The US Food and Drug Administration (FDA) on Tuesday issued draft guidance providing considerations for sponsors who wish to recommend the use of liquids or soft foods as vehicles for administering drugs.
Liquids and soft foods are listed as optional vehicles for drug administration for certain oral drugs, especially when the target population for the drug, such as infants or small children, may be unable to swallow solid oral dosage forms.
To include recommendations for administering a drug with liquids (other than water) or soft foods in a product's labeling, drugmakers must assess whether the vehicles are suitable for use with the specific drug.
"Although sponsors are required to develop age-appropriate formulations as part of a pediatric drug development program occasionally the development of age-appropriate dosage forms and formulations proves to be exceedingly complex," FDA writes, noting that in some cases a liquid or soft food vehicle may be the only option for oral delivery.
Specifically, the guidance provides considerations for selecting liquids and/or soft foods for use as vehicles, a standardized in vitro
methodology and data recommendations for drug product quality assessments to qualify vehicles and recommendations for labeling.
According to FDA, a standardized approach to selecting and assessing liquid and soft food vehicles is important to ensuring consistent quality when a drug is administered with a vehicle.
When considering liquids or soft foods for use as a vehicle for drug administration, FDA says that only those with "no appreciable effect on drug product performance should be proposed."
Potential liquid or soft food vehicles should also be screened based on the drug substance and drug product being investigated, the properties of the proposed vehicle (such as its acidity/alkalinity or binding/chelating characteristics) and the target population(s).
The guidance, once finalized, will apply to drugs submitted to the agency in investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs) and in supplements to those applications.
However, FDA says the guidance is not applicable to abbreviated new drug applications (ANDAs) and says that sponsors should look to product specific guidance for recommendations on the use of liquids or soft foods as vehicles for drug administration with regard to generic drugs.
, Federal Register Notice