Food Interaction Studies
Alcami is equipped and ready to handle study design and execution of food interaction studies to support a variety of oral solid dosage forms, including tablets, capsules, and suspensions. Our subject matter experts have developed and executed studies using infant formula, yogurt, orange juice, apple sauce, smoothies, and a variety of other foods and drinks.
- Alternate methods for administration are often needed for solid oral dosage forms, especially for pediatric and geriatric patient groups
- Foods and drinks are often used as taste-masking agents and thus require food studies
- Complex analytical methodology may be needed due to the wide variety of matrices encountered
- Evaluation of functionality after exposure, compared to a control
- Evaluation of the stability of the product in the food or drink under test
- Studies are designed around an understanding of the chemical characteristics of the active and excipient components, as well as the foods/drinks to be evaluated
Services offered at Alcami
- Excellent reputation for responsiveness, problem-solving, and reliable outcomes
- cGMP compliant with robust quality systems and exemplary compliance record
- Onsite XRPD capabilities
- Experience interpreting the general guidance to design food studies for various products
- Scientific expertise to aid in the selection of foods/drinks for regulatory acceptance and technical success
- Expedited services and flexibility to change the project scope, as needed
- Full range of complementary services to support needs
Ready to Get Started?
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