Developing an API into a Drug Product
Thursday 24th April at Courtyard San Diego Old Town, California USA
Summary:
In order to get an active pharmaceutical ingredient into clinical trials it is necessary to carry out preformulation and formulation studies. The seminar will contain scientific content delivered by Professor Graham Buckton (School of Pharmacy University of London) who is an acknowledge expert in the field. After the event Pharmaterials and PII representatives will be happy to discuss how we can help with your development needs.
Seminar content
1pm Arrival and coffee
1.30 pm Preformulation and physical form
What physico-chemical information is needed in order to develop an API into a drug product? Polymorphism, amorphous forms, their screening and control – why is this important? How and when to test for polymorphs and how to understand amorphous forms. What data are vital for any company looking to license a compound out to big pharma? What will the regulator (FDA/EMEA) want to see?
2.30 pm Tea/coffee
3 pm Formulation development for poorly soluble drugs
Understanding the challenges of your API and how that will impact on the formulation selection. An overview of available strategies for getting poorly soluble drugs into solution, for gastro-intestinal and IV formulations. Discussion of suitable cost effective strategies for phase 1 formulation.
4pm Close / networking event
YOU MUST REGISTER TO ATTEND,
contact Sharon.Hogarth@pharmaterials.co.uk |
