Initial Burst Measures of Release Kinetics from Fiber Matrices
Tóm tắt
A comprehensive axisymmetric diffusion model of drug release from a fiber is developed to account for both the initial burst (IB) phenomenon as well as the later diffusion-dominated release. This model is an enhancement over previous models in that a set of four IB parameters are calculated, which both describe the initial burst phenomenon as well as improve the fit for the diffusion-dominated release phase. This model is also an enhancement over previous models in allowing: finite dissolution volumes, finite stirring levels of the medium, and user-specified initial drug dispersion within the device. Five different drug release data sets are used to verify the model and to derive values for the IB parameters. Two of the data sets are from experiments conducted in this study, and the other three sets are from previously published data. These data sets were selected to cover a wide range of possibilities, i.e., from nearly 0% to nearly 100% of the total drug release during IB, yet the model handles all cases equally well. © 2003 Biomedical Engineering Society.
PAC2003: 8780-y, 8715Vv
Tài liệu tham khảo
Chen, B. H., and D. J. Lee. Finite element analysis of slow drug release through deformed coating film: Effect of morphology and average thickness of coating film. Int. J. Pharm.234:25–42, 2001.
Chen, B. H., and D. J. Lee. Slow release of drug through deformed coating film: Effects of morphology and drug diffusivity in the coating film. J. Pharm. Sci.90:1478–1496, 2001.
Cook, T. J., G. L. Amidon, and V. C. Yang. Polypeptides for controlled release applications: Synthesis and preliminary characterization and release studies. Int. J. Pharm.159:197–206, 1997.
Ebube, N. K., A. H. Hikal, C. M. Wyandt, D. C. Don, L. G. Miller, and A. B. Jones. Sustained release of acetaminophen from heterogeneous matrix tablets: Influence of polymer ratio, polymer loading, and coactive on drug release. Pharm. Dev. Technol.2:161–170, 1997.
Geze, A., M. C. Venier-Julienne, D. Mathieu, R. Filmon, R. Phan-Luu, and J. P. Benoit. Development of 5–iodo-2–deoxyuridine milling process to reduce initial burst release from PLGA microparticles. Int. J. Pharm.178:257–268, 1999.
Gopferich, A.Erosion of composite polymer matrices. Biomaterials18:397–403, 1997.
Ibim, S. M., A. A. Ambrosio, D. Larrier, H. R. Allcock, and C. T. Laurencin. Controlled macromolecule release from poly(phosphazene) matrixes. J. Controlled Release40:31–39, 1996.
Miyajima, M., A. Koshika, J. Okada, and M. Ikeda. Effect of polymer/basic drug interactions on the two-stage diffusion-controlled release from a poly(-lactic acid) matrix. J. Controlled Release61:295–304, 1999.
Miyajima, M., A. Koshika, J. Okada, A. Kusai, and M. Ikeda. Factors influencing the diffusion-controlled release of papaverine from poly(-lactic acid) matrix. J. Controlled Release56:85–94, 1998.
Miyajima, M., A. Koshika, J. Okada, A. Kusai, and M. Ikeda. Mechanism of drug release from poly(-lactic acid) matrix containing acidic or neutral drugs. J. Controlled Release60:199–209, 1999.
Qian, F., A. Szymanski, and J. Gao. Fabrication and characterization of controlled release poly(-lactic-co-glycolide) millirods. J. Biomed. Mater. Res.55:512–522, 2001.
Reddy, J. N. An Introduction to the Finite Element Method. New York: McGraw-Hill, 1985, p. 46.
Sagiv, A.Theoretical formulation of the diffusion through a slab—Theory validation. J. Membr. Sci.199:125–134, 2002.
Siepmann, J., F. Lecomte, and R. Bodmeier. Diffusion-controlled drug delivery systems: Calculation of the required composition to achieve desired profiles. J. Controlled Release60:379–389, 1999.
Streubel, A., J. Siepmann, N. A. Peppas, and R. Bodmeier. Bimodal drug release with multilayer matrix tablets: Transport mechanisms and device design. J. Controlled Release69:455–468, 2000.
Vandamme, T. F., and J. F. N. Mukendi. Controlled release of levamisole from poly-(∈-caprolactone) matrices. III. Effect of molecular weight and polymer coating on drug release. J. Pharm. Sci.145:77–86, 1996.
Vergnaud, J. M. Liquid transport processes in polymeric materials. Modeling and Industrial Applications. Englewood Cliffs, NJ: Prentice-Hall, 1991, Sec. 10–2.
Vergenaud, J. M.Problems encountered for food safety with polymer packages: Chemical exchange, recycling. Adv. Colloid Interface Sci.78:267, 1998.
Vercruysse, C. W. J., E. A. P. De Maeyer, and R. M. H. Verbeeck. Fluoride release of polyacid-modified composite resins with and without bonding agents. Dent. Mater.17:354–358, 2001.
Wu, X. Y., and Y. Zhou. Finite element analysis of diffusional drug release from complex matrix systems. II. Factors influencing release kinetics. J. Controlled Release51:57–71, 1998.
Zhou, F., C. Vervaet, and J. P. Remon. Matrix pellets based on the combination of waxes, starches, and maltodextrins. Int. J. Pharm.133:155–160, 1996.
Zhou, Y., and X. Y. Wu. Finite element analysis of diffusional drug release from complex matrix systems. I. Complex geometries and composite structures. J. Controlled Release49:277–288, 1997.