Formulation development is an important part of the product development of new medicines. A well-designed formulation can have a crucial role for the drug candidate's success clinically. Our formulation scientists have good knowledge of the drug development process and can help from early preformulation to production of GMP classed trial material.
With an increased number of drug candidates in pipeline and a tight time schedule for pharmaceutical companies to reach clinical testing, an early plan for what administration route and formulation is needed for the specific active pharmaceutical ingredient (API) is required. There can be several reasons to outsource the formulation development externally, such as time limitations internally or the need to quickly recruit the right expertise and analytical capacity when needed during the development process. We at RISE can help solve an existing formulation problem or have a larger active role during the formulation development of a new drug candidate and involve an expert team to work as an extension of the own company.
Formulation development requires a deep understanding of how the physicochemical properties of an API will affect the stability, solubility and bioavailability of the molecule. Depending on the API (small molecules or biologics, such as peptides, proteins, enzymes, nucleotides and antibodies), specific expertise and an adjusted formulation strategy is needed to guide in the right choice of excipients/carriers and dosage form. The development of a new drugs may require that the formulation is being adjusted and optimized during the preclinical phase and initial animal studies, and further developed before clinical testing and finalized drug product.
At RISE we have expert knowledge in formulation and a broad instrument park for analysis and characterization of API/formulation. We also have the ability for specific analysis development for the API to ensure that the right formulation strategy is being developed that maximizes the stability, solubility and bioavailability of the drug.
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