Formulation optimizationPharmaceutical InformationUpdated on Aug 28, 2019 View more like this | Visit SHIRLEY, NY | Contact Cathy Miller |
Steps of formulation development
A formulation contains the active pharmaceutical ingredient (API) and other inactive excipients.
• Firstly, excipient compatibility studies. Aiming to select viable excipients that are chemically and physically compatible with the API(s). The excipients selected during the excipient compatibility study are incorporated into the process feasibility study using DOE.
• Next, selecting the final excipients and define the optimal levels for all excipients in the formulation.
• Finally, designing and conduct a formulation optimization study to optimize the excipient levels in the final formulation system.
Creative Peptides offers design and optimization of formulations from early pre-clinical stage to Phase I and Phase II clinical trials and commercial manufacturing. We are dedicated to help you achieve the optimal formulation for your APIs.
A formulation contains the active pharmaceutical ingredient (API) and other inactive excipients.
• Firstly, excipient compatibility studies. Aiming to select viable excipients that are chemically and physically compatible with the API(s). The excipients selected during the excipient compatibility study are incorporated into the process feasibility study using DOE.
• Next, selecting the final excipients and define the optimal levels for all excipients in the formulation.
• Finally, designing and conduct a formulation optimization study to optimize the excipient levels in the final formulation system.
Creative Peptides offers design and optimization of formulations from early pre-clinical stage to Phase I and Phase II clinical trials and commercial manufacturing. We are dedicated to help you achieve the optimal formulation for your APIs.
