Bacterial endotoxin requirements for dry powder inhalants and their excipients: are they critical quality attributes?

PDA J Pharm Sci Technol. 2014 Sep-Oct;68(5):386-93. doi: 10.5731/pdajpst.2014.00997.

Abstract

This review article considers whether bacterial endotoxin levels are a critical quality attribute for dry powder inhalants and their major excipient Lactose, NF. Based on international no-effect levels for workplace endotoxin exposure, the technical literature, typical indoor and outdoor airborne endotoxin levels, and manufacturing capabilities for Lactose, NF and dry powder inhalation products, a strong case is presented that bacterial endotoxin is not a critical quality attribute and endotoxin specifications are not required for inhalation products and their excipients.

Publication types

  • Review

MeSH terms

  • Administration, Inhalation
  • Consumer Product Safety
  • Drug Compounding
  • Drug Contamination / prevention & control*
  • Dry Powder Inhalers
  • Endotoxins / analysis*
  • Excipients / administration & dosage
  • Excipients / analysis*
  • Excipients / standards
  • Humans
  • Lactulose / administration & dosage
  • Lactulose / analysis*
  • Lactulose / standards
  • Patient Safety
  • Pharmaceutical Preparations / administration & dosage
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / standards
  • Quality Control
  • Technology, Pharmaceutical / methods
  • Technology, Pharmaceutical / standards

Substances

  • Endotoxins
  • Excipients
  • Pharmaceutical Preparations
  • Lactulose