References
- Ciurzyńska A, Lenart A. Freeze-drying application in food processing and biotechnology – a review. Pol J Food Nutr Sci. 2011;61:165–171.
- Franks F. Historical background. In: Franks F, editor. Freeze-drying of pharmaceuticals and biopharmaceuticals: principles and practice. The Royal Society of Chemistry; 2007. p. 1–12.
- Smith T. A history of lyophilization in pharmaceutical applications. North Olmsted (OH): Advanstar Communications; 2004. p. 44–49.
- De Beer TRM, Wiggenhorn M, Hawe A, et al. Optimization of a pharmaceutical freeze-dried product and its process using an experimental design approach and innovative process analyzers. Talanta. 2011;83:1623–1633.
- Kasper JC, Winter G, Friess W. Recent advances and further challenges in lyophilization. Eur J Pharm Biopharm. 2013;85:162–169.
- Patel S, Pikal MJ. Emerging freeze-drying process development and scale-up issues. AAPS PharmSciTech. 2011;12:372–378.
- Chongprasert S. Influence of drug polymorphism on the physical chemistry of freeze-drying. PhD [dissertation]. West Lafayette (IN): Purdue University; 1998. Available from: ProQuest Dissertations Publishing.
- Baheti A, Kumar L, Bansal AK. Excipients used in lyophilization of small molecules. J Excip Food Chem. 2010;1:41–54.
- Pikal MJ. Freeze-drying of proteins: process, formulation, and stability. In: Cleland JL, Langer R, editors. Formulation and delivery of proteins and peptides. Washington (DC): American Chemical Society; 1994. p. 120–133.
- Franks F. Freeze-drying of bioproducts: putting principles into practice. Eur J Pharm Biopharm. 1998;45:221–229.
- Morais AR, Alencar ÉN, Xavier Júnior FH, et al. Freeze-drying of emulsified systems: a review. Int J Pharm. 2016;503:102–114.
- Nail SL, Gatlin LA. Freeze-drying: principles and practice. In: Nema S, Ludwig JD, editors. Pharmaceutical dosage forms: parenteral medications. Vol 2. New York (NY): Marcel Dekker; 2010. p. 353–381.
- Pyne A. Phase transitions during freeze-drying: influence of processing conditions and formulation variables. PhD [dissertation]. Minneapolis (MN): University of Minnesota Twin Cities; 2001. Available from: ProQuest Dissertations Publishing.
- Habib YS, Augsburger LL, Shangraw RF. Production of inert cushioning beads: effect of excipients on the physicomechanical properties of freeze-dried beads containing microcrystalline cellulose produced by extrusion–spheronization. Int J Pharm. 2002;233:67–83.
- Lai F, Pini E, Corrias F, et al. Formulation strategy and evaluation of nanocrystal piroxicam orally disintegrating tablets manufacturing by freeze-drying. Int J Pharm. 2014;467:27–33.
- Liu J, Viverette T, Virgin M, et al. A study of the impact of freezing on the lyophilization of a concentrated formulation with a high fill depth. Pharm Dev Technol. 2005;10:261–272.
- Matthews KH. Freeze-drying of shaped pharmaceutical dosage forms. Eur Ind Pharm. 2009;9–11.
- Scoffin K Lyophilisation: the truth. Pharmaceutical Manufacturing and Packing Sourcer; 2013 [cited 2015 May 25]. Available from: http://www.samedanltd.com/magazine/15/issue/202/article/3608
- Hibler S, Gieseler H. Heat transfer characteristics of current primary packaging systems for pharmaceutical freeze-drying. J Pharm Sci. 2012;101:4025–4031.
- Searles JA, Carpenter JF, Randolph TW. The ice nucleation temperature determines the primary drying rate of lyophilization for samples frozen on a temperature-controlled shelf. J Pharm Sci. 2001;90:860–871.
- Geidobler R, Winter G. Controlled ice nucleation in the field of freeze-drying: fundamentals and technology review. Eur J Pharm Biopharm. 2013;85:214–222.
- Rambhatla S, Ramot R, Bhugra C, et al. Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling. AAPS PharmSciTech. 2004;5:54–62.
- Kasper JC, Friess W. The freezing step in lyophilization: physico-chemical fundamentals, freezing methods and consequences on process performance and quality attributes of biopharmaceuticals. Eur J Pharm Biopharm. 2011;78:248–263.
- Liu J. Physical characterization of pharmaceutical formulations in frozen and freeze-dried solid states: techniques and applications in freeze-drying development. Pharm Dev Technol. 2006;11:3–28.
- Rambhatla S. Heat and mass transfer scale-up issues during freeze-drying. PhD [dissertation]. Storrs (CT): University of Connecticut; 2003. Available from: ProQuest Dissertations Publishing.
- Rambhatla S, Pikal MJ. Heat and mass transfer in freeze-drying process development. In: Lyophilization of biopharmaceuticals. Arlington (VA): American Association of Pharmaceutical Scientists; 2005. p. 75–110.
- Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm. 2000;203:1–60.
- Considine DM, Considine GD. Freeze-drying. In: Considine DM, editor. Van Nostrand’s scientific encyclopedia. Boston (MA): Springer; 1995. p. 1197–1386.
- Pikal MJ. Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze drying. PDA J Pharm Sci Tech. 1985;39:115–139.
- Carpenter JF, Pikal MJ, Chang BS, et al. Rational design of stable lyophilized protein formulations: some practical advice. Pharm Res. 1997;14:969–975.
- Date PV, Samad A, Devarajan PV. Freeze thaw: a simple approach for prediction of optimal cryoprotectant for freeze drying. AAPS PharmSciTech. 2010;11:304–313.
- McLoughlin CM, McMinn WAM, Magee TRA. Microwave-vacuum drying of pharmaceutical powders. Drying Technol. 2003;21:1719–1733.
- Jangle RD, Pisal SS. Vacuum foam drying: an alternative to lyophilization for biomolecule preservation. Indian J Pharm Sci. 2012;74:91–100.
- Tong HHY, Du Z, Wang GN, et al. Spray freeze drying with polyvinylpyrrolidone and sodium caprate for improved dissolution and oral bioavailability of oleanolic acid, a BCS class IV compound. Int J Pharm. 2011;404:148–158.
- Wanning S, Süverkrüp R, Lamprecht A. Pharmaceutical spray freeze drying. Int J Pharm. 2015;488:136–153.
- Williams R, Johnston K, Young T, et al. Process for production of nanoparticles and microparticles by spray freezing into liquid. US6862890. 2005.
- Hu J, Johnston KP, Williams RO. Spray freezing into liquid particle engineering technology to enhance dissolution of poorly water soluble drugs: organic solvent versus organic/aqueous co-solvent systems. Eur J Pharm Sci. 2003;20:295–303.
- Overhoff KA, Engstrom JD, Chen B, et al. Novel ultra-rapid freezing particle engineering process for enhancement of dissolution rates of poorly water-soluble drugs. Eur J Pharm Biopharm. 2007;65:57–67.
- Zhang M, Li H, Lang B, et al. Formulation and delivery of improved amorphous fenofibrate solid dispersions prepared by thin film freezing. Eur J Pharm Biopharm. 2012;82:534–544.
- Claussen IC, Ustad TS, Stømmen I, et al. Atmospheric freeze-drying – a review. Drying Technol. 2007;25:947–957.
- Sreekhar C, Chambliss WG, Wyandt CM. A novel freeze pelletization technique for preparing matrix pellets. Pharm Technol. 2004;28:98–110.
- Yang W, Owens DE, Williams RO. Pharmaceutical cryogenic technologies. In: Williams RO, Watts AB, Miller DA, editors. Formulating poorly water soluble drugs. Arlington (VA): American Association of Pharmaceutical Scientists; 2012. p. 443–500.
- De Waard H, Hinrichs WLJ, Visser MR, et al. Unexpected differences in dissolution behavior of tablets prepared from solid dispersions with a surfactant physically mixed or incorporated. Int J Pharm. 2008;349:66–73.
- Elgindy N, Elkhodairy K, Molokhia A, et al. Lyophilization monophase solution technique for improvement of the physicochemical properties of an anticancer drug, flutamide. Eur J Pharm Biopharm. 2010;74:397–405.
- Moes JJ, Koolen SLW, Huitema ADR, et al. Pharmaceutical development and preliminary clinical testing of an oral solid dispersion formulation of docetaxel (ModraDoc001). Int J Pharm. 2011;420:244–250.
- Ansari MT, Karim S, Ranjha NM, et al. Physicochemical characterization of artemether solid dispersions with hydrophilic carriers by freeze dried and melt methods. Arch Pharm Res. 2010;33:901–910.
- Ansari MT, Hussain A, Nadeem S, et al. Preparation and characterization of solid dispersions of artemether by freeze-dried method. BioMed Res Int. 2015;2015:1–11.
- Elgindy N, Elkhodairy K, Molokhia A, et al. Lyophilization monophase solution technique for preparation of amorphous flutamide dispersions. Drug Dev Ind Pharm. 2011;37:754–764.
- Bandarkar FS, Khattab IS. Lyophilized gliclazide-poloxamer solid dispersions for enhancement of in vitro dissolution and in vivo bioavailability. J Pharm Sci. 2011;3:122–127.
- Emara LH, Badr RM, Elbary AA. Improving the dissolution and bioavailability of nifedipine using solid dispersions and solubilizers. Drug Dev Ind Pharm. 2002;28:795–807.
- Xu W-J, Xie H-J, Cao Q-R, et al. Enhanced dissolution and oral bioavailability of valsartan solid dispersions prepared by a freeze-drying technique using hydrophilic polymers. Drug Deliv. 2016;23:41–48.
- Van Drooge DJ, Hinrichs WLJ, Frijlink HW. Incorporation of lipophilic drugs in sugar glasses by lyophilization using a mixture of water and tertiary butyl alcohol as solvent. J Pharm Sci. 2004;93:713–725.
- De Waard H, De Beer T, Hinrichs WLJ, et al. Controlled crystallization of the lipophilic drug fenofibrate during freeze-drying: elucidation of the mechanism by in-line raman spectroscopy. Aaps J. 2010;12:569–575.
- De Waard H, Hinrichs WLJ, Frijlink HW. A novel bottom–up process to produce drug nanocrystals: controlled crystallization during freeze-drying. J Control Release. 2008;128:179–183.
- Lee J, Cheng Y. Critical freezing rate in freeze drying nanocrystal dispersions. J Control Release. 2006;111:185–192.
- Dixit M, Kulkarni PK. Lyophilization monophase solution technique for improvement of the solubility and dissolution of piroxicam. Res Pharm Sci. 2012;7:13.
- Ekenlebie EP. Pharmaceutical process optimisation of bulk lyophilisates: implications of powder handling. PhD [dissertation]. Birmingham: Aston University; 2014. Available from: Aston Research Explorer.
- Builders PF, Bonaventure AM, Tiwalade A, et al. Novel multifunctional pharmaceutical excipients derived from microcrystalline cellulose–starch microparticulate composites prepared by compatibilized reactive polymer blending. Int J Pharm. 2010;388:159–167.
- Al-Khattawi A, Mohammed AR. Compressed orally disintegrating tablets: excipients evolution and formulation strategies. Expert Opin Drug Deliv. 2013;10:651–663.
- Ngwuluka NC, Nep EI, Ochekpe NA, et al. Eudragit E100 and polysaccharide polymer blends as matrices for modified-release drug delivery I: physicomechanical properties. Trop J Pharm Res. 2015;14:2155–2162.
- Yoon H-S, Kweon D-K, Lim S-T. Effects of drying process for amorphous waxy maize starch on theophylline release from starch-based tablets. J Appl Polym Sci. 2007;105:1908–1913.
- Jeong SH, Fu Y, Park K. Frosta®: a new technology for making fast-melting tablets. Expert Opin Drug Deliv. 2005;2:1107–1116.
- Sugimoto M, Maejima T, Narisawa S, et al. Factors affecting the characteristics of rapidly disintegrating tablets in the mouth prepared by the crystalline transition of amorphous sucrose. Int J Pharm. 2005;296:64–72.
- Sugimoto M, Matsubara K, Koida Y, et al. The preparation of rapidly disintegrating tablets in the mouth. Pharm Dev Technol. 2001;6:487–493.
- Alanazi FK. Evaluation of spray and freeze dried excipient bases containing disintegration accelerators for the formulation of metoclopramide orally disintegrating tablets. Saudi Pharm J. 2007;15:105–119.
- Abdul S, Chandewar AV, Jaiswal SB. A flexible technology for modified-release drugs: multiple-unit pellet system (MUPS). J Control Release. 2010;147:2–16.
- Balaxi M, Nikolakakis I, Malamataris S. Preparation of porous microcrystalline cellulose pellets by freeze-drying: effects of wetting liquid and initial freezing conditions. J Pharm Sci. 2010;99:2104–2113.
- Bashaiwoldu AB, Podczeck F, Newton JM. A study on the effect of drying techniques on the mechanical properties of pellets and compacted pellets. Eur J Pharm Sci. 2004;21:119–129.
- Gómez-Carracedo A, Souto C, Martínez-Pacheco R, et al. Incidence of drying on microstructure and drug release profiles from tablets of MCC–lactose–Carbopol® and MCC–dicalcium phosphate–Carbopol® pellets. Eur J Pharm Biopharm. 2008;69:675–685.
- Wlosnewski JC, Kumpugdee-Vollrath M, Sriamornsak P. Effect of drying technique and disintegrant on physical properties and drug release behavior of microcrystalline cellulose-based pellets prepared by extrusion/spheronization. Chem Eng Res Des. 2010;88:100–108.
- Onofre FO, Wang YJ. Sustained release properties of crosslinked and substituted starches. J Appl Polym Sci. 2010;117:1558–1565.
- Ma C, Prabhu S. Characterization of a novel lyophilized chitosan hydrogel complex for the controlled release of a highly water soluble drug, niacinamide. Int J Drug Deliv. 2011;3:55–63.
- Te Wierik GHP, Bergsma J, Arends-Scholte AW, et al. A new generation of starch products as excipient in pharmaceutical tablets. I. Preparation and binding properties of high surface area potato starch products. Int J Pharm. 1996;134:27–36.
- Odeku OA, Schmid W, Picker-Freyer KM. Material and tablet properties of pregelatinized (thermally modified) dioscorea starches. Eur J Pharm Biopharm. 2008;70:357–371.
- Odeku OA, Picker-Freyer KM. Freeze-dried pregelatinized dioscorea starches as tablet matrix for sustained release. J Excip Food Chem. 2010;1:21–32.
- Ngwuluka NC, Nep EI, Ochekpe NA, et al. Eudragit E100 and polysaccharide polymer blends as matrices for modified-release drug delivery II: swelling and release studies. Trop J Pharm Res. 2015;14:2163–2170.
- Risbud MV, Hardikar AA, Bhat SV, et al. pH-sensitive freeze-dried chitosan–polyvinyl pyrrolidone hydrogels as controlled release system for antibiotic delivery. J Control Release. 2000;68:23–30.
- Melia CD, Timmins P. Natural polysaccharides in hydrophilic matrices. In: Timmins P, Pygall SR, Melia CD, editors. Hydrophilic matrix tablets for oral controlled release. New York (NY): Springer; 2014. p. 87–122.
- Sánchez L, Torrado S, Lastres J. Gelatinized/freeze-dried starch as excipient in sustained release tablets. Int J Pharm. 1995;115:201–208.
- Choi MJ, Briançona S, Andrieua J, et al. Effect of freeze-drying process conditions on the stability of nanoparticles. Drying Technol. 2004;22:335–346.
- Patil VV, Dandekar PP, Patravale VB, et al. Freeze drying: potential for powdered nanoparticulate product. Drying Technol. 2010;28:624–635.
- Sonaje K, Chen Y-J, Chen H-L, et al. Enteric-coated capsules filled with freeze-dried chitosan/poly(γ-glutamic acid) nanoparticles for oral insulin delivery. Biomaterials. 2010;31:3384–3394.
- Jeong SH, Lee J, Woo JS Fast disintegrating tablets. In: Wen H, Park K, editors. Oral controlled release formulation design and drug delivery. Hoboken (NJ): John Wiley & Sons; 2010. p. 155–167.
- Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol. 1998;50:375–382.
- Gole DJ, Levinson RS, Wilkinson PK, et al. Pharmaceutical and other dosage forms. US5648093I. 1997.
- Lafon L Galenic form for oral administration and its method of preparation by lyophilization of an oil-in-water emulsion. US4616047. 1986.
- Bauer KH. A partially freeze-dried lyophilization technology for producing fast-melting tablets. Pharm Technol Eur. 2007;19:63–69.
- Gole DJ, Levinson RS, Davies JD, et al. Preparation of pharmaceutical and other matrix systems by solid-state dissolution. WO1991009591I. 1991.
- Lundegaard AR, Lund L, Larsen JN. Grazax®: an oromucosal vaccine for treating grass pollen allergy with immunotherapy. In: Jorgensen L, Nielsen HM, editors. Delivery technologies for biopharmaceuticals. John Wiley & Sons; 2009. p. 395–404.
- Lal M, Priddy S, Bourgeois L, et al. Development of a fast-dissolving tablet formulation of a live attenuated enterotoxigenic E. coli vaccine candidate. Vaccine. 2013;31:4759–4764.
- Chandrasekhar R, Hassan Z, AlHusban F, et al. The role of formulation excipients in the development of lyophilised fast-disintegrating tablets. Eur J Pharm Biopharm. 2009;72:119–129.
- AlHusban F, Perrie Y, Mohammed AR. Formulation and characterisation of lyophilised rapid disintegrating tablets using amino acids as matrix forming agents. Eur J Pharm Biopharm. 2010;75:254–262.
- Liew KB, Odeniyi MA, Peh KK. Application of freeze-drying technology in manufacturing orally disintegrating films. Pharm Dev Technol. 2015;21:346–353.
- Shamma R, Elkasabgy N. Design of freeze-dried soluplus/polyvinyl alcohol-based film for the oral delivery of an insoluble drug for the pediatric use. Drug Deliv. 2016;23:489–499.
- Sudhakar Y, Kuotsu K, Bandyopadhyay AK. Buccal bioadhesive drug delivery – a promising option for orally less efficient drugs. J Control Release. 2006;114:15–40.
- Ayensu I, Mitchell JC, Boateng JS. Development and physico-mechanical characterisation of lyophilised chitosan wafers as potential protein drug delivery systems via the buccal mucosa. Colloid Surface B. 2012;91:258–265.
- Whitehead L, Fell JT, Collett JH, et al. Floating dosage forms: an in vivo study demonstrating prolonged gastric retention. J Control Release. 1998;55:3–12.
- Kim J-Y, Kim S-H, Rhee Y-S, et al. Preparation of hydroxypropylmethyl cellulose-based porous matrix for gastroretentive delivery of gabapentin using the freeze-drying method. Cellulose. 2013;20:3143–3154.
- Abdelwahed W, Degobert G, Stainmesse S, et al. Freeze-drying of nanoparticles: formulation, process and storage considerations. Adv Drug Deliver Rev. 2006;58:1688–1713.
- Kianfar F, Antonijevic M, Chowdhry B, et al. Lyophilized wafers comprising carrageenan and pluronic acid for buccal drug delivery using model soluble and insoluble drugs. Colloid Surface B. 2013;103:99–106.