Hodnocení stability filmů z natrium-alginátu a chitosanu
Autoři:
Miloslava Rabišková; Kateřina Dvořáčková; Lenka Kofroňová
Působiště autorů:
Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences Brno
Vyšlo v časopise:
Čes. slov. Farm., 2012; 61, 26-33
Kategorie:
Původní práce
Souhrn
Pelety s obsahem rutinu připravené metodou extruze/sferonizace se potáhly obalem složeným z natrium-alginátu a chitosanu. U pelet se před obalením zhodnotily důležité jakostní parametry a po obalení disoluční profil léčiva v disolučních prostředích o pH odpovídajícím podmínkám v gastrointestinálním traktu. Vzorky obalených pelet se založily do boxů určených pro testování stability při různých podmínkách, tj. 25 °C a 60 % relativní vlhkosti (RH); 30 °C a 65 % RH a 40 °C a 75 % RH. Po 1, 3, 6, 9 a 12 měsících (nebo po 1, 3 a 6 měsících) se disoluce léčiva opakovala a porovnala s počátečními profily pomocí faktorů podobnosti. Všechny hodnoty faktorů podobnosti vyšší než 50 naznačují výbornou stabilitu obalu tvořeného natrium-alginátem a chitosanem.
Klíčová slova:
alginát • chitosan • filmy • transport léčiv do kolonu • stabilita
Zdroje
1. Sutherland I. W. Alginates. In: Byrom, D. ed. Biomaterials - Novel Materials from Biological Sources, NewYork: Stockton 1991, pp. 309–331.
2. Andriamanantoaninaa H., Rinaudo M. Characterization of the alginates from five madagascan brown algae. Carbohydr Polym 2010; 82, 555–60.
3. Draget I. K., Tailor C. Chemical, physical and biological properties of alginates and their biomedical implications. Food Hydrocolloids 2011; 25, 251-256.
4. Dupuy B., Arien A., Minnot A. P. FT-IR of membranes made with alginate/polylysine complexes-variations with the mannuronic or guluronic content of the polysaccharides. Artif Cells Blood Substit Immobil Biotechnol 1994; 22, 71–82.
5. George M., Abraham T. E. Polyionic hydrocolloids for the intestinal delivery of protein drugs: Alginate and chitosan – a review. J. Control. Release 2006; 114, 1–14.
6. Chen S. C., Wu Y. C., Mi F. L., Lin Y. H., Yu L. C., Sung H. W. A novel pH sensitive hydrogel composed of N,O-carboxymethyl chitosan and alginate cross-linked by genipin for protein drug delivery. J. Control. Release 2004; 96, 285–300.
7. Nwe N., Chandrkrachang S., Stevens W., Maw T., Tan T., Khor E., Wong S. Production of fungal chitosan by solid state and submerged fermentation, Carbohydr Polym 2002; 49, 235–237.
8. Rhazi M., Desbriéres J., Tolamaite A., Alagui A., Vottero P. Investigation of different natural sources of chitin: influence of the source and deacetylation process on the physicochemical characteristics of chitosan. Polym Int 2000; 49, 337–344.
9. Muzzarelli R. A. A. Human enzymatic activities related to the therapeutic administration of chitin derivatives. Cell Mol Life Sci 1997; 53, 131–140.
10. Lehr C. M., Bouwstra J. A., Schacht E. H., Junginger H. E. In vitro evaluation of mucoadhesive properties of chitosan and some other natural polymers. Int J Pharm 1992; 78, 43–48.
11. Deacon M. P., McGurk S., Roberts C. J., Williams P. M., Tendler S. J., Davies M. C., Davis S. S., Harding S. E. Atomic force microscopy of gastric mucin and chitosan mucoadhesive systems. Biochem J 2000; 348, 557–563.
12. He P., Davis S. S., Illum L. In vitro evaluation of the mucoadhesive properties of chitosan microspheres. Int J Pharm 1998; 166, 75–88.
13. Kotze A. F., Luessen H. L., Thanou M., Verhoef J. C., de Boer A. G., Junginger H. E., Lehr C. M. Chitosan and chitosan derivatives as absorption enhancers for peptide drugs across mucosal epithelia. In: Mathiowitz, E., Chickering, D. E., Lehr, C. M. eds. Bioadhesive Drug Delivery Systems, New York: Marcel Dekker Inc. 1999, pp. 341–385.
14. Schipper N. G. M., Olsson S., Hoogstraate J. A., deBoer A. G., Varum K. M., Artursson P. Chitosans as absorption enhancers for poorly absorbable drugs: 2. Mechanism of absorption enhancement. Pharm Res 1997; 14, 923–929.
15. Artursson P., Lindmark T., Davis S. S., Illum L. Effect of chitosan on the permeability of monolayers of intestinal epithelial cells (Caco-2). Pharm Res 1994; 11, 1358–1361.
16. Smith J., Wood E., Dornish M. Effect of chitosan on epithelial cell tight junctions. Pharm Res 2004; 21, 43–49.
17. Natsume H., Iwata S., Ohtake K., Miyamoto M., Yamaguchi M., Hosoya K., Kobayashi D., Sugibayashi K., Morimoto Y. Screening of cationic compounds as an absorption enhancers for nasal drug delivery. Int J Pharm 1999; 185, 1–12.
18. Senel S., Hincal A. A. Drug permeation enhancement via buccal route: Possibilities and limitations. J Control Release 2001; 72, 133–144.
19. Grabnar I., Bogataj M., Mrhar A. Influence of chitosan and polycarbophil on permeation of a model hydrophilic drug into the urinary bladder wall. Int J Pharm 2003; 256, 167–173.
20. Sinswat P., Tengamnuay P. Enhancing effect of chitosan on nasal absorption of salmon calcitonin in rats: comparison with hydroxypropyl- and dimethyl-ß-cyclodextrins. Int J Pharm 2003; 257, 15–22.
21. Sandri G., Rossi S., Ferrari F., Bonferoni M.C., Muzzarelli C., Caramella C. Assessment of chitosan derivatives as buccal and vaginal penetration enhancers. Eur J Pharm Sci 2004; 21, 351–359.
22. Yao K. D., Peng T., Feng H. B., He Y. Y. Swelling kinetics and release characteristic of crosslinked chitosan-polyether polymer network (semi- IPN) hydrogels. J Polym Sci A, Polym Chem 1994; 32, 1213–1223.
23. Kast C. E., Schnürch A. B. Thiolated polymers-thiomers: development and in vitro evaluation of chitosan-thioglycolic acid conjugates. Biomaterials 2001; 22, 2345–2352.
24. Thanou M., Kotzé A. F., Scharringhausen T., Lueßen H. L., de Boer A. G., Verhoef J. C., Junginger H. E. Effect of degree of quaternization of N-trimethyl chitosan chloride for enhanced transport of hydrophilic compounds cross intestinal Caco-2 cell monolayers. J Control Release 2000; 64, 15–25.
25. Cheng G. X., Liu J., Zhao R. Z., Yao K. D., Sun P. C., Men A. J., Wang W. H., Wei L. Studies on dynamic behavior of water in crosslinked chitosan hydrogel. J Appl Polym Sci 1998; 67, 983–988.
26. Mi F. L., Sung H. W., Shyu S. S. Drug release from chitosan-alginate complex beads reinforced by a naturally occurring crosslinking agent. Carbohydr Polym 2002; 48, 61–72.
27. Scala-Bertola J., Gajdziok J., Rabišková M., Bonneaux F., Lecompte T., Sapin A., Maincent P. for oral administration of low-molecular-weight heparin. Drug Dev. Ind. Pharm. 2009; 35, 1503-1510.
28. Gander B., Ventouras K., Gurny R., Doelker E. In vitro dissolution medium with supramicellar surfactant concentration and its relevance for in vivo absorption. Int. J. Pharm. 1985; 27, 117–124.
29. Raimundo A. H., Evans D. F., Rogers J., Silk, D. B. A. Gastrointestinal pH profiles in ulcerative colitis. Gastroenterology 1992; 102, A681.
30. Fallingborg J., Christensen L. A., Jacobsen B. A., Rasmussen S. N. Very low intraluminal colonic pH in patients with active ulcerative colitis. Dig Dis Sci 1993; 38, 1989–1993.
31. Washington N., Washington C., Wilson C. G. Drug delivery to the large intestin and rectum. In: Physiological Pharmaceutics: Barriers to Drug Absorption, 2nd ed., New York: Taylor and Francis 2001, 143–180.
32. Rajabi-Siahboomi A. R., Bowtell R. W., Mansfield P., Henderson A., Davis M. C., Melia C. D. Structure and behaviour in hydrophilic matrix sustained release dosage forms: 2. NMR-imaging studies of dimensional changes in the gel layer and core of HPMC tablets undergoing hydration. J Control Release 1994; 31, 121–128.
33. Ashby L. J., Beezer A. E., Buckton G. In vitro dissolution testing of oral controlled release preparations in the presence of artificial food stuffs. I. exploration of alternative methodology: Microcalorimetry. Int J Pharm 1989; 51, 245-251.
34. Eastman I. M., Miller E. G. Gastrointestinal pH in rats as determined by the glass electrode. J Biol Chem 1935; 255–262.
35. Dvořáčková K., Škrabáková G., Rabišková M. Influence of formulation technology on theophylline release from chitosan-based pellets. Čes slov Farm 2009; 58, 216–224.
36. Peréz J. P., Rabišková M. Influence of the drying technique on theophylline pellets prepared by extrusion-spheronization. Int J Pharm 2002; 242, 349–351.
37. Deasy P. B., Law M. F. L. Use of extrusion-spheronization to develop an improved oral doage form of indomethacin. Int J Pharm 1997; 148, 201–209.
38. Rowe R. S., Sheskey P. J., Owen S. C. Handbook of Pharmaceutical Excipients. 5th ed. Washington: Pharmaceutical Press 2006, pp. 146–147.
39. Dvořáčková K., Bautzová T., Rabišková M. Dissolution study in the evaluation of oral preparations with controlled release of drugs. Chem Listy 2011; 105, 50–54.
40. Jedrzejas M. J. Structural and functional comparison of polysaccharide-degrading enzymes. Critical Reviews in Biochemistry and Molecular Biology 2000; 35, 221–251.
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