Production of Submicronic Powder by Spray-Freezing

Werly, Emil F.; Bauman, Elven K.

doi:10.1080/00039896.1964.10663881

Cited by 14 publications

(4 citation statements)

References 6 publications

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“…One of the impediments to using proteins in pharmaceutical formulations has been their inherent instability upon dehydration, as proteins are sensitive to a variety of physical and chemical degradative processes, which are either facilitated or directly mediated by loss of water . Common bioindustrial dehydration processes are lyophilization or freeze‐drying, spray‐drying and microglassification, which may have different effects on the protein integrity. Fourier‐transform infrared (FTIR), Raman and solid state nuclear magnetic resonance (NMR) spectroscopic investigations of several soluble globular proteins have indicated that protein denaturation may be induced by lyophilization, spray‐drying, and precipitation with organic solvents followed by drying .…”

Section: Introductionmentioning

confidence: 99%

Differential dehydration effects on globular proteins and intrinsically disordered proteins during film formation

et al. 2017

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Globular proteins composed of different secondary structures and fold types were examined by synchrotron radiation circular dichroism spectroscopy to determine the effects of dehydration on their secondary structures. They exhibited only minor changes upon removal of bulk water during film formation, contrary to previously reported studies of proteins dehydrated by lyophilization (where substantial loss of helical structure and gain in sheet structure was detected). This near lack of conformational change observed for globular proteins contrasts with intrinsically disordered proteins (IDPs) dried in the same manner: the IDPs, which have almost completely unordered structures in solution, exhibited increased amounts of regular (mostly helical) secondary structures when dehydrated, suggesting formation of new intra‐protein hydrogen bonds replacing solvent‐protein hydrogen bonds, in a process which may mimic interactions that occur when IDPs bind to partner molecules. This study has thus shown that the secondary structures of globular and intrinsically disordered proteins behave very differently upon dehydration, and that films are a potentially useful format for examining dehydrated soluble proteins and assessing IDPs structures.

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Section: Introductionmentioning

confidence: 99%

Differential dehydration effects on globular proteins and intrinsically disordered proteins during film formation

et al. 2017

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“…Currently, freeze‐drying (Pikal, 1994; Rey, 2016; Roy & Gupta, 2004) and spray drying (SD) (Ameri & Maa, 2006; Grasmeijer et al, 2019; S. H. Lee et al, 2011; Vehring, 2008) are two main solidification methods. Spray‐freeze drying as a recent solidification method has attracted attention since its first introduction in 1964 (Werly & Bauman, 1964), because it has advantages over classical SD and freeze‐drying. It can not only enhance the apparent solubility of poorly water‐soluble drugs, but also minimize the possibility of phase separation (Wanning et al, 2015).…”

Section: Challenges Still Remaining In Hmementioning

confidence: 99%

Hot melt extrusion: An emerging manufacturing method for slow and sustained protein delivery

Zheng

Pokorski

2021

WIREs Nanomed Nanobiotechnol

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With the rapid development of the biopharmaceutical industry, an increasing number of new therapeutic protein products (TPPs) have been approved by the FDA and many others are under pre‐clinical and clinical evaluation. A major limitation of biopharmaceuticals is their limited half‐life when administered systemically. A one‐time, implantable, sustained protein delivery device would be advantageous in order to improve the quality of life of patients. Hot melt extrusion (HME) is a mature technology that has been extensively used for a broad spectrum of applications in the polymer and pharmaceutical industry and has achieved success as evidenced by a variety of FDA‐approved commercial products. These commercial products are mostly for sustained delivery of small molecule therapeutics, leaving a significant gap for HME formulation of therapeutic proteins. With the increasing need of sustained TPP delivery, HME shows promise as a downstream processing method due to its high efficiency and economic value. Several challenges remain for the application of HME in protein delivery. Progress of HME for protein delivery, challenges encountered, and potential solutions will be detailed in this review article. This article is categorized under: Implantable Materials and Surgical Technologies > Nanomaterials and Implants Biology‐Inspired Nanomaterials > Protein and Virus‐Based Structures

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“…One of the most promising for the preparation of PLGA and PLA MP is spray freeze-drying (SFD) of drug-polymer solutions/dispersions that enables a broad range of applications, particularly for proteins and biologics (Wanning et al 2015). Spray freeze-drying is a well-established process since its first appearance in 1964 (Werly and Bauman 1964) in the food and pharmaceutical industry for processing and powder engineering (Ishwarya et al 2015;Dutta et al 2018).…”

Section: Spray Freeze-dryingmentioning

confidence: 99%

Meeting the unmet: from traditional to cutting-edge techniques for poly lactide and poly lactide-co-glycolide microparticle manufacturing

Schoubben

Ricci

Giovagnoli

2019

J. Pharm. Investig.

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Background Polylactides (PLA) and poly lactide-co-glycolides (PLGA) undoubtedly are among the major drivers in the pharmaceutical market. Their relevance in pharmaceutics and biomedicine is well established in light of their sustainability, safety, tunable biodegradability, and versatility. However, polymer degradability and plasticity can somehow restrain industrial developability of PLA and PLGA formulations, especially in the form of microparticles (MP). Area covered This review wants to deal with the known manufacturing issues of PLA/PLGA MP, debating the potential contribution of modern and cutting-edge manufacturing technologies to the solution of unmet production needs. Technological and regulatory aspects will be considered outlining the potential role of advanced manufacturing techniques in the advancement of PLA/PLGA MP production processes. Expert opinion The multifaceted complexity of PLA/PLGA MP manufacturing processes demands adequate standardization and updated guidelines covering the so far unmet industrialization requirements. Novel and evolving manufacturing technologies will surely support the future development of bench-to-production plant transfer for such products. Careful evaluation of production costs is demanded in order to ensure process sustainability and patient's outreach.

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Production of Submicronic Powder by Spray-Freezing

Cited by 14 publications

References 6 publications

Differential dehydration effects on globular proteins and intrinsically disordered proteins during film formation

Differential dehydration effects on globular proteins and intrinsically disordered proteins during film formation

Hot melt extrusion: An emerging manufacturing method for slow and sustained protein delivery

Meeting the unmet: from traditional to cutting-edge techniques for poly lactide and poly lactide-co-glycolide microparticle manufacturing

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