PubMed Health⌕ Search
Home/Archive/PubMed

PubMed · 15081151

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

Hartwig Steckel·Franz H Furkert
View original source ↗Export metadata ↓

Abstract

Alpha-lactose monohydrate is the standard carrier used for dry powder inhalation drug products. The physico-chemical characteristics of this carrier material need to be monitored and specified carefully in order to guarantee functionality of the powder formulation. But also microbiological acceptance criteria need to be considered during development and routine testing. In this study, the endotoxin content of 19 batches of alpha-lactose monohydrate provided by two different manufacturers was determined with a semi-quantitative LAL assay. The endotoxin content was found to be less than 18 endotoxin units (EU)/g lactose in all cases and less than 3 EU/g in most cases. Assuming that the typical lactose has an endotoxin content of 10 EU/g and that a patient inhales six times daily 25 mg of lactose and that the total amount of lactose reaches the lung, this translates to an endotoxin exposure of 1.5 EU per day. On the other hand, the proposal for endotoxins in air limits the endotoxin concentration to 50 EU/m3 which corresponds to approximately 3333 EU inhaled endotoxins a day during normal breathing (breathing at rest conditions). The maximum endotoxin exposure by dry powder inhalations is thus two log steps lower than the recommended acceptable daily intake.

Explore related subjects

Administration, InhalationDrug CarriersDrug ContaminationEndotoxinsLactoseLimulus TestPowdersQuality ControlTechnology, PharmaceuticalComparative StudyJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

Hartwig Steckel, Franz H Furkert. 2004-05-04. Endotoxin testing in inhalation grade lactose-a useful quality parameter?. https://doi.org/10.1016/j.ijpharm.2004.02.003

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed2008

Concurrent carbogen and radiation therapy in children with high-risk brainstem gliomas.

In an attempt to improve local control, we assessed the feasibility of the addition of 4 min of carbogen inhalation (as a radiosensitizer) to daily fractionated radiotherapy in pediatric patients with high grade and/or diffuse brainstem gliomas. Ten patients inhaled carbogen for >90% of the radiation treatments. Median survival time from start of therapy was 0.80 years. Carbogen inhalation did not appear to improve the dismal prognosis.

Administration, Inhalation↗
PubMed2007

2. Advances in pharmacotherapy for COPD.

Chronic obstructive pulmonary disease (COPD) is the most common chronic lung disease in the world. In 1999, COPD ranked sixth among the most common causes of death and twelfth as a worldwide burden of disease. It has been estimated that by the year 2020 COPD will be the third leading cause of death and fifth as a worldwide burden of disease. Thus, COPD is a major medical problem and there is evidence that it is increasing throughout the world. Despite recognition of COPD as an important international health problem, COPD has been neglected among common diseases, with little investment in research on its underlying cellular and molecular mechanisms. Recently, global and Japanese guidelines for COPD have been published. These guidelines seem to be useful to improve the underdiagnosis and undertreatment of COPD. In this review, I describe briefly the current recommendation for pharmacological therapy of stable COPD according to the global and Japanese guidelines for COPD.

Administration, Inhalation↗