Comparative in vitro study of oesophageal adhesiveness of different commercial formulations containing alendronate

European Journal of Pharmaceutical Sciences

Volumn 31, Issue 5, 2007, Pages 262-270

  Shakweh, Monjed ^a   Bravo Osuna, Irene ^a   Ponchel, Gilles ^a  

^a UNIV PARIS SUD   (France)

Author keywords

Alendronate; Bioadhesion; Generic; Oesophagus; Tablet; Therapeutic equivalence

Indexed keywords

ALENAT; ALENDRONAT TEVA; ALENDRONIC ACID; CROSCARMELLOSE SODIUM; GENERIC DRUG; POLYMER; STADA; UNCLASSIFIED DRUG;

ADHESION; ANIMAL TISSUE; ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DRUG DOSAGE FORM; DRUG FORMULATION; ESOPHAGUS; ESOPHAGUS INJURY; ESOPHAGUS MUCOSA; EUROPE; IN VITRO STUDY; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; SWINE; TABLET;

ADHESIVENESS; ALENDRONATE; ANIMALS; BONE DENSITY CONSERVATION AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, GENERIC; ESOPHAGITIS; ESOPHAGUS; MUCOUS MEMBRANE; SWINE; TABLETS;

EID: 34447526052     PISSN: 09280987     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejps.2007.03.012     Document Type: Article

References (20)

1. Batchelor H.K., Banning D., Dettmar P.W., Hampson F.C., Jolliffe I.G., and Craig D.G.M. An in vitro mucosal model for prediction of the bioadhesion of alginate solutions to the oesophagus. Int. J. Pharm. 238 (2002) 123-132
2. Cilurzo F., Minghetti P., Casiraghi F.A., and Montanari L. Polymethacrylate salts as new low-swellable mucoadhesive materials. J. Control. Rel. 88 (2003) 43-53
3. Committee for Proprietary Medicinal Products (CPMP). Note for Guidance for the Investigation of Bioavailability and Bioequivalence, 2001, 19 pp. Available at www.emea.eu.int/pdfs/human/ewp/140198en.pdf. Last accessed July 25, 2006.
4. Dai Q., Liu J.B., Brasseur J.G., Thangada V.K., Thomas B., Parkman H., and Miller L.S. Volume (3-dimensional) space-time reconstruction of esophageal peristaltic contraction by using simultaneous US and manometry. Gastrointest. Endosc. 58 (2003) 913-919
5. de Groen P.C., Lubbe D.F., Hirsch L.J., Daifotis A., Stephenson W., Freedholm D., Pryor-Tillotson S., Seleznick M.J., Pinkas H., and Wang K.K. Esophagitis associated with the use of alendronate. N. Engl. J. Med. 335 (1996) 1016-1021
6. Dobrucali A., Tobey N.A., Awayda M.S., Argote C., Abdulnour-Nakhoul S., Shao S., and Orlando R.C. Physiological and morphological effects of alendronate on rabbit esophageal epithelium. Am. J. Physiol. Gastrointest. Liver Physiol. 283 (2002) G576-G586
7. Drake W.M., Worsley D.F., Lentle B.C., and Kendler D.L. Monitoring oesophageal transit of wax-polished alendronate in healthy postmenopausal women: a new technique for the study of pill transit time. Curr. Ther. Res. 63 (2002) 103-109
8. Duchêne D., Ponchel G., Wouessidjewe D., Lejoyeux F., and Peppas N.A. Méthodes d'évaluation de la bioadhésion et facteurs influents, S.T.P. Pharma 4 (1988) 688-697
9. Epstein S., Geusen P., Fisher J.E., Hill S.L., Roy S., Rodan G., Muniappa N., Wollenberg G.K., Handt L., Kelly N., Chan C.C., Reszka A.A., and Prahalada S. Disintegration and esophageal irritation profiles of alendronate formulations: implications for clinical safety and efficacy. J. Appl. Res. 5 (2005) 253-265
10. Fu J., Sun X., and Zhang Z.R. Study of bioadhesive properties of carbomer934 by a gamma camera in vivo. World J. Gastroenterol. 8 (2002) 176-179
11. Geresh S., Gdalevsky G.Y., Gilboa I., Voorspoels J., Remon J.P., and Kost J. Bioadhesive grafted starch copolymers as platforms for peroral drug delivery: a study of theophylline release. J. Control. Rel. 94 (2004) 391-399
12. Kane S., Borisov N.N., and Brixner D. Pharmacoeconomic evaluation of gastrointestinal tract events during treatment with risedronate or alendronate: a retrospective cohort study. Am. J. Manage. Care 10 (2004) S216-S228
13. Lejoyeux F., Ponchel G., and Duchêne D. Influence of some technological parameters on the bioadhesive characteristics of polyacrylic acid matrices, S.T.P. Pharma 5 (1989) 893-898
14. Lejoyeux F., Ponchel G., Wouessidjewe D., Peppas N.A., and Duchêne D. Bioadhesive tablets: influence of the testing medium composition on bioadhesion. Drug Dev. Ind. Pharm. 15 (1989) 2037-2048
15. Marvola M., Vahervuo K., Sothmann A., Marttila E., and Rajaniemi M. Development of a method for study of the tendency of drug products to adhere to the oesophagus. J. Pharm. Sci. 71 (1982) 975-977
16. Mittal R.K., Liu J., Puckett J.L., Bhalla V., Bhargava V., Tipnis N., and Kassab G. Sensory and motor function of the esophagus: lessons from ultrasound imaging. Gastroenterology 128 (2005) 487-497
17. Peppas N.A., and Huang Y. Nanoscale technology of mucoadhesive interactions. Adv. Drug Deliv. Rev. 56 (2004) 1675-1687
18. Perkins A.C., Wilson C.G., Frier M., Blackshaw P.E., Dansereau R.J., Vincent R.M., Wenderoth D., Hathaway S., Li Z., and Spiller R.C. The use of scintigraphy to demonstrate the rapid oesophageal transit of the oval film-coated placebo risedronate tablet compared to a round uncoated placebo tablet when administered with minimal volumes of water. Int. J. Pharmacol. 222 (2001) 295-303
19. Ponchel G., Touchard F., Duchêne D., and Peppas N.A. Bioadhesive analysis of controlled release systems. I. Fracture and interpenetration analysis in poly(acrylic acid)-containing systems. J. Control. Rel. 5 (1987) 129-141
20. Richardson J.C., Dettman P.W., Hampson F.C., and Melia C.D. Oesophageal bioadhesion of sodium alginate suspensions. 2. Suspension behaviour on oesophageal mucosa. Eur. J. Pharm. Sci. 24 (2005) 107-114