Case Study

Nanomilling From Screening To Scale-Up

Source: Altasciences
Vaccine Manufacturing GettyImages-1384850913

In this study conducted by Altasciences' Contract Development and Manufacturing Organization (CDMO), a client presented a highly active compound poised for clinical trials, backed by impressive in vitro activity and a favorable toxicity profile. Despite these promising attributes, the compound faced challenges stemming from poor aqueous solubility and suboptimal bioavailability. Recognizing the need for formulation enhancements to fully harness the drug's inherent potential, the proposed solution involved the creation of a nanosuspension through aqueous nanomilling.

The rationale behind this approach lies in the transformation of particle size from micrometers to the nanometer range, leading to a substantial increase in the surface area to volume ratio. This, in turn, results in a significant boost in the dissolution rate and overall bioavailability of the compound. The study aimed to assess the feasibility of nanomilling for the client's drug and to formulate a stable, nanoparticulate suspension of the active pharmaceutical ingredient (API) that could effectively enhance bioavailability. This investigation highlights the strategic use of nanotechnology to overcome formulation challenges and optimize the therapeutic potential of the drug in preparation for clinical trials.

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