Ingredient-specific Particle Sizing: Reducing Risk, Cutting Cost and Saving Time in Preclinical Inhalable Formulation Development

of new drug approval applications submitted to regulatory authorities, pharmaceutical companies are continuing to pursue new delivery methods for their drug products. The inhalation and nasal products had combined sales exceeding US$22 billion in 2007 for treatment of asthma, COPD, allergic rhinitis, influenza, migraine and osteoporosis, and for use in general anaesthesia. 1 One common trend is to develop respiratory delivery technologies for drugs currently administered via injection. Despite some initial problems, such as the failure of Pfizer’s Exubera (inhaled insulin), the concept of systemic delivery via the lung is by no means dead, and many companies continue to develop inhaled drug products. While the indications for many inhalable and nasal drug delivery products have been somewhat limited to diseases such as allergic rhinitis and asthma, this is likely to change soon. Continuous research and development activities are gradually opening up opportunities in new therapeutic areas. Nasal drug delivery is becoming more common due to the potential for increased drug uptake rates, improved bioavailability for certain drugs (relative to oral dosing), and convenient administration. A growing number of nasally delivered, systemically acting drugs for a number of therapeutic areas are reaching the market or are in the pipeline. Other areas where new nasal and inhalation drug delivery approaches could provide an alternative to current dosage forms (such as intravenous administration) are crisis situations (seizure and heart attack), motion sickness and psychotropic drugs.