Accelerated Formulation Development and Fast to IND (fIND)
Improved Pharma performs the following four steps to accelerate development of the best form and formulation.
- Preformulation – Solid state chemistry and solid state properties.
This step is key to finding the right form of your drug candidate. Improved Pharma helps you evaluate or discover new forms and select the best one for development. If needed, Improved Pharma can conduct a polymorph screen and determine the structure of the forms produced.
- Amorphous screening or salt screening If your molecule is poorly soluble Improved Pharma can perform amorphous screening and salt screening utilizing Synchrotron data to find the best form to take into the clinic and also the best form to insure good exposure in toxicology studies. Improved Pharma has high-level project directors who make sure the form chosen is the best for your particular needs.
Improved Pharma also selects the best formulation for the chosen form to ensure stability and good performance and verifies the stability of this form using structural information based on Synchrotron analysis and accelerated stability studies. Improved Pharma provides a protocol tailored to your specific needs.
- Toxicity testing-Enhanced Exposure Improved Pharma’s studies will lead to the best formulation for GLP studies and a method of testing using this formulation. Improved Pharma can arrange for GLP testing if required. Improved Pharma can avoid delays by close coordination with its closely linked GLP laboratories.
- IND submission and GMP manufacturing Improved Pharma’s studies will provide you with all of the information needed to manufacture Phase I supplies and can arrange for this manufacturing at a site nearby.
Thus, Improved Pharma has the skills and interest to work with you to make sure your molecule makes it to the clinic in an optimum formulation