Powder filling of electrospun material in vials: A proof-of-concept study

被引:0
|
作者
Szabo, Edina [1 ]
Zahonyi, Petra [1 ]
Galata, Dorian L. [1 ]
Madarasz, Lajos [1 ]
Vass, Panna [1 ]
Farkas, Attila [1 ]
Dhondt, Jens [2 ]
Andersen, Sune K. [2 ]
Vigh, Tamas [2 ]
Verreck, Geert [2 ]
Csontos, Istvan [1 ]
Marosi, Gyorgy [1 ]
Nagy, Zsombor K. [1 ]
机构
[1] Budapest Univ Technol & Econ BME, Dept Organ Chem & Technol, Muegyet Rakpart 3, H-1111 Budapest, Hungary
[2] Johnson & Johnson, Div Janssen Pharmaceut, Oral Solid Dosage Drug Prod Dev Pharmaceut Dev &, Pharmaceut Res & Dev, Turnhoutseweg 30, B-2340 Beerse, Belgium
关键词
Electrospinning; Scale-up; Continuous manufacturing; Vial filling; Reconstitution dosage form; Powder feeding; RECONSTITUTION TIME; FLOW PROPERTIES; COMPACTABILITY; FORMULATIONS; TECHNOLOGIES; CHALLENGES;
D O I
10.1016/j.ijpharm.2021.121413
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The present paper reports the powder filling of milled electrospun materials in vials, which contained voriconazole and sulfobutylether-beta-cyclodextrin. High-speed electrospinning was used for the production of the fibrous sample, which was divided into 6 parts. Each portion was milled using different milling methods and sizes of sieves to investigate whether the milling influences the powder and filling properties. Bulk and tapped density tests, laser diffraction and angle of repose measurements were applied to characterize the milled powders, while a vibratory feeder was used for the feeding experiments. The correlation between the material property descriptors and the feeding responses was investigated by multivariate data analysis. Based on the results, three samples were chosen for the vial filling, which was accomplished with 3400 mg electrospun material containing 200 mg voriconazole, representative of the commercial product. The feed rate was set to fit the 240 g/h production rate of the electrospinning and the relative standard deviation of three repeated vial filling was determined to see the accuracy of the process. This research shows that by applying a suitable milling method it is possible to process electrospun fibers to a powder, which can be filled into vials and used as reconstitution dosage forms.
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页数:11
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