Enteric coated spheres produced by extrusion/spheronization provide effective gastric protection and efficient release of live therapeutic bacteria

International Journal of Pharmaceutics

Volumn 493, Issue 1-2, 2015, Pages 483-494

  De Barros, João M S ^a   Lechner, Tabea ^a   Charalampopoulos, Dimitrios ^a   Khutoryanskiy, Vitaliy V ^a   Edwards, Alexander D ^a  

^a UNIVERSITY OF READING   (United Kingdom)

Author keywords

Enteric delivery; Extrusion spheronisation; Oral delivery; Probiotics

Indexed keywords

ALGINIC ACID; EUDRAGIT; LACTOSE; MICROCRYSTALLINE CELLULOSE; PROBIOTIC AGENT; ACRYLIC ACID RESIN; CALCIUM CHLORIDE; CELLULOSE; EUDRAGIT L100-55; GLUCURONIC ACID; HEXURONIC ACID;

ARTICLE; BACTERIAL CELL; CELL SURVIVAL; CELL SUSPENSION; CELL VIABILITY; CRUSHING STRENGTH; DRUG DELIVERY SYSTEM; DRUG RELEASE; ENTERIC COATED TABLET; IN VITRO STUDY; INFRARED SPECTROSCOPY; LACTOBACILLUS CASEI; MECHANICAL STIMULUS TEST; NONHUMAN; PELLET EXTRUSION; PRIORITY JOURNAL; SCANNING ELECTRON MICROSCOPY; SPHERONIZATION; STOMACH ACID; WATER CONTENT; CHEMISTRY; INTESTINAL SECRETIONS; STOMACH JUICE;

ACRYLIC RESINS; ALGINATES; CALCIUM CHLORIDE; CELLULOSE; GASTRIC JUICE; GLUCURONIC ACID; HEXURONIC ACIDS; INTESTINAL SECRETIONS; LACTOBACILLUS CASEI; LACTOSE; PROBIOTICS;

EID: 84939495169     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2015.06.051     Document Type: Article

References (39)

1. S. Abdul, A.V. Chandewar, and S.B. Jaiswal A flexible technology for modified-release drugs: multiple-unit pellet system (MUPS) J. Control. Release 147 2010 2 16
2. P.R. Bajaj, S.A. Survase, M.V. Bule, and R.S. Singhal Studies on viability of Lactobacillus fermentum by microencapsulation using extrusion spheronization Food Biotechnol. 24 2010 150 164
3. M.I. Brachkova, A. Duarte, and J.F. Pinto Evaluation of the viability of Lactobacillus spp. after the production of different solid dosage forms J. Pharm. Sci. 98 2009 3329 3339
4. P.A. Bron, P. van Baarlen, and M. Kleerebezem Emerging molecular insights into the interaction between probiotics and the host intestinal mucosa Nat. Rev. Microbiol. 10 2012 66 78
5. M.T. Cook, T. Saratoon, G. Tzortzis, A. Edwards, D. Charalampopoulos, and V.V. Khutoryanskiy CLSM method for the dynamic observation of pH change within polymer matrices for oral delivery Biomacromolecules 14 2013 387 393
6. M.T. Cook, G. Tzortzis, D. Charalampopoulos, and V.V. Khutoryanskiy Production and evaluation of dry alginate-chitosan microcapsules as an enteric delivery vehicle for probiotic bacteria Biomacromolecules 12 2011 2834 2840
7. M.T. Cook, G. Tzortzis, D. Charalampopoulos, and V.V. Khutoryanskiy Microencapsulation of probiotics for gastrointestinal delivery J. Control. Release 162 2012 56 67
8. B.M. Corcoran, C. Stanton, G. Fitzgerald, and R.P. Ross Life under stress: the probiotic stress response and how it may be manipulated Curr. Pharm. Des. 14 2008 1382 1399
9. J.M.S. de Barros, T. Scherer, D. Charalampopoulos, V.V. Khutoryanskiy, and A.D. Edwards A laminated polymer film formulation for enteric delivery of live vaccine and probiotic bacteria J. Pharm. Sci. 103 2014 2022 2032
10. A. Dukić-Ott, M. Thommes, J.P. Remon, P. Kleinebudde, and C. Vervaet Production of pellets via extrusion-spheronisation without the incorporation of microcrystalline cellulose: a critical review Eur. J. Pharm. Biopharm. 71 2009 38 46
11. A.D. Edwards, and N.K.H. Slater Formulation of a live bacterial vaccine for stable room temperature storage results in loss of acid, bile and bile salt resistance Vaccine 26 2008 5675 5678
12. A.D. Edwards, and N.K.H. Slater Protection of live bacteria from bile acid toxicity using bile acid adsorbing resins Vaccine 27 2009 3897 3903
13. C. Forestier, C. De Champs, C. Vatoux, and B. Joly Probiotic activities of Lactobacillus casei rhamnosus: in vitro adherence to intestinal cells and antimicrobial properties Res. Microbiol. 152 2001 167 173
14. N. Fu, and X.D. Chen Towards a maximal cell survival in convective thermal drying processes Food Res. Int. 44 2011 1127 1149
15. R. Fuller Probiotics in human medicine Gut 32 1991 439 442
16. W.R. Gombotz, and S. Wee Protein release from alginate matrices Adv. Drug Deliv. Rev. 31 1998 267 285
17. S.-F. Hung, C.-M. Hsieh, Y.-C. Chen, Y.-C. Wang, H.-O. Ho, and M.-T. Sheu Characterizations of plasticized polymeric film coatings for preparing multiple-unit floating drug delivery systems (muFDDSs) with controlled-release characteristics PLoS One 9 2014 e100321
18. I. Husson, B. Leclerc, G. Spenlehauer, M. Veillard, F. Puisieux, and G. Couarraze Influence of size polydispersity on drug release from coated pellets Int. J. Pharm. 86 1992 113 121
19. N. Huyghebaert, A. Vermeire, S. Neirynck, L. Steidler, E. Remaut, and J.P. Remon Evaluation of extrusion/spheronisation, layering and compaction for the preparation of an oral, multi-particulate formulation of viable, hIL-10 producing Lactococcus lactis Eur. J. Pharm. Biopharm. 59 2005 9 15
20. N. Huyghebaert, A. Vermeire, and J.P. Remon In vitro evaluation of coating polymers for enteric coating and human ileal targeting Int. J. Pharm. 298 2005 26 37
21. V.A. Kilor, N.P. Sapkal, J.G. Awari, and B.D. Shewale Development and characterization of enteric-coated immediate-release pellets of aceclofenac by extrusion/spheronization technique using kappa-carrageenan as a pelletizing agent AAPS PharmSciTech 11 2010 336 343
22. H.S. Kim, B.J. Kamara, I.C. Good, and G.L. Jr. Enders Method for the preparation of stabile microencapsulated lactic acid bacteria J. Ind. Microbiol. 3 1988 253 257
23. M. Kouimtzi, R.J. Pinney, and J.M. Newton Survival of bacteria during extrusion-spheronization Pharm. Pharmacol. Commun. 3 1997 347 351
24. H. Kranz, K. Jurgens, M. Pinier, and J. Siepmann Drug release from MCC- and carrageenan-based pellets: experiment and theory Eur. J. Pharm. Biopharm. 73 2009 302 309
25. K.T. Mahbubani, N.K.H. Slater, and A.D. Edwards Protection of dried probiotic bacteria from bile using bile adsorbent resins New Biotechnol. 31 2014 69 72
26. C. Morgan, N. Herman, P. White, and G. Vesey Preservation of micro-organisms by drying; a review J. Microbiol. Methods 66 2006 183 193
27. J.M. Newton, S.R. Chapman, and R.C. Rowe The assessment of the scale-up performance of the extrusion/spheronisation process Int. J. Pharm. 120 1995 95 99
28. S. Ohtake, and Y.J. Wang Trehalose: current use and future applications J. Pharm. Sci. 100 2011 2020 2053
29. N. Rouge, E. Allémann, M. Gex-Fabry, L. Balant, E.T. Cole, P. Buri, and E. Doelker Comparative pharmacokinetic study of a floating multiple-unit capsule, a high-density multiple-unit capsule and an immediate-release tablet containing 25 mg atenolol Pharm Acta Helv 73 1998 81 87
30. M. SchrÖDer, and P. Kleinebudde Development of disintegrating pellets obtained from extrusion/spheronization Pharm. Pharmacol. Commun. 1 1995 415 418
31. F. Siepmann, J. Siepmann, M. Walther, R.J. MacRae, and R. Bodmeier Polymer blends for controlled release coatings J. Control. Release 125 2008 1 15
32. V.R. Sinha, M.K. Agrawal, and R. Kumria Influence of formulation and excipient variables on the pellet properties prepared by extrusion spheronization Curr. Drug Deliv. 2 2005 1 8
33. H.K. Solanki, D.D. Pawar, D.A. Shah, V.D. Prajapati, G.K. Jani, A.M. Mulla, and P.M. Thakar Development of microencapsulation delivery system for long-term preservation of probiotics as biotherapeutics agent Biomed. Res. Int. 2013 2013 620719
34. D. Sonaglio, B. Bataille, C. Ortigosa, and M. Jacob Factorial design in the feasibility of producing Microcel MC 101 pellets by extrusion/spheronization Int. J. Pharm. 115 1995 53 60
35. J.J. Sousa, A. Sousa, F. Podczeck, and J.M. Newton Factors influencing the physical characteristics of pellets obtained by extrusion-spheronization Int. J. Pharm. 232 2002 91 106
36. P. Sriamornsak, J. Nunthanid, M. Luangtana-anan, and S. Puttipipatkhachorn Alginate-based pellets prepared by extrusion/spheronization: A preliminary study on the effect of additive in granulating liquid Eur. J. Pharm. Biopharm. 67 2007 227 235
37. P. Sriamornsak, J. Nunthanid, M. Luangtana-anan, Y. Weerapol, and S. Puttipipatkhachorn Alginate-based pellets prepared by extrusion/spheronization: Effect of the amount and type of sodium alginate and calcium salts Eur. J. Pharm. Biopharm. 69 2008 274 284
38. A. Streubel, J. Siepmann, and R. Bodmeier Gastroretentive drug delivery systems Expert Opin. Drug Deliv. 3 2006 217 233
39. C. Vervaet, L. Baert, and J.P. Remon Extrusion-spheronisation: a literature review Int. J. Pharm. 116 1995 131 146