New Drug Development
Why Outsource to a New Drug Development CRO?
For small drug-discovery firms, outsourcing Preformulation CRO is the only economically viable route. For companies producing large numbers of NCEs, insourcing becomes an option. However, outsourcing to a preclinical CRO has many compelling advantages associated with increased expertise and lower total costs:
- Access to a team of drug-discovery experts with Preformulation study experience across a broad range of compound structures and dosage form
- No setup costs for recruiting and equipment acquisition
- No delay associated with setting up an in-house department
- No wasted capacity or delays associated with uneven volumes of new compounds
- No shut down costs associated with finishing preclinical development
Preformulation development studies were conducted to determine the physical and chemicalcharacteristics of the compound of interest be it a small organic molecule, peptide or protein. The data of these studies generated were a prerequisite to dosage form development and also the data required for submission of the Chemistry, Manufacturing and Control (CMC) section of the Investigational New Drug application (IND). Adept provides the following general Preformulation development studies.
Preformulation studies:
- 1. Pka and or pI
- 2. pH-solubility profile
- 3. pH-stability profile at accelerated temperatures
- 4. Partition coefficient and distribution coefficient as a function of pH
- 5. Salt formation characteristics
- 6. Dissociation constants
- 7. Disintegration studies
- 8. Dissolution studies
- 9. Hygroscopicity analysis
- 10. Lipophilicity analysis
- 11. Moisture analysis
- 12. Excipient compatibility studies
- 13. Determination Accelerated stability studies
- 14. Accelerated stability studies with controlled storage at 40º C/75% RH, 60º C
- 15. Viscosity analysis
- 16. Intrinsic solubility
- 17. Preparation and writing of the CMC for the IND
If your drug-discovery team needs help determining Preformulation studies, Adept can help, either as part our Drug development suport for your program, or as stand-alone consulting. Contact us for details