Solid Dispersion Technology As a Strategy to Improve the Bioavailability of Poorly Soluble Drugs

References

• Gribbon P , AndreasS. High-throughput drug discovery: what can we expect from HTS?Drug Discov. Today1(10), 17–22 (2005).
   Google Scholar
• Lipinski CA , LombardoF , DominyBW , FeeneyPJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv. Drug Deliv. Rev.64, 4–17 (2012).
   Web of Science ®Google Scholar
• Ku MS . Use of the biopharmaceutical classification system in early drug development. AAPS J.10(1), 208–212 (2008).
   PubMed Web of Science ®Google Scholar
• Savjani KT , GajjarAK , SavjaniJK. Drug solubility: importance and enhancement techniques. ISRN Pharm.2012, 1–10 (2012).
   Google Scholar
• Sugano K , OkazakiA , SugimotoS , TavornvipasS , OmuraA. Solubility and dissolution profile assessment in drug discovery. Drug Metab. Pharmacokinet.22(4), 225–254 (2007).
   PubMed Web of Science ®Google Scholar
• Amidon GL , LennernäsH , ShahVP , CrisonJR. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res.12(3), 413–420 (1995).
   PubMed Web of Science ®Google Scholar
• Yu LX , AmidonGL , PolliJEet al. Biopharmaceutics classification system: the scientific basis for biowaiver extensions. Pharm. Res.19(7), 921–925 (2002).
   PubMed Web of Science ®Google Scholar
• Stegemann S , LeveillerF , FranchiD , DeJong H , LindenH. When poor solubility becomes an issue: from early stage to proof of concept. Eur. J. Pharm. Sci.31(5), 249–261 (2007).
   PubMed Web of Science ®Google Scholar
• Bellantone RA . Fundamentals of amorphous systems: thermodynamic aspects. In: Amorphous Solid Dispersions. Advances inDelivery Science and Technology. ShahN, SandhuH, ChoiD, ChokshiH, MalickA ( Eds). Springer, NY, USA, 3–34 (2014).
   Google Scholar
• Shah N , SandhuH , ChoiDS , ChokshiH , MalickAW. Amorphous solid dispersions: Theory and Practice. Springer, NY, USA (2014).
   Google Scholar
• Williams III RO , WattsAB , MillerDA. Formulating Poorly Water Soluble Drugs.Springer, NY, USA (2012).
   Google Scholar
• Rodriguez-Aller M , GuillarmeD , VeutheyJ-L , GurnyR. Strategies for formulating and delivering poorly water-soluble drugs. J. Drug Deliv. Sci. Tech.30, 342–351 (2015).
   Web of Science ®Google Scholar
• Kawabata Y , WadaK , NakataniM , YamadaS , OnoueS. Formulation design for poorly water-soluble drugs based on biopharmaceutics classification system: basic approaches and practical applications. Int. J. Pharm.420(1), 1–10 (2011).
   PubMed Web of Science ®Google Scholar
• Vemula VR , LagishettyV , LingalaS. Solubility enhancement techniques. Int. J. Pharm. Sci. Rev. Res.5(1), 41–51 (2010).
   PubMedGoogle Scholar
• Singh A , WorkuZA , VanDen Mooter G. Oral formulation strategies to improve solubility of poorly water-soluble drugs. Expert Opin. Drug Deliv.8(10), 1361–1378 (2011).
   PubMed Web of Science ®Google Scholar
• Douroumis D , FahrA. Drug Delivery Strategies for Poorly Water-Soluble Drugs. Wiley Online Library, NY, USA (2013).
   Google Scholar
• Van Duong T , VanDen Mooter G. The role of the carrier in the formulation of pharmaceutical solid dispersions. Part II: amorphous carriers. Expert Opin. Drug Deliv.13(12), 1681–1694 (2016).
   PubMed Web of Science ®Google Scholar
• Sekiguchi K , ObiN. Studies on absorption of eutectic mixture. I. A comparison of the behavior of eutectic mixture of sulfathiazole and that of ordinary sulfathiazole in man. Chem. Pharm. Bull.9(11), 866–872 (1961).
   Web of Science ®Google Scholar
• Chiou WL , RiegelmanS. Pharmaceutical applications of solid dispersion systems. J. Pharm. Sci.60(9), 1281–1302 (1971).
   PubMed Web of Science ®Google Scholar
• Newman A , KnippG , ZografiG. Assessing the performance of amorphous solid dispersions. J. Pharm. Sci.101(4), 1355–1377 (2012).
   PubMed Web of Science ®Google Scholar
• Prasad D , JainA , GaradS. Oral delivery of poorly soluble drugs. In: Poorly Soluble Drugs. WebsterGK, BellRG, JdJ ( Eds). Taylor & Francis Group, NY, USA, 149–210 (2016).
   Google Scholar
• Serajuddin A . Solid dispersion of poorly water‐soluble drugs: early promises, subsequent problems, and recent breakthroughs. J. Pharm. Sci.88(10), 1058–1066 (1999).
   PubMed Web of Science ®Google Scholar
• Leuner C , DressmanJ. Improving drug solubility for oral delivery using solid dispersions. Eur. J. Pharm. Biopharm.50(1), 47–60 (2000).
   PubMed Web of Science ®Google Scholar
• Vaka S , BommanaM , DesaiD , DjordjevicJ , PhuapraditW , ShahN. Excipients for amorphous solid dispersions. In: Amorphous Solid Dispersions. Advances in Delivery Science and Technology. ShahN, SandhuH, ChoiD, ChokshiH, MalickA ( Eds). Springer, NY, USA, 123–161 (2014).
   Google Scholar
• Allen L , AnselHC. Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems.Lippincott Williams & Wilkins, MD, USA (2013).
   Google Scholar
• Zografi G , NewmanA. Interrelationships between structure and the properties of amorphous solids of pharmaceutical interest. J. Pharm. Sci.106(1), 5–27 (2017).
   PubMed Web of Science ®Google Scholar
• Pudipeddi M , SerajuddinAT , MufsonD. Integrated drug product development – from lead candidate selection to life-cycle management. In: The Process of New Drug Discovery and Development.SmithCG, O'DonnellJT ( Eds). CRC Press, FL, USA, 33–72 (2006).
   Google Scholar
• Vasconcelos T , SarmentoB , CostaP. Solid dispersions as strategy to improve oral bioavailability of poor water soluble drugs. Drug Discov. Today12(23), 1068–1075 (2007).
   PubMed Web of Science ®Google Scholar
• Levy G . Effect of particle size on dissolution and gastrointestinal absorption rates of pharmaceuticals. Am. J. Pharm. Sci. Support. Public Health135, 78–92 (1963).
   PubMedGoogle Scholar
• Goldberg AH , GibaldiM , KanigJL. Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures I: Theoretical considerations and discussion of the literature. J. Pharm. Sci.54(8), 1145–1148 (1965).
   PubMed Web of Science ®Google Scholar
• Goldberg AH , GibaldiM , KanigJL. Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures II: Experimental evaluation of a eutectic mixture: urea‐acetaminophen system. J. Pharm. Sci.55(5), 482–487 (1966).
   Web of Science ®Google Scholar
• Goldberg AH , GibaldiM , KanigJL , MayersohnM. Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures IV: Chloramphenicol urea system. J. Pharm. Sci.55(6), 581–583 (1966).
   PubMed Web of Science ®Google Scholar
• Goldberg A , GibaldiM , KanigJ. Increasing dissolution rates and gastrointestinal absorption of drugs via solid solutions and eutectic mixtures III: Experimental evaluation of griseofulvin—succinic acid solid solution. J. Pharm. Sci.55(5), 487–492 (1966).
   Web of Science ®Google Scholar
• Mishra DK , DhoteV , BhargavaA , JainDK , MishraPK. Amorphous solid dispersion technique for improved drug delivery: basics to clinical applications. Drug Deliv. Transl. Res.5(6), 552–565 (2015).
   PubMed Web of Science ®Google Scholar
• Mohammadi G , HematiV , NikbakhtM-Ret al. In vitro and in vivo evaluation of clarithromycin–urea solid dispersions prepared by solvent evaporation, electrospraying and freeze drying methods. Powder Technol.257, 168–174 (2014).
   Web of Science ®Google Scholar
• Chiou WL , RiegelmanS. Preparation and dissolution characteristics of several fast‐release solid dispersions of griseofulvin. J. Pharm. Sci.58(12), 1505–1510 (1969).
   PubMed Web of Science ®Google Scholar
• Simonelli A , MehtaS , HiguchiW. Dissolution rates of high energy polyvinylpyrrolidone (PVP)‐sulfathiazole coprecipitates. J. Pharm. Sci.58(5), 538–549 (1969).
   PubMed Web of Science ®Google Scholar
• Van Den Mooter G . The use of amorphous solid dispersions: a formulation strategy to overcome poor solubility and dissolution rate. Drug Discov. Today Technol.9(2), e79–e85 (2012).
   Google Scholar
• Van Drooge D , HinrichsW , VisserM , FrijlinkH. Characterization of the molecular distribution of drugs in glassy solid dispersions at the nano-meter scale, using differential scanning calorimetry and gravimetric water vapour sorption techniques. Int. J. Pharm.310(1), 220–229 (2006).
   PubMedGoogle Scholar
• Qi S , BeltonP , NollenbergerK , ClaydenN , ReadingM , CraigDQ. Characterisation and prediction of phase separation in hot-melt extruded solid dispersions: a thermal, microscopic and NMR relaxometry study. Pharm. Res.27(9), 1869–1883 (2010).
   PubMed Web of Science ®Google Scholar
• Vasanthavada M , TongW-Q , JoshiY , KislaliogluMS. Phase behavior of amorphous molecular dispersions I: determination of the degree and mechanism of solid solubility. Pharm. Res.21(9), 1598–1606 (2004).
   PubMed Web of Science ®Google Scholar
• Konno H , HandaT , AlonzoDE , TaylorLS. Effect of polymer type on the dissolution profile of amorphous solid dispersions containing felodipine. Eur. J. Pharm. Biopharm.70(2), 493–499 (2008).
   PubMed Web of Science ®Google Scholar
• Marsac PJ , LiT , TaylorLS. Estimation of drug–polymer miscibility and solubility in amorphous solid dispersions using experimentally determined interaction parameters. Pharm. Res.26(1), 139 (2009).
   PubMed Web of Science ®Google Scholar
• Rumondor AC , IvanisevicI , BatesS , AlonzoDE , TaylorLS. Evaluation of drug-polymer miscibility in amorphous solid dispersion systems. Pharm. Res.26(11), 2523–2534 (2009).
   PubMed Web of Science ®Google Scholar
• Sun Y , TaoJ , ZhangGG , YuL. Solubilities of crystalline drugs in polymers: an improved analytical method and comparison of solubilities of indomethacin and nifedipine in PVP, PVP/VA, and PVAc. J. Pharm. Sci.99(9), 4023–4031 (2010).
   PubMed Web of Science ®Google Scholar
• Lin D , HuangY. A thermal analysis method to predict the complete phase diagram of drug–polymer solid dispersions. Int. J. Pharm.399(1-2), 109–115 (2010).
   PubMedGoogle Scholar
• Qian F , HuangJ , ZhuQet al. Is a distinctive single Tg a reliable indicator for the homogeneity of amorphous solid dispersion? Int. J. Pharm. 395(1-2), 232–235 (2010).
   PubMedGoogle Scholar
• Zhao Y , InbarP , ChokshiHP , MalickAW , ChoiDS. Prediction of the thermal phase diagram of amorphous solid dispersions by Flory–Huggins theory. J. Pharm. Sci.100(8), 3196–3207 (2011).
   PubMed Web of Science ®Google Scholar
• Hallouard F , MehenniL , Lahiani-SkibaM , AnouarY , SkibaM. Solid dispersions for oral administration: an overview of the methods for their preparation. Curr. Pharm. Des.22(32), 4942–4958 (2016).
   PubMed Web of Science ®Google Scholar
• Kim K-T , LeeJ-Y , LeeM-Y , SongC-K , ChoiJ-H , KimD-D. Solid dispersions as a drug delivery system. J. Pharm. Investig.41(3), 125–142 (2011).
   Google Scholar
• Vo CL-N , ParkC , LeeB-J. Current trends and future perspectives of solid dispersions containing poorly water-soluble drugs. Eur. J. Pharm. Biopharm.85(3), 799–813 (2013).
   PubMed Web of Science ®Google Scholar
• Singh N , MkS. Solid dispersion-a novel approach for enhancement of bioavailability of poorly soluble drugs in oral drug delivery system. Glob. J. Pharmaceu. Sci.3(2), 17 (2017).
   Google Scholar
• Suzuki H , YakushijiK , MatsunagaSet al. Amorphous solid dispersion of meloxicam enhanced oral absorption in rats with impaired gastric motility. J. Pharm. Sci.107(1), 446–452 (2018).
   PubMed Web of Science ®Google Scholar
• Apiwongngam J , LimwikrantW , JintapattanakitA , JaturanpinyoM. Enhanced supersaturation of chlortetracycline hydrochloride by amorphous solid dispersion. J. Drug Deliv. Sci. Technol.47, 417–426 (2018).
   Web of Science ®Google Scholar
• Figueirêdo CBM , NadvornyD , VieiraACQDMet al. Enhanced delivery of fixed-dose combination of synergistic antichagasic agents posaconazole-benznidazole based on amorphous solid dispersions. Eur. J. Pharm. Sci.119, 208–218 (2018).
   PubMed Web of Science ®Google Scholar
• Dannenfelser RM , HeH , JoshiY , BatemanS , SerajuddinAT. Development of clinical dosage forms for a poorly water soluble drug I: application of polyethylene glycol–polysorbate 80 solid dispersion carrier system. J. Pharm. Sci.93(5), 1165–1175 (2004).
   PubMed Web of Science ®Google Scholar
• Ghebremeskel AN , VemavarapuC , LodayaM. Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: stability testing of selected solid dispersions. Pharm. Res.23(8), 1928–1936 (2006).
   PubMed Web of Science ®Google Scholar
• Pouton CW . Formulation of poorly water-soluble drugs for oral administration: physicochemical and physiological issues and the lipid formulation classification system. Eur. J. Pharm. Sci.29(3-4), 278–287 (2006).
   PubMed Web of Science ®Google Scholar
• Saffoon N , UddinR , HudaNH , SutradharKB. Enhancement of oral bioavailability and solid dispersion: a review. J. Appl. Pharm. Sci.1(7), 13–20 (2011).
   Google Scholar
• Kapoor B , KaurR , KourS , BehlH , KourS. Solid dispersion: an evolutionary approach for solubility enhancement of poorly water soluble drugs. Int. J. Recent Adv. Pharm. Res.2, 1–16 (2012).
   Google Scholar
• Tambe A , PanditaN. Enhanced solubility and drug release profile of boswellic acid using a poloxamer-based solid dispersion technique. J. Drug Deliv. Sci. Technol.44, 172–180 (2018).
   Web of Science ®Google Scholar
• Khatri P , ShahMK , PatelN , JainS , VoraN , LinS. Preparation and characterization of pyrimethamine solid dispersions and an evaluation of the physical nature of pyrimethamine in solid dispersions. J. Drug Deliv. Sci. Technol.45, 110–123 (2018).
   Web of Science ®Google Scholar
• Jiménez De Los Santos CJ , Pérez-MartínezJI , Gómez-PantojaME , MoyanoJR. Enhancement of albendazole dissolution properties using solid dispersions with Gelucire 50/13 and PEG 15000. J. Drug Deliv. Sci. Technol.42, 261–272 (2017).
   Web of Science ®Google Scholar
• Tran TT-D , TranPH-L , LimJ , ParkJB , ChoiS-K , LeeB-J. Physicochemical principles of controlled release solid dispersion containing a poorly water-soluble drug. Ther. Deliv.1(1), 51–62 (2010).
   PubMedGoogle Scholar
• Guo S , WangG , WuT , BaiF , XuJ , ZhangX. Solid dispersion of berberine hydrochloride and Eudragit® S100: formulation, physicochemical characterization and cytotoxicity evaluation. J. Drug Deliv. Sci. Technol.40, 21–27 (2017).
   Web of Science ®Google Scholar
• Shamma RN , BashaM. Soluplus®: A novel polymeric solubilizer for optimization of carvedilol solid dispersions: formulation design and effect of method of preparation. Powder Technol.237, 406–414 (2013).
   Web of Science ®Google Scholar
• Craig DQ . The mechanisms of drug release from solid dispersions in water-soluble polymers. Int. J. Pharm.231(2), 131–144 (2002).
   PubMed Web of Science ®Google Scholar
• Noyes AA , WhitneyWR. The rate of solution of solid substances in their own solutions. J. Am. Chem. Soc.19(12), 930–934 (1897).
   Google Scholar
• Nernst W . Theorie der reaktionsgeschwindigkeit in heterogenen systemen. Z. Phys. Chem.47(1), 52–55 (1904).
   Google Scholar
• Higuchi W , MirN , DesaiS. Dissolution rates of polyphase mixtures. J. Pharm. Sci.54(10), 1405–1410 (1965).
   PubMed Web of Science ®Google Scholar
• Fernández-Colino A , BermudezJ , AriasF , QuinterosD , GonzoE. Development of a mechanism and an accurate and simple mathematical model for the description of drug release: application to a relevant example of acetazolamide-controlled release from a bio-inspired elastin-based hydrogel. Mater. Sci. Eng. C Mater. Biol. Appl.61, 286–292 (2016).
   PubMed Web of Science ®Google Scholar
• Romero AI , VillegasM , CidAG , ParentisML , GonzoEE , BermúdezJM. Validation of kinetic modeling of progesterone release from polymeric membranes. Asian J. Pharm. Sci.31(1), 54–62 (2017).
   Google Scholar
• Simonazzi A , CidAG , ParedesAJet al. Development and in vitro evaluation of solid dispersions as strategy to improve albendazole biopharmaceutical behavior. Ther. Deliv.9(9), 623–638 (2018).
   PubMed Web of Science ®Google Scholar
• Simonazzi A , DaviesC , CidAG , GonzoE , ParadaL , BermúdezJM. Preparation and characterization of Poloxamer 407 solid dispersions as an alternative strategy to improve benznidazole bioperformance. J. Pharm. Sci.9(9), 623–638 (2018).
   Google Scholar
• Hurter P , ThomasH , NadigD , Embiata-SmithD , PaoneA. Implementing continuous manufacturing to streamline and accelerate drug development. AAPS Newsmagazine16, 15–19 (2013).
   PubMed Web of Science ®Google Scholar
• Schaber SD , GerogiorgisDI , RamachandranR , EvansJMB , BartonPI , TroutBL. Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study. Ind. Eng. Chem. Res.50(17), 10083–10092 (2011).
   Web of Science ®Google Scholar
• Bley H , FussneggerB , BodmeierR. Characterization and stability of solid dispersions based on PEG/polymer blends. Int. J. Pharm.390(2), 165–173 (2010).
   PubMed Web of Science ®Google Scholar
• Li F-Q , HuJ-H , DengJ-X , SuH , XuS , LiuJ-Y. In vitro controlled release of sodium ferulate from Compritol 888 ATO-based matrix tablets. Int. J. Pharm.324(2), 152–157 (2006).
   PubMedGoogle Scholar
• Yao W-W , BaiT-C , SunJ-P , ZhuC-W , HuJ , ZhangH-L. Thermodynamic properties for the system of silybin and poly (ethylene glycol) 6000. Thermochim. Acta437(1-2), 17–20 (2005).
   Web of Science ®Google Scholar
• Timko RJ , LordiNG. Thermal characterization of citric acid solid dispersions with benzoic acid and phenobarbital. J. Pharm. Sci.68(5), 601–605 (1979).
   PubMed Web of Science ®Google Scholar
• Emås M , NyqvistH. Methods of studying aging and stabilization of spray-congealed solid dispersions with carnauba wax. 1. Microcalorimetric investigation. Int. J. Pharm.197(1), 117–127 (2000).
   PubMedGoogle Scholar
• Hurley D , PotterCB , WalkerGM , HigginbothamCL. Investigation of ethylene oxide-co-propylene oxide for dissolution enhancement of hot-melt extruded solid dispersions. J. Pharm. Sci.doi:https://doi.org/10.1016/j.xphs.2018.01.016 (2018). (Epub ahead of print).
   PubMedGoogle Scholar
• Breitenbach J . Melt extrusion: from process to drug delivery technology. Eur. J. Pharm. Biopharm.54(2), 107–117 (2002).
   PubMed Web of Science ®Google Scholar
• Seo A , HolmP , KristensenHG , SchæferT. The preparation of agglomerates containing solid dispersions of diazepam by melt agglomeration in a high shear mixer. Int. J. Pharm.259(1–2), 161–171 (2003).
   PubMedGoogle Scholar
• Crowley MM , ZhangF , RepkaMAet al. Pharmaceutical applications of hot-melt extrusion: part I. Drug Dev. Ind. Pharm.33(9), 909–926 (2007).
   PubMed Web of Science ®Google Scholar
• Follonier N , DoelkerE , ColeET. Various ways of modulating the release of diltiazem hydrochloride from hot-melt extruded sustained release pellets prepared using polymeric materials. J. Control. Rel.36(3), 243–250 (1995).
   Web of Science ®Google Scholar
• Andrews GP , JonesDS , DiakOA , MccoyCP , WattsAB , McginityJW. The manufacture and characterisation of hot-melt extruded enteric tablets. Eur. J. Pharm. Biopharm.69(1), 264–273 (2008).
   PubMed Web of Science ®Google Scholar
• Doelker E . Cellulose derivatives. In: Biopolymers I. Advances in Polymer Science. LangerRS, PeppasNA ( Eds). Springer, Heidelberg, Berlin, 199–265 (1993).
   Google Scholar
• Todd DB . Introduction to compounding. In: Plastics Compounding, Equipment and Processing.ToddDB ( Ed.). Hanser Gardner Publications, OH, USA (1998).
   Google Scholar
• Gurunath S , KumarSP , BasavarajNK , PatilPA. Amorphous solid dispersion method for improving oral bioavailability of poorly water-soluble drugs. J. Pharm. Res.6(4), 476–480 (2013).
   Google Scholar
• Desai J , AlexanderK , RigaA. Characterization of polymeric dispersions of dimenhydrinate in ethyl cellulose for controlled release. Int. J. Pharm.308(1), 115–123 (2006).
   PubMedGoogle Scholar
• Yoshihashi Y , IijimaH , YonemochiE , TeradaK. Estimation of physical stability of amorphous solid dispersion using differential scanning calorimetry. J. Therm. Anal. Calorim.85(3), 689–692 (2006).
   Web of Science ®Google Scholar
• Sammour OA , HammadMA , MegrabNA , ZidanAS. Formulation and optimization of mouth dissolve tablets containing rofecoxib solid dispersion. AAPS PharmSciTech.7(2), E167–E175 (2006).
   Web of Science ®Google Scholar
• Huo T , TaoC , ZhangMet al. Preparation and comparison of tacrolimus-loaded solid dispersion and self-microemulsifying drug delivery system by in vitro/in vivo evaluation. Eur. J. Pharm. Sci.114, 74–83 (2018).
   PubMed Web of Science ®Google Scholar
• Adeli E . The use of spray freeze drying for dissolution and oral bioavailability improvement of azithromycin. Powder Technol.319, 323–331 (2017).
   Web of Science ®Google Scholar
• Mann AKP , SchenckL , KoynovAet al. Producing amorphous solid dispersions via co-precipitation and spray drying: impact to physicochemical and biopharmaceutical properties. J. Pharm. Sci.107(1), 183–191 (2018).
   PubMed Web of Science ®Google Scholar
• Overhoff KA , MorenoA , MillerDA , JohnstonKP , WilliamsRO. Solid dispersions of itraconazole and enteric polymers made by ultra-rapid freezing. Int. J. Pharm.336(1), 122–132 (2007).
   PubMed Web of Science ®Google Scholar
• Yang G , ZhaoY , FengN , ZhangY , LiuY , DangB. Improved dissolution and bioavailability of silymarin delivered by a solid dispersion prepared using supercritical fluids. Asian J. Pharm. Sci.10(3), 194–202 (2015).
   Web of Science ®Google Scholar
• Paudel A , WorkuZA , MeeusJ , GunsS , VanDen Mooter G. Manufacturing of solid dispersions of poorly water soluble drugs by spray drying: formulation and process considerations. Int. J. Pharm.453(1), 253–284 (2013).
   PubMed Web of Science ®Google Scholar
• Bikiaris DN . Solid dispersions, Part I: recent evolutions and future opportunities in manufacturing methods for dissolution rate enhancement of poorly water-soluble drugs. Expert Opin. Drug Deliv.8(11), 1501–1519 (2011).
   PubMed Web of Science ®Google Scholar
• Abuzar SM , HyunS-M , KimJ-Het al. Enhancing the solubility and bioavailability of poorly water-soluble drugs using supercritical antisolvent (SAS) process. Int. J. Pharm.538(1), 1–13 (2018).
   PubMedGoogle Scholar
• Momenkiaei F , RaofieF. Preparation of Curcuma Longa L. extract nanoparticles using supercritical solution expansion. J. Pharm. Sci.108(4), 1581–1589 (2019).
   PubMed Web of Science ®Google Scholar
• Wu K , LiJ , WangW , WinsteadDA. Formation and characterization of solid dispersions of piroxicam and polyvinylpyrrolidone using spray drying and precipitation with compressed antisolvent. J. Pharm. Sci.98(7), 2422–2431 (2009).
   PubMed Web of Science ®Google Scholar
• Muhrer G , MeierU , FusaroF , AlbanoS , MazzottiM. Use of compressed gas precipitation to enhance the dissolution behavior of a poorly water-soluble drug: Generation of drug microparticles and drug–polymer solid dispersions. Int. J. Pharm.308(1), 69–83 (2006).
   PubMedGoogle Scholar
• Pestieau A , KrierF , LebrunP , BrouwersA , StreelB , EvrardB. Optimization of a PGSS (particles from gas saturated solutions) process for a fenofibrate lipid-based solid dispersion formulation. Int. J. Pharm.485(1), 295–305 (2015).
   PubMedGoogle Scholar
• Juppo AM , BoissierC , KhooC. Evaluation of solid dispersion particles prepared with SEDS. Int. J. Pharm.250(2), 385–401 (2003).
   PubMedGoogle Scholar
• Varshosaz J , HassanzadehF , MahmoudzadehM , SadeghiA. Preparation of cefuroxime axetil nanoparticles by rapid expansion of supercritical fluid technology. Powder Technol.189(1), 97–102 (2009).
   Web of Science ®Google Scholar
• Pathak P , MezianiMJ , DesaiT , SunY-P. Nanosizing drug particles in supercritical fluid processing. J. Am. Chem. Soc.126(35), 10842–10843 (2004).
   PubMed Web of Science ®Google Scholar
• Reverchon E , DeMarco I , DellaPorta G. Rifampicin microparticles production by supercritical antisolvent precipitation. Int. J. Pharm.243(1-2), 83–91 (2002).
   PubMedGoogle Scholar
• Lee S , NamK , KimMSet al. Preparation and characterization of solid dispersions of itraconazole by using aerosol solvent extraction system for improvement in drug solubility and bioavailability. Arch. Pharm. Res.28(7), 866–874 (2005).
   PubMed Web of Science ®Google Scholar
• Kalogiannis CG , PavlidouE , PanayiotouCG. Production of amoxicillin microparticles by supercritical antisolvent precipitation. Ind. Eng. Chem. Res.44(24), 9339–9346 (2005).
   Web of Science ®Google Scholar
• Crawford DE . Extrusion–back to the future: using an established technique to reform automated chemical synthesis. Beilstein J. Org. Chem.13(1), 65–75 (2017).
   PubMedGoogle Scholar
• Chen G-L , HaoW-H. Factors affecting zero-order release kinetics of porous gelatin capsules. Drug Dev. Ind. Pharm.24(6), 557–562 (1998).
   PubMed Web of Science ®Google Scholar
• Johnson DM , TaylorWF. Degradation of fenprostalene in polyethylene glycol 400 solution. J. Pharm. Sci.73(10), 1414–1417 (1984).
   PubMed Web of Science ®Google Scholar
• Guillaume F , Guyot-HermannA , DuclosRet al. Elaboration and physical study of an oxodipine solid dispersion in order to formulate tablets. Drug Dev. Ind. Pharm.18(8), 811–827 (1992).
   Web of Science ®Google Scholar
• Suzuki H , SunadaH. Some factors influencing the dissolution of solid dispersions with nicotinamide and hydroxypropylmethylcellulose as combined carriers. Chem. Pharm. Bull.46(6), 1015–1020 (1998).
   Web of Science ®Google Scholar
• Johari G , KimS , ShankerRM. Dielectric studies of molecular motions in amorphous solid and ultraviscous acetaminophen. J. Pharm. Sci.94(10), 2207–2223 (2005).
   PubMed Web of Science ®Google Scholar
• Pokharkar VB , MandpeLP , PadamwarMN , AmbikeAA , MahadikKR , ParadkarA. Development, characterization and stabilization of amorphous form of a low Tg drug. Powder Technol.167(1), 20–25 (2006).
   Web of Science ®Google Scholar
• Chiou WL . Pharmaceutical applications of solid dispersion systems: x‐ray diffraction and aqueous solubility studies on griseofulvin‐polyethylene glycol 6000 systems. J. Pharm. Sci.66(7), 989–991 (1977).
   PubMed Web of Science ®Google Scholar
• Bhugra C , PikalMJ. Role of thermodynamic, molecular, and kinetic factors in crystallization from the amorphous state. J. Pharm. Sci.97(4), 1329–1349 (2008).
   PubMed Web of Science ®Google Scholar
• Aso Y , YoshiokaS , KojimaS. Molecular mobility‐based estimation of the crystallization rates of amorphous nifedipine and phenobarbital in poly (vinylpyrrolidone) solid dispersions. J. Pharm. Sci.93(2), 384–391 (2004).
   PubMed Web of Science ®Google Scholar
• Zhou D , GrantDJ , ZhangGG , LawD , SchmittEA. A calorimetric investigation of thermodynamic and molecular mobility contributions to the physical stability of two pharmaceutical glasses. J. Pharm. Sci.96(1), 71–83 (2007).
   PubMed Web of Science ®Google Scholar
• Meng F , GalaU , ChauhanH. Classification of solid dispersions: correlation to (i) stability and solubility (ii) preparation and characterization techniques. Drug Dev. Ind. Pharm.41(9), 1401–1415 (2015).
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration, New Drug Application (NDA) (2019). www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/
   Google Scholar
• Bhatnagar P , DhoteV , ChandraMahajan S , KumarMishra P , KumarMishra D. Solid dispersion in pharmaceutical drug development: from basics to clinical applications. Curr. Drug Deliv.11(2), 155–171 (2014).
   PubMed Web of Science ®Google Scholar
• Newman A , NagapudiK , WenslowR. Amorphous solid dispersions: a robust platform to address bioavailability challenges. Ther. Deliv.6(2), 247–261 (2015).
   PubMed Web of Science ®Google Scholar