Solid state chemistry is the lynchpin to successful fast development in a large number of cases. Improved Pharma uses its knowledge to get the solid state chemistry right in a fast, economical way. Thus, stability, handling, and solubility problems are avoided and development is accelerated.
Solid State chemistry - Finding the right polymorph early
Improved Pharma uses 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. This process can be carried out during the scale up of the synthesis. Then the selected form is manufactured. This form is fully characterized and used for both the preclinical studies and the clinical supplies. Forms of interest include crystalline forms, salts, liquid crystals, nanoparticles, and amorphous materials. Improved Pharma assigns its inventions to the client.
Poorly soluble compounds
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, cocrystal, liquid crystal, nanoparticle, or amorphous form. Improved Pharma’s strategies are superior for poorly soluble compounds.
Stability
Improved Pharma uses FPOC and its extensive experience with solid state stability to prepare stable clinical supplies. During the solid form screening, extensive stability studies under accelerated and forced degradation conditions are performed. These studies focus on both chemical and physical stability of the solid form. Improved Pharma has a strategy using a minimum of experiments to obtain information on the stability of clinical supplies for the clinical study. These stability studies are used to select the form for manufacture into clinical supplies.
Control
Improved Pharma will typically develop a method to insure control of the solid form in the API and drug product. This method will be easy to use and typically involves comparison of the observed pattern with a reference pattern.
Particle size
Improved Pharma has extensive experience with particle size methods. In many cases it will be critical to understand particle size in the manufactured lot(s). Improved Pharma has the experience and knowledge to understand particle size effects on bioavailability and stability.
FPOC
FPOC contains a stability prediction module that facilitates decision making in cases where development is difficult due to stability problems.Contact Improved Pharma for more information or a proposal in any of the above areas.
