Mullard A. 2019 FDA drug approvals. Nat Rev Drug Discovery. 2020;19(2):79–84.
Global Lyophilized Injectable Drugs Market – Industry Trends and Forecast to 2031 (2024). Data Bridge Market Research. https://www.databridgemarketresearch.com/reports/global-lyophilized-injectable-drugs-market. Accessed 10 March 2025.
Preston KB, Randolph TW. Stability of lyophilized and spray dried vaccine formulations. Adv Drug Deliv Rev. 2021;171:50–61.
Butreddy A, Janga KY, Ajjarapu S, Sarabu S, Dudhipala N. Instability of therapeutic proteins—An overview of stresses, stabilization mechanisms and analytical techniques involved in lyophilized proteins. Int J Biol Macromol. 2021;167:309–25.
Franks F. Freeze-drying of bioproducts: putting principles into practice. Eur J Pharm Biopharm. 1998;45(3):221–9.
Saraiva R. Formulation Approaches for Biologics: Strategies to Enhance Stability and Bioavailability. Journal of Formulation Science & Bioavailability. 2024;8(3):1–3.
Kommineni N, Butreddy A, Jyothi VGSS, Angsantikul P. Freeze-drying for the preservation of immunoengineering products. iScience. 2022;25(10):105127.
Sonju JJ, Shrestha P, Dahal A, Gu X, Johnson WD, Zhang D, Muthumula CMR, Meyer SA, Mattheolabakis G, Jois SD. Lyophilized liposomal formulation of a peptidomimetic-Dox conjugate for HER2 positive breast and lung cancer. Int J Pharm. 2023;639:122950.
Wan W, Guo N, Pan D, Yu C, Weng Y, Luo S, Ding H, Xu Y, Wang L, Lang L, Xie Q. First experience of 18F-alfatide in lung cancer patients using a new lyophilized kit for rapid radiofluorination. J Nucl Med. 2013;54(5):691–8.
Wang F, He Q, Wang J, Yuan Q, Guo H, Chai L, Wang S, Hu L, Zhang Y. Neuroprotective effect of salvianolate lyophilized injection against cerebral ischemia in type 1 diabetic rats. BMC Complement Altern Med. 2017;17:1–12.
Gangwani MK, Aziz M, Aziz A, Priyanka F, Weissman S, Phan K, Dahiya DS, Ahmed Z, Sohail AH, Lee-Smith W, Kamal F. Fresh versus frozen versus lyophilized fecal microbiota transplant for recurrent Clostridium difficile infection: a systematic review and network meta-analysis. J Clin Gastroenterol. 2023;57(3):239–45.
Butreddy A, Dudhipala N, Janga KY, Gaddam RP. Lyophilization of small-molecule injectables: an industry perspective on formulation development, process optimization, scale-up challenges, and drug product quality attributes. AAPS PharmSciTech. 2020;21:1–20.
Sane P, Bogner RH, Bhatnagar B, Tchessalov S. Reconstitution of highly concentrated lyophilized proteins: part 1 amorphous formulations. J Pharm Sci. 2020;109(5):1681–91.
Ai L, Li Y, Zhou L, Yao W, Zhang H, Hu Z, Han J, Wang W, Wu J, Xu P, Wang R. Lyophilized mRNA-lipid nanoparticle vaccines with long-term stability and high antigenicity against SARS-CoV-2. Cell discovery. 2023;9(1):9.
CAS PubMed PubMed Central Google Scholar
Anamur C, Winter G, Engert J. Stability of collapse lyophilized influenza vaccine formulations. Int J Pharm. 2015;483(1–2):131–41.
Kasper JC, Winter G, Friess W. Recent advances and further challenges in lyophilization. Eur J Pharm Biopharm. 2013;85(2):162–9.
Tang X, Cheng Y, Shameem M. Challenges and Considerations in the Development of a High Protein Concentration Lyophilized Drug Product. In: Principles and Practices of Lyophilization in Product Development and Manufacturing. Cham: Springer International Publishing; 2023. p. 103–21.
Kowsari K, Lu L, Persak SC, Hu G, Forrest W, Berger R, Givand JC, Babaee S. Injectability of high concentrated suspensions using model microparticles. J Pharm Sci. 2024;113(12):3525–37.
Werk T, Ludwig IS, Luemkemann J, Mahler HC, Huwyler J, Hafner M. Technology, applications, and process challenges of dual chamber systems. J Pharm Sci. 2016;105(1):4–9.
Ingle RG, Fang WJ. Prefilled dual chamber devices (DCDs)–promising high-quality and convenient drug delivery system. Int J Pharm. 2021;597: 120314.
Doughty DV, Clawson CZ, Lambert W, Subramony JA. Understanding subcutaneous tissue pressure for engineering injection devices for large-volume protein delivery. J Pharm Sci. 2016;105:2105–13.
Allmendinger A, Mueller R, Schwarb E, Chipperfield M, Huwyler J, Mahler H-C, Fischer S. Measuring tissue back-pressure - in vivo injection forces during subcutaneous injection. Pharm Res. 2015;32:2229–40.
Pepin XJH, Grant I, Wood JM. SubQ-Sim: A subcutaneous physiologically based biopharmaceutics model. Part 1: the injection and system parameters. Pharm Res. 2023;40:2195–214.
CAS PubMed PubMed Central Google Scholar
Fischer I, Schmidt A, Bryant A, Besheer A. Calculation of injection forces for highly concentrated protein solutions. Int J Pharm. 2015;493:70–4.
Thueer T, Birkhaeuer L, Reilly D. Development of an advanced injection time model for an autoinjector. Medical Devices: Evidence and Research. 2018;11:215–24.
Fitzgibbon S, Folk CR, Jazayeri J. Reducing probability of glass breakage in drug delivery devices. US Patent 11200298B2. 2021.
Zhong X, Guo T, Vlachos P, Veilleux J-C, Shi GH, Collins DS, Ardekani AM. An experimentally validated dynamic model for spring-driven autoinjectors. Int J Pharm. 2021;594: 120008.
Sree V, Zhong X, Bilionis I, Ardekani A, Tepole AB. Optimizing autoinjector devices using physics-based simulations and Gaussian processes. J Mech Behav Biomed Mater. 2023;140: 105695.
Frenning G, Ahnfelt E, Sjögren E, Lennernäs H. Computational fluid dynamics (CFD) studies of a miniaturized dissolution system. Int J Pharm. 2017;521:274–81.
D’hers S, Abad Vazquez AN, Gurman P, Elman NM. Rapid reconstitution packages (RRPs) for stable storage. Drug Delivery and Translational Research. 2019;9:631–40.
Sleziona D, Ely DR, Thommes M. Modeling of particle dissolution behavior using a geometrical phase-field approach. Mol Pharm. 2022;19:3749–56.
So C, Chiang P-C, Mao C. Modeling drug dissolution in 3-dimensional space. Pharm Res. 2022;39:907–17.
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