Modeling and comparison of dissolution profiles

European Journal of Pharmaceutical Sciences - Tập 13 Số 2 - Trang 123-133 - 2001
Paulo Costa1, José Manuel Sousa Lobo1
1Serviço de Tecnologia Farmacêutica, Faculdade de Farmácia da Universidade do Porto Rua Anı́bal Cunha, 164, 4050-047 Porto, Portugal

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Tài liệu tham khảo

Baker, 1974, Controlled release: mechanisms and rates, 15

Bhanja, 1994, In-vitro release kinetics of salbutamol sulphate microcapsules coated with both Eudragit RS 100 and Eudragit RL 100, Drug Dev. Ind. Pharm., 20, 375, 10.3109/03639049409050190

Bonny, 1991, Matrix type controlled release systems. I. Effect of percolation on drug dissolution kinetics, Pharm. Acta Helv., 66, 160

Chang, 1986, Control of drug release rates through the use of mixtures of polycaprolactone and cellulose propionate polymers, Pharm. Tech., 10, 24

Chow, 1997, Statistical comparison between dissolution profiles of drug products, J. Biopharm Stat., 7, 241, 10.1080/10543409708835184

Christensen, 1980, Physical interpretation of parameters in the Rosin–Rammler–Sperling–Weibull distribution for drug release from controlled release dosage forms, J. Pharm. Pharmacol., 32, 580, 10.1111/j.2042-7158.1980.tb13002.x

Cobby, 1974, Influence of shape factors on kinetics of drug release from matrix tablets. I. Theoretical, J. Pharm. Sci., 63, 725, 10.1002/jps.2600630516

Cobby, 1974, Influence of shape factors on kinetics of drug release from matrix tablets. II. Experimental, J. Pharm. Sci., 63, 732, 10.1002/jps.2600630517

Costa, 1999

Costa, 1996, Nitroglicerina em sistemas de libertação transdérmica - Determinação da velocidade de libertação, Rev. Port. Farm., 46, 4

Crank, 1975, Diffusion in a plane sheet, 47

Desai, 1966, Investigation of factors influencing release of solid drug dispersed in inert matrices. III. Quantitative studies involving the polyethylene plastic matrix, J. Pharm. Sci., 55, 1230, 10.1002/jps.2600551113

Desai, 1966, Investigation of factors influencing release of solid drug dispersed in inert matrices. IV. Some studies involving the polyvinyl chloride matrix, J. Pharm. Sci., 55, 1235, 10.1002/jps.2600551114

Desai, 1966, Investigation of factors influencing release of solid drug dispersed in inert matrices. II. Quantification of procedures, J. Pharm. Sci., 55, 1224, 10.1002/jps.2600551112

El-Arini, 1995, Modeling of drug release from polymer matrices: effect of drug loading, Int. J. Pharm., 121, 141, 10.1016/0378-5173(94)00418-5

El-Arini, 1998, Dissolution properties of praziquantel–PVP systems, Pharm. Acta Helv., 73, 89, 10.1016/S0031-6865(97)00051-4

Fassihi, 1998, Evaluation and comparison of dissolution data derived from different modified release dosage forms: an alternative method, J. Control Release, 55, 45, 10.1016/S0168-3659(98)00022-4

Ford, 1991, Mathematical modeling of drug release from hydroxypropylmethylcellulose matrices: effect of temperature, Int. J. Pharm., 71, 95, 10.1016/0378-5173(91)90071-U

Gibaldi, 1967, Establishment of sink conditions in dissolution rate determinations - theoretical considerations and application to nondisintegrating dosage forms, J. Pharm. Sci., 56, 1238, 10.1002/jps.2600561005

Gibaldi, 1982, Vol. 15

Gill, 1988, Repeated measurement: split–plot trend analysis versus analysis of first differences, Biometrics, 44, 289, 10.2307/2531919

Goldsmith, 1978, On methods of expressing dissolution rate data, J. Pharm. Pharm., 30, 347, 10.1111/j.2042-7158.1978.tb13253.x

1995

Harland, 1988, Drug–polymer matrix swelling and dissolution, Pharm. Res., 5, 488, 10.1023/A:1015913207052

Hastedt, 1990, Diffusion in porous materials above the percolation threshold, Pharm. Res., 7, 893, 10.1023/A:1015985521029

Higuchi, 1961, Rate of release of medicaments from ointment bases containing drugs in suspension, J. Pharm. Sci., 50, 874, 10.1002/jps.2600501018

Higuchi, 1963, Mechanism of sustained-action medication. Theoretical analysis of rate of release of solid drugs dispersed in solid matrices, J. Pharm. Sci., 52, 1145, 10.1002/jps.2600521210

Higuchi, 1962, Analysis of data on the medicament release from ointments, J. Pharm. Sci., 51, 802, 10.1002/jps.2600510825

Hixson, 1931, Dependence of reaction velocity upon surface and agitation, Ind. Eng. Chem., 23, 923, 10.1021/ie50260a018

Hopfenberg, 1976, 26

Ju, 1997, On the assessment of similarity of drug dissolution profiles - A simulation study, Drug Inf. J., 31, 1273, 10.1177/009286159703100427

Jun, 1983, Preparation and in vitro dissolution tests of egg albumin microcapsules of nitrofurantoin, Int. J. Pharm., 16, 65, 10.1016/0378-5173(83)90129-1

Katzhendler, 1997, Modeling of drug release from erodible tablets, J. Pharm. Sci., 86, 110, 10.1021/js9600538

Khan, 1975, The concept of dissolution efficiency, J. Pharm. Pharmacol., 27, 48, 10.1111/j.2042-7158.1975.tb09378.x

Khan, 1972, Effect of compaction pressure on the dissolution efficiency of some direct compression systems, Pharm. Act. Helv., 47, 594

Kim, 1997, Application of binary polymer system in drug release rate modulation. 2. Influence of formulation variables and hydrodynamic conditions on release kinetics, J. Pharm. Sci., 86, 323, 10.1021/js960307p

Kitazawa, 1975, Effects of hardness on the desintegration time and the dissolution rate of uncoated caffeine tablets, J. Pharm. Pharmacol., 27, 765, 10.1111/j.2042-7158.1975.tb09397.x

Kitazawa, 1977, Interpretation of dissolution rate data from in vivo testing of compressed tablets, J. Pharm. Pharmacol., 29, 453, 10.1111/j.2042-7158.1977.tb11368.x

Korsmeyer, 1983, Mechanism of solute release from porous hydrophilic polymers, Int. J. Pharm., 15, 25, 10.1016/0378-5173(83)90064-9

Langenbucher, 1972, Linearization of dissolution rate curves by the Weibull distribution, J. Pharm. Pharmacol., 24, 979, 10.1111/j.2042-7158.1972.tb08930.x

Leuenberger, 1989, Percolation theory, fractal geometry and dosage form, Pharm. Acta Helv., 64, 34

Lin, 1989, In vitro dissolution behaviour of some sustained-release theophylline dosage forms, Pharm. Acta Helv., 64, 236

Liu, 1997, Statistical evaluation of Similarity factor f2 as a criterion for assessment of similarity between dissolution profiles, Drug Inf. J., 31, 1255, 10.1177/009286159703100426

Liu, 1996, Statistical issues on the FDA conjugated estrogen tablets bioequivalence guidance, Drug Inf. J., 30, 881, 10.1177/009286159603000403

Lu, 1996, Optima: a windows-based program for computer-aided optimization of controlled-release dosage forms, Pharm. Dev. Tech., 1, 405, 10.3109/10837459609031435

Lu, 1996, Nonlinear data fitting for controlled release devices: an integrated computer program, Int. J. Pharm., 129, 243, 10.1016/0378-5173(95)04356-X

Moore, 1996, Mathematical comparison of dissolution profiles, Pharm. Tech., 20, 64

Mulye, 1995, A simple model based on first order kinetics to explain release of highly water soluble drugs from porous dicalcium phosphate dihydrate matrices, Drug Dev. Ind. Pharm., 21, 943, 10.3109/03639049509026658

Niebergall, 1963, Dissolution rate studies. II. Dissolution of particles under conditions of rapid agitation, J. Pharm. Sci., 52, 236, 10.1002/jps.2600520310

1999

Pedersen, 1978, Versatile kinetic approach to analysis of dissolution data, J. Pharm. Sci., 67, 1450, 10.1002/jps.2600671034

Peppas, 1985, Analysis of Fickian and non-Fickian drug release from polymers, Pharm. Acta Helv., 60, 110

Pillay, 1999, In vitro release modulation from crosslinked pellets for site-specific drug delivery to the gastrointestinal tract. I. Comparison of pH-responsive drug release and associated kinetics, J. Control. Release, 59, 29, 10.1016/S0168-3659(98)00196-5

Polli, 1997, Methods to compare dissolution profiles and a rationale for wide dissolution specifications for metoprolol tartrate tablets, J. Pharm. Sci., 86, 690, 10.1021/js960473x

Prista, 1995, Vol. I, 453

Rescigno, 1992, Bioequivalence, Pharm. Res., 9, 925, 10.1023/A:1015809201503

Romero, 1991, Statistical optimization of a controlled release formulation obtained by a double compression process: application of a hadamard matrix and a factorial design, Vol. 2, 44

Salomon, 1980, Formulation des comprimés à libération prolongée, Pharm. Acta Helv., 55, 174

Sangalli, 1994, Inert monolithic device with a central hole for constant drug release, Eur. J. Pharm. Biopharm., 40, 370

Schwartz, 1968, Drug release from wax matrices. I. Analysis of data with first-order kinetics and with the diffusion-controlled model, J. Pharm. Sci., 57, 274, 10.1002/jps.2600570206

Schwartz, 1968, Drug release from wax matrices. II. Application of a mixture theory to the sulfanilamide–wax system, J. Pharm. Sci., 57, 278, 10.1002/jps.2600570207

Seki, 1980, Controlled release of 3,5-diester prodrugs of 5-fluoro-2-deoxyuridine from poly-l-lactic acid microspheres, J. Pharm. Sci., 79, 985, 10.1002/jps.2600791108

Shah, 1996, Methods to compare dissolution profiles, Drug Inf. J., 30, 1113, 10.1177/009286159603000428

Shukla, 1989, Effect of drug (core) particle size on the dissolution of theophylline from microspheres made from low molecular weight cellulose acetate propionate, Pharm. Res., 6, 418, 10.1023/A:1015939600866

Shukla, 1991, Effect of drug loading and molecular weight of cellulose acetate propionate on the release characteristics of theophylline microspheres, Pharm. Res., 8, 1369

Staufer, 1994

Tsong, 1996, Statistical assessment of mean differences between two dissolution data sets, Drug Inf. J., 30, 1105, 10.1177/009286159603000427

Varelas, 1995, Zero-order release from biphasic polymer hydrogels, J. Control. Release, 34, 185, 10.1016/0168-3659(94)00085-9

Vudathala, 1992, Dissolution of fludrocortisone from phospholipid coprecipitates, J. Pharm. Sci., 82, 282, 10.1002/jps.2600810318

Wagner, 1969, Interpretation of percent dissolved–time plots derived from In vitro testing of conventional tablets and capsules, J. Pharm. Sci., 58, 1253, 10.1002/jps.2600581021