Innovative Dosage Forms
Development of a novel pharmaceutical dosage form with a validation concept to pharmacopoeia standards.
A pharmacy wanted to develop a novel dosage form that, until then, only a few competitors offered. Over four months I accompanied it from the first calculation to a handover-ready formulation: requested purchase prices for raw materials and labs, calculated possible margins, proposed what concretely needed to be bought, and co-developed the formulation from compounding substances per Ph. Eur. in the lab. The formulation was refined iteratively until it was right olfactorily, economically and in regulatory terms. Quality standards were researched for the specific context, an independent test by accredited labs requested in advance, and a quality concept handed over.
The result is a stable, reproducible dosage form that scales from laboratory to compounding scale. Validated to pharmaceutical standards, with a successful pilot phase and positive market response.
References and contacts for this project can be provided on request.