Endotoxin testing in inhalation grade lactose—a useful quality parameter?

Steckel, Hartwig; Furkert, Franz H.

doi:10.1016/j.ijpharm.2004.02.003

Cited by 4 publications

(2 citation statements)

References 2 publications

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“…Bacterial endotoxin requirements are not regarded as a critical quality attribute in dry powder inhalants [51]. However, considering the recombinant source of the protein, as well as the potential lifelong administration of an AAT-based inhalable product, we considered this preliminary purification worthwhile, since inhaled endotoxins are known to cause airway and systemic side effects [52,53].…”

Section: Discussionmentioning

confidence: 99%

Recombinant Alpha-1 Antitrypsin as Dry Powder for Pulmonary Administration: A Formulative Proof of Concept

et al. 2022

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Alpha-1 antitrypsin (AAT) deficiency is a genetic disorder associated with pulmonary emphysema and bronchiectasis. Its management currently consists of weekly infusions of plasma-purified human AAT, which poses several issues regarding plasma supplies, possible pathogen transmission, purification costs, and parenteral administration. Here, we investigated an alternative administration strategy for augmentation therapy by combining recombinant expression of AAT in bacteria and the production of a respirable powder by spray drying. The same formulation approach was then applied to plasma-derived AAT for comparison. Purified, active, and endotoxin-free recombinant AAT was produced at high yields and formulated using L-leucine and mannitol as excipients after identifying compromise conditions for protein activity and good aerodynamic performances. An oxygen-free atmosphere, both during formulation and powder storage, slowed down methionine-specific oxidation and AAT inactivation. This work is the first peer-reviewed report of AAT formulated as a dry powder, which could represent an alternative to current treatments.

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Section: Discussionmentioning

confidence: 99%

Recombinant Alpha-1 Antitrypsin as Dry Powder for Pulmonary Administration: A Formulative Proof of Concept

et al. 2022

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“…Experimental and epidemiological studies describing endotoxin dose response curves based on acute and chronic effects have shown no-effect levels of 90 -1,800 EU/m 3 in air (Steckel & Furkert 2004). In order to relate endotoxin concentrations in air to endotoxin levels in water, it is necessary to quantify aerosolised endotoxin densities arising from typical water-using activities.…”

Section: No Threshold Limits For Endotoxin Exist In Australiamentioning

confidence: 99%

Alternative water sources and endotoxin

O'Toole

Sinclair

Jeavons

et al. 2008

Water Science and Technology

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The primary objective of this preliminary study was to ascertain the concentration of endotoxin in a variety of Australian water types, including recycled water. A total of 42 sampling sites were surveyed, the majority on at least 2 separate occasions (total number of samples analysed was 76). Samples were collected from a variety of locations throughout Australia including: drinking water distribution (12), drinking water reservoir (4), wastewater treatment train (11) and finished recycled water (15). Class A recycled waters, defined microbiologically in Australian regulations as having <10 E. coli per 100 mL, where the treatment train did not include membrane filtration, gave rise to an average measured endotoxin concentration of 2.030 Endotoxin Units (EU) per mL (N=7). For recycled Class A water samples, where membrane filtration was part of the treatment train (N=3) the average endotoxin concentration was 41 EU/mL. Measured endotoxin concentrations in drinking water varied from <4 to 119 EU/mL. Results of this preliminary study indicate that endotoxin concentrations in recycled water may be reduced to levels at least as low as those found in drinking water but for some recycled waters, where membrane filtration is not practiced, higher endotoxin concentrations may persist.

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Overcoming the Undesirable Properties of dry-powder Inhalers With Novel Engineered Mannitol Particles

Nokhodchi

Larhrib

2013

Ther. Deliv.

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Endotoxin testing in inhalation grade lactose—a useful quality parameter?

Cited by 4 publications

References 2 publications

Recombinant Alpha-1 Antitrypsin as Dry Powder for Pulmonary Administration: A Formulative Proof of Concept

Recombinant Alpha-1 Antitrypsin as Dry Powder for Pulmonary Administration: A Formulative Proof of Concept

Alternative water sources and endotoxin

Overcoming the Undesirable Properties of dry-powder Inhalers With Novel Engineered Mannitol Particles

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