FDA publishes papers and guidance providing pathways for demonstrating bioequivalence of proton pump inhibitors via nasogastric tubes using in-vitro studies

FDA’s Office of Generic Drugs published a paper in the American Association of Pharmaceutical Scientists (AAPS) Journal providing recommendations for in vitro testing of proton pump inhibitors (PPIs) to support bioequivalence in generic drug applications. The paper provides an overview of factors impacting use of drug products via nasogastric (NG) tubes. 

The paper explains why these generics must be tested via NG tube and summarizes in vitro testing options for generic drug applicants.  In vitro studies for NG tube administration are a practical approach for generic companies because they are sensitive, reproducible, and allow for detection of differences in performance profiles between the test and the reference products. 

FDA used this information to update ten product-specific guidances (PSGs) to provide recommendations for in vitro feeding tube studies, including products containing dexlansoprazole, esomeprazole, lansoprazole, and pantoprazole. These guidances provide applicants clear pathways for demonstrating bioequivalence via NG tubes using in vitro studies. 

Use of in vitro studies over in vivo studies allow for faster generic drug approval without compromising product safety or efficacy. This paper and the updated PSGs clarify FDA’s expectations for generic drug applications for PPIs with the NG tube indication. This body of research will ultimately benefit patients by resulting in more timely access to generic drugs.

Relevant Links:

Pubmed article 

Product-specific guidances

FDA’s generic drug regulatory science research