Laboratory Products

Why Pre-formulation Studies are Crucial to Successful Drug Development

Feb 16 2018 Read 458 Times

It is vital to understand the behaviour of a new active pharmaceutical ingredient (API) under various stress conditions to provide a solid foundation for development of a robust dosage form which can survive processing and a prolonged shelf live. The result of a poor, or no, pre-formulation study could be increased time and cost of drug development, an unstable product, or worse. Efforts taken on comprehensive pre-formulation studies are more than repaid via cost and time savings.

Newly discovered proteins identified through genomics, proteomics, or traditional medical research have historically been utilised in drug development with minimal knowledge about their mechanisms of action, structural characteristics and biochemical properties.

Proteins are inherently unstable, which has potential to alter its desired form, which could significantly compromise not only the drug’s efficacy, but patients’ safety. This is why pre-formulation is such an essential part of the drug development process. It is the group of studies undertaken in early biopharmaceutical development, prior to formulation development, focused on discovering the physicochemical properties of a new drug molecule which could affect its performance and consequent dosage form. It provides a scientific sketch of the drug in development.

Having a clear understanding of a protein’s behaviour and awareness of any adverse effects related to a product, demonstrates the worth of conducting pre-formulation studies. Getting things right the first time is much more preferable to making costly mistakes and it is also a much faster route to market. Furthermore, patent expirations and a reduction in the development of new, first-in-class molecules over the past 15 years has occasioned the strategy of drug repurposing. This is yet another reason to conduct comprehensive pre-formulation studies. Many companies outsource pre-formulation studies to service providers such as the R&D consultancy division of Biopharma Group.

Read comments0

Do you like or dislike what you have read? Why not post a comment to tell others / the manufacturer and our Editor what you think. To leave comments please complete the form below. Providing the content is approved, your comment will be on screen in less than 24 hours. Leaving comments on product information and articles can assist with future editorial and article content. Post questions, thoughts or simply whether you like the content.


Digital Edition

International Labmate Buyers Guide 2018

June 2018

In This Edition Articles - Choosing the Optimum Plasma Spectrochemistry Technique for Measuring Elemental Impurities in Pharmaceuticals - Monitoring Airborne Molecular Contamination in Indoo...

View all digital editions

Events

INTERPHEX JAPAN 2018

Jun 27 2018 Tokyo, Japan

PREP 2018

Jul 08 2018 Baltimore, MD, USA

AACC Annual Meeting & Clinical Lab Expo 2018

Jul 29 2018 Chicago, IL, USA

HPLC 2018

Jul 29 2018 Washington DC, USA

M&M 2018

Aug 05 2018 Baltimore, MD, USA

View all events