Alcami’s scientists have substantial experience designing and executing food interaction studies that comply with the highest quality standards, which have expedited formulation selection and regulatory approval for a variety of pharmaceutical dosage forms.
Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients. Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. For immediate release, enteric-coated, modified release, or extended-release dosage forms, a food study is required to evaluate whether the alternate route of administration impacts the therapeutic dose.
Effective, compliant food study design must include:
For solid formulations that may be administered by sprinkling the drug product on a liquid or soft food vehicle, the FDA requires food studies on any foods intended to be listed on the drug product. The guidance strongly recommends scientifically rigorous, in vitro manipulation and extraction studies be performed to evaluate the effect of any indicated foods on the therapeutic dose. Alcami has experience designing in vitro studies that meet FDA requirements, which include the following:
Alcami is an experienced partner for performing food studies using a variety of dosage forms, including tablets, capsules, and suspensions. Our teams have designed and executed many successful studies for home administration by using foods and drinks such as orange juice, apple sauce, infant formula, yogurt, and smoothies. Our experience with these studies enables us to provide our customers with expedited timing from study design through execution, and issuance of the final report.
Alcami has the capabilities and expertise needed for effective, compliant food studies:
Onsite XRPD capabilities for integrity testing
Experience developing and modifying analytical methods for use in food studies with various dosage forms
Scientific expertise to aid in the selections of foods/drinks for regulatory acceptance and technical success
Experience interpreting the general guidance to design food studies for FDA filed & approved products
Exemplary record of cGMP compliance with robust quality systems
Experienced Project Management team which ensures scope and timelines are communicated and achieved
Reputation for responsiveness, problem-solving, and reliability
Range of complementary development and manufacturing services capable of supporting full product development