Advances in Solid Dispersion Technology: Method-Dependent Solubility Enhancement Approaches
DOI:
https://doi.org/10.22270/ajprd.v14i3.1835Keywords:
Solid dispersion, solubility enhancement, bioavailability, amorphous systems, hot-melt extrusion, spray drying,Abstract
Solid dispersion technology is widely recognized as an effective approach for enhancing the solubility and oral bioavailability of poorly water-soluble drugs. A large number of newly developed pharmaceutical compounds belong to Biopharmaceutics Classification System (BCS) Class II and IV categories, where poor aqueous solubility limits dissolution and gastrointestinal absorption, resulting in reduced therapeutic efficacy. Solid dispersions improve drug dissolution through mechanisms such as particle size reduction, enhanced wettability, amorphization, reduced crystallinity, and increased surface area. This review highlights the fundamental concepts, mechanisms, classification, carriers, preparation methods, characterization techniques, recent advances, applications, and future prospects of solid dispersion technology. Various hydrophilic carriers including polyethylene glycol (PEG), polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose (HPMC), and Soluplus® are extensively used to enhance dissolution behavior and maintain supersaturation. Conventional techniques such as fusion and solvent evaporation, along with advanced technologies including hot-melt extrusion, spray drying, freeze drying, electrospinning, and supercritical fluid processing, are discussed in terms of their advantages, limitations, and industrial applicability. Recent innovations such as ternary solid dispersions, nanostructured systems, lipid-based formulations, artificial intelligence-assisted optimization, and continuous manufacturing have significantly improved formulation efficiency and scalability. Commercially available products demonstrate the successful industrial application of solid dispersions in oral drug delivery. However, challenges including physical instability, recrystallization, moisture sensitivity, and scale-up difficulties continue to affect formulation development. Future advancements in smart polymers, green manufacturing technologies, and personalized medicine are expected to further expand the potential of solid dispersion systems in modern pharmaceutical research and industry.
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Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm. 2000;50(1):47-60. doi:10.1016/S0939-6411(00)00076-9.
Baghel S, Cathcart H, O’Reilly NJ. Polymeric amorphous solid dispersions: a review. Adv Drug Deliv Rev.2016;100:116-125. doi:10.1016/j.addr.2015.01.009.
Janssens S, Van den Mooter G. Review: physical chemistry of solid dispersions. J Pharm Pharmacol. 2009;61(12):1571-1586. doi:10.1211/jpp/61.12.0001.
Huang Y, Dai WG. Fundamental aspects of solid dispersion technology for poorly soluble drugs. Acta Pharm Sin B. 2014;4(1):18-25. doi:10.1016/j.apsb.2013.11.001.
Vo CLN, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85(3):799-813. doi:10.1016/j.ejpb.2013.09.007.
Craig DQM. The mechanisms of drug release from solid dispersions in water-soluble polymers. Int J Pharm. 2002;231(2):131-144. doi:10.1016/S0378-5173(01)00891-2.
Yu L. Amorphous pharmaceutical solids: preparation, characterization and stabilization. Adv Drug Deliv Rev. 2001;48(1):27-42. doi:10.1016/S0169-409X(01)00098-9.
Rumondor ACF, Marsac PJ, Stanford LA, Taylor LS. Phase behavior of amorphous solid dispersions. Mol Pharm. 2009;6(5):1492-1505. doi:10.1021/mp900129v.
Paudel A, Worku ZA, Meeus J, Guns S, Van den Mooter G. Manufacturing of solid dispersions by spray drying. Int J Pharm. 2013;453(1):253-284. doi:10.1016/j.ijpharm.2012.07.015.
Tekade AR, Yadav JN. A review on solid dispersion and carriers used therein for solubility enhancement of poorly water soluble drugs. Adv Pharm Bull. 2020;10(3):359-369. doi:10.34172/apb.2020.044.
Vo CLN, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85(3):799-813. doi:10.1016/j.ejpb.2013.09.007.
Baghel S, Cathcart H, O’Reilly NJ. Polymeric amorphous solid dispersions: a review. Adv Drug Deliv Rev.2016;100:116-125. doi:10.1016/j.addr.2015.01.009.
Kim D, Kim Y, Tin YY, et al. Recent technologies for amorphization of poorly water-soluble drugs. Pharmaceutics. 2021;13(8):1318. doi:10.3390/pharmaceutics13081318.
Janssens S, Van den Mooter G. Review: physical chemistry of solid dispersions. J Pharm Pharmacol. 2009;61(12):1571-1586. doi:10.1211/jpp/61.12.0001.
Tran PHL, Tran TTD. Electrospinning in pharmaceutical drug delivery systems. Pharmaceutics. 2020;12(6):497. doi:10.3390/pharmaceutics12060497.
Paudel A, Worku ZA, Meeus J, Guns S, Van den Mooter G. Manufacturing of solid dispersions by spray drying. Int J Pharm. 2013;453(1):253-284. doi:10.1016/j.ijpharm.2012.07.015.
Repka MA, Shah S, Lu J, et al. Melt extrusion: process to product. Expert Opin Drug Deliv. 2012;9(1):105-125. doi:10.1517/17425247.2012.633508.
Maniruzzaman M, Boateng JS, Snowden MJ, Douroumis D. A review of hot-melt extrusion. ISRN Pharmaceutics.2012;2012:436763. doi:10.5402/2012/436763.
Huang Y, Dai WG. Fundamental aspects of solid dispersion technology for poorly soluble drugs. Acta Pharm Sin B. 2014;4(1):18-25. doi:10.1016/j.apsb.2013.11.001.
Tekade AR, Yadav JN. A review on solid dispersion and carriers used therein for solubility enhancement of poorly water soluble drugs. Adv Pharm Bull. 2020;10(3):359-369. doi:10.34172/apb.2020.044.
Leuner C, Dressman J. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm. 2000;50(1):47-60. doi:10.1016/S0939-6411(00)00076-9.
Baghel S, Cathcart H, O’Reilly NJ. Polymeric amorphous solid dispersions: a review. Adv Drug Deliv Rev.2016;100:116-125. doi:10.1016/j.addr.2015.01.009.
Janssens S, Van den Mooter G. Review: physical chemistry of solid dispersions. J Pharm Pharmacol. 2009;61(12):1571-1586. doi:10.1211/jpp/61.12.0001.
Huang Y, Dai WG. Fundamental aspects of solid dispersion technology for poorly soluble drugs. Acta Pharm Sin B. 2014;4(1):18-25. doi:10.1016/j.apsb.2013.11.001.
VO CLN, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85(3):799-813. doi:10.1016/j.ejpb.2013.09.007.
Serajuddin ATM. Solid dispersion of poorly water-soluble drugs: early promises, subsequent problems, and recent breakthroughs. J Pharm Sci. 1999;88(10):1058-1066. doi:10.1021/js980403l.
Craig DQM. The mechanisms of drug release from solid dispersions in water-soluble polymers. Int J Pharm. 2002;231(2):131-144. doi:10.1016/S0378-5173(01)00891-2.
Repka MA, Shah S, Lu J, et al. Melt extrusion: process to product. Expert Opin Drug Deliv. 2012;9(1):105-125. doi:10.1517/17425247.2012.633508.
Paudel A, Worku ZA, Meeus J, Guns S, Van den Mooter G. Manufacturing of solid dispersions by spray drying. Int J Pharm. 2013;453(1):253-284. doi:10.1016/j.ijpharm.2012.07.015.
Tekade AR, Yadav JN. A review on solid dispersion and carriers used therein for solubility enhancement of poorly water soluble drugs. Adv Pharm Bull. 2020;10(3):359-369. doi:10.34172/apb.2020.044.
Baghel S, Cathcart H, O’Reilly NJ. Polymeric amorphous solid dispersions: a review. Adv Drug Deliv Rev.2016;100:116-125. doi:10.1016/j.addr.2015.01.009.
Janssens S, Van den Mooter G. Review: physical chemistry of solid dispersions. J Pharm Pharmacol. 2009;61(12):1571-1586. doi:10.1211/jpp/61.12.0001.
Huang Y, Dai WG. Fundamental aspects of solid dispersion technology for poorly soluble drugs. Acta Pharm Sin B. 2014;4(1):18-25. doi:10.1016/j.apsb.2013.11.001.
Vo CLN, Park C, Lee BJ. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur J Pharm Biopharm. 2013;85(3):799-813. doi:10.1016/j.ejpb.2013.09.007.
Repka MA, Shah S, Lu J, et al. Melt extrusion: process to product. Expert Opin Drug Deliv. 2012;9(1):105-125. doi:10.1517/17425247.2012.633508.
Paudel A, Worku ZA, Meeus J, Guns S, Van den Mooter G. Manufacturing of solid dispersions by spray drying. Int J Pharm. 2013;453(1):253-284. doi:10.1016/j.ijpharm.2012.07.015.
Kim D, Kim Y, Tin YY, et al. Recent technologies for amorphization of poorly water-soluble drugs. Pharmaceutics. 2021;13(8):1318. doi:10.3390/pharmaceutics13081318.
Maniruzzaman M, Boateng JS, Snowden MJ, Douroumis D. A review of hot-melt extrusion. ISRN Pharmaceutics.2012;2012:436763. doi:10.5402/2012/436763.
Tran PHL, Tran TTD. Electrospinning in pharmaceutical drug delivery systems. Pharmaceutics. 2020;12(6):497. doi:10.3390/pharmaceutics12060497.
Tekade AR, Yadav JN. A review on solid dispersion and carriers used therein for solubility enhancement of poorly water soluble drugs. Adv Pharm Bull. 2020;10(3):359-369. doi:10.34172/apb.2020.044.
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