Technologies > API Micronization
API Microniz
API Micronization XPRESS

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Micronization XPRESS — A 7-day Accelerated Development Program to Micronize Your API for Enhanced Solubility and Bioavailability

A significant number of 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.

Our streamlined Micronization XPRESS program can quickly provide testing sample formulations for subsequent validation during in vivo studies using small (1-5g) quantities of the API that is often in short supply at the early stages of preclinical development. Based on our extensive experience in 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 by a short-term stability study to confirm integrity of the API using HPLC or other methods provided by a client, or we help to develop these methods.

Following completion of the proof-of-principle Micronization XPRESS study, we offer a Micronization D-SPRINT program that builds on the success of the initial finding and further refines lead formulations, provides more thorough characterization of physico-chemical properties, collects a richer set of stability data points, develops lyophilization protocols for wet formulations, and lays a foundation for 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
  • API stability control
 
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