Respiratory Administration of Infliximab Dry Powder for Local Suppression of Inflammation

Faghihi, Hooshang; Najafabadi, Abdolhossein Rouholamini; Daman, Zahra; Ghasemian, Elham; Montazeri, Hamed; Vatanara, Alireza

doi:10.1208/s12249-019-1308-0

Cited by 19 publications

(16 citation statements)

References 36 publications

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“…A clinical trial is also in progress for the mAb fragment CSJ117 for asthma [42]. In another publication, Faghihi et al demonstrated successful formulation and administration of infliximab dry powder to suppress asthma-related inflammation in an animal model [22]. These studies, considered alongside this work, demonstrate the therapeutic potential of inhaled dry powder mAb formulations to treat a range of lung diseases.…”

Section: Discussionmentioning

confidence: 67%

“…By fine-tuning the spray drying process parameters, powders suitable for inhaled delivery (e.g., with aerodynamic diameters < 5 μm) can be generated. Spray drying of proteins and mAbs has been demonstrated in the literature, typically for reconstitution into an IV formulation, and a few reports for inhalation [21][22][23]. A recent review extensively detailed work on spray-dried proteins [24].…”

Section: Introductionmentioning

confidence: 99%

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Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation

et al. 2021

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Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge. Here, spray drying was used to manufacture a dry powder pulmonary formulation of bevacizumab, a monoclonal antibody approved to treat non-small cell lung cancer (NSCLC) by intravenous infusion. By reformulating bevacizumab for local delivery, reduced side effects, lower doses, and improved patient compliance are possible. The formulation had aerosol properties suitable for delivery to the deep lung, as well as good physical stability at ambient temperature for at least 6 months. Bevacizumab’s anti-VEGF bioactivity was not impacted by the manufacturing process. The formulation was efficacious in an in vivo rat model for NSCLC at a 10-fold decrease in dose relative to the intravenous control.

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Section: Discussionmentioning

confidence: 67%

Section: Introductionmentioning

confidence: 99%

Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation

et al. 2021

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“…Faghihi et al characterised and optimised an inhalable powder formulation of IgG antibodies by a design of experiment approach on the levels of three excipients (cysteine, trehalose and tween 20) [163]. Utilising an ovalbumin-challenged mice model, the group later demonstrated that the bioactivity of infliximab was preserved upon spray drying as reflected by a reduced TNFα (tumour necrosis factor alpha) secretion in lung tissues [164]. As an alternative to SD, SFD has gained popularity recently [157,161].…”

Section: Proteinsmentioning

confidence: 99%

Inhalation delivery technology for genome-editing of respiratory diseases

Chow

Chang

Chan

2021

Advanced Drug Delivery Reviews

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The clustered regulatory interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (CRISPR/ Cas9) system has significant therapeutic potentials for lung congenital diseases such as cystic fibrosis, as well as other pulmonary disorders like lung cancer and obstructive diseases. Local administration of CRISPR/Cas9 therapeutics through inhalation can achieve high drug concentration and minimise systemic exposure. While the field is advancing with better understanding on the biological functions achieved by CRISPR/Cas9 systems, the lack of progress in inhalation formulation and delivery of the molecule may impede their clinical translation efficiently. This forward-looking review discussed the current status of formulations and delivery for inhalation of relevant biologics such as genes (plasmids and mRNAs) and proteins, emphasising on their design strategies and preparation methods. By adapting and optimising formulation strategies used for genes and proteins, we envisage that development of inhalable CRISPR/Cas9 liquid or powder formulations for inhalation administration can potentially be fast-tracked in near future.

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“…19,49 In summary, multivalent sialylated IgG Fcs offer many advantages over existing approaches to deliver high-avidity blocking or triggering of sialic acid-dependent receptors, such as Siglecs (Table 1). The proven abilities of the Fc to be intravenously injected 16 and of Fc-fusions to be delivered directly into the eye 115 or as an aerosol to the respiratory tract 116 are particularly noteworthy. As the binding epitope for all hemagglutinins is sialic acid and is determined by the host, these ligands are less prone to viral escape by genetic drift compared to mAbs and, unlike mAbs, are more readily manufactured and improvable through click-chemistry approaches to the glycan backbone as a consequence of introducing additional N-linked glycosylation at exposed sites in the Fc.…”

Section: Sialic Acid Receptors Of Virusesmentioning

confidence: 99%

The therapeutic potential of sialylated Fc domains of human IgG

Pleass

2021

mAbs

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Pathogens frequently use multivalent binding to sialic acid to infect cells or to modulate immunity through interactions with human sialic acid-binding immunoglobulin-type lectins (Siglecs). Molecules that interfere with these interactions could be of interest as diagnostics, anti-infectives or as immune modulators. This review describes the development of molecular scaffolds based on the crystallizable fragment (Fc) region of immunoglobulin (Ig) G that deliver high-avidity binding to innate immune receptors, including sialic acid-dependent receptors. The ways in which the sialylated Fc may be engineered as immune modulators that mimic the anti-inflammatory properties of intravenous polyclonal Ig or as blockers of sialic-acid-dependent infectivity by viruses are also discussed.

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Respiratory Administration of Infliximab Dry Powder for Local Suppression of Inflammation

Cited by 19 publications

References 36 publications

Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation

Local Treatment of Non-small Cell Lung Cancer with a Spray-Dried Bevacizumab Formulation

Inhalation delivery technology for genome-editing of respiratory diseases

The therapeutic potential of sialylated Fc domains of human IgG

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