Preformulation

Proper pharmaceutical formulation enables an APIs optimal performance. At Particle Sciences, we design delivery systems and excipients to work as a unit. From dry powders to multiphasic emulsions to encapsulation systems, they are all means to the same end: getting the right amount of API to the right place at the right time.

At Particle Sciences, the formulation process starts by clearly defining the client's goals for API performance. Next, API characteristics are documented through a thorough preformulation effort and mapped against the desired performance. From this, a clear picture emerges as to what the entire delivery system needs to accomplish, enabling the design of a clear program incorporating timelines, milestones and performance testing. Throughout the drug development process at Particle Sciences, extensive use is made of computational tools such as Design of Experiments (DoE) and modeling software.

Particle Sciences has developed a proprietary preformulation approach we call DOSE™ which is based on a combination of empirically collected data and our propriety computational tools. This reduces the amount of time and resources used in developing formulations by providing insight into the physicochemical behavior of the APIs and narrowing the excipient space that needs to be evaluated during product development. This powerful approach of combining hands-on measurements with predictive software provides PSI's clients with a competitive advantage by decreasing the time and expense necessary to make informed decisions early on in the formulation development process.

Solubility mapping: The software calculates the degree of physical compatibility—solubility or miscibility—of active pharmaceutical ingredients (APIs) with any other ingredient being considered. Each API, solvent, polymer or excipient can be characterized by the 3 HSPs (Hansen Solubility Parameters - dispersion, polar and hydrogen bonding) and their mutual compatibility, based on "like dissolves like", is calculated by the "distance" between the two sets of HSPs. By using a proprietary panel of solvents and an extensive database of known HSP values vetted against performance, Particle Sciences is able to quickly characterize a given compound. The result of utilizing this tool is increased efficiency and a more scientifically rational approach to formulation development.

Drug elution modeling: The third tool accurately models the release of a given API from a non-degrading polymeric device, such as an implant or an intravaginal ring. Using a base set of system measurements, the proprietary software combines a number of mathematical diffusion models to predict the release kinetics from arbitrary device formats, and allows Particle Sciences to significantly reduce the time needed for prototyping drug-device combination products.

Particulate stability modeling: Introduced in mid-2011 this proprietary program combines electrostatic and steric stabilization theories to calculate inter-particle forces in dispersed systems, informing the design of stable nano or micro particle suspensions.

Particle Sciences works closely with other leading experts to refine Particles Sciences' programs for our specific needs. Using this approach, physical properties such as solubilities, logP, permeation and release kinetics, and surface characteristics can be calculated and actionable predictions can be made that guide the development process.