Quality by design: discussing and assessing the solid dispersions risk.
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Salette Reis | Luise L Chaves | Alexandre C C Vieira | Bruno Sarmento | Domingos C Ferreira | B. Sarmento | S. Reis | D. Ferreira | L. L. Chaves | A. Vieira
[1] Nicholas R. Abu-Absi,et al. Real time monitoring of multiple parameters in mammalian cell culture bioreactors using an in-line Raman spectroscopy probe. , 2011, Biotechnology and bioengineering.
[2] Javed Ali,et al. Solid Dispersion: An Alternative Technique for Bioavailability Enhancement of Poorly Soluble Drugs , 2009 .
[3] Priyanka A. Patel,et al. SOLID DISPERSIONS: AN OVERVIEW TO MODIFY BIOAVAILABILITY OF POORLY WATER SOLUBLE DRUGS , 2013 .
[4] S. Varia,et al. Study of phase behavior of poly(ethylene glycol)-polysorbate 80 and poly(ethylene glycol)-polysorbate 80-water mixtures. , 2000, Journal of pharmaceutical sciences.
[5] N. Udupa,et al. Solid dispersions: a review. , 2009, Pakistan journal of pharmaceutical sciences.
[6] P. Tran,et al. Controlled Release Systems Containing Solid Dispersions: Strategies and Mechanisms , 2011, Pharmaceutical Research.
[7] M. Khan,et al. Quality by design: understanding the formulation variables of a cyclosporine A self-nanoemulsified drug delivery systems by Box-Behnken design and desirability function. , 2007, International journal of pharmaceutics.
[8] Vipin Saxena,et al. Ibuprofen-phospholipid solid dispersions: improved dissolution and gastric tolerance. , 2012, International journal of pharmaceutics.
[9] G. Mooter,et al. The use of amorphous solid dispersions: A formulation strategy to overcome poor solubility and dissolution rate. , 2012, Drug discovery today. Technologies.
[10] M. Singh,et al. Review on various techniques of solubility enhancement of poorly soluble drugs with special emphasis on solid dispersion , 2015 .
[11] Lilli Møller Andersen,et al. Quality Risk Management , 2021, Handbook of Pharmaceutical Manufacturing Formulations, Second Edition.
[12] Alexander T. Florence,et al. Physicochemical Principles of Pharmacy , 1988 .
[13] C. Cavallari,et al. Preparation and characterisation of ibuprofen-poloxamer 188 granules obtained by melt granulation. , 2002, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[14] L. D. S. Alves,et al. Avanços, propriedades e aplicações de dispersões sólidas no desenvolvimento de formas farmacêuticas sólidas , 2012 .
[15] Xinsheng Peng,et al. Development and optimization of solid lipid nanoparticle formulation for ophthalmic delivery of chloramphenicol using a Box-Behnken design , 2011, International journal of nanomedicine.
[16] B. Sarmento,et al. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. , 2007, Drug discovery today.
[17] Nae-oh Chung,et al. Mechanism of freeze-drying drug nanosuspensions. , 2012, International journal of pharmaceutics.
[18] Susumu Hasegawa,et al. Evaluation of solid dispersions on a molecular level by the Raman mapping technique. , 2008, International journal of pharmaceutics.
[19] T. De Beer,et al. Raman spectroscopy for the in-line polymer-drug quantification and solid state characterization during a pharmaceutical hot-melt extrusion process. , 2011, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[20] K. V. Ramana Murthy,et al. Evaluation of modified gum karaya as carrier for the dissolution enhancement of poorly water-soluble drug nimodipine. , 2002, International journal of pharmaceutics.
[21] R. Williams,et al. Enhancing bioavailability through thermal processing. , 2013, International journal of pharmaceutics.
[22] P. Sharma,et al. A Review on: Solubility Enhancement by Implementing Solid Dispersion Technique for Poorly Water Soluble Drug , 2012 .
[23] C Vervaet,et al. In-line and real-time process monitoring of a freeze drying process using Raman and NIR spectroscopy as complementary process analytical technology (PAT) tools. , 2009, Journal of pharmaceutical sciences.
[24] Dave A. Miller,et al. Fusion production of solid dispersions containing a heat-sensitive active ingredient by hot melt extrusion and Kinetisol dispersing. , 2010, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[25] Chandra Vemavarapu,et al. Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: selection of polymer-surfactant combinations using solubility parameters and testing the processability. , 2007, International journal of pharmaceutics.
[26] J. Rantanen,et al. Use of in-line near-infrared spectroscopy in combination with chemometrics for improved understanding of pharmaceutical processes. , 2005, Analytical chemistry.
[27] S. Furlanetto,et al. Study of formulation variables influencing the drug release rate from matrix tablets by experimental design. , 2006, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[28] Carl-Fredrik Mandenius,et al. Process analytical technology (PAT) for biopharmaceuticals , 2011, Biotechnology journal.
[29] M. Brion,et al. The supercritical micronization of solid dispersions by Particles from Gas Saturated Solutions using experimental design , 2009 .
[30] Hans Lennernäs,et al. The use of biopharmaceutic classification of drugs in drug discovery and development: current status and future extension , 2005, The Journal of pharmacy and pharmacology.
[31] Owen W Gooding,et al. Process optimization using combinatorial design principles: parallel synthesis and design of experiment methods. , 2004, Current opinion in chemical biology.
[32] H. Claycamp,et al. Perspective on Quality Risk Management of Pharmaceutical Quality , 2007 .
[33] Hans Leuenberger,et al. Spray Freeze-drying – The Process of Choice for Low Water Soluble Drugs? , 2002 .
[34] L. Granero,et al. Intestinal absorption enhancement via the paracellular route by fatty acids, chitosans and others: a target for drug delivery. , 2005, Current drug delivery.
[35] J. Parikh,et al. Process optimization and characterization of poloxamer solid dispersions of a poorly water-soluble drug , 2007, AAPS PharmSciTech.
[36] P. Matsson,et al. Understanding polymer-lipid solid dispersions--the properties of incorporated lipids govern the crystallisation behaviour of PEG. , 2010, International journal of pharmaceutics.
[37] M. Khan,et al. Process analytical technology: nondestructive evaluation of cyclosporine A and phospholipid solid dispersions by near infrared spectroscopy and imaging. , 2008, Journal of pharmaceutical sciences.
[38] R. Williams,et al. Dispersing for the production of plasticizer free morphous solid dispersions ames , 2010 .
[39] Naseem A. Charoo,et al. Quality by design approach for formulation development: a case study of dispersible tablets. , 2012, International journal of pharmaceutics.
[40] Emad B. Basalious,et al. Application of Pharmaceutical QbD for Enhancement of the Solubility and Dissolution of a Class II BCS Drug using Polymeric Surfactants and Crystallization Inhibitors: Development of Controlled-Release Tablets , 2011, AAPS PharmSciTech.
[41] A. Kalia,et al. SOLID DISPERSIONS: AN APPROACH TOWARDS ENHANCING DISSOLUTION RATE Review Article , 2011 .
[42] V. Khutoryanskiy. Hydrogen-bonded interpolymer complexes as materials for pharmaceutical applications. , 2007, International journal of pharmaceutics.
[43] Ajazuddin,et al. A novel and alternative approach to controlled release drug delivery system based on solid dispersion technique , 2012 .
[44] M. Rizwan,et al. Bioavailability enhancement strategies: basics, formulation approaches and regulatory considerations. , 2011, Current drug delivery.
[45] J. M. Marchetti,et al. Dissolution rate enhancement of loratadine in polyvinylpyrrolidone K-30 solid dispersions by solvent methods , 2013 .
[46] Diane J Burgess,et al. Quality by design approach to understand the process of nanosuspension preparation. , 2009, International journal of pharmaceutics.
[47] G. Van den Mooter,et al. Evaluation of Inutec SP1 as a new carrier in the formulation of solid dispersions for poorly soluble drugs. , 2006, International journal of pharmaceutics.
[48] C Vervaet,et al. Implementation of a process analytical technology system in a freeze-drying process using Raman spectroscopy for in-line process monitoring. , 2007, Analytical chemistry.
[49] George Zografi,et al. Assessing the performance of amorphous solid dispersions. , 2012, Journal of pharmaceutical sciences.
[50] D. Bikiaris,et al. Tailoring the Release Rates of Fluconazole Using Solid Dispersions in Polymer Blends , 2008, Drug development and industrial pharmacy.
[51] S. Jagdale,et al. Preparation and in vitro evaluation of Allopurinol-Gelucire 50/13 solid dispersions , 2010 .
[52] L. Freitas,et al. The Preparation of Ternary Solid Dispersions of an Herbal Drug via Spray Drying of Liquid Feed , 2010 .
[53] G. Van den Mooter,et al. Review: physical chemistry of solid dispersions , 2009 .
[54] Antonio P. Costa,et al. Application of quality by design to formulation and processing of protein liposomes. , 2012, International journal of pharmaceutics.
[55] M. Khan,et al. Formulation and Evaluation of a Protein-loaded Solid Dispersions by Non-destructive Methods , 2010, The AAPS Journal.
[56] Jérôme Mantanus,et al. Design space approach in the optimization of the spray-drying process. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[57] Gabriele Reich,et al. A quality by design study applied to an industrial pharmaceutical fluid bed granulation. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[58] Chandra Vemavarapu,et al. Use of Surfactants as Plasticizers in Preparing Solid Dispersions of Poorly Soluble API: Stability Testing of Selected Solid Dispersions , 2006, Pharmaceutical Research.
[59] H. Bajaj,et al. Bioavailability Enhancement: A Review , 2011 .
[60] Johannes G Khinast,et al. An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation. , 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[61] I. Khattab,et al. LYOPHILIZED GLICLAZIDEPOLOXAMER SOLID DISPERSIONS FOR ENHANCEMENT OF IN VITRO DISSOLUTION AND INVIVO BIOAVAILABILITY , 2011 .
[62] Evdokia Korakianiti,et al. Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals , 2011, Pharmaceutical Research.
[63] J. Martens,et al. Upscaling of the hot-melt extrusion process: comparison between laboratory scale and pilot scale production of solid dispersions with miconazole and Kollicoat IR. , 2012, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[64] Chuanbin Wu,et al. The utilization of drug–polymer interactions for improving the chemical stability of hot‐melt extruded solid dispersions , 2014, The Journal of pharmacy and pharmacology.
[65] Jinming Gao,et al. Nanonization strategies for poorly water-soluble drugs. , 2011, Drug discovery today.
[66] P. Mura,et al. Comparison of the effect of chitosan and polyvinylpyrrolidone on dissolution properties and analgesic effect of naproxen. , 2004, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[67] R Gopinath,et al. Pharmaceutical Preformulation Studies - Current Review , 2011 .
[68] Michael Levin. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System , 2001 .
[69] R. Shah,et al. Quality by design: characterization of self-nano-emulsified drug delivery systems (SNEDDs) using ultrasonic resonator technology. , 2007, International journal of pharmaceutics.
[70] J. Rantanen,et al. Influence of solvent evaporation rate and formulation factors on solid dispersion physical stability. , 2011, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[71] Géza Horváth,et al. Comparison of solid dispersions produced by supercritical antisolvent and spray-freezing technologies. , 2009, International journal of pharmaceutics.
[72] B. Ursekar,et al. Design, optimization, preparation and evaluation of dispersion granules of valsartan and formulation into tablets. , 2009, Current drug delivery.
[73] Lynne S Taylor,et al. Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine. , 2008, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[74] G. Aggarwal,et al. An Overview on Solubility Enhancement Techniques for Poorly Soluble Drugs and Solid Dispersion as an Eminent Strategic Approach , 2013 .
[75] H Lennernäs,et al. Oral biopharmaceutics tools - time for a new initiative - an introduction to the IMI project OrBiTo. , 2014, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[76] S. Okonogi,et al. Dissolution improvement of high drug-loaded solid dispersion , 2006, AAPS PharmSciTech.
[77] Viness Pillay,et al. Box-Behnken experimental design in the development of a nasal drug delivery system of model drug hydroxyurea: Characterization of viscosity, in vitro drug release, droplet size, and dynamic surface tension , 2005, AAPS PharmSciTech.
[78] Viktoriya Ioffe-Dahan,et al. The Twofold Advantage of the Amorphous Form as an Oral Drug Delivery Practice for Lipophilic Compounds: Increased Apparent Solubility and Drug Flux Through the Intestinal Membrane , 2012, The AAPS Journal.
[79] P. Mura,et al. Development and characterization of naproxen-chitosan solid systems with improved drug dissolution properties. , 2003, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[80] Susan D'Souza,et al. AAPS Workshop on the Role of Dissolution in QbD and Drug Product Life Cycle: A Commentary , 2010 .
[81] W. Hinrichs,et al. Inulin solid dispersion technology to improve the absorption of the BCS Class IV drug TMC240. , 2010, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[82] Mark Reynolds,et al. Interdependence of drug substance physical properties and corresponding quality control strategy. , 2012, Journal of pharmaceutical sciences.
[83] Karthik Nagapudi,et al. Amorphous Active Pharmaceutical Ingredients in Preclinical Studies: Preparation, Characterization, and Formulation , 2008 .
[84] Sumeet Sharma,et al. Pharmaceutical Quality by Design , 2013 .
[85] Paul A. Dickinson,et al. Clinical Relevance of Dissolution Testing in Quality by Design , 2008, The AAPS Journal.
[86] R. Strickley. Solubilizing Excipients in Oral and Injectable Formulations , 2004, Pharmaceutical Research.
[87] Dave A. Miller,et al. Production of advanced solid dispersions for enhanced bioavailability of itraconazole using KinetiSol® Dispersing , 2010, Drug development and industrial pharmacy.
[88] H. Wu,et al. Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development. , 2011, International journal of pharmaceutics.
[89] Roger Nosal,et al. API Quality by Design Example from the Torcetrapib Manufacturing Process , 2007, Journal of Pharmaceutical Innovation.
[90] O. Sammour,et al. QbD approach of rapid disintegrating tablets incorporating indomethacin solid dispersion , 2011, Pharmaceutical development and technology.
[91] W. Ali,et al. Stochiometrically governed molecular interactions in drug: poloxamer solid dispersions. , 2010, International journal of pharmaceutics.
[92] Andre Raw,et al. Quality by Design: Concepts for ANDAs , 2008, The AAPS Journal.
[93] Koichi Wada,et al. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. , 2011, International journal of pharmaceutics.
[94] Geoff G. Z. Zhang,et al. Phase transformation considerations during process development and manufacture of solid oral dosage forms. , 2004, Advanced drug delivery reviews.
[95] C. Goddeeris,et al. Free flowing solid dispersions of the anti-HIV drug UC 781 with Poloxamer 407 and a maximum amount of TPGS 1000: investigating the relationship between physicochemical characteristics and dissolution behaviour. , 2008, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[96] Stephen T Buckley,et al. In vitro models to evaluate the permeability of poorly soluble drug entities: challenges and perspectives. , 2012, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[97] C. Shah,et al. Enhancement of dissolution of Fenofibrate by Solid dispersion Technique , 2010 .
[98] J. Brus,et al. Characterization of solid polymer dispersions of active pharmaceutical ingredients by 19F MAS NMR and factor analysis. , 2013, Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy.
[99] Roger Nosal,et al. PQLI Key Topics - Criticality, Design Space, and Control Strategy , 2008, Journal of Pharmaceutical Innovation.
[100] Miqin Zhang,et al. Chitosan-based hydrogels for controlled, localized drug delivery. , 2010, Advanced drug delivery reviews.
[101] Ravikanth Kona,et al. Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets , 2012, AAPS PharmSciTech.
[102] G. Van den Mooter,et al. Influence of polyethylene glycol chain length on compatibility and release characteristics of ternary solid dispersions of itraconazole in polyethylene glycol/hydroxypropylmethylcellulose 2910 E5 blends. , 2008, European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences.
[103] A. Verma,et al. SOLUBILITY ENHANCEMENT OF POORLY WATER SOLUBLE DRUGS BY SOLID DISPERSION , 2012 .
[104] P. Gao,et al. Characterization of Supersaturatable Formulations for Improved Absorption of Poorly Soluble Drugs , 2012, The AAPS Journal.
[105] Alavattam Sreedhara,et al. A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design. , 2011, Journal of pharmaceutical sciences.
[106] AR Chabukswar,et al. Preparation and Characterization of Metformin Hydrochloride — Compritol 888 ATO Solid Dispersion , 2011, Journal of young pharmacists : JYP.
[107] A S Rathore,et al. Process analytical technology (PAT) for biopharmaceutical products: Part I. concepts and applications , 2010, Biotechnology and bioengineering.
[108] R. Bodmeier,et al. Characterization and stability of solid dispersions based on PEG/polymer blends. , 2010, International journal of pharmaceutics.
[109] Rutesh H Dave,et al. Development of polyvinylpyrrolidone-based spray-dried solid dispersions using response surface model and ensemble artificial neural network. , 2013, Journal of pharmaceutical sciences.
[110] David S. Jones,et al. Using Flory–Huggins phase diagrams as a pre‐formulation tool for the production of amorphous solid dispersions: a comparison between hot‐melt extrusion and spray drying , 2014, The Journal of pharmacy and pharmacology.
[111] Han‐Gon Choi,et al. Enhanced dissolution of ibuprofen using solid dispersion with poloxamer 407 , 2008, Archives of pharmacal research.
[112] H. Karanth,et al. Industrially feasible alternative approaches in the manufacture of solid dispersions: A technical report , 2006, AAPS PharmSciTech.
[113] Kwok Chow,et al. Engineering of pharmaceutical materials: an industrial perspective. , 2008, Journal of pharmaceutical sciences.
[114] Wei Wu,et al. Enhanced dissolution of silymarin/polyvinylpyrrolidone solid dispersion pellets prepared by a one-step fluid-bed coating technique , 2008 .
[115] J. Rantanen,et al. Fast-track to a solid dispersion formulation using multi-way analysis of complex interactions. , 2013, Journal of pharmaceutical sciences.
[116] Ashwinkumar D. Patel,et al. Characterization and performance assessment of solid dispersions prepared by hot melt extrusion and spray drying process. , 2013, International journal of pharmaceutics.
[117] S. Brocchini,et al. Anomalous properties of spray dried solid dispersions. , 2009, Journal of pharmaceutical sciences.
[118] B. Griffin,et al. Biopharmaceutical challenges associated with drugs with low aqueous solubility--the potential impact of lipid-based formulations. , 2008, Advanced drug delivery reviews.
[119] Rutesh H Dave,et al. Investigation of the effects of process variables on derived properties of spray dried solid-dispersions using polymer based response surface model and ensemble artificial neural network models. , 2014, European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V.
[120] Michael Glodek,et al. Process Robustness - A PQRI White Paper , 2006 .
[121] M. Khan,et al. Risperidone solid dispersion for orally disintegrating tablet: its formulation design and non-destructive methods of evaluation. , 2010, International journal of pharmaceutics.
[122] A. Rathore,et al. Quality by design for biopharmaceuticals , 2009, Nature Biotechnology.
[123] H W Frijlink,et al. Unexpected differences in dissolution behavior of tablets prepared from solid dispersions with a surfactant physically mixed or incorporated. , 2008, International journal of pharmaceutics.
[124] Jiao Yang,et al. An improved kinetics approach to describe the physical stability of amorphous solid dispersions. , 2010, International journal of pharmaceutics.
[125] Amrit Paudel,et al. Manufacturing of solid dispersions of poorly water soluble drugs by spray drying: formulation and process considerations. , 2013, International journal of pharmaceutics.
[126] Lawrence X. Yu. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control , 2008, Pharmaceutical Research.