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 and is an important step to complete before moving forward with formulation studies, as knowledge up front will save valuable time and money long-term. 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.
Improved Pharma has also developed an accelerated timeline that goes from the first demonstration batch to the IND in 52 weeks. Professor Stephen Byrn, the founder of both SSCI and Improved Pharma, developed the popular fast to IND service named INDiGO, now marketed by Evotec. Synchrotron-based Fast to IND (S-fIND) builds upon this concept by using the power of the synchrotron to improve the speed of the development. Synchrotron analysis enables the detection of new polymorphs and the analysis of formulations with greatly enhanced sensitivity, learning more about the system in ways not possible with traditional techniques. More knowledge leads to quicker solutions and avoids unwanted surprises that can often appear later in development.
For more about S-fIND, please refer to this paper.