Utilizing Synchrotron-based analytical and Pair Distribution Function Data, Improved Pharma provides an expert assessment of the current status of your polymorph screening activities. These Synchrotron-based studies provide structural knowledge and also analytical information at/near the lowest possible detection limit. Improved Pharma may suggest additional experiments or approaches to determine which form is most stable. Improved Pharma can also use its superior expertise in solid state chemistry to design a solid form screening and selection process based on the structure and known properties of the starting drug. Finally, Improved Pharma can suggest when it is most appropriate to search for salts, cocrystals, or amorphous forms typically utilizing Synchrotron-based approaches.
Polymorphism and solid-state chemistry are the lynchpin in successful fast development. Improved Pharma uses its knowledge and expertise with Synchrotron-based data to get the solid-state chemistry right in a fast economical way. Thus stability, handling, and solubility problems are avoided and development is accelerated.
Solubility – Getting the solid-state chemistry right is particularly important for poorly soluble compounds. For these materials, it is possible to gain substantial improvement in solubility by using the proper solid form – typically a salt, amorphous form or cocrystal. Additionally, materials milled to small particle size with surfactants provide another approach to enhancing solubility. Improved Pharma’s strategies are superior for poorly soluble compounds.
Particle size – Improved Pharma has extensive experience with particle size issues and analytical methods to determine particle size. It is critical to understand particle size in the manufactured lot(s). Furthermore, in some cases, milling with surfactants is sufficient to achieve the desired solubility. Improved Pharma has the experience and knowledge to understand particle size effects on bio-availability and stability.
An IVIVC or relationship can be extremely helpful in formulation design. Improved Pharma is capable of carrying out the screening experiments necessary to find a medium for an IVIVC, if possible. Improved Pharma could use dog or pig bioavailability data for these studies if requested.