инкапсулированными в них нестероидными противовоспалительными средствами.

Об авторах

С. А. Кедик
Московский технологический университет (ИТХТ)
Россия


В. В. Суслов
Московский технологический университет (ИТХТ)
Россия


И. П. Седишев
ЗАО «Институт фармацевтических технологий»
Россия


Т. Т. Нгуен
Московский технологический университет (ИТХТ)
Россия


Е. А. Шняк
ЗАО «Институт фармацевтических технологий»
Россия


Список литературы

1. A.A. Mansour. Cox-2 specific inhibitors (COXIBS) crisis // Basrah Journal of Surgery. 2003. V.9. P. 138-143.

2. T. Ramasamyab, H.B. Ruttalac, S. Shanmugamd, S.K. Umadevi. Eudragit-coated aceclofenac-loaded pectin microspheres in chronopharmacological treatment of rheumatoid arthritis // Drug Delivery. 2013. V. 20. P. 65-77.

3. C. Sostres, C.J. Gargallo, M.T. Arroyo, A. Lanas. Adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs, aspirin and coxibs) on upper gastrointestinal tract // Best Practice Research Clinical Gastroenterology. 2010. V. 24. P. 121-132.

4. A.H.A. Hassanein, M.A.E. Abdelrahim, A.S.A. Said, R.R.S. Hussein, M. Abuseif. The incidence of upper gastrointestinal complications of non-steroidal anti-inflammatory drugs in elderly patients // Medicine Science. 2014. V. 3. P. 1032-1045.

5. J.F. Fries, C.A. Williams, D.A. Bloch. The relative toxicity of nonsteroidal anti-inflammatory drugs // Arthritis Rheum. 1991. V. 34. P. 1353-1357.

6. A.H. El-Kamel, M.S. Sokar, S.S. Al Gamal, V.F. Naggar. Preparation and evaluation of ketoprofen floating oral delivery system // Int.J.Pharm. 2001. V. 220. P. 13-21.

7. М.Ю. Леонова, Ю.Б. Белоусов. Лекарственные формы с модифицированным высвобождением и системы доставки лекарств. - М.: Литтерра, 2011. 655 с.

8. Patent US № 6217911. Sustained release non-steroidal, antiinflammatory and lidocaine PLGA microspheres / W.M. Vaughn, J.E. van Hamont, J.A. Setterstrom.

9. P. Del Gaudio, P. Russo, M.R. Lauro, P. Colombo, P. Rita. Encapsulation of ketoprofen and ketoprofen lysinate by prilling for controlled drug release // AAPS Pharm.Sci.Tech. 2009. V. 10. P. 1178-1185.

10. К.В. Алексеев, Е.В. Блынская, С.А. Кедик. Фармацевтическая нанотехнология: учебное пособие. - М.: Институт фармацевтических технологий. 2012. 542 с.

11. Е.С. Жаворонок, С.А. Кедик, А.В. Панов, Е.А. Петрова, В.В. Суслов. Полимерные микрочастицы для медицины и биологии: учеб. пособие. - М.: ИФТ, 2014. 480 с.

12. Long acting injections and implants / Ed. by C.W. Wright, D.J. Burgess. - N.Y.: Springer, 2012. 458 p.

13. Microincapsulation. Methods and industrial applications / Ed. by S. Benita. - N.Y.: Taylor and Francis, 2006. 756 p.

14. В.А. Лившиц, А.П. Бонарцев, А.Л. Иорданский, Е.А. Иванов, Т.А. Махина, В.Л. Мышкина, Г.А Бонарцева. Микросферы из поли-3-гидроксибутирата для пролонгированного высвобождения лекарственных веществ // Высокомолекулярные соединения, Сер. А. 2009. Т. 51. № 7. С. 1243-1251.

15. Е.А. Петрова. Разработка состава и технологии получения инъекционной лекарственной формы налтрексона с модифированным высвобождением: Дисс.. канд. фарм. наук. - М. 2014. 147 с.

16. P. Singh , V.K. Chaudhari, P.K. Verma, A.K. Singh, V.K. Yadav. Multiunit floating drug delivery system a significant tool for the treatment of peptic ulcer disease // Int. J Pharm. Sci. Res. 2015. V. 6. P. 1351-1362.

17. J. Sjoegren, L.F. Prescott, W.S. Nimmoe. Rate Control in Drug Therapy - Edinburgh: Churchill Livingstone, 1985. P. 38-47.

18. F. Castelli, B. Conti, D.E. Maccarrone, U. Conte, G. Puglisi. Comparative study of ‘in vitro’ release of anti-inflammatory drugs from polylactide-co-glycolide microspheres // Int. J. Pharm. 1998. V. 176. P. 85-98.

19. К.В. Алексеев, И. А. Грицкова, С. А. Кедик. Полимеры для фармацевтической технологии: учебное пособие. - М. 2011. 511 с.

20. M.N. Ranjha, H. Khan, S. Naseem. Encapsulation and characterization of controlled release flurbiprofen loaded microspheres using beeswax as an encapsulating agent // J Mater Sci: Mater Med. 2010. V. 21. P. 1621-1630.

21. C. Sankar, B. Mishra. Development and in vitro evaluations of gelatin A microspheres of ketorolac tromethamine for intranasal administration // Acta Pharm. 2003. V. 53. P. 101-110.

22. S.K. Noveen Kumar Reddy, V.R. Ravi Kumar, R. Revathi, V. Ganesan. Preparation and evaluation of ethyl cellulose microspheres of ibuprofen for sustained drug delivery // Int. J Pharm. Res. 2010. V. 2. Is. 8. A. 019

23. С.А. Кедик, Е.С. Жаворонок, И.П. Седишев, А.В. Панов, В.В. Суслов, Е.А. Петрова, М.Д. Сапельников, Д.О. Шаталов, Д.В. Ерёмин. Полимеры для систем доставки лекарственных веществ пролонгированного действия (обзор). Полимеры и сополимеры молочной и гликолевой кислот // Разработка и регистрация лекарственных средств. 2013. № 2 (3). С. 18-35.

24. W.B. Liechty, D.R. Kryscio, B.V. Slaughter, N.A. Peppas. Polymers for drug delivery systems // Annu. Rev. Chem. Biomol. Eng. 2010. V. 1. P. 149-173.

25. T. Ramasamy, S.K. Noveenkumar reddy, V.R. Ravi Kumar, R. Revathi, V. Ganesan. Eudragit-coated aceclofenac-loaded pectin microspheres in and on cell membrane molecular models // Biophysical Chem. 2010. V. 147. P. 53-58.

26. В.И. Севастьянов, М.П. Кирпичников. Биосовместимые материалы. - М.: Медицинское информационное агентство. 2011. 408 с.

27. B.K. Nanjwade, H.M. Bechra, G.K. Derkar, F.V. Manvi, V.K. Nanjwade. Dendrimers: Emerging polymers for drug-delivery systems // Eur. J Pharm. Sci. 2009. V. 38. Р. 185-196.

28. A.V.R. Urs, K. Kavitha, G.N. Sockan. Albumin microspheres: an unique system as drug delivery carriers for non steroidal anti-inflammatory drugs (nsaids) // Int. J Pharm. Sci. Rev. Res. 2010. V. 5. Issue 2. Р. 2799-2813.

29. R. Abdeen, N. Salahuddin. Modified chitosan-clay nanocomposite as a drug delivery system intercalation and in vitro release of ibuprofen // Hindawi Publishing Corporation J Chem. 2013. P. 9.

30. S. Abd El-Rasoul, M.M. Ahmed. Chitosan polymer as a coat of calcium alginate microcapsules loaded by non-steroidal antiinflammatory drug. // Bull. Pharm. Sci., Assiut Univ. 2010. V. 33. P. 179-186.

31. J. Shaji, V. Jain, S. Lodha. Chitosan: a novel pharmaceutical excipient // Int. J Pharm. Applied Sci. 2010. V. 1. P. 50-53.

32. J.H. Hamman. Chitosan based polyelectrolyte complexes as potential carrier materials in drug delivery systems. // Mar. Drugs. 2010. V. 8. P. 1305-1322.

33. Е.А. Петрова, С.А. Кедик, К.В. Алексеев, Е.В. Блынская, А.В. Панов, В.В. Суслов, Н.В.Тихонова. Оценка эффективности метода двойного эмульгирования при получении микросфер налтрексона на основе сополимера молочной и гликолевой кислот // Вестник МИТХТ. 2013. Т. 8. № 2. С. 58-63.

34. A. Verma, A. Tripathi, S.A. Saraf, S. Saraf. Fabrication and evaluation of sustained release microspheres of ketorolac tromethamine // Int. J Pharm. and Pharm. Sci. 2010. V. 2. Suppl. 4.

35. C. Nagda, N.P. Chotai, U. Patel, S. Patel, T. Soni, P. Patel, L. Hingorani. Preparation and characterization of spray-dried mucoadhesive microspheres of aceclofenac // Drug Devel. Ind. Pharm. 2009. V. 35. P. 1155-1166.

36. P. Giunchedi, B. Conti, L. Maggi, U. Conte. Cellulose acetate butyrate and polycaprolactone for ketoprofen spray-dried microsphere preparation // J Microencapsul. 1994. V. 11. P. 381-393.

37. H. Ichikawa, Y. Fukumori, C.M. Adeyeye. Design of prolonged-release microcapsules containing diclofenac sodium for oral suspensions and their preparation by the Wurster process // Int. J Pharm. 1997. V. 156. P. 39-48.

38. Е.А. Петрова, С.А. Кедик, К.В. Алексеев, Е.В. Блынская, А.В. Панов, В.В. Суслов, Н.В. Тихонова. Изучение параметров микроинкапсулирования при получении пролонгированной формы налтрексона // Хим. фарм. ж. 2014. Т. 48. № 1. С. 50-53.

39. A.K. Dhamankar, J.V. Manwar, D.D. Kumbhar. The novel formulation design of O/W microemulsion of ketoprofen for improving transdermal absorption // Int. J Pharm.Tech. Res. 2009. V. 1. P. 1449-1457.

40. Т.Т.Т. Нгуен, С.А. Кедик, В.В. Суслов, Е.А. Шняк, Е.В. Ворфоломеева, Е.В. Никонорова. Разработка метода получения полимерных микросфер, содержащих иммобилизованный диклофенак // Тонкие хим. технологии. 2015. Т.10. № 4. С. 27-31.

41. R. Bodmeier, H. Chen. Preparation and characterization of microspheres containing the anti-inflammatory agents, indomethacin, ibuprofen, and ketoprofen // J Controlled Release. 1989. V. 10. P. 167-175.

42. M. Najmuddin, S.S. Asgar ali, V. Patel, T. Khan. Formulation and in vitro evaluation of floating microspheres of ketoprofen prepared by emulsion solvent diffusion method // Int. J Appl. Pharm. 2010. V. 2. P. 1-15.

43. A.K. Saha, S.D. Ray. Effect of cross-linked biodegradable polymers on sustained release of sodium diclofenac-loaded microspheres // Brazilian J Pharm. Sci. 2013. V. 49. P. 873-888.

44. N.G. Raghavendra Rao, U. Kulkarni, A. Deshmukh, D.K. Suresh. Preparation and characterization of ionotropic cross-linked chitosan microparticles for controlled release of aceclofenac // Int. J Pharm. Sci. Drug Res. 2010. V. 2. P. 107-111.

45. S.G. Kumbar, A.R. Kulkarni, M. Aminabhavi. Crosslinked chitosan microspheres for encapsulation of diclofenac sodium: effect of crosslinking agent // J Microencapsul. 2002. V. 19. P. 173-180.

46. S.T. Mathew, S.G. Devi, K.V Sandhya. Formulation and evaluation of ketorolac tromethamine-loaded albumin microspheres for potential intramuscular administration // AAPS Pharm.Sci.Tech. 2007. V. 8. P. 100-108.

47. A. Aggarwal, S. Kaur, F.K. Tiwary, S. Gupta. Chitosan microspheres prepared by an aqueous process: release of indomethacin // J Microencapsul. 2001. V. 18. P. 819-823.

48. F. Pavanetto, P. Perugini, B. Conti, T. Modena, I. Genta. Evaluation of process parameters involved in chitosan microsphere preparation by the o/w/o multiple emulsion method // J Microencapsul. 1996. V. 130. P. 679-880.

49. M.S. Roy, B.K. Gupta. Indomethacinloaded microspheres: design and preparation by a multiple-emulsification technique and their in vitro evaluation // Pharm. Res. 1992. V. 9. P. 1132-1136.

50. M.L. Gonzalez-Rodriguez, M.A. Holgado, C. Sanchez-Lafuente, A.M. Rabasco, A. Fini. Alginate/chitosan particulate systems for sodium diclofenac release // Int. J Pharm. 2002. V. 232. P. 225-234.

51. M.A. Bayomi. Aqueous preparation and evaluation of albumin-chitosan microspheres containing indomethacin // Drug Dev. Ind. Pharm. 2004. V. 30. P. 329-339.

52. W.J. Lin, W.W. Kang. Comparison of chitosan and gelatin coated microparticles: prepared by hot-melt method. // J Microencapsul. 2003. V. 20. P. 169-177.

53. B. Devrim, A. Bozkir, K. Canefe. Formulation and evaluation of reconstitutable suspensions containing ibuprofen-loaded Eudragit microspheres //.Acta Pol. Pharm. 2011. V. 68. P. 593-599.

54. C.Y. Yang, S.Y. Tsay, R.C.C. Tsiang. An enhanced process for ethyl cellulose microcapsules by solvent evaporation in an O/W emulsion // J Microencapsul. 2000. V. 17. P. 269-277.

55. C.Y. Yang, S.Y. Tsay, R.C.C. Tsiang. Encapsulating aspirin into a surfactantfree ethyl cellulose microsphere using non-toxic solvents by emulsion solvent evaporation technique // J Microencapsul. 2001. V. 18. P. 223-236.

56. Q.Y. Guo, L.W. Chan, P.W.S. Heng. Investigation of the release of aspirin from spray-congealed micro-pellets // J Microencapsul. 2005. V. 22. P. 245-251.

57. V.D. Vilivalam, C.M. Adeyeye. Development and evaluation of controlled-release diclofenac microspheres and tabletted microspheres // J Microencapsul. 1994. V. 11. P. 455-470.

58. S.Y. Lin, K.S. Chen, H.H. Teng, M.J. Li. In vitro degradation and dissolution behaviours of microspheres prepared by three low molecular weight polyesters // J Microencapsul. 2000. V. 17. P. 577-586.

59. Т.Т. Нгуен Тхи, С.А. Кедик, В.В. Суслов, Е.А. Шняк, Е.В. Ворфоломеева, Е.В. Никонорова. Разработка метода получения полимерных микросфер, содержащих иммобилизованный диклофенак // Тонкие химические технологии. 2015. Т. 10. № 1. С. 56-59.

60. K.M. Manjanna, B. Shivakumar, T.M. Pramod Kumar. Microencapsulation: an acclaimed novel drug-delivery system for nsaids in arthritis // J Digital Library. 2010. V. 27. P. 509-545.

61. M. Tuncay, S. Calis, H.S. Kas, M.T. Ercan, I. Peksoy, A.A. Hincal. In vitro and in vivo evaluation of diclofenac sodium loaded albumin microspheres // J Microencapsul. 2000. V. 17. P. 145-155.

62. C. Sajeev, G. Vinay, R. Archna, R.N. Saha. Oral controlled release formulation of diclofenac sodium by microencapsulation with ethyl cellulose // J Microencapsul. 2002. V. 19. P. 753-760.

63. M. Eltayeb, E. Stride, M. Edirisinghe. Preparation, characterization and release kinetics of ethylcellulose nanoparticles encapsulating ethylvanillin as a model functional component // J Func. Foods. 2015. V. 14. P. 726-735.

64. P. Sipos, I. Csóka, S. Srčič, K.a PintyeHódi, I. Erős. Influence of preparation conditions on the properties of Eudragit microspheres produced by a double emulsion method // J Drug Devel. Res. 2005. V. 64. P. 41-54.

65. A.G.E. Rsoy, S.C. EvIk. Sustained release properties of alginate microspheres and tabletted microspheres of diclofenac sodium // J Microencapsul. 2000. V. 17. P. 565-575.

66. P.M. Satturwar, P.M. Mandaogade, A.K. Dorle. A novel method for preparation of Eudragit RL microcapsules // J Microencapsul. 2002. V. 19. P. 407-413.

67. M.C. Adeyeye, E. Mwangi, B. Katondo, A. Jain, H. Ichikawa, Y. Fukumori. Dissolution stability studies of suspensions of prolonged-release diclofenac microcapsules prepared by the Wurster process: I. Eudragitbased formulation and possible drugexcipient interaction // J Microencapsul. 2005. V. 22. P. 333-342.

68. M.E. Palomo, M.P. Ballesteros, P. Frutos. Solvent and plasticizer influences on ethylcellulose-microcapsules // J Microencapsul. 1996. V. 13. P. 307-318.

69. S.S. Biju, S. Saisivam, N.S.M.G. Rajan, P.R. Mishra. Dual coated erodible microcapsules for modified release of diclofenac sodium // Eur. J Pharm. Biopharm. 2004. V. 58. P. 61-67.

70. R. Pignatello, D. Amico, S. Chiechio, C. Spadaro, G. Puglisi, P. Giunchedi. Preparation and analgesic activity of Eudragit RS100® microparticles containing diflunisal // Drug Delivery. 2001. V. 8. P. 35-45.

71. D. Perumal. Microencapsulation of ibuprofen and Eudragit RS 100 by the emulsion solvent diffusion technique // Int. J Pharm. 2001. V. 218. P. 1-11.

72. S. Tamilvanan, B. Sa. Effect of production variables on the physical characteristics of ibuprofen-loaded polystyrene microparticles // J Microencapsul. 1999. V. 16. P. 411-418.

73. G. Weiβ, A. Knoch, A. Laicher, F. Stanislaus, R. Daniels. Simple coacervation of hydroxypropyl methylcellulose phthalate (HPMCP) II. Microencapsulation of ibuprofen // Int. J Pharm. 1995. V. 124. P. 97-105.

74. R. Pignatello, C. Bucolo, P. Ferrara, A. Maltese, A. Puleo, G. Puglisi. Eudragit RS100® nanosuspensions for the ophthalmic controlled delivery of ibuprofen // Eur. J Pharm. Sci. 2002. V. 16. P. 53-61.

75. E.S. Ghaly, S. Sepulveda. In vitro evaluation of sustained release ibuprofen microspheres // P R Health Sci. J. 1996. V. 15. P. 97-100.

76. M. Saravanan, K. Bhaskar, G. Srinivasa Rao, M.D. Dhanaraju. Ibuprofenloaded ethylcellulose/polystyrene microspheres: an approach to get prolonged drug release with reduced burst effect and low ethylcellulose content // J Microencapsul. 2003. V. 20. P. 289-302.

77. S. Tirkkonen, L. Turakka, P. Paronen. Microencapsulation of indomethacin by gelatin-acacia complex coacervation in the presence of surfactants // J Microencapsul. 1994. V. 11. P. 615-626.

78. S. Tirkkonen, P. Paronen. Release of indomethacin from tabletted ethylcellulose microcapsules // Int. J Pharm. 1993. - V. 92. P. 55-62.

79. D. Ermis, A. Yuksel. Preparation of spraydried microspheres of indomethacin and examination of the effects of coating on dissolution rates // J Microencapsul. 1999. V. 16. P. 315-324.

80. I.L. Gyun Shin, S.Y. Kim, Y.M. Lee, C.S. Cho, Y.K. Sung. Methoxy poly(ethylene glycol)/ε-caprolactone amphiphilic block copolymeric micelle containing indomethacin: I. Preparation and characterization // J Contr. Release. 1998. V. 51. P. 1-11.

81. W. Tiyaboonchai1, G.C. Ritthidej. Development of indomethacin sustained release microcapsules using chitosancarboxymethylcellulose complex coacervation // J Sci. Technol. 2003. V. 25. P. 245-254.

82. T. A. Ahmed, B. M. Aljaeid. Preparation, characterization, and potential application of chitosan, chitosan derivatives, and chitosan metal nanoparticles in pharmaceutical drug delivery // Drug Design Develop. Therapy. 2016. V. 10. P. 483-494.

83. El-Gibaly, S.M. Safwat, M.O. Ahmed. Microencapsulation of ketoprofen using w/o/w complex emulsion technique // J Microencapsul. 1996. V. 13. P. 67-87.

84. G.F. Palmieri, G. Bonacucina, P.D. Martino, S. Martelli. Gastro-resistant microspheres containing ketoprofen. // J Microencapsul. - 2002. V. 19. P. 111-119.

85. P. Giunchedi, M.L. Torre, L. Maggi, B. Conti, U. Conte. Cellulose acetate trimellitate ethylcellulose blends for non-steroidal anti-inflammatory drug (NSAID) microspheres // J Microencapsul. 1996. V. 13. P. 89-98.

86. T. Mateović-Rojnik, R. Frlan, M. Bogataj, P. Bukovec, A. Mrhar. Effect of preparation temperature in solvent evaporation process on Eudragit RS microsphere properties // Chem. Pharm. Bull. 2005. V. 53. P. 143-146.

87. S. Goto, M. Kawata, M. Nakamura, K. Maekawa, T. Aoyama. Eudragit RS and RL (acrylic resins) microcapsules as pH insensitive and sustained release preparations of ketoprofen // J Microencapsul. 1986. V. 3. P. 293-304.

88. T. Yamada, H. Onishi, Y. Machida. In vitro and in vivo evaluation of sustained release chitosan-coated ketoprofen microparticles // Yakugaku Zasshi. 2001. V. 121. P. 239-245.

89. V.R. Sinha, R.V. Kumar, G. Singh. Ketorolac tromethamine formulations: an overview // Expert Opinion Drug Delivery. 2009. V. 6. P. 961-975.

90. T.M. Sam, D.S. Gayathri, V.V. Prasanth, B. Vinod. Characterization and pharmacokinetic evaluation of gamma sterilized ketorolac tromethamine loaded albumin microspheres for intramuscular administration // Current Drug Delivery. 2013. V. 10. P. 158-166.

91. S. Bhaskaran, M. Sanmathi. Poly(lactic acid) microspheres of ketorolac tromethamine for parenteral controlled drug delivery system // Indian J Pharm. Sci. 2001. V. 40. P. 538-545.

92. H. Wu, M.A. Khan. Quality-by-design: аn integrated process analytical technology approach to determine the nucleation and growth mechanisms during a dynamic pharmaceutical coprecipitation process // J Pharm. Sci. 2011. V. 100. P. 1969-1986.

93. Y. Javadzadeh, F. Ahadi, S. Davaran, G. Mohammadi, A. Sabzevari, K. Adibkia. Preparation and physicochemical characterization of naproxen-PLGA nanoparticles // Coll. Surfaces B: Biointerfaces. 2010. V. 81. - P. 498-502.


Для цитирования:


Кедик С.А., Суслов В.В., Седишев И.П., Нгуен Т.Т., Шняк Е.А. ЛЕКАРСТВЕННЫЕ ФОРМЫ НЕСТЕРОИДНЫХ ПРОТИВОВОСПАЛИТЕЛЬНЫХ СРЕДСТВ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ. Разработка и регистрация лекарственных средств. 2017;(2):74-83.

For citation:


Kedik S.A., Suslov V.V., Sedishev I.P., Nguen T.T., Shnyak E.A. DOSAGE FORMS OF NONSTEROIDAL ANTI-INFLAMMATORY PHARMACEUTICAL SUBSTANCE FOR CONTROLLED RELEASE. Drug development & registration. 2017;(2):74-83. (In Russ.)

Просмотров: 85


Creative Commons License
Контент доступен под лицензией Creative Commons Attribution 4.0 License.


ISSN 2305-2066 (Print)
ISSN 2658-5049 (Online)