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Micronization XPRESS - NAT’s 7-day Accelerated Development Program to Rapidly Micronize your API for Enhanced Solubility and Bioavailability
Significant number of the drug development candidates display low solubility and bioavailability and thus present significant challenges in achieving desired therapeutic effects. Micronization allows for a dramatic increase of the API’s surface area and may lead to substantial improvements in pharmacological properties.
The streamlined Micronization XPRESS program offered by NAT aims to quickly provide testing sample formulations for subsequent validation in the clients’ in vivo studies using small (1-5g) quantities of the API that is often in short supply at the early stages of the preclinical development. Based on our extensive experience in the wet and dry milling, we developed a panel of highly effective approaches leading to a quick optimization of the milling conditions to low-micron or often sub-micron sized particles.
We support Micronization XPRESS program by a short-term stability study to confirm integrity of the API using HPLC or other methods provided by a client, or additionally help to develop these methods.
Following completion of the proof-of-principle Micronization XPRESS study, NAT offers a Micronization D-SPRINT program that will build on the success of the initial finding and further refine lead formulations, provide more thorough characterization of the physico-chemical properties, collect richer set of stability data points, develop lyophilization protocols for the wet formulations, and lay foundation for the scale-up and pilot production.
Critical features of our pioneering Micronization XPRESS program:
- Unparalleled speed with a 7-day completion time
- Delivery of a ready-for-testing formulation for in vivo studies
- Small amount of the API required for the full study
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