Pharmaceutical formulation development links the discovery of a new drug substance to the successful development of a commercial drug product. Some drug entities are difficult to deliver in vivo due to formulation complexity or because of API solubility. The latter can require special drug delivery approaches or special API preparation schemes. At times, because of the dosage and potency of the therapeutic entity, there is a need for metered delivery, i.e., a sustained release methodology. Formulation development scientists must determine the most appropriate route to achieving effective drug delivery based on patient need, then optimize the formulation’s characteristics based on a knowledge of the drug product’s bioavailability and processing requirements. Pre-formulation activities involve the characterization of a drug’s physical, chemical, and mechanical properties in order to choose what other ingredients (excipients) should be used in the preparation. Tornado’s Raman spectroscopy-based analyzers can provide high-quality data that can be gathered quickly and reliably during formulation development. Raman techniques have the capability of analyzing the composition, as well as the distribution of components and their physicochemical properties, which are prominent factors governing drug dissolution profiles and their associated bioavailability. Raman can also be useful in characterizing drug-excipient interactions. In complex delivery formulations, this can be critical quality information concerning physiological efficacy. Thus, useful information can be obtained bridging formulation development to the final product quality. See Tornado’s white paper on the study of CBD inclusion in cyclodextrin as a formulation delivery vehicle to get a better idea how our Raman instrumentation can contribute to effective formulation development.
Pharmaceutical Formulation - Formulation And Development with Tornado Analyzers
“The Tornado HyperFlux PROPlus has gathered thousands of reproducible spectra since we acquired it in mid-2019 without requiring a single repair.”
– Angela Spangenberg, Senior Research Scientist, DisperSol Technologies