Formulation and Drug Delivery

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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.

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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.

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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.