Characterization of a non-stoichiometric hydrate (active) in low dose capsules with ssNMR

Apr 30, 2024 | 11 a.m. PDT | 2 p.m. EDT

Solid-state NMR is a powerful and sensitive analytical tool for directly characterizing active pharmaceutical ingredients in a drug product without interference from excipients. This work focuses on identifying the hydration state in a non-stochiometric hydrate in a 1% drug load capsule formulation using 19F ssNMR with other characterization techniques.

Determination of the water content in a non-stoichiometric hydrate(NSH), when present in a formulation, is extremely important due to physico-chemical and content uniformity issues potentially caused by the variability in the lattice water content, which changes with external RH. ssNMR was used to identify the hydration state in one such NSH (active) formulated as a 1% drug load capsule since this technique bypasses interference from formulation excipients. Using the changes in peak shifts observed in the 0-100% RH range, 19F ssNMR could successfully determine the lattice water content (0-0.85 moles) in NSH in the drug product.

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