Cool Runnings

THE CURRENT CLIMATE

Key drivers in recent years within the pharmaceutical and healthcare sectors relating to temperature-sensitive APIs and finished products include:

• Growth of temperature-sensitive products from R&D to marketplace
• Increasing focus by regulatory authorities
• Broader guidelines/regulations
• Increased media focus
• The need to deliver complete, integrated solutions for the purpose of the customer

One significant change within recent years has been an increasing focus on temperate products; the MHRA aptly stated that “30 per cent of serious GDP deficiencies during 2004 and 2005 related to storage and transportation of medicines other than cold chain products”, raising the question, what are these products types and why? The correct definition coined by the MHRA is as follows: “temperate chain distribution refers to storage and transportation of products that are chemically and physically stable between +15 and +30°C, with occasional excursions permitted to +35°C”. The reasoning behind such stability is that major time and temperature excursions beyond these ranges leads to separation, change in crystalline structure, sedimentation of active ingredients and reduced product shelf life (1). Products within this range can include anaesthetics, oncology products, eye drops, selective serotonin reuptake inhibitors (SSRIs) and antibiotics.

Another crucial point to mention that reinforces the need for the increasing spotlight on products within this range is that medicines with a combined worth of $65 billion currently stand to lose patent protection within two years and will be taken up by Indian generic manufacturers, who are currently pushing through patent challenges (2). Furthermore it has been reported that the NHS would make considerable savings amounting to several billion pounds by switching, where possible, to cheaper generic versions of drugs whose patents have or are due to expire.