Design and monitoring of photostability systems for amlodipine dosage forms

International Journal of Pharmaceutics

Volumn 265, Issue 1-2, 2003, Pages 125-132

  Ragno, G ^a   Cione, E ^a   Garofalo, A ^a   Genchi, G ^a   Ioele, G ^a   Risoli, A ^a   Spagnoletta, A ^a  

^a UNIVERSITY OF CALABRIA   (Italy)

Author keywords

Amlodipine; Cyclodextrins; Liposomes; Microspheres; Photodegradation; Supramolecular systems

Indexed keywords

AMLODIPINE; CYCLODEXTRIN; EXCIPIENT; LIPOSOME; MICROSPHERE;

ARTICLE; BIOLOGICAL MONITORING; CONCENTRATION RESPONSE; DRUG DESIGN; DRUG FORMULATION; DRUG MONITORING; DRUG STABILITY; DRUG SYNTHESIS; MOLECULAR WEIGHT; PHOTODEGRADATION; PRIORITY JOURNAL; SPECTROPHOTOMETRY;

EID: 0141867745     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2003.07.001     Document Type: Article

References (37)

1. Albini, A., Fasani, E., 1998. Photochemistry of drugs: an overview on practical problems. In: Albini, A., Fasani, E. (Eds.), Drugs Photochemistry and Photostability. The Royal Society of Chemistry, Cambridge, pp. 1-74.
2. Béchard S.R., Quraishi O., Kwong E. Film coating: effect of titanium dioxide concentration and film thickness on the photostability of nifedipine. Int. J. Pharm. 87:1992;133-139.
3. Beijersbergen van Henegouwen G.M.J. Medicinal photochemistry: phototoxic and phototherapeutic aspects of drugs. Adv. Drug Res. 29:1997;79-170.
4. Biloti D.N., dos Reis M.M., Ferreira M.M.C., Pessine F.B.T. Photochemical behavior under UVA radiation of β-cyclodextrin included Parsol 1789 with a chemiometric approach. J. Mol. Struct. 480-481:1999;557-561.
5. Bisaccia B., Indiveri C., Palmieri F. Purification of reconstitutively active α-ketoglutarate carrier from pig heart mitochondria. Biochim. Biophys. Acta. 810:1985;362-369.
6. Bisby R.H., Mead C., Morgan C.G. Active uptake of drugs into photosensitive liposomes and rapid release on UV photolysis. Photochem. Photobiol. 71:2000;57-61.
7. Brisaert M., Gabriëls M., Matthijs V., Plaizier-Vercammen J. Liposomes with tretinoin: a physical and chemical evaluation. J. Pharm. Biomed. Anal. 26:2001;909-917.
8. Connors K.A. Prediction of binding constants of α-cyclodextrin complexes. J. Pharm. Sci. 85:1996;796-802.
9. Csabai K., Vikmon M., Szejtli J., Redenti E., Poli G., Ventura P. Complexation of manidipine with cyclodextrins and their derivatives. J. Inclusion Phenom. Macromol. Chem. 31:1998;169-178.
10. Cserhati T., Forgacs E., Szejtli J. Inclusion complex formation of antisense nucleotides with hydroxypropyl-β-cyclodextrin. Int. J. Pharm. 141:1996;1-7.
11. de Villiers M.M., van der Watt J.G., Lotter A.P. Kinetic study of the solid state photolytic degradation of two polymorphic forms of furosemide. Int. J. Pharm. 88:1992;275-283.
12. Desai D.S., Abdelnasser M.A., Rubitski B.A., Varia S.A. Photostabilization of uncoated tablets of sorivudine and nifedipine by incorporation of synthetic iron oxides. Int. J. Pharm. 103:1994;69-76.
13. Filipovic-Grcic J., Becirevic-Lacan M., Skalko N., Jalsenjak I. Chitosan microsheres of nifedipine and nifedipine-cyclodextrin inclusion complexes. Int. J. Pharm. 135:1996;183-190.
14. Genchi G., Spagnoletta A., De Santis A., Stefanizzi L., Palmieri L. Purification and characterization of the reconstitutively active citrate carrier from maize mitochondria. Plant Physiol. 120:1999;841-847.
15. Guyot M., Fawaz F. Nifedipine loaded-polymeric microspheres: preparation and physical characteristics. Int. J. Pharm. 175:1998;61-74.
16. Habib M.J., Asker A.F. Photostabilization of riboflavin by incorporation into liposomes. J. Parenter. Sci. Technol. 45:1991;124-127.
17. Hasan, T., 1992. Photosensitizer delivery mediated by macromolecular carrier systems. In: Henderson, B.W., Dougherty, T.J. (Eds.), Photodynamic Therapy. Basic Principles and Clinical Applications. Marcel Dekker, New York, pp. 187-200.
18. Higuhi T., Connors K.A. Phase-solubility techniques. Adv. Anal. Chem. Instrum. 4:1969;117-122.
19. Ho A.H.L., Puri A., Sugden J.K. Effect of sweetening agents on the light stability of aqueous solutions of L-ascorbic acid. Int. J. Pharm. 107:1994;199-203.
20. ICH Harmonized Tripartite Guideline, 1996. Photostability Testing of New Drug Substance and Products. Federal Register 62, 27115-27122.
21. Jiménez M.C., Miranda M.A., Tormos R. Photochemistry of naproxen in the presence of β-cyclodextrin. J. Photochem. Photobiol. A Chem. 104:1997;119-121.
22. Krämer R., Heberger C. Functional reconstitution of carrier proteins by removal of detergent with a hydrophobic ion exchange column. Biochim. Biophys. Acta. 863:1986;289-296.
23. Loftsson T., Frioriksdóttir H., Másson M. Solubilization of β-cyclodextrin. Eur. J. Pharm. Sci. 4:1996;S143.
24. Loukas Y.L., Jayasekera P., Gregoriadis G. Novel liposome-based multicomponent system for the protection of photolabile agents. Int. J. Pharm. 117:1995;85-94.
25. Marinkovic V., Agbaba D., Karljikovic-Rajic K., Comor J., Zivanov-Stakic D. UV derivative spectrophotometric study of the photochemical degradation of nisoldipine. Il Farmaco. 55:2000;128-133.
26. Mielcarek J. Photochemical stability of the inclusion complexes formed by modified 1 4-dihydropyridine derivatives with β-cyclodextrin. J. Pharm. Biomed. Anal. 15:1997;681-686.
27. Mielcarek J., Daczkowska E. Photodegradation of inclusion complexes of isradipine with methyl-β-cyclodextrin. J. Pharm. Biomed. Anal. 21:1999;393-398.
28. Morgan C.G., Bisby R.H., Johnson S.A., Mitchell A.C. Fast solute release from photosensitive liposomes: an alternative to "caged" reagents for use in biological systems. FEBS Lett. 375:1995;113-116.
29. Ragno G., Garofalo A., Vetuschi C. Photodegradation monitoring of amlodipine by derivative spectrophotometry. J. Pharm. Biomed. Anal. 27:2002;19-24.
30. Sansdrap P., Moës A.J. Influence of manufacturing parameters on the size characteristics and the release profiles of nifedipine from poly (DL-lactide-co-glycolide) microspheres. Int. J. Pharm. 98:1993;157-164.
31. Skowronski T.A., Rabek J.F., Rånby B. The role of commercial pigments in the photodegradation of poly (vinyl chloride) (PVC). Polym. Degrad. Stab. 8:1984;37-53.
32. Thoma K., Klimek R. Photostabilization of drugs in dosage forms without protection from packaging materials. Int. J. Pharm. 67:1991;169-175.
33. Editorial, 1996. Relevant literature on photostability testing of actual drug substances and drug formulations. In: Tønnesen, H.H. (Ed.), Photostability of Drugs and Drug Formulations. Tylor & Francis, London, pp. 371-399.
34. Tønnesen H.H. Formulation and stability testing of photolabile drugs. Int. J. Pharm. 225:2001;1-14.
35. Tønnesen H.H., Karlsen J. Studies on curcumin and curcuminoids. X. The use of curcumin as a formulation aid to protect light-sensitive drugs in soft gelatine capsules. Int. J. Pharm. 38:1987;247-249.
36. Yeung P.K.F., Mosher S.J., Pollak P.T. Liquid chromatography assay for amlodipine: chemical stability and pharmacokinetics in rabbits. J. Pharm. Biomed. Anal. 7:1991;565-571.
37. Yüksel N., Tinçer T., Baykara T. Interaction between nicardipine hydrochloride and polymeric microspheres for a controlled release system. Int. J. Pharm. 140:1996;145-154.