Chapter 2: Pitfalls in Formulation Development
FAILURE TO CONSIDER THE INTENDED ROUTE OF ADMINISTRATION CAN NEGATIVELY IMPACT THE API'S STABILITY AND SOLUBILITY Carefully considering the intended route of administration and its effects on the API's stability and solubility and selecting appropriate excipients accordingly. SGS Quay Pharma provide cost-effective screening platforms using solvents and/or excipients that are tailored to each API, considering key aspects such as indication, route of administration and intended species. We include PK assessments in the service, enabling formulation comparisons and PK/dose prediction modelling in our pre-clinical services. INADEQUATE TESTING OF THE FORMULATION'S STABILITY AND COMPATIBILITY WITH OTHER INGREDIENTS CAN LEAD TO EXCIPIENT INTERACTIONS OR DEGRADATION OF THE API Thoroughly testing the formulation's stability and compatibility with other ingredients via excipient
There are several potential pitfalls in finished product development that if not addressed during the formulation process, can lead to costly delays in product launch, including: INSUFFICIENT CHARACTERIZATION OF THE ACTIVE PHARMACEUTICAL INGREDIENT (API) CAN LEAD TO POOR STABILITY AND BIOAVAILABILITY OF THE API IN THE FINAL FORMULATION. Thoroughly characterizing the physicochemical properties of your key starting materials, excipients and finished products is vital when making decisions regarding processing equipment, packaging materials and environmental conditions. Adequate quantitative and qualitative testing methods provides a baseline to work from to inform the drug product development process. Without this deep knowledge there can be a significant impact on efficacious dosage form and/or long-term drug performance.
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