Developing an API into a Drug Product 

3rd June - Best Western Quy Mill Hotel, Cambridge UK

4th June - Kassam Stadium, Oxford

Summary:

In order to get an active pharmaceutical ingredient into clinical trials it is necessary to carry out preformulation and formulation studies. This free to attend half day seminar is designed to help. 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

Presenter:

Professor Graham Buckton

Graham has BPharm, PhD and DSc degrees from the University of London UK. He is Professor of Pharmaceutics at the School of Pharmacy, University of London and his research has covered materials science and its impact in a wide range of drug delivery systems, including solid oral dosage forms and inhaled therapeutics. He research has been recognised with numerous awards, including the Pfizer Award, the Sunner Award, and the British Pharmaceutical Conference Science Medal. He is Editor of International Journal of Pharmaceutics and has served on the editorial board of many journals. He has been a member of the Committee on Safety of Medicines and chaired its Chemistry, Pharmacy and Standards sub-committee (the body that reviews product licence applications in the UK) and as such has a good regulatory knowledge. He is a British Pharmacopoeia Commissioner and has chaired the BP excipients committee. Graham was the first Chairman of the Academy of Pharmaceutical Sciences of Great Britain and has been award an Academy Medal, he ia a Fellow of the Royal Phamaceutical Society of Great Britain, The Royal Society of Chemistry and the AAPS. He has run many training courses for learned societies and has been an invited lecturer across the world on the themes of materials properties and drug delivery. He has acted as consultant to companies in Europe, USA and  India. Graham is founder and Chief Executive Officer of Pharmaterials Ltd.

Who should attend: 

The seminar is an introduction to pharmaceutical development and would be well suited to those in bio-tech and virtual companies who are starting to face the challenges of developing actives into medicines. There will also be opportunities for networking and advanced question and answer sessions which will be well suited to those with a good knowledge of development and who wish to improve their understanding of the physical form issues surrounding a drug substance.

Registration details:

There is no fee to attend this seminar. Numbers are limited so please apply as soon as possible.

YOU MUST REGISTER TO ATTEND, 

contact Chris.Landeg@pharmaterials.co.uk