Comparing freeze drying and spray drying of interleukins using model protein CXCL8 and its variants

Fiedler, Daniela; Hartl, Sonja; Gerlza, Tanja; Trojacher, Christina; Kungl, Andreas J.; Khinast, Johannes; Roblegg, Eva

doi:10.1016/j.ejpb.2021.08.006

Cited by 8 publications

(7 citation statements)

References 57 publications

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“…Fiedler et al . [ 107 ] have shown that both spray drying (inlet 60°C and outlet 29°C) and spray freeze drying can be used to produce dry powder versions of three interleukin-8 based proteins (7–74 kDa) that were shown to be stable for up to 12 weeks of storage without the use any adjuvant or any specialized excipients. Although the authors have reported that there was no alteration in the structural and functional integrity of the spray-dried or spray freeze–dried interleukins, the geometric diameters of the particles were shown to be greater than the range suitable for inhalation primarily due to particle agglomeration.…”

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

“…Nevertheless, the study by Fiedler et al . [ 107 ] demonstrated that spray drying and spray freeze drying when conducted at optimal conditions can be used for production of stable dry powder versions of biomolecules.…”

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

“…2011 [ 106 ] Standardized powder entrainment tube Dry powders of poly(caprolactone) nanoparticles encapsulating levofloxacin using polyvinyl alcohol (PVA) and mannitol as excipients In vitro emitted dose of 90% and FPF of 14% from NGI studies reported Fiedler et al . (2021) [ 107 ] Not applicable Spray-dried interleukin-8 using phosophate-buffered saline as the dissolution media Dry powder versions of interleukin were shown to be stable after 12 weeks of storage without any signs of protein unfolding, compromised binding affinity Lo et al . 2021 [ 108 ] Size 3 gelatin capsule (Capsugel®, Morristown, NJ, USA) was loaded into Breezhaler® (Novartis AG, Basel, Switzerland) Spray freeze–dried bovine serum albumin using hydroxypropyl beta-cyclodextrin as the protein stabilizer FPF in the range of 60 to 80% and MMAD in the range of 1–5 micron were reported for the tested formulations based on NGI studies Liang et al .…”

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

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Formulation, Device, and Clinical Factors Influencing the Targeted Delivery of COVID-19 Vaccines to the Lungs

Mossadeq

Shah

et al. 2022

AAPS PharmSciTech

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The COVID-19 pandemic has proven to be an unprecedented health crisis in the human history with more than 5 million deaths worldwide caused to the SARS-CoV-2 and its variants ( https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). The currently authorized lipid nanoparticle (LNP)–encapsulated mRNA vaccines have been shown to have more than 90% vaccine efficacy at preventing COVID-19 illness (Baden et al . New England J Med 384(5):403–416, 2021 ; Thomas et al ., 2021 ). In addition to vaccines, other small molecules belonging to the class of anti-viral and anti-inflammatory compounds have also been prescribed to reduce the viral proliferation and the associated cytokine storm. These anti-viral and anti-inflammatory compounds have also been shown to be effective in reducing COVID-19 exacerbations especially in reducing the host inflammatory response to SARS-CoV-2. However, all of the currently FDA-authorized vaccines for COVID-19 are meant for intramuscular injection directly into the systemic circulation. Also, most of the small molecules investigated for their anti-COVID-19 efficacy have also been explored using the intravenous route with a few of them explored for the inhalation route (Ramakrishnan et al . Lancet Respir Med 9:763–772, 2021 ; Horby et al . N Engl J Med 384(8):693–704, 2021 ). The fact that the SARS-CoV-2 enters the human body mainly via the nasal and airway route resulting in the lungs being the primary organs of infection as characterized by acute respiratory distress syndrome (ARDS)–mediated cytokine storm in the alveolar region has made the inhalation route gain significant attention for the purposes of targeting both vaccines and small molecules to the lungs (Mitchell et al ., J Aerosol Med Pulm Drug Deliv 33(4):235–8, 2020 ). While there have been many studies reporting the safety and efficacy of targeting various therapeutics to the lungs to treat COVID-19, there is still a need to match the choice of inhalation formulation and the delivery device platform itself with the patient-related factors like breathing pattern and respiratory rate as seen in a clinical setting. In that perspective, this review aims to describe the various formulation and patient-related clinical factors that can play an important role in the judicious choice of the inhalation delivery platforms or devices for the development of inhaled COVID-19 vaccines.

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Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

See 1 more Smart Citation

Formulation, Device, and Clinical Factors Influencing the Targeted Delivery of COVID-19 Vaccines to the Lungs

Mossadeq

Shah

et al. 2022

AAPS PharmSciTech

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“…Wilson et al showed that protein formulations processed by spray drying in general are more heterogenous than those dehydrated by freeze drying . On the other hand, Fiedler et al reported no difference between freeze or spray drying regarding the structure and activity of different interleukins after 12 weeks storage (4–8 °C) . For spray drying to become a viable alternative to lyophilization for producing dried biopharmaceuticals, additional development of process and formulation methods is needed to ensure that the efficiencies of spray drying can be achieved without compromising product quality.…”

Section: Introductionmentioning

confidence: 99%

Effect of Atomic Layer Coating on the Stability of Solid Myoglobin Formulations

et al. 2023

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The effects of atomic layer (ALC) coating on physical properties and storage stability were examined in solid powders containing myoglobin, a model protein. Powders containing myoglobin and mannitol (1:1 w/w) were prepared by lyophilization or spray drying and subjected to aluminum oxide or silicon oxide ALC coating. Uncoated samples of these powders as well as coated and uncoated samples of myoglobin as received served as controls. After preparation (t 0 ), samples were analyzed for moisture content, reconstitution time, myoglobin secondary structure, crystallinity, and protein aggregate content. Samples were stored for 3 months (t 3 ) under controlled conditions (53% RH, 40 °C) in both open and closed vials and then analyzed as above. At t 3 , the recovery of soluble native (i.e., monomeric) protein depended on formulation, coating type, and drying method and was up to 2-fold greater in coated samples than in uncoated controls. Promisingly, some samples with high recovery also showed low soluble aggregate content (<10%) at t 3 and low total monomer loss; the latter was correlated to sample moisture content. Overall, the results demonstrate that ALC coatings can stabilize solid protein formulations during storage, providing benefits over uncoated controls.

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“…Enzyme preparation used in the process of catalytic processing is a kind of bioactive substance, which can be processed into different purities and dosage forms, including immobilized enzymes and cells obtained by immobilization technology (L. Guo et al, 2010). With advantages of less energy consuming and economic cost, vacuum freeze-drying has been widely used in food in recent years to expand the commercial application of enzymes (Fiedler et al, 2021). Besides, the enzyme is usually xed in the carrier by physical and chemical methods to obtain immobilized enzyme, for example, the protease is bound to the carrier by covalent bond and non-covalent bond (Alptekin et al, 2010).…”

Section: Introductionmentioning

confidence: 99%

Optimization of κ-Selenocarrageenase Production by Pseudoalteromonas sp.X13 and Its Immobilization

Deng

Wang²,

Hong

et al. 2022

Preprint

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The bioenzymatic production of selenium oligosaccharides addresses the problems resulted from high molecular weight and poor water solubility of κ-selenocarrageenan, and lays a foundation for its application as adjuvant drugs for cancer treatment, and food additive. κ-Selenocarrageenase extracted from Pseudoalteromonas sp. Xi13 can degrade κ-selenocarrageenan to selenium oligosaccharides. The maximum optimized κ-selenocarrageenase activity using RSM was increased by 1.4 times, reached 8.416 U/ mL, under the optimum fermentation conditions: 1.6% κ-selenocarrageenan, 3.7 mmol/L Ca2+, and 33℃. The immobilized κ-selenocarrageenase exhibits good stability, 58.28% of enzyme activity was remained after reusing for four times. Selenium content of κ-selenocarrageenan oligosaccharide degraded by immobilized κ-selenocarrageenase was 47.06 µg/g, 8.3% higher than that degraded by the lyophilized enzyme. The results indicate that immobilized κ-selenocarrageenase is suitable for industrial applications and has commercial potential.

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Comparing freeze drying and spray drying of interleukins using model protein CXCL8 and its variants

Cited by 8 publications

References 57 publications

Formulation, Device, and Clinical Factors Influencing the Targeted Delivery of COVID-19 Vaccines to the Lungs

Formulation, Device, and Clinical Factors Influencing the Targeted Delivery of COVID-19 Vaccines to the Lungs

Effect of Atomic Layer Coating on the Stability of Solid Myoglobin Formulations

Optimization of κ-Selenocarrageenase Production by Pseudoalteromonas sp.X13 and Its Immobilization

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