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Pharmaceutical Technology Europe-03-01-2008
Pharmaceutical Technology Europe
20th Anniversary Special Feature: Two decades of packaging development
March 01, 2008
Primary Packaging
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Twenty years ago it was commonplace for pills, tablets and capsules to come in small, plastic or even glass bottles. Syrups were a much more common galenic solution than today, and individual dosages of injectables were only offered in glass vials and ampoules.
A stability-indicating HPLC procedure for determination of diltiazem hydrochloride in extemporaneously compounded oral liquids
March 01, 2008
Manufacturing and processing
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The stability of drugs in solid forms such as powders, tablets and capsules is usually determined very thoroughly by the drug's manufacturer. Based on stability study data, the shelf-life of a drug substance or a drug product is assigned. In addition to dispensing solid dosage forms to patients, pharmacists are frequently asked to compound oral liquid preparations for which the shelf-life or beyond-use date are assigned based on the pharmacist's best judgment - often without the benefit of stability data.
The challenge of 21st century influenza
March 01, 2008
Manufacturing and processing
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Conventional influenza vaccines use an egg-based culture and harvest process. This is slow and inflexible compared with emerging cell culture-based approaches that respond rapidly to the influenza virus's inherent ability to 'drift' or, more dangerously, 'shift' - a critical factor that would arise in the event of a pandemic.
Automation works
March 01, 2008
Spotlight
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My personal experience of lab automation is limited to supervising a peptide synthesiser back in the late 1980s. The machine was eye-wateringly expensive - but it was soon paying its way in terms of productivity and research publications. So if I were a stake-holder in a company pondering whether to invest in a well-designed gadget that could automate a routine operation, I'd say: 'go for it'.
Supporting critical Phase I–IV clinical studies by outsourcing supporting elements
March 01, 2008
Outsourcing
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The pharmaceutical industry has experienced a number of difficulties during recent years. Greater competition from generics (more than 60% of prescription drugs are supplied from the generic market) and increased gaps in the drug pipeline that result in acquisitions or strategic alliances has led to a feeling of uncertainty in the bio/pharma marketplace. There have also been changes in the marketplace with a shift from primary care to specialty drugs, the introduction of personalized medicine driving the need for biomarker/diagnostic technology and the introduction of biopharmaceuticals.
Making data analysis lean
March 01, 2008
PAT
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Six sigma, process analytical technology (PAT) and related initiatives are driving greater use of statistical analysis methods to increase process understanding and improve manufacturing capabilities.
Outsourcing still the way forward
March 01, 2008
Talking Point
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During the past two decades, outsourcing has become increasingly prevalent as the way to gain competitive advantage. This trend has led to a significant increase in the number of services and functions available for outsourcing, and there are emerging opportunities for niche outsourcing to contractors that provide specialized sets of tools and access to cutting-edge technology.