The influence of lyophilization on the polymorphic behavior of mannitol

AJ Cannon, EH Trappler - PDA journal of pharmaceutical science …, 2000 - journal.pda.org
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The impact of protein concentration on mannitol and sodium chloride crystallinity and polymorphism upon lyophilization

D Dixon, S Tchessalov, A Barry, N Warne - Journal of pharmaceutical …, 2009 - Elsevier
The effect of protein concentration, in the range of 0–26 mg/mL for two Fc-fusion proteins, on
the crystallinity and polymorphism of mannitol and sodium chloride in a lyophilized model …

The influence of lysozyme on mannitol polymorphism in freeze-dried and spray-dried formulations depends on the selection of the drying process

H Grohganz, YY Lee, J Rantanen, M Yang - International journal of …, 2013 - Elsevier
Freeze-drying and spray-drying are often applied drying techniques for biopharmaceutical
formulations. The formation of different solid forms upon drying is often dependent on the …

Quantitative analysis of mannitol polymorphs. X-ray powder diffractometry—exploring preferred orientation effects

SNC Roberts, AC Williams, IM Grimsey… - Journal of pharmaceutical …, 2002 - Elsevier
Mannitol is a polymorphic pharmaceutical excipient, which commonly exists in three forms:
alpha, beta and delta. Each polymorph has a needle-like morphology, which can give …

Effect of cyclophosphamide on the solid form of mannitol during lyophilization

K Patel, B Munjal, AK Bansal - European Journal of Pharmaceutical …, 2017 - Elsevier
Mannitol is a commonly used bulking agent in lyophilized formulations. It can crystallize into
multiple solid forms during lyophilization thereby exhibiting phase heterogeneity and …

Moisture induced polymorphic transition of mannitol and its morphological transformation

T Yoshinari, RT Forbes, P York… - International journal of …, 2002 - Elsevier
The effects of moisture on the polymorphic transition of crystalline mannitol were
investigated. Mannitol has three polymorphic forms, and was classified as α, β, and δ form …

Freezing step controls the mannitol phase composition heterogeneity

K Nakagawa, W Murakami, J Andrieu… - … Engineering Research and …, 2009 - Elsevier
Freeze-dried samples were prepared from D-mannitol solution by selected freezing
conditions. Crystalline structures of prepared samples were determined by XRD analysis …

Influence of protein on mannitol polymorphic form produced during co-spray drying

WL Hulse, RT Forbes, MC Bonner, M Getrost - International journal of …, 2009 - Elsevier
The stabilizing ability of the excipient on pharmaceutically relevant proteins for potential
therapeutic use is an extensive area of research but the effect the protein has on the …

Crystallization of D-mannitol in binary mixtures with NaCl: phase diagram and polymorphism

C Telang, R Suryanarayanan, L Yu - Pharmaceutical research, 2003 - Springer
Purpose. To study the crystallization, polymorphism, and phase behavior of D-mannitol in
binary mixtures with NaCl to better understand their interactions in frozen aqueous solutions …

The characterization and comparison of spray-dried mannitol samples

WL Hulse, RT Forbes, MC Bonner… - Drug development and …, 2009 - Taylor & Francis
Background: Following the production of spray-dried mannitol powders, it is essential that
the polymorphic content of each individual product is completely characterized. The …