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Poor solubility can be a real issue during drug development, as it can lead to low bioavailability, which causes suboptimal drug delivery, and often risks the drug being withdrawn from development.

Serialisation has been widely talked about across the industry for some time. Despite this, many companies have failed to prioritise developing a solution meaning ensuring compliance come the various market deadlines is becoming increasingly difficult. 

Getting a drug from formulation development to first in human (FIH) trials can be a complex process that costs pharmaceutical companies huge amounts of time and money, and if a drug fails, it can be catastrophic for the businesses involved.

Inhalation drug products have a multitude of benefits when delivering treatment to the lungs, including a faster onset because of direct delivery to the area requiring therapeutic treatment and reduced occurrence of adverse effects.

Staffan Widengren, Director of Corporate Projects at Recipharm recently took part in a Manufacturing Chemist roundtable to discuss the challenge of new serialisation regulations put in place to protect against counterfeit medicines.

This month Erik Haeffler, Vice President of Manufacturing Services at Recipharm took to the Medicine Maker alongside other serialisation experts to discuss whether the industry is ready for the upcoming regulatory deadlines and to dispel the misconception that serialisation is simply ‘adding a label to the box.’

The approach involved testing the interactions of 30 different excipients with six commercially available drugs, with a diverse range of properties.

Dr Amjad Alhalaweh, a formulation scientist at Recipharm, takes to Pharmaceutical Manufacturing 

Erik Haeffler, Vice President of Manufacturing Services and Head of CSR at Recipharm, discusses the DSCSA enforcement delay with Contract Pharma and outlines what companies should be doing now to ensure they are ready ahead of the deadline next year.

Despite the FDA’s decision to delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) in the US until 2018, companies need to continue to press ahead with their preparations for serialisation. 

Recipharm’s Torkel Gren joins Synthonics and Rush University representatives to discuss a new technology that improves pharmacokinetic (PK) properties in metal coordinated pharmaceuticals (MCPs).