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Food & Drug 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.
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Key Concepts

  • 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

Available Food & Drug Interaction Studies

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Integrity

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Potency

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Stability

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Homogeneity

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Dissolution & Drug Release Testing

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
 

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