Use of Liquids and/or Soft Foods as Vehicles for Drug Administration

FDA has issued new draft guidance: “Use of Liquids and/or Soft Foods as Vehicles for Drug

Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments Guidance for Industry.”

The introduction reads: “This guidance applies to orally administered drug products and provides recommendations to sponsors who will use or recommend use of liquids3 18 and/or soft foods as vehicles for drug administration in investigational new drug applications (INDs), new drug applications (NDAs), Biologics License Applications (BLAs), as applicable, and in supplements to these applications. This guidance addresses the approaches recommended for suitability determination of vehicles intended for use with specific drug products by providing the following…Considerations for selection of liquids and/or soft foods as vehicles…Standardized in vitro methodology and data recommendations for drug product quality assessments to qualify vehicle(s) for drug product administration… Recommendations to communicate acceptable (qualified) vehicles in drug product labeling. If certain foods are found unacceptable, they should also be included in the labelling.

See: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM614401.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology