The influence of hydroxypropyl methylcellulose (HPMC) molecular weight, concentration and effect of food on in vivo erosion behavior of HPMC matrix tablets

Journal of Controlled Release - Tập 187 - Trang 50-58 - 2014
Arun Kumar Jain1, Erik Söderlind2, Anna Viridén2, Barbara Schug3, Bertil Abrahamsson2, Christian Knopke3, Farhad Tajarobi2, Henning Blume3, Maria Anschütz3, Anette Welinder2, Sara Richardson2, Stefan Nagel1, Susanna Abrahmsén-Alami2, Werner Weitschies1
1Institute of Pharmacy, Ernst-Moritz-Arndt-University of Greifswald, 17487 Greifswald, Germany
2Pharmaceutical Development, AstraZeneca R&D, 431 83 Mölndal, Sweden
3SocraTec R&D GmbH, 61440 Oberursel, Germany

Tài liệu tham khảo

Alderman, 1984, A review of cellulose ethers in hydrophilic matrixes for oral controlled-release dosage forms, Int. J. Pharm. Technol. Prod. Manuf., 5, 1 Reynolds, 1998, Polymer erosion and drug release characterization of hydroxypropyl methyl cellulose matrixes, J. Pharm. Sci., 87, 1115, 10.1021/js980004q Li, 2005, The use of hypromellose in oral drug delivery, J. Pharm. Pharmacol., 57, 533, 10.1211/0022357055957 Tajarobi, 2009, The Impact of dose and solubility of additives on the release from HPMC matrix tablets-identifying critical conditions, Pharm. Res., 26, 1496, 10.1007/s11095-009-9861-y Maderuelo, 2011, Critical factors in the release of drugs from sustained release hydrophilic matrices, J. Control. Release, 154, 2, 10.1016/j.jconrel.2011.04.002 Mitchell, 2007, Investigation of hypromellose particle size effects on drug release from sustained release hydrophilic matrix tablets, Drug Dev. Ind. Pharm., 33, 952, 10.1080/03639040601134132 Viriden, 2009, The effect of chemical heterogeneity of HPMC on polymer release from matrix tablets, Eur. J. Pharm. Sci., 36, 392, 10.1016/j.ejps.2008.11.003 Gao, 1996, Swelling of hydroxypropyl methylcellulose matrix tablets. 2. Mechanistic study of the influence of formulation variables on matrix performance and drug release, J. Pharm. Sci., 85, 732, 10.1021/js9504595 Tritt-Goc, 2005, Spatially resolved solvent interaction with glassy HPMC polymers studied by magnetic resonance microscopy, Solid State Nucl. Magn. Reson., 28, 250, 10.1016/j.ssnmr.2005.10.012 Tajarobi, 2009, Simultaneous probing of swelling, erosion and dissolution by NMR-microimaging—effect of solubility of additives on HPMC matrix tablets, Eur. J. Pharm. Sci., 37, 89, 10.1016/j.ejps.2009.01.008 Kavanagh, 2004, Swelling and erosion properties of hydroxypropyl methylcellulose (Hypromellose) matrices—influence of agitation rate and dissolution medium composition, Int. J. Pharm., 279, 141, 10.1016/j.ijpharm.2004.04.016 Asare-Addo, 2011, Effect of ionic strength and pH of dissolution media on theophylline release from hypromellose matrix tablets—apparatus USP III, simulated fasted and fed conditions, Carbohydr. Polym., 86, 85, 10.1016/j.carbpol.2011.04.014 Williams, 2010, The effect of sucrose and salts in combination on the drug release behaviour of an HPMC matrix, Eur. J. Pharm. Biopharm., 76, 433, 10.1016/j.ejpb.2010.09.001 Abrahamsson, 1993, Absorption, gastrointestinal transit, and tablet erosion of felodipine extended-release (ER) tablets, Pharm. Res., 10, 709, 10.1023/A:1018959732744 Abrahamsson, 1998, Drug absorption from nifedipine hydrophilic matrix extended-release (ER) tablet-comparison with an osmotic pump tablet and effect of food, J. Control. Release, 52, 301, 10.1016/S0168-3659(97)00267-8 Davis, 2009, Scintigraphic study to investigate the effect of food on a HPMC modified release formulation of UK-294,315, J. Pharm. Sci., 98, 1568, 10.1002/jps.21507 Lobo, 2012, Optimization of LY545694 tosylate controlled release tablets through pharmacoscintigraphy, Pharm. Res., 29, 2912, 10.1007/s11095-012-0798-1 Weitschies, 2005, Impact of the intragastric location of extended release tablets on food interactions, J. Control. Release, 108, 375, 10.1016/j.jconrel.2005.08.018 Ghimire, 2010, In-vitro and in-vivo erosion profiles of hydroxypropyl methylcellulose (HPMC) matrix tablets, J. Control. Release, 147, 70, 10.1016/j.jconrel.2010.06.015 Weitschies, 2011, In vivo imaging of drug delivery systems in the gastrointestinal tract, Int. J. Pharm., 417, 216, 10.1016/j.ijpharm.2011.07.031 Weitschies, 2005, Magnetic Marker Monitoring: an application of biomagnetic measurement instrumentation and principles for the determination of the gastrointestinal behavior of magnetically marked solid dosage forms, Adv. Drug Deliv. Rev., 57, 1210, 10.1016/j.addr.2005.01.025 Weitschies, 2008, Bioavailability of amoxicillin and clavulanic acid from extended release tablets depends on intragastric tablet deposition and gastric emptying, Eur. J. Pharm. Biopharm., 70, 641, 10.1016/j.ejpb.2008.05.011 Weitschies, 2001, Magnetic marker monitoring of disintegrating capsules, Eur. J. Pharm. Sci., 13, 411, 10.1016/S0928-0987(01)00140-3 Weitschies, 2001, Determination of the disintegration behavior of magnetically marked tablets, Eur. J. Pharm. Biopharm., 52, 221, 10.1016/S0939-6411(01)00178-3 2013, USP Monograph - Felodipine Extended-Release Tablet, 3539 Bork, 2001, The 8-layered magnetically shielded room of the PTB: design and construction, 970 Schnabel, 2004, A sensor configuration for a 304 SQUID vector magnetometer, Neurol. Clin. Neurophysiol., 70, 1 Siepmann, 1999, HPMC-matrices for controlled drug delivery: a new model combining diffusion, swelling, and dissolution mechanisms and predicting the release kinetics, Pharm. Res., 16, 1748, 10.1023/A:1018914301328 Washington, 2001 Schiller, 2005, Intestinal fluid volumes and transit of dosage forms as assessed by magnetic resonance imaging, Aliment. Pharmacol. Ther., 22, 971, 10.1111/j.1365-2036.2005.02683.x Sun, 1982, The role of opiate receptors and cholinergic neurons in the gastrocolonic response, Gastroenterology, 82, 689, 10.1016/0016-5085(82)90312-2 Wright, 1980, Effect of dietary components on gastrocolonic response, Am. J. Physiol., 238, G228 Luiking, 1998, Migrating motor complex cycle duration is determined by gastric or duodenal origin of phase III, Am. J. Physiol., 275, G1246 Hasler, 2003, Physiology of gastric motility and gastric emptying, 195 Coupe, 1991, Correlation of the gastric emptying of nondisintegrating tablets with gastrointestinal motility, Pharm. Res., 8, 1281, 10.1023/A:1015855829864 Cassilly, 2008, Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy, Neurogastroenterol. Motil., 20, 311, 10.1111/j.1365-2982.2007.01061.x Garbacz, 2008, Irregular absorption profiles observed from diclofenac extended release tablets can be predicted using a dissolution test apparatus that mimics in vivo physical stresses, Eur. J. Pharm. Biopharm., 70, 421, 10.1016/j.ejpb.2008.05.029 Wilson, 2010, Gastrointestinal transit and drug absorption, 41 Dressman, 1990, Upper gastrointestinal (GI) pH in young, healthy men and women, Pharm. Res., 7, 756, 10.1023/A:1015827908309 Koziolek, 2013, Simulating the postprandial stomach: physiological considerations for dissolution and release testing, Mol. Pharm., 10, 1610, 10.1021/mp300604u Koziolek, 2013, Simulating the postprandial stomach: biorelevant test methods for the estimation of intragastric drug dissolution, Mol. Pharm., 10, 2211, 10.1021/mp300607e Pal, 2004, Gastric flow and mixing studied using computer simulation, Proc. R. Soc. B Biol. Sci., 271, 2587, 10.1098/rspb.2004.2886 Abrahamsson, 2005, A novel in vitro and numerical analysis of shear-induced drug release from extended-release tablets in the fed stomach, Pharm. Res., 22, 1215, 10.1007/s11095-005-5272-x