Understanding peroral absorption: regulatory aspects and contemporary approaches to tackling solubility and permeability hurdles
Tóm tắt
Từ khóa
Tài liệu tham khảo
Bergström, 2014, Early pharmaceutical profiling to predict oral drug absorption: current status and unmet needs, Eur J Pharm Sci, 57, 173, 10.1016/j.ejps.2013.10.015
Dokoumetzidis, 2006, A century of dissolution research: from noyes and whitney to the biopharmaceutics classification system, Int J Pharm, 321, 1, 10.1016/j.ijpharm.2006.07.011
Noyes, 1897, The rate of solution of solid substances in their own solutions, J Am Chem Soc, 19, 930, 10.1021/ja02086a003
Brünner, 1904, Reaktionsgeschwindigkeit in heterogen systemen, Z Phys Chem, 47, 56, 10.1515/zpch-1904-4705
Hixson, 1931, Dependence of reaction velocity upon surface and agitation, Ind Eng Chem, 23, 923, 10.1021/ie50260a018
United States Pharmacopoeia (USPXV). Rockville, Maryland: The United States Pharmacopoeial Convection; 1950.
Danckwerts, 1951, Significance of liquid-film coefficients in gas absorption, Ind Eng Chem, 43, 1460, 10.1021/ie50498a055
Higuchi, 1961, Rate of release of medicaments from ointment bases containing drugs in suspension, J Pharm Sci, 50, 874, 10.1002/jps.2600501018
Brown, 2014, USP and dissolution—20 years of progress, Dissolut Technol, 2014, 24, 10.14227/DT210314P24
Federation International Pharmaceutique, 1981, FIP guidelines for dissolution testing of solid oral products, Die Pharm Ind, 42, 334
Amidon, 1995, A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res, 12, 413, 10.1023/A:1016212804288
Dahan, 2009, Prediction of solubility and permeability class membership: provisional BCS classification of the world’s top oral drugs, AAPS J, 11, 740, 10.1208/s12248-009-9144-x
Martinez, 2002, A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals, J Clin Pharmacol, 42, 620, 10.1177/00970002042006005
Pavurala, 2013, A mechanistic approach for modeling oral drug delivery, Comp Chem Eng, 57, 196, 10.1016/j.compchemeng.2013.06.002
Yu, 1996, Transport approaches to the biopharmaceutical design of oral drug delivery systems: prediction of intestinal absorption, Adv Drug Deliv Rev, 19, 359, 10.1016/0169-409X(96)00009-9
Lipinski, 2001, Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings, Adv Drug Deliv Rev, 46, 3, 10.1016/S0169-409X(00)00129-0
Azarmi, 2007, Current perspectives in dissolution testing of conventional and novel dosage forms, Int J Pharm, 328, 12, 10.1016/j.ijpharm.2006.10.001
Alsenz, 2007, High throughput solubility measurement in drug discovery and development, Adv Drug Deliv Rev, 59, 546, 10.1016/j.addr.2007.05.007
Noyes, 1987, The rate of solution of solid substances in their own solutions, J Am Chem Soc, 19, 930, 10.1021/ja02086a003
Dressman, 1998, Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms, Pharm Res, 15, 11, 10.1023/A:1011984216775
Bansil, 2006, Mucin structure, aggregation, physiological functions and biomedical applications, Curr Opin Colloid Interface Sci, 11, 164, 10.1016/j.cocis.2005.11.001
Behrens, 2001, Transport of lipophilic drug molecules in a new mucus-secreting cell culture model based on HT29-MTX cells, Pharm Res, 18, 1138, 10.1023/A:1010974909998
Sahay, 2010, Endocytosis of nanomedicines, J Control Release, 145, 182, 10.1016/j.jconrel.2010.01.036
Smith, 1999, Pharmacokinetics and metabolism in early drug discovery, Curr Opin Chem Biol, 3, 373, 10.1016/S1367-5931(99)80056-8
Lipka, 1996, Transmembrane transport of peptide type compounds: prospects for oral delivery, J Control Release, 39, 121, 10.1016/0168-3659(95)00145-X
Petri, 2006, Effect of erythromycin on the absorption of fexofenadine in the jejunum, ileum and colon determined using local intubation in healthy volunteers, Int J Clin Pharmacol Ther, 44, 71, 10.5414/CPP44071
Sai, 2005, Biochemical and molecular pharmacological aspects of transporters as determinants of drug disposition, Drug Metab Pharmacokinet, 20, 91, 10.2133/dmpk.20.91
Estudante, 2013, Intestinal drug transporters: an overview, Adv Drug Deliv Rev, 65, 1340, 10.1016/j.addr.2012.09.042
Minuesa, 2011, Drug uptake transporters in antiretroviral therapy, Pharm Ther, 132, 268, 10.1016/j.pharmthera.2011.06.007
Kunta, 2004, Intestinal drug transporters: in vivo function and clinical importance, Curr Drug Metab, 5, 109, 10.2174/1389200043489144
Varma, 2006, Functional role of P-glycoprotein in limiting peroral drug absorption: optimizing drug delivery, Curr Opin Chem Biol, 10, 367, 10.1016/j.cbpa.2006.06.015
Abrahamsson, 2003, Application of the biopharmaceutic classification system now and in the future, 495
Curatolo, 1998, Physical chemical properties of oral drug candidates in the discovery and exploratory development settings, Pharm Sci Technol Today, 1, 387, 10.1016/S1461-5347(98)00097-2
Lipinski, 2000, Drug-like properties and the causes of poor solubility and poor permeability, J Pharmacol Toxicol Methods, 44, 235, 10.1016/S1056-8719(00)00107-6
van de Waterbeemd, 2001, Property-based design: optimization of drug absorption and pharmacokinetics, J Med Chem, 44, 1313, 10.1021/jm000407e
Lipinski, 2004, Navigating chemical space for biology and medicine, Nature, 432, 855, 10.1038/nature03193
Wenlock, 2003, A comparison of physiochemical property profiles of development and marketed oral drugs, J Med Chem, 46, 1250, 10.1021/jm021053p
Palm, 1997, Polar molecular surface properties predict the intestinal absorption of drugs in humans, Pharm Res, 14, 568, 10.1023/A:1012188625088
Clark, 1999, Rapid calculation of polar molecular surface area and its application to the prediction of transport phenomena. 1. Prediction of intestinal absorption, J Pharm Sci, 88, 807, 10.1021/js9804011
Veber, 2002, Molecular properties that influence the oral bioavailability of drug candidates, J Med Chem, 45, 2615, 10.1021/jm020017n
Ritchie, 2009, The impact of aromatic ring count on compound developability—are too many aromatic rings a liability in drug design?, Drug Discov Today, 14, 1011, 10.1016/j.drudis.2009.07.014
Dressman, 1985, Absorption potential: estimating the fraction absorbed for orally administered compounds, J Pharm Sci, 74, 588, 10.1002/jps.2600740523
Yalkowsky, 2006, A ‘rule of unity’ for human intestinal absorption, Pharm Res, 23, 2475, 10.1007/s11095-006-9000-y
Fleisher, 1999, Drug, meal and formulation interactions influencing drug absorption after oral administration: clinical implications, Clin Pharmacokinet, 36, 233, 10.2165/00003088-199936030-00004
Freire, 2011, Does sex matter? The influence of gender on gastrointestinal physiology and drug delivery, Int J Pharm, 415, 15, 10.1016/j.ijpharm.2011.04.069
Avdeef, 2001, Physicochemical profiling (solubility, permeability and charge state), Curr Top Med Chem, 1, 277, 10.2174/1568026013395100
Kimura, 2002, Gastrointestinal transit and drug absorption, Biol Pharm Bull, 25, 149, 10.1248/bpb.25.149
Fujioka, 2008, Evaluation of in vivo dissolution behavior and GI transit of griseofulvin, a BCS class II drug, Int J Pharm, 352, 36, 10.1016/j.ijpharm.2007.10.008
Cook, 2002, An industrial implementation of the biopharmaceutics classification system, Dissolut Technol, 9, 6, 10.14227/DT090202P6
Cook, 2010, Impact of biopharmaceutics classification system-based biowaivers, Mol Pharm, 7, 1539, 10.1021/mp1001747
Committee for Proprietary Medical Products (CPMP). Note for guidance on the investigation of bioavailability and bioequivalence. CPMP/EWP/QWP/1408/98. 2001: London. p. 1–18. Available from: 〈http://www.vivodevelopment.com/En/guidline_PDF/EMEA%20Note%20for%20Guidance%20on%20BE.pdf〉
Oh, 1991, Predicting oral drug absorption in humans: a macroscopic mass balance approach for passive and carrier-mediated compounds, 3
Sakore, 2011, In vitro–in vivo correlation (IVIVC): a strategic tool in drug development, J Bioequiv Availab, 2011, S3
Batchelor, 2013, Application of in vitro biopharmaceutical methods in development of immediate release oral dosage forms intended for paediatric patients, Eur J Pharm Biopharm, 85, 833, 10.1016/j.ejpb.2013.04.015
Alelyunas, 2009, Application of a dried-DMSO rapid throughput 24-h equilibrium solubility in advancing discovery candidates, Eur J Pharm Sci, 37, 172, 10.1016/j.ejps.2009.02.007
Saal, 2012, Optimizing solubility: kinetic versus thermodynamic solubility temptations and risks, Eur J Pharm Sci, 47, 589, 10.1016/j.ejps.2012.07.019
Zhou, 2007, Development of a high throughput equilibrium solubility assay using miniaturized shake-flask method in early drug discovery, J Pharm Sci, 96, 3052, 10.1002/jps.20913
Hörter, 1997, Influence of physicochemical properties on dissolution of drugs in the gastrointestinal tract, Adv Drug Deliv Rev, 25, 3, 10.1016/S0169-409X(96)00487-5
Lue, 2008, Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound, Eur J Pharm Biopharm, 69, 648, 10.1016/j.ejpb.2007.12.013
Klein, 2010, The use of biorelevant dissolution media to forecast the in vivo performance of a drug, AAPS J, 12, 397, 10.1208/s12248-010-9203-3
Aiache, 1997, FIP guidelines for dissolution testing of solid oral products, Dissolut Technol, 4, 5, 10.14227/DT040497P5
Wei, 2006, Biorelevant dissolution media as a predictive tool for glyburide a class II drug, Eur J Pharm Sci, 29, 45, 10.1016/j.ejps.2006.05.004
Lehto, 2011, Use of conventional surfactant media as surrogates for FaSSIF in simulating in vivo dissolution of BCS class II drugs, Eur J Pharm Biopharm, 78, 531, 10.1016/j.ejpb.2011.02.007
Tsume, 2013, Dissolution effect of gastric and intestinal pH fora BCS class II drug, pioglitazone: new in vitro dissolution system to predict in vivo dissolution, J Bioequiv Availab, 5, 224, 10.4172/jbb.1000162
Motz, 2007, Permeability assessment for solid oral drug formulations based on Caco-2 monolayer in combination with a flow through dissolution cell, Eur J Pharm Biopharm, 66, 286, 10.1016/j.ejpb.2006.10.015
Zakeri-Milani, 2009, Biopharmaceutical classification of drugs using intrinsic dissolution rate (IDR) and rat intestinal permeability, Eur J Pharm Biopharm, 73, 102, 10.1016/j.ejpb.2009.04.015
Muenster, 2011, Volume to dissolve applied dose (VDAD) and apparent dissolution rate (ADR): tools to predict in vivo bioavailability from orally applied drug suspensions, Eur J Pharm Biopharm, 78, 522, 10.1016/j.ejpb.2011.01.023
Lennernäs, 2014, Human in vivo regional intestinal permeability: importance for pharmaceutical drug development, Mol Pharm, 11, 12, 10.1021/mp4003392
Kukes VG, Ramenskaya GV, Vasilenko GF, Vasilenko KS, Krasnykh LM, Savchenko AY, et al. Federal Service on Surveillance in Healthcare and Social Development. Methodological recommendations for drug manufacturers on in vitro equivalence test for generic drug products according to biowaiver procedure. 2010. Available from: 〈http://www.fip.org/files/fip/BPS/BCS/Biowaiver%20guidance%20(ru)%20-%20ENG%20March%202011.pdf〉
Lennernäs, 2013, Regional intestinal drug permeation: biopharmaceutics and drug development, Eur J Pharm Sci, 57, 333, 10.1016/j.ejps.2013.08.025
Wahlang, 2011, Identification of permeability-related hurdles in oral delivery of curcumin using the Caco-2 cell model, Eur J Pharm Biopharm, 77, 275, 10.1016/j.ejpb.2010.12.006
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. Guidance for industry. 2000. Available from: 〈http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070246.pdf〉
Blume, 1999, The biopharmaceutics classification system (BCS): class III drugs—better candidates for BA/BE waiver?, Eur J Pharm Sci, 9, 117, 10.1016/S0928-0987(99)00076-7
Tsume, 2014, The biopharmaceutics classification system: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC, Eur J Pharm Sci, 57, 152, 10.1016/j.ejps.2014.01.009
Wu, 2005, Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system, Pharm Res, 22, 11, 10.1007/s11095-004-9004-4
Custodio, 2008, Predicting drug disposition, absorption/elimination/transporter interplay and the role of food on drug absorption, Adv Drug Deliv Rev, 60, 717, 10.1016/j.addr.2007.08.043
Shah, 2011, Recent advances and novel strategies in pre-clinical formulation development: an overview, J Control Release, 156, 281, 10.1016/j.jconrel.2011.07.003
Gao, 2012, Drug nanocrystals: in vivo performances, J Control Release, 160, 418, 10.1016/j.jconrel.2012.03.013
Kalepu, 2015, Insoluble drug delivery strategies: review of recent advances and business prospects, Acta Pharm Sin B, 5, 442, 10.1016/j.apsb.2015.07.003
Basavaraj, 2014, Can formulation and drug delivery reduce attrition during drug discovery and development—review of feasibility, benefits and challenges, Acta Pharm Sin B, 4, 3, 10.1016/j.apsb.2013.12.003
Desai, 2012, Overcoming poor oral bioavailability using nanoparticle formulations—opportunities and limitations, Drug Discov Today, 9, e87, 10.1016/j.ddtec.2011.12.001
Huang, 2014, Fundamental aspects of solid dispersion technology for poorly soluble drugs, Acta Pharm Sin B, 4, 18, 10.1016/j.apsb.2013.11.001
Vo, 2013, Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs, Eur J Pharm Biopharm, 85, 799, 10.1016/j.ejpb.2013.09.007
Blagden, 2007, Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates, Adv Drug Deliv Rev, 59, 617, 10.1016/j.addr.2007.05.011
Elder, 2013, Use of pharmaceutical salts and cocrystals to address the issue of poor solubility, Int J Pharm, 453, 88, 10.1016/j.ijpharm.2012.11.028
Semalty, 2014, Cyclodextrin and phospholipid complexation in solubility and dissolution enhancement: a critical and meta-analysis, Expert Opin Drug Deliv, 11, 1255, 10.1517/17425247.2014.916271
Brewster, 2007, Cyclodextrins as pharmaceutical solubilizers, Adv Drug Deliv Rev, 59, 645, 10.1016/j.addr.2007.05.012
Mu, 2013, Lipid-based formulations for oral administration of poorly water-soluble drugs, Int J Pharm, 453, 215, 10.1016/j.ijpharm.2013.03.054
Chen, 2011, Nanonization strategies for poorly water-soluble drugs, Drug Discov Today, 16, 354, 10.1016/j.drudis.2010.02.009
Dinarvand, 2015, Oral delivery of nanoparticles containing anticancer SN38 and hSET1 antisense for dual therapy of colon cancer, Int J Biol Macromol, 78, 112, 10.1016/j.ijbiomac.2015.03.066
Kharia, 2015, Development and optimisation of mucoadhesive nanoparticles of acyclovir using design of experiments approach, J Microencapsul, 32, 521, 10.3109/02652048.2015.1010457
Sharma, 2015, Investigating the role of pluronic-g-cationic polyelectrolyte as functional stabilizer for nanocrystals: impact on paclitaxel oral bioavailability and tumor growth, Acta Biomater, 26, 169, 10.1016/j.actbio.2015.08.005
Gadadare, 2015, Ultra rapidly dissolving repaglinide nanosized crystals prepared via bottom-up and top-down approach: influence of food on pharmacokinetics behavior, AAPS PharmSciTech, 16, 787, 10.1208/s12249-014-0267-8
Lai, 2009, Mucus-penetrating nanoparticles for drug and gene delivery to mucosal tissues, Adv Drug Deliv Rev, 61, 158, 10.1016/j.addr.2008.11.002
Durán-Lobato, 2014, Enhanced cellular uptake and biodistribution of a synthetic cannabinoid loaded in surface-modified poly(lactic-co-glycolic acid) nanoparticles, J Biomed Nanotechnol, 10, 1068, 10.1166/jbn.2014.1806
Chellampillai, 2011, Improved bioavailability of orally administered andrographolide from pH-sensitive nanoparticles, Eur J Drug Metab Pharmacokinet, 35, 123, 10.1007/s13318-010-0016-7
Cho, 2010, Enhanced dissolution of megestrol acetate microcrystals prepared by antisolvent precipitation process using hydrophilic additives, Int J Pharm, 396, 91, 10.1016/j.ijpharm.2010.06.016
Dalvi, 2013, Precipitation and stabilization of ultrafine particles of Fenofibrate in aqueous suspensions by RESOLV, Powder Technol, 236, 75, 10.1016/j.powtec.2012.05.038
Bege, 2013, In situ forming nimodipine depot system based on microparticles for the treatment of posthemorrhagic cerebral vasospasm, Eur J Pharm Biopharm, 84, 99, 10.1016/j.ejpb.2012.12.016
Zhang, 2013, Preparation of apigenin nanocrystals using supercritical antisolvent process for dissolution and bioavailability enhancement, Eur J Pharm Sci, 48, 740, 10.1016/j.ejps.2012.12.026
Angi, 2014, Novel continuous flow technology for the development of a nanostructured Aprepitant formulation with improved pharmacokinetic properties, Eur J Pharm Biopharm, 86, 361, 10.1016/j.ejpb.2013.10.004
Saremi, 2013, Enhanced oral delivery of docetaxel using thiolated chitosan nanoparticles: preparation, in vitro and in vivo studies, Biomed Res Int, 2013, 150478, 10.1155/2013/150478
Tam, 2015, AH. Fabrication of doxorubicin nanoparticles by controlled antisolvent precipitation for enhanced intracellular delivery, Colloids Surf B Biointerfaces, 139, 249, 10.1016/j.colsurfb.2015.12.026
Chen, 2014, Bexarotene nanocrystal-oral and parenteral formulation development, characterization and pharmacokinetic evaluation, Eur J Pharm Biopharm, 87, 160, 10.1016/j.ejpb.2013.12.005
Liu, 2015, Effect of particle size on oral absorption of carvedilol nanosuspensions: in vitro and in vivo evaluation, Int J Nanomed, 10, 6425, 10.2147/IJN.S87143
Ahuja, 2015, Formulation, optimization and in vitro-in vivo evaluation of febuxostat nanosuspension, Int J Pharm, 478, 540, 10.1016/j.ijpharm.2014.12.003
Quan, 2012, A novel surface modified nitrendipine nanocrystals with enhancement of bioavailability and stability, Int J Pharm, 430, 366, 10.1016/j.ijpharm.2012.04.025
Onoue, 2013, In vitro/in vivo characterization of nanocrystalline formulation of tranilast with improved dissolution and hepatoprotective properties, Eur J Pharm Biopharm, 85, 952, 10.1016/j.ejpb.2013.09.003
Nkansah, 2013, Development and evaluation of novel solid nanodispersion system for oral delivery of poorly water-soluble drugs, J Control Release, 169, 150, 10.1016/j.jconrel.2013.03.032
Yoshida, 2012, Aminoalkyl methacrylate copolymers for improving the solubility of tacrolimus. I: evaluation of solid dispersion formulations, Int J Pharm, 428, 18, 10.1016/j.ijpharm.2012.02.041
Choudhary, 2012, Development and characterization of an atorvastatin solid dispersion formulation using skimmed milk for improved oral bioavailability, Acta Pharm Sin B, 2, 421, 10.1016/j.apsb.2012.05.002
Visser, 2010, Inulin solid dispersion technology to improve the absorption of the BCS Class IV drug TMC240, Eur J Pharm Biopharm, 74, 233, 10.1016/j.ejpb.2009.10.004
Shi, 2013, Impact of amorphous and semicrystalline polymers on the dissolution and crystallization inhibition of pioglitazone solid dispersions, Powder Technol, 247, 211, 10.1016/j.powtec.2013.06.039
Kawabata, 2010, Novel crystalline solid dispersion of tranilast with high photostability and improved oral bioavailability, Eur J Pharm Sci, 39, 256, 10.1016/j.ejps.2009.12.009
Mora, 2013, Characterization, dissolution and in vivo evaluation of solid acetazolamide complexes, Carbohydr Polym, 98, 380, 10.1016/j.carbpol.2013.06.012
Mennini, 2014, Physico-chemical characterization in solution and in the solid state of clonazepam complexes with native and chemically-modified cyclodextrins, J Pharm Biomed Anal, 89, 142, 10.1016/j.jpba.2013.11.009
Salústio, 2012, Release profile of ibuprofen in β-cyclodextrin complexes from two different solid dosage forms, Powder Technol, 221, 245, 10.1016/j.powtec.2012.01.008
Miao, 2016, Enhanced oral bioavailability of lurasidone by self-nanoemulsifying drug delivery system in fasted state, Drug Dev Ind Pharm, 42, 1234, 10.3109/03639045.2015.1118496
Zhang, 2012, Characterization and evaluation of self-microemulsifying sustained-release pellet formulation of puerarin for oral delivery, Int J Pharm, 427, 337, 10.1016/j.ijpharm.2012.02.013
Christiansen, 2014, Cinnarizine food-effects in beagle dogs can be avoided by administration in a Self Nano emulsifying drug delivery system (SNEDDS), Eur J Pharm Sci, 57, 164, 10.1016/j.ejps.2013.11.003
Elgart, 2013, Improved oral bioavailability of BCS class 2 compounds by self nano-emulsifying drug delivery systems (SNEDDS): the underlying mechanisms for amiodarone and talinolol, Pharm Res, 30, 3029, 10.1007/s11095-013-1063-y
Bajaj, 2013, Self-nanoemulsifying drug delivery system of cefpodoxime proxetil containing tocopherol polyethylene glycol succinate, Drug Dev Ind Pharm, 39, 635, 10.3109/03639045.2012.683440
Beg, 2012, Development, optimization, and characterization of solid self-nanoemulsifying drug delivery systems of valsartan using porous carriers, AAPS PharmSciTech, 13, 1416, 10.1208/s12249-012-9865-5
Miao, 2015, Characterization and evaluation of self-nanoemulsifying sustained-release pellet formulation of ziprasidone with enhanced bioavailability and no food effect, Drug Deliv, 21, 1
Hyma, 2013, Formulation and characterisation of self-microemulsifying drug delivery system of pioglitazone, Biomed Prev Nutr, 3, 345, 10.1016/j.bionut.2013.09.005
Kalhapure, 2012, Akamanchi. Oleic acid based heterolipid synthesis, characterization and application in self-microemulsifying drug delivery system, Int J Pharm, 425, 9, 10.1016/j.ijpharm.2012.01.004
Liu, 2012, Preparation and evaluation of self-microemulsifying drug delivery system of baicalein, Fitoterapia, 83, 1532, 10.1016/j.fitote.2012.08.021
Videira, 2013, Experimental design towards an optimal lipid nanosystem: a new opportunity for paclitaxel-based therapeutics, Eur J Pharm Sci, 49, 302, 10.1016/j.ejps.2013.03.005
Patil-Gadhe, 2014, Montelukast-loaded nanostructured lipid carriers: part I oral bioavailability improvement, Eur J Pharm Biopharm, 88, 160, 10.1016/j.ejpb.2014.05.019
Beloqui, 2013, Mechanism of transport of saquinavir-loaded nanostructured lipid carriers across the intestinal barrier, J Control Release, 166, 115, 10.1016/j.jconrel.2012.12.021
Sanganwar, 2008, Dissolution-rate enhancement of fenofibrate by adsorption onto silica using supercritical carbon dioxide, Int J Pharm, 360, 213, 10.1016/j.ijpharm.2008.04.041
Ambrogi, 2012, MCM-41 for furosemide dissolution improvement, Microp Mesop Mater, 147, 343, 10.1016/j.micromeso.2011.07.007
Ambrogi, 2007, Improvement of dissolution rate of piroxicam by inclusion into MCM-41 mesoporous silicate, Eur J Pharm Sci, 32, 216, 10.1016/j.ejps.2007.07.005
Mellaerts, 2008, Increasing the oral bioavailability of the poorly water soluble drug itraconazole with ordered mesoporous silica, Eur J Pharm Biopharm, 69, 223, 10.1016/j.ejpb.2007.11.006
Salonen, 2005, Mesoporous silicon microparticles for oral drug delivery: loading and release of five model drugs, J Control Release, 108, 362, 10.1016/j.jconrel.2005.08.017
Chen, 2015, Physical characterization and in vivo pharmacokinetic study of self-assembling amphotericin B-loaded lecithin-based mixed polymeric micelles, Int J Nanomed, 10, 7265
Dahmani, 2012, Enhanced oral bioavailability of paclitaxel in pluronic/LHR mixed polymeric micelles: preparation, in vitro and in vivo evaluation, Eur J Pharm Sci, 47, 179, 10.1016/j.ejps.2012.05.015
Smith, 2011, Cocrystals of quercetin with improved solubility and oral bioavailability, Mol Pharm, 8, 1867, 10.1021/mp200209j
Basavoju, 2008, Indomethacin-saccharin cocrystal: design, synthesis and preliminary pharmaceutical characterization, Pharm Res, 25, 530, 10.1007/s11095-007-9394-1
Évora, 2014, A thermodynamic based approach on the investigation of a diflunisal pharmaceutical co-crystal with improved intrinsic dissolution rate, Int J Pharm, 466, 68, 10.1016/j.ijpharm.2014.02.048
Soares, 2014, Evaluation of analytical tools and multivariate methods for quantification of co-former crystals in ibuprofen-nicotinamide co-crystals, J Pharm Biomed Anal, 89, 166, 10.1016/j.jpba.2013.11.005
Mulye, 2012, Improvement in physicochemical properties of ezetimibe using a crystal engineering technique, Powder Technol, 222, 131, 10.1016/j.powtec.2012.02.020
Sadekar, 2013, Poly(amido amine) dendrimers as absorption enhancers for oral delivery of camptothecin, Int J Pharm, 456, 175, 10.1016/j.ijpharm.2013.07.071
Gupta, 2007, Polypropylene imine dendrimer mediated solubility enhancement: effect of pH and functional groups of hydrophobes, J Pharm Pharm Sci, 10, 358
Cheng, 2005, Polyamidoamine dendrimers used as solubility enhancers of ketoprofen, Eur J Med Chem, 40, 1390, 10.1016/j.ejmech.2005.08.002
Yáñez, 2011, Intestinal lymphatic transport for drug delivery, Adv Drug Deliv Rev, 63, 923, 10.1016/j.addr.2011.05.019
Carrière, 2016, Impact of gastrointestinal lipolysis on oral lipid based formulations and bioavailability of lipophilic drugs, Biochimie, 125, 297, 10.1016/j.biochi.2015.11.016
Pouton, 2006, Formulation of poorly water-soluble drugs for oral administration: physicochemical and physiological issues and the lipid formulation classification system, Eur J Pharm Sci, 29, 278, 10.1016/j.ejps.2006.04.016
Kumar, 2011, Nonionic surfactant vesicular systems for effective drug delivery-an overview, Acta Pharm Sin B, 1, 208, 10.1016/j.apsb.2011.09.002
Pandita, 2014, Solid lipid nanoparticles enhance oral bioavailability of resveratrol, a natural polyphenol, Food Res Int, 62, 1165, 10.1016/j.foodres.2014.05.059
Das, 2011, Recent advances in lipid nanoparticle formulations with solid matrix for oral drug delivery, AAPS PharmSciTech, 12, 62, 10.1208/s12249-010-9563-0
Iqbal, 2012, Nanostructured lipid carriers system: recent advances in drug delivery, J Drug Target, 20, 813, 10.3109/1061186X.2012.716845
Chiou, 1971, Pharmaceutical applications of solid dispersion systems, J Pharm Sci, 60, 1281, 10.1002/jps.2600600902
van der Mooter, 2012, The use of amorphous solid dispersions: a formulation strategy to overcome poor solubility and dissolution rate, Drug Discov Today, 9, e79, 10.1016/j.ddtec.2011.10.002
Lu, 2013, Polymeric micelles and alternative nanonized delivery vehicles for poorly soluble drugs, Int J Pharm, 453, 198, 10.1016/j.ijpharm.2012.08.042
Gaucher, 2005, Block copolymer micelles: preparation, characterization and application in drug delivery, J Control Release, 109, 169, 10.1016/j.jconrel.2005.09.034
Good, 2009, Solubility advantage of pharmaceutical cocrystals, Cryst Growth Des, 9, 2252, 10.1021/cg801039j
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Regulatory classification of pharmaceutical co-crystals. Guidance for industry. 2013. Available from: 〈http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM516813.pdf〉
Jayasankar, 2010, Transformation pathways of cocrystal hydrates when coformer modulates water activity, J Pharm Sci, 99, 3977, 10.1002/jps.22245
Sanphui, 2012, Pharmaceutical cocrystals of niclosamide, Cryst Growth Des, 12, 4588, 10.1021/cg300784v
McNamara, 2006, Use of a glutaric acid cocrystal to improve oral bioavailability of a low solubility API, Pharm Res, 23, 1888, 10.1007/s11095-006-9032-3
Vig, 2013, Amino acids as promoieties in prodrug design and development, Adv Drug Deliv Rev, 65, 1370, 10.1016/j.addr.2012.10.001
Rodriguez-Aller, 2013, In vivo distribution and ex vivo permeation of cyclosporine A prodrug aqueous formulations for ocular application, J Control Release, 170, 153, 10.1016/j.jconrel.2013.04.019
Li, 2014, A macromolecular prodrug strategy for combinatorial drug delivery, J Colloid Interface Sci, 417, 301, 10.1016/j.jcis.2013.11.061
Falcoz, 2002, Pharmacokinetics of GW433908, a prodrug of amprenavir, in healthy male volunteers, J Clin Pharmacol, 42, 887, 10.1177/009127002401102803
Vierling, 2003, Prodrugs of HIV protease inhibitors, Curr Pharm Des, 9, 1755, 10.2174/1381612033454441
Bimbo, 2010, Biocompatibility of thermally hydrocarbonized porous silicon nanoparticles and their biodistribution in rats, ACS Nano, 4, 3023, 10.1021/nn901657w
Wang, 2010, Oxidized mesoporous silicon microparticles for improved oral delivery of poorly soluble drugs, Mol Pharmacol, 7, 227, 10.1021/mp900221e
Kapoor, 2009, Influence of surface chemistry of mesoporous alumina with wide pore distribution on controlled drug release, J Control Release, 140, 34, 10.1016/j.jconrel.2009.07.015
Zhang, 2011, Inclusion of the poorly water-soluble drug simvastatin in mesocellular foam nanoparticles: drug loading and release properties, Int J Pharm, 410, 118, 10.1016/j.ijpharm.2010.07.040
Cao, 2013, Seventy-two-hour release formulation of the poorly soluble drug silybin based on porous silica nanoparticles: in vitro release kinetics and in vitro/in vivo correlations in beagle dogs, Eur J Pharm Sci, 48, 64, 10.1016/j.ejps.2012.10.012
Chen, 2012, Mesoporous silica nanoparticles with manipulated microstructures for drug delivery, Colloids Surf B Biointerfaces, 95, 274, 10.1016/j.colsurfb.2012.03.012
Korotcenkov, 2010, Silicon porosification: state of the art, Crit Rev Solid State Mater Sci, 35, 153, 10.1080/10408436.2010.495446