Abstract
Purpose. We sought to determine whether disintegration and dissolution behavior differs among various albendazole generic formulations obtained from third world countries and to compare them with the innovator's product.
Methods. Dissolution behavior of various albendazole formulations was studied with USP Apparatus 2 in SGFsp and in a modified SGFsp which contained 0.1% of the nonionic surfactant Triton® × 100. Disintegration was tested according to the European Pharmacopoeia.
Results. Dissolution experiments in SGFsp showed a wide range in rate and extent of albendazole dissolution. The innovator product released 81 percent within two hours, a profile matched by only one other formulation. For other formulations 32 to 64% was released within two hours. Use of a modified SGFsp, containing 0.1% Triton® × 100 to simulate the surface tension of gastric juice, resulted in less discrimination between products. The innovator product again showed the fastest and most complete dissolution, with ninety percent released within two hours. The generic formulations released between 67 and 82%, except for one formulation which achieved only 43% release. The results in SGFsp plus Triton® × 100 may be more meaningful than in SGFsp, since the surface tension of the medium is closer to the physiological value. All formulations passed the disintegration test according to the European Pharmacopoeia, with disintegration times ranging from 2.5 to 11 minutes.
Conclusions. Generic albendazole products vary widely in their dissolution behavior. Differences among products were greater in SGFsp than in SGFsp plus Triton® × 100. These differences were not reflected in the disintegration behavior of the products.
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REFERENCES
B. Neuse-Schwarz. Qualitätsvergleiche und warum man sie braucht. Pharmazeutische Zeitung 142: 3938-3940 (1997).
D. B. Jack in Handbook of Clinical Pharmacokinetic Data, Macmillan Publishers Ltd, Basingstoke, UK (1992).
G. L. Amidon, H. Lennernäs, V. P. Shah, and J. R. Crison. A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 12: 413-420 (1995).
P. Finholt and S. Solvang. Dissolution kinetics of drugs in human gastric juice — The role of surface tension. J. Pharm. Sci. 57: 1322-1326 (1968).
The United States Pharmacopoeia (USPXXIII). United States Pharmacopoeial Convention, Inc., Rockville, MD, USA (1995).
European Pharmacopeia 3rd Edition. Deutscher Apotheker Verlag Stuttgart (1997).
I. Borst, T. T. Quach, and A. H. Beckett. In vivo prediction for generic conventional release diltiazem tablets based on hydrodynamically validated dissolution test methodologies. Pharm. Res. 13: S-263 (1996).
S. L. Lin, J. Menig, and L. Lachman. Interdependence of physiological surfactant and drug particle size on the dissolution behavior of water insoluble drugs. J. Pharm. Sci. 57: 2143-8 (1968).
E. Galia, E. Nicolaides, D. Hörter, R. Löbenberg, C. Reppas, and J. B. Dressman. Evaluation of various dissolution media for predicting in vivo performance of class I and II drugs. Pharm. Res. 15: 698-705 (1998).
U. Haas. Physik für Pharmazeuten und Mediziner. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart (1988).
H. O. Ammar and S. A. El-Nahhas. Solubilization of bromhexine hydrochloride by non-ionic surfactants. Pharmazie 49: 583-585 (1994).
S. Solvang and P. Finholt. Effect of tablet processing and formulation factors on dissolution rate of the active ingredient in human gastric juice. J. Pharm. Sci. 59: 49-52 (1970).
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Galia, E., Horton, J. & Dressman, J.B. Albendazole Generics—A Comparative In Vitro Study. Pharm Res 16, 1871–1875 (1999). https://doi.org/10.1023/A:1018907527253
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DOI: https://doi.org/10.1023/A:1018907527253