Non-Invasive, Continuous, Quantitative Detection of Solvent Content in Vacuum Tray Drying.
capacitance probe
spray-dried powder
tray drying
vacuum drying
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
02 Aug 2024
02 Aug 2024
Historique:
received:
19
04
2024
accepted:
04
06
2024
medline:
16
8
2024
pubmed:
16
8
2024
entrez:
16
8
2024
Statut:
epublish
Résumé
A non-invasive capacitance instrument was embedded in the base of a vacuum-drying tray to monitor continuously the residual amount of solvent left in a pharmaceutical powder. Proof of concept was validated with Microcrystalline Cellulose laced with water, as well as water/acetone mixtures absorbed in a spray-dried Copovidone powder. To illustrate the role of impermeability of the base, we derive a model of vapor sorption that reveals the existence of a kinetic limit when solids are thinly spread, and a diffusion limit with greatly diminished effective diffusivity at large powder thickness. By monitoring the residual solvent content of powders, this new in situ technique offers advantages over indirect methods like mass spectrometry of vapor effluents, but without complications associated with probe fouling. To prescribe design guidelines and interpret signals, we model the electric field shed by the probe when a powder holds variable solvent mass fraction in the vertical direction.
Identifiants
pubmed: 39150583
doi: 10.1208/s12248-024-00944-4
pii: 10.1208/s12248-024-00944-4
doi:
Substances chimiques
Solvents
0
Cellulose
9004-34-6
Powders
0
Pyrrolidines
0
microcrystalline cellulose
OP1R32D61U
Vinyl Compounds
0
Water
059QF0KO0R
Acetone
1364PS73AF
poly(vinylpyrrolidone-co-vinyl-acetate)
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
89Informations de copyright
© 2024. Merck & Co., Inc., Rahway NJ, USA and its affiliates.
Références
Conder EW, Cosbie AS, Gaertner J, Hicks W, Huggins S, MacLeod CS, Remy B, Yang BS, Engstrom JD, Lamberto DJ, Papageorgiou CD. The pharmaceutical drying unit operation: an industry perspective on advancing the science and development approach for scale-up and technology transfer. Org Process Res Dev. 2017;21:420–429. https://doi.org/10.1021/acs.oprd.6b00406 .
Parikh DM. Vacuum drying: basics and application. Chem Eng. 2015;122:48–54.
Ward KR, Matejtschuk P. The principles of freeze-drying and application of analytical technologies. In: Wolkers WF, Oldenhof H, editors. Cryopreservation and Freeze-Drying Protocols. Methods in Molecular Biology. New York: Humana; 2021. 2180, pp. 99–127. https://doi.org/10.1007/978-1-0716-0783-1_3 .
Rimpiläinen V, Heikkinen LM, Vauhkonen M. Moisture distribution and hydrodynamics of wet granules during fluidized-bed drying characterized with volumetric electrical capacitance tomography. Chem Eng Sci. 2012;75:220–234. https://doi.org/10.1016/j.ces.2012.03.028 .
Wang H, Yang W. Application of electrical capacitance tomography in pharmaceutical fluidised beds - a review. Chem Eng Sci. 2021;231:116236. https://doi.org/10.1016/j.ces.2020.116236 .
doi: 10.1016/j.ces.2020.116236
Glish G, Vachet R. The basics of mass spectrometry in the twenty-first century. Nat Rev Drug Discov. 2003;122:140–150. https://doi.org/10.1038/nrd1011 .
Igne B, Ciurczak, EW. Near-infrared spectroscopy in the pharmaceutical industry. In: Ozaki Y. Huck C, Tsuchikawa S, Engelsen SB, editors. Near-Infrared Spectroscopy. Singapore: Springer; 2021. 2180, pp. 391–412. 10.1007/978-981-15-8648-4_18
Adamovics JA. Chromatographic Analysis of Pharmaceuticals. 2nd ed. New York: Marcel Dekker; 1997.
Achanta PS, Jaki BU, McAlpine JB, Friesen JB, Niemitz M, Chen SN, Pauli GF. Quantum mechanical NMR full spin analysis in pharmaceutical identity testing and quality control. J Pharm Biomed Anal. 2021;192:113601. https://doi.org/10.1016/j.jpba.2020.113601 .
doi: 10.1016/j.jpba.2020.113601
pubmed: 33049645
Louge MY, Mandur J, Blincoe W, Tantuccio A, Meyer RF. Non-invasive, continuous, quantitative detection of powder level and mass holdup in a metal feed tube. Powder Technol. 2021;382:467–477. https://doi.org/10.1016/j.powtec.2020.12.068 .
Lee SL, O’Connor TF, Yang X, Cruz CN, Chatterjee S, Madurawe RD, Moore CMV, Yu LX, Woodcock J. Modernizing pharmaceutical manufacturing: from batch to continuous production. J Pharm Innov. 2015;10:191–199. https://doi.org/10.1007/s12247-015-9215-8 .
Riley CA, Louge M. Quantitative capacitive measurements of voidage in gas-solid flows. Part Sci Technol. 1989;7:51–59. https://doi.org/10.1080/02726358908906523 .
Louge M, Tuccio M, Lander E, Connors P. Capacitance measurements of the volume fraction and velocity of dielectric solids near a grounded wall. Rev Sci Instrum. 1996;67:1869–1877. https://doi.org/10.1063/1.1146991 .
Dorman RA, Kissinger, CD, Lagace, LJ. Capacitance type non-contact displacement and vibration measuring device and method of maintaining calibration. U.S. Patent No. 4,067,225. 1978
Louge MY, Foster RL, Jensen N, Patterson R. A portable capacitance snow sounding instrument. Cold Reg Sci Technol. 1998;28:73–81. https://doi.org/10.1016/S0165-232X(98)00015-9 .
doi: 10.1016/S0165-232X(98)00015-9
Louge, MY, Valance, A, Ould el-Moctar, A, Dupont, P. Packing variations on a ripple of nearly monodisperse dry sand. J Geophys Res Earth Surf 2010;115:02001. https://doi.org/10.1029/2009JF001384 .
Louge MY, Valance A, Xu J, Ould el-Moctar A, Chasle, P. Water vapor transport across an arid sand surface - non-linear thermal coupling, wind-driven pore advection, subsurface waves, and exchange with the atmospheric boundary layer. J Geophys Res Earth Surf. 2022;127:2021–006490. https://doi.org/10.1029/2021JF006490 .
Louge, MY, Steiner R, Keast SC, Decker R, Dent, J, Schneebeli M. Application of capacitance instrumentation to the measurement of density and velocity of flowing snow. Cold Reg Sci Technol. 1997;25:47–63 https://doi.org/10.1016/S0165-232X(96)00016-X .
Wells, P. Capacitive fluid level sensor. U.S. Patent No. 5,042,299. 1991.
Hart JR. Capacitive fluid level sensor. U.S. Patent No. 5,103,368. 1992.
McEwan, TE. Electronic multi-purpose material level sensor. U.S. Patent No. 5,609,059. 1997.
Reverter F, Li X, Meijer GC. Liquid-level measurement system based on a remote grounded capacitive sensor. Sens Actuators A. 2007;138:1–8. https://doi.org/10.1016/j.sna.2007.04.027 .
doi: 10.1016/j.sna.2007.04.027
Goekler LE. Capacitive liquid level sensor. U.S. Patent No. 5,017,909. 1991.
Cohen L, Rose RA. Capacitance-type fluid level sensor for IV and catheter bags. U.S. Patent No. 5,135,485. 1992.
Nyce, DS. Isolated capacitive fluid level sensor. U.S. Patent No. 7,258,005. 2007.
Wang HG, Che HQ, Ye JM, Tu QY, Wu ZP, Yang WQ, Ocone R. Application of process tomography in gas-solid fluidised beds in different scales and structures. Meas Sci Technol. 2018;29:044001. https://doi.org/10.1088/1361-6501/aaa509 .
doi: 10.1088/1361-6501/aaa509
Böttcher CJF, Bordewijk, P. Theory of Electric Polarization, vol. II: Dielectrics in Time-dependent fields. New York: Elsevier; 1978.
Incropera FP, DeWitt DP, Bergman TL Lavine AS. Fundamentals of Heat and Mass Transfer, 6th ed. New York; Wiley: 2007. pp. 212–218.
Bagnara R. A unified proof for the convergence of Jacobi and Gauss-Seidel methods. SIAM Rev. 1995;37:93–97. https://doi.org/10.1137/1037008 .
Shen L, Chen Z. Critical review of the impact of tortuosity on diffusion. Chem Eng Sci. 2007;62:3748–3755. https://doi.org/10.1016/j.ces.2007.03.041 .