FDA publishes draft guidance: Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality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

FDA is announcing the availability of a draft guidance for industry entitled Use of Liquids and/or Soft Foods as Vehicles for Drug Administration:  General Considerations for Selection and In Vitro Methods for Product Quality Assessments.  In the absence of availability of a dosage form that is appropriate for the targeted patient population (e.g., pediatric, geriatric), small amounts of liquids and/or soft foods can be used as described in the FDA-approved product labeling for immediate ingestion as the suitable vehicle(s) for oral administration of the specific drug product.  Generally, drug products mixed in small amounts of liquids (5 to 15 mL) or soft foods are used in pediatric and other patient populations who are unable to swallow solid oral dosage forms.  This guidance provides recommendations to sponsors who will use or recommend use of liquids 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.

The guidance provides considerations regarding the selection of liquids and/or soft foods as vehicles, methodology and data recommendations for drug product quality assessments to qualify vehicle(s), and recommendations regarding communicating vehicles that have been found acceptable or unacceptable in the labeling.  The recommendations are intended to ensure that selection of a vehicle does not compromise drug product performance.  This guidance and the methods it describes do not replace existing guidance documents that address food-effect assessments on the drug product or dosage form, or stability testing conducted to support a shelf-life determination.  

To comment on the draft guidance, please visit the public docket, FDA-2018-N-2544.