Pharma Bytes: Interview with Per Holm of Lundbeck

Andrea Charles

Dr. Per Holm, Chief Specialist Product Development and Lifecycle Lundbeck, joined Pharma IQ for a quick Q&A session on formulation development ahead of the Global Preformulation & Formulation Summit, taking place in Amsterdam from the 11th -13th April 2011.

Pharma IQ: Please could you tell us a bit about your current role?  

P Holm: I am responsible for our drug delivery strategy within primarily solid dosage forms and implementing new process and formulation technologies 

Pharma IQ: What is the biggest challenge facing formulation development teams? How are the industry and providers seeking to overcome it?  

P Holm: The biggest challenge is to provide a fast development program with a clear risk evaluation. One solution is providing standard formulation technology platforms with known design spaces ready to be applied in the different stages of the product development program. 

Pharma IQ: Early stage preformulation is a hot topic in formulation development, what are the benefits?
Preformulaiton is the fundament for the development program including stability screening, compatibility and one often overlooked factor particle size distribution characterisation (shape and morphology).

Pharma IQ: How have advances in drug delivery devices impacted on formulations?  

P Holm:
Drug delivery devices have not had any impact on our formulations of solid dosage form. In other areas like transdermal and nasal/pulmonal delivery advanced delivery devices have a significant impact and has to be closely interlinked with the formulation development.   

Pharma IQ: What strategies are companies employing for enhancing solubility?  

P Holm
: Still primarily solid dispersion and nano-particles. Co-crystal techniques might also be important in the future. 

Pharma IQ: What would be your top tips for planning a robust formulation strategy?  

P Holm:
Should provide a fast development process with low risk involved applying processs with known design space and up-scaling ability, (cost effective if possible).

Pharma IQ: For anyone interesting in attending the Global Preformulation & Formulation Summit, what will be your key take home message?  

P Holm: The importance of applying the thinking of QbD in a rational and operational manner employing risk analysis and DoE in the development of standard technology platforms.