Ketotifen-loaded microspheres prepared by spray-drying poly(D,L-lactide) and poly(D,L-lactide-co-glycolide) polymers: Characterization and in vivo evaluation

Journal of Pharmaceutical Sciences

Volumn 97, Issue 8, 2008, Pages 3153-3169

  Guerrero, Sandra ^a   Muñíz, Enriqueta ^a   Teijón, César ^a   Olmo, Rosa ^a   Teijón, José M ^a   Blanco, M Dolores ^a  

^a UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

Author keywords

In vitro in vivo correlation; Ketotifen; Microspheres; Poly(D,L lactide); Poly(D,L lactide co glycolide); Spray drying

Indexed keywords

KETOTIFEN; MICROSPHERE;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG DEGRADATION; DRUG DELIVERY SYSTEM; DRUG DISPOSITION; DRUG EFFECT; DRUG RELEASE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MALE; NONHUMAN; PORTAL HYPERTENSION; RAT; SPRAY DRYING;

EID: 52449107294     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21241     Document Type: Article

References (50)

1. Grant SM, Goa KL, Fitton A, Sorkin EM. 1990. Ketotifen. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in asthma and allergic disorders. Drugs 40:412-448.
2. Bielory L, Lien KW, Bigelsen S. 2005. Efficacy and tolerability of newer antihistamines in the treatment of allergic conjunctivitis. Drugs 65:215-228.
3. Kalia N, Brown NJ, Wood RFM, Pockley AG. 2005. Ketotifen abrogates local and systemic consequences of rat intestinal ischemia-reperfusion injury. J Gastroenterol Hepatol 20:1032-1038.
4. Yicheng Z, Stuart B. 2003. Ketotifen reverses MDRl-mediated multidrug resistance in human breast cancer cells in vitro and alleviates cardio-toxicity induced by doxorubicin in vivo. Cancer Chem Pharmacol 51:407-414.
5. Grahnén A, Lönnebo A, Beck O, Eckernäs SA, Dahlström B, Lindström B. 1992. Pharmacokinetics of ketotifen after oral-administration to healthy male-subjects. Biopharm Drug Dispos 13:255-262.
6. Humbert H, Cabiac MD, Bosshardt H. 1994. In-vitro in-vivo correlation of a modified-release oral form of ketotifen - In-vitro dissolution rate specification. J Pharm Sci 83:131-136.
7. Yagi N, Taniuchi Y, Hamada K, Sudo J, Sekikawa H. 2002. Pharmacokinetics of ketotifen fumarate alter intravenous, intranasal, oral and rectal administration in rabbits. Biol Pharm Bull 25: 1614-1618.
8. Drugs.com. Drug Information Online. www.drugs.com.
9. 1 antagonists in amygdala-kindled rats. Brain Res 991:258-261.
10. Elsayed MMA, Abdallah OY, Naggar VF, Khalafallah NM. 2006. Deformable liposomes and ethosomes: Mechanism of enhanced skin delivery. Int J Pharm 322:60-66.
11. Inoue K, Ogawa K, Okada J, Sugibayashi K. 2005. Enhancement of skin permeation of ketotifen by supersaturation generated by amorphous form of the drug. J Control Release 108:306-318.
12. Chiang CH, Chen JL, Liu YT, Wang DP. 1998. Therapeutic effect and pharmacokinetics of ketotifen transdermal delivery system. Drug Develop Ind Pharm 24:213-217.
13. Karlgard CCS, Wong NS, Jones LW, Moresoli C. 2003. In vitro uptake and release studies of ocular pharmaceutical agents by silicon-containing and p-HEMA hydrogel contact lens materials. Int J Pharm 257:141-151.
14. Anderson JM, Shive MS. 1997. Biodegradation and biocompatibility of PLA and PLGA microspheres. Adv Drug Del Rev 28:5-24.
15. Cao Y, Mitchell G, Messina A, Price L, Thompson E, Penington A, Morrison W, O'Connor A, Stevens G, Cooper-White J. 2006. The influence of architecture on degradation and tissue ingrowth into three-dimensional poly(lactic-co-glycolic acid) scaffolds in vitro and in vivo. Biomaterials 27:2854-2864.
16. Blanco MD, Sastre RL, Teijón C, Olmo R, Teijón JM. 2006. Degradation behaviour of microspheres prepared by spray-drying poly(D, L-lactide) and poly(D, L-lactide-co-glycolide) polymers. Int J Pharm 326:139-147.
17. Palma MD, Aller MA, Vara E, Nava MP, García C, Arias-Díaz J, Balibrea JL, Arias J. 2005. Portal hypertension produces an evolutive hepato-intest-inal pro- and anti-inflammatory response in the rat. Cytokine 31:213-226.
18. Bain DF, Munday DL, Smith A. 1999. Solvent influence on spray-dryed biodegradable microspheres. J Microencapsul 16:453-474.
19. Fu YJ, Mi FL, Wong TB, Shyn SS. 2001. Characteristics and controlled release of anticancer drug loaded poly (D, L-lactide) microparticles prepared by spray drying technique. J Microencapsul 18:733-747.
20. Wang FJ, Wang CH. 2003. Etanidazole-loaded microspheres fabricated by spray-drying different poly(actide/glycolide) polymers: Effects on microsphere properties. J Biomater Sci Polymer Edn 14: 157-183.
21. Blanco MD, Sastre RL, Teijón C, Olmo R, Teijón JM. 2005. 5-Fluorouracil-loaded microspheres prepared by spray-drying poly(D, L-lactide) and poly(D, L-lactide-co-glycolide) polymers: Characterization and drug release. J Microencapsul 22:671-682.
22. Limé F, Irgun K. 2007. Monodisperse polymeric particles by photoinitiated precipitation polymerization. Macromolecules 40:1962-1968.
23. Liu J, Chew C, Gan L, Teo W, Gan L. 1997. Synthesis of monodisperse polystyrene microlatexes by emulsion polymerization using a polymerizable surfactant. Langmuir 13:4988-4994.
24. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layloff T, Viswanathan CT, Cook CE, McDowall RD, Pittman KA, Spector S. 1992. Analytical methods validation: Bioavailability, bioequivalence, and pharmacokinetic studies. J Pharm Sci 81:309-312.
25. Benoit MA, Baras B, Gillard J. 1999. Preparation and characterization of protein-loaded poly(ε-caprolactone) microparticles for oral vaccine delivery. Int J Pharm 184:73-84.
26. Alkhamis KA, Obeidat WM, Najib NM. 2001. Adsorption of allopurinol and ketotifen by chitosan. AAPS Pharm Sci Tech 2 article 3:1-7. (http://www. pharmscitech.com).
27. Ritschel WA, Kearns GL. 2004. Handbook of basic pharmacokinetics - Including clinical applications, 6th edition. Washington, DC: American Pharmacists Association (APhA).
28. Doménech J, Martínez J, Plá JM. 1997. Biofarmacia y Farmacocinética. Volumen I: Farmacocinética. Madrid: Editorial Síntesis.
29. Uppoor VRS. 2001. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Release 72:127-132.
30. Blanco-Prieto MJ, Campanero MA, Besseghir K, Heimgatner F, Gander B. 2004. Importance of single or blended polymer types for controlled in vitro release and plasma levels of a somatostatin analogue entrapped in PLA/PLGA microspheres. J Control Release 96:437-448.
31. Humason GL. 1979. Animal tissue techniques, 4th edition. New York, NY: Freeman WH.
32. Dolinsky A. 2001. High-temperature spray drying. Drying Technol 19:785-807.
33. Lúck M, Pistel KF, Li YX, Blunk T, Múller RH, Kissel T. 1998. Plasma protein adsorption on biodegradable microspheres consisting of poly(D, L-lactide-co-glycolide), poly(L-lactide) or ABA triblock copolymers containing poly(oxyethylene). Influence of production method and polymer composition. J Control Release 55:107-120.
34. Shin SC, Choi JS. 2005. Antihistamine effects of triprolidine from the transdermal administration of the TPX matrix in rats. Arch Pharm Res 28:111-114.
35. Mathir ZM, Dangor CM, Govender T, Chetty DJ. 1997. In vitro characterization of a controlled-release chlorpheniramine maleate delivery system prepared by the air-suspension technique. J Microencapsul 14:743-751.
36. Okabe S, Najaki S, Tachibana M. 1992. Effect of ketotifen on acute gastric lesions and gastric secretion in rats. Jpn J Phamacol 59:251-254.
37. Weller PF. 1991. The immunobiology of eosinophils. N Engl J Med 324:1110-1118.
38. Goldman H, Proujanski R. 1986. Allergic procititis and gastroenteritis in children. Clinical and mucosal biopsy features in 53 cases. Am J Surg Pathol 10:75-86.
39. Melamed I, Feanny D, Sherman PJ, Roifman CM. 1991. Benefit of ketotifen in patients with eosinophilic gastroenteritis. Am J Med 90:310-314.
40. Jones E. 1996. Methylene chloride, an overview of human and environmental effects. Pharm Technol Eur 8:30-32.
41. Blanco MD, Bernardo MV, Sastre RL, Olmo R, Muñíz E, Teijón JM. 2003. Preparation of bupivacaine-loaded poly(ε- caprolactone) microspheres by spray drying: Drug release studies and biocompatibility. Eur J Pharm Biopharm 55:229-236.
42. Joshi M, Misra A. 2001. Dry powder inhalation of liposomal ketotifen fumarate: Formulation and characterization. Int J Pharm 223:15-27.
43. Bittner B, Kissel T. 1999. Ultrasonic atomization for spray drying: A versatile technique for the preparation of protein loaded biodegradable microspheres. J Microencapsul 16:325-341.
44. Trapani G, Lopedota A, Boghetich G, Latrofa A, Franco M, Sanna E, Liso G. 2003. Encapsulation and release of the hypnotic agent zolpidem from biodegradable polymer microparticles containing hydroxypropyl-b-cyclodextrin. Int J Pharm 268: 47-57.
45. Bain DF, Munday DL, Smith A. 1999. Modulation of rifampicin release from spray-dried microspheres using combinations of poly-(D, L-lactide). J Micoencapsul 16:369-385.
46. Diez-Arias JA, Aller MA, Palma MD, Arias JL, Muñíz E, Sánchez M, Arias J. 2001. Increased duodenal mucosa infiltration by mast cells in rats with portal hypertension. Dig Surg 18:34-40.
47. Diehl KH, Hull R, Morton D, Pfister R, Rabemampianina Y, Smith D, Vidal JM, Van de Vorstenbosch C. 2001. A good practice guide to the administration of substances and removal of blood, including routes and volumes. J Appl Toxicol 21: 15-23.
48. Ise T, Kobayashi K, Biller W, Häberle A. 1998. Sodium balance and blood pressure response to salt ingestion in uninephrectomized rats. Kidney Int 54:S245-S249.
49. Zhang X, Mehvar R. 2001. Dextran-methylprednisolone succinate as a prodrug of methylprednisolone: Plasma and tissue disposition. J Pharm Sci 90: 2078-2087.
50. Schliecker G, Schmidt C, Fuchs S, Ehinger A, Sandow J, Kissel T. 2004. In vitro and in vivo correlation of buserelin release from biodegradable implants using statistical moment analysis. J Control Release 94:25-37.