Development of a novel transdermal patch of alendronate, a nitrogen-containing bisphosphonate, for the treatment of osteoporosis

Journal of Bone and Mineral Research

Volumn 25, Issue 12, 2010, Pages 2582-2591

  Kusamori, Kosuke ^a   Katsumi, Hidemasa ^a   Abe, Mari ^a   Ueda, Asuka ^a   Sakai, Ryota ^a   Hayashi, Rie ^a   Hirai, Yuka ^a   Quan, Ying Shu ^a,b   Kamiyama, Fumio ^b   Sakane, Toshiyasu ^a   Yamamoto, Akira ^a  

^a KYOTO PHARMACEUTICAL UNIVERSITY   (Japan)

^b CosMED Pharmaceutical Company Ltd ^*  (Japan)

Author keywords

Bisphosphonates; Osteoporosis; Skin; Transdermal Delivery

Indexed keywords

ALENDRONIC ACID; CALCIUM;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BONE MASS; CALCIUM BLOOD LEVEL; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG EFFECT; DRUG PENETRATION; FEMALE; HUMAN; HUMAN TISSUE; HYPERCALCEMIA; MALE; NONHUMAN; OSTEOPOROSIS; OVARIECTOMY; RAT; SKIN IRRITATION;

EID: 78649585440     PISSN: 08840431     EISSN: None     Source Type: Journal    
DOI: 10.1002/jbmr.147     Document Type: Article

References (42)

1. Schenk R, Eggli P, Fleisch H, et al. Quantitative morphometric evaluation of the inhibitory activity of new aminobisphosphonates on bone resorption in the rat. Calcif Tissue Int. 1986; 38: 342-349.
2. Fleisch H., Experimental basis for the use of bisphosphonates in Paget's disease of bone. Clin Orthop Relat Res. 1987; 217: 72-78.
3. Lambrinoudaki I, Christodoulakos G, Botsis D., Bisphosphonates. Ann NY Acad Sci. 2006; 1092: 397-402.
4. Van Beek ER, Cohen LH, Leroy IM, et al. Differentiating the mechanisms of antiresorptive action of nitrogen containing bisphosphonates. Bone. 2003; 33: 805-811.
5. Ezra A, Golomb G., Administration routes and delivery systems of bisphosphonates for the treatment of bone resorption. Adv Drug Deliv Rev. 2000; 42: 175-195.
6. Drake MT, Clarke BL, Khosla S., Bisphosphonates: mechanism of action and role in clinical practice. Mayo Clin Proc. 2008; 83: 1032-1045.
7. Fleisch H., Development of bisphosphonates. Breast Cancer Res. 2002; 4: 30-34.
8. Russell RG., Bisphosphonates: mode of action and pharmacology. Pediatrics. 2007; 119 (Suppl 2): S150-62.
9. Fisher JE, Rodan GA, Reszka AA., In vivo effects of bisphosphonates on the osteoclast mevalonate pathway. Endocrinology. 2000; 141: 4793-4796.
10. Rodan GA, Reszka AA., Bisphosphonate mechanism of action. Curr Mol Med. 2002; 2: 571-577.
11. Dunford JE, Rogers MJ, Ebetino FH, et al. Inhibition of protein prenylation by bisphosphonates causes sustained activation of Rac, Cdc42, and Rho GTPases. J Bone Miner Res. 2006; 21: 684-694.
12. Reszka AA, Rodan GA., Bisphosphonate mechanism of action. Curr Rheumatol Rep. 2003; 5: 65-74.
13. Sato M, Grasser W., Effects of bisphosphonates on isolated rat osteoclasts as examined by reflected light microscopy. J Bone Miner Res. 1990; 5: 31-40.
14. Porras AG, Holland SD, Gertz BJ., Pharmacokinetics of alendronate. Clin Pharmacokinet. 1999; 36: 315-328.
15. Graham DY., What the gastroenterologist should know about the gastrointestinal safety profiles of bisphosphonates. Dig Dis Sci. 2002; 47: 1665-1678.
16. Sener G, Sehirli O, Cetinel S, et al. Protective effect of taurine against alendronate-induced gastric damage in rats. Fundam Clin Pharmacol. 2005; 19: 93-100. (Pubitemid 40207490)
17. Naniwa T, Maeda T, Mizoshita T, et al. Alendronate-induced esophagitis: possible pathogenic role of hypersensitivity to alendronate. Intern Med. 2008; 47: 2083-2085.
18. Kaye PS., Gastric hemorrhage and ulceration in hiatal hernia sac associated with alendronate. Dig Dis Sci. 1999; 44: 903-904.
19. Lacy MQ, Dispenzieri A, Gertz MA, et al. Mayo clinic consensus statement for the use of bisphosphonates in multiple myeloma. Mayo Clin Proc. 2006; 81: 1047-1053.
20. Kamatari M, Koto S, Ozawa N, et al. Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate. J Bone Miner Metab. 2007; 25: 302-309.
21. Choi A, Gang H, Chun I, et al. The effects of fatty acids in propylene glycol on the percutaneous absorption of alendronate across the excised hairless mouse skin. Int J Pharm. 2008; 357: 126-131.
22. Flynn GL, Yalkowsky SH., Correlation and prediction of mass transport across membranes. I. Influence of alkyl chain length on flux-determining properties of barrier and diffusant. J Pharm Sci. 1972; 61: 838-852.
23. Yano T, Nakagawa A, Tsuji M, et al. Skin permeability of various non-steroidal anti-inflammatory drugs in man. Life Sci. 1986; 39: 1043-1050.
24. Scheuplein RJ, Blank IH, Brauner GJ, et al. Percutaneous absorption of steroids. J Invest Dermatol. 1969; 52: 63-70.
25. Draize JH, Woodard G, Calvery HO., Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membrane. J Pharmacol Exp Ther. 1944; 82: 377-390.
26. Bucks DA, Hostynek JJ, Hinz RS, et al. Uptake of two zwitterionic surfactants into human skin in vivo. Toxicol Appl Pharmacol. 1993; 120: 224-227.
27. Wong JA, Renton KW, Crocker JF, et al. Determination of pamidronate in human whole blood and urine by reversed-phase HPLC with fluorescence detection. Biomed Chromatogr. 2004; 18: 98-101.
28. Yamaoka K, Tanigawara Y, Nakagawa T, et al. A pharmacokinetic analysis program (MULTI) for microcomputer. J Pharmacobio-Dyn. 1981; 4: 879-885.
29. Azuma Y, Sato H, Oue Y, et al. Alendronate distributed on bone surfaces inhibits osteoclastic bone resorption in vitro and in experimental hypercalcemia models. Bone. 1995; 16: 235-245.
30. Xiang A, Kanematsu M, Mitamura M, et al. Analysis of change patterns of microcomputed tomography 3-dimensional bone parameters as a high-throughput tool to evaluate antiosteoporotic effects of agents at an early stage of ovariectomy-induced osteoporosis in mice. Invest Radiol. 2006; 41: 704-712.
31. Bronaugh RL, Stewart RF, Congdon ER., Methods for in vitro percutaneous absorption studies. II. Animal models for human skin. Toxicol Appl Pharmacol. 1982; 62: 481-488.
32. Mazières B, Rouanet S, Velicy J, et al. Topical ketoprofen patch (100mg) for the treatment of ankle sprain: a randomized, double-blind, placebo-controlled study. Am J Sports Med. 2005; 33: 515-523.
33. Teichmann A, Otberg N, Jacobi U, et al. Follicular penetration: development of a method to block the follicles selectively against the penetration of topically applied substances. Skin Pharmacol Physiol. 2006; 19: 216-223.
34. Saunders Y, Ross JR, Broadley KE, et al. Steering Group Systematic review of bisphosphonates for hypercalcaemia of malignancy. Palliat Med. 2004; 18: 418-431. (Pubitemid 39162655)
35. Iwamoto J, Uzawa M, Sato Y, et al. Effect of alendronate on bone mineral density and bone turnover markers in post-gastrectomy osteoporotic patients. J Bone Miner Metab. 2010; 28: 202-208.
36. Doneray H, Ozkan B, Caner I, et al. Intragastric alendronate therapy in two infants with vitamin D intoxication: a new method. Clin Toxicol. 2008; 46: 300-302.
37. Atabek ME, Pirgon O, Sert A., Oral alendronate therapy for severe vitamin D intoxication of the infant with nephrocalcinosis. J Pediatr Endocrinol Metab. 2006; 19: 169-172.
38. Markowitz GS, Fine PL, Stack JI, et al. Toxic acute tubular necrosis following treatment with zoledronate (Zometa). Kidney Int. 2003; 64: 281-289.
39. Sener G, Paskaloglu K, Kapucu C, et al. Octreotide ameliorates alendronate-induced gastric injury. Peptides. 2004; 25: 115-121.
40. Sener G, Kapucu C, Cetinel S, et al. Gastroprotective effect of leukotriene receptor blocker montelukast in alendronate-induced lesions of the rat gastric mucosa. Prostaglandins Leukot Essent Fatty Acids. 2005; 72: 1-11.
41. Festjens N, Kalai M, Smet J, et al. Butylated hydroxyanisole is more than a reactive oxygen species scavenger. Cell Death Differ. 2006; 13: 166-169.
42. Sasse A, Colindres P, Brewer MS., Effect of natural and synthetic antioxidants on the oxidative stability of cooked, frozen pork patties. J Food Sci. 2009; 74: 30-35.