Improved Pharma uses its knowledge in solid state chemistry to design a solid form for powder in a capsule and powder in a bottle formulation for Phase I. In the event that problems were noted in Phase I studies, a separate formulation design component will be included for Phase II supplies. In some cases the formulation design work will include the development of a preliminary IVIVC (in-vivo in-vitro correlation) dissolution test. Improved Pharma has extensive experience with amorphous formulations, gel caps, SECs, coated particles, microencapsulation, roller compaction, granulation and other methods. Improved Pharma also has extensive experience with stabilizing unstable formulations. In short, Improved Pharma has the experience to solve formulation and stability problems that might occur when making Phase I or Phase II supplies.
Polymorphism and Solid State Chemistry
Polymorphism and solid state chemistry are the lynchpin in successful fast development. 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.
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, cocrystal, 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.
Formulation for Phase I and Phase II
In some cases, it will not be possible to use powder in a capsule or bottle for phase II clinical supplies. For example, a flow aid may be needed or the powder may have such a low bulk density that high dose capsules cannot be prepared. In such cases, a formulation will need to be prepared. Improved Pharma will carry out rapid excipient compatibility studies and discover the best formulation for Phase II. Improved Pharma focuses on noninteracting formulations so that the release profile provided by the solid form is preserved in the formulation. This work can typically done during the Phase I trial thus insuring there is no delay in the development process.
IVIVC
An IVIVC can be extremely helpful in formulation design. Although Improved Pharma will typically use powder in a capsule for the First in Human studies, an IVIVC would be very helpful in designing a Phase II formulation. Improved Pharma is capable of carrying out the screening experiments necessary to find a medium for an IVIVC, if possible. Improved Pharma would use dog bioavailability data for these studies.
