Automated sample preparation of protein solid dosage forms: Novel application for the tablet processing workstation

SLAS Technology - Tập 28 - Trang 258-263 - 2023
Ivana Fileš1, Vincent Andersson1
1Global Research Technologies, Novo Nordisk A/S, Novo Nordisk Park, Måløv 2760, Denmark

Tài liệu tham khảo

Mantaj, 2020, Recent advances in the oral delivery of biologics, Pharm J, 15, 759

Moroz, 2016, Oral delivery of macromolecular drugs: where we are after almost 100 years of attempts, Adv Drug Delivery Rev, 101, 108, 10.1016/j.addr.2016.01.010

Mennen, 2019, The evolution of high-throughput experimentation in pharmaceutical development and perspectives on the future, Org Process Res Dev, 23, 1213, 10.1021/acs.oprd.9b00140

Brown, 2004, Dissolution testing of poorly soluble compounds, Pharm Tech, 28

Bharate, 2016, Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review, J. Excipients and Food Chem., 1, 1131

Craig, 2002, The mechanisms of drug release from solid dispersions in water-soluble polymers, Int J Pharm, 231, 131, 10.1016/S0378-5173(01)00891-2

Bolognesi, 2013, Physicochemical principles of protein aggregation, Prog Mol Biol Transl Sci, 117, 53, 10.1016/B978-0-12-386931-9.00003-9

Hamada, 2009, Effect of additives on protein aggregation, Current Pharm. Biotechnol, 10, 400, 10.2174/138920109788488941

Randolph, 2015, Do not drop: mechanical shock in vials causes cavitation, protein aggregation, and particle formation, J Pharm Sci, 104, 602, 10.1002/jps.24259

Jayaraman, 2014, Agitation-induced aggregation and subvisible particulate formation in model proteins, Eur J Pharm Biopharm, 87, 299, 10.1016/j.ejpb.2014.01.004

Zidar, 2020, Surfaces affect screening reliability in formulation development of biologics, Pharm Res, 37, 1, 10.1007/s11095-019-2733-1

Defante, 2020, The impact of the metal interface on the stability and quality of a therapeutic fusion protein, Mol Pharm, 17, 569

Opio, 2011, Expanding the application of the tablet processing workstation to support the sample preparation of oral suspensions, J Lab Autom, 16, 229, 10.1016/j.jala.2011.02.001

Shamrock, 2000, Automated sample preparation of roxifiban tablets: transfer of a manual method to an automated workstation, J Pharm Biomed Anal, 21, 1225, 10.1016/S0731-7085(99)00232-0

Toro, 2004, Development and validation of a fully automated method for the chromatographic determination of content uniformity of drug tablets, J Pharm Biomed Anal, 36, 57, 10.1016/j.jpba.2004.05.011

Höller, 2003, Automated determination of selected water-soluble vitamins in tablets using a bench-top robotic system coupled to reversed-phase (RP-18) HPLC with UV detection, J Pharm Biomed Anal, 31, 151, 10.1016/S0731-7085(02)00574-5

Halberg, 2019, Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial, Lancet Diabetes Endocrinol, 7, 179, 10.1016/S2213-8587(18)30372-3

Hubálek, 2020, Molecular engineering of safe and efficacious oral basal insulin, Nat Commun, 11, 1

Ermer, 2006, Validation during drug product development – considerations as a function of the stage of drug development, 243

Oliva, 2003, Effect of high shear rate on stability of proteins: kinetic study, J Pharm Biomed Anal, 33, 145, 10.1016/S0731-7085(03)00223-1

Knopp, 2021, Capacity of infusion lines for insulin adsorption: effect of flow rate on total adsorption, J Diabetes Sci Technol, 15, 109, 10.1177/1932296819876924

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SLAS Technology

Tập 28

258-263

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