Making sure that a nasal spray pump is appropriate for the formulation and choosing a high-performing, well-characterised, and reliable device can minimize challenges and speed up time to market. This article reviews factors to consider in selecting a device.
The studies presented show formulation approaches that can meet the challenges of nasal dry powder vaccines.
For sponsors with nasal sprays in Phase III development, having knowledge of the necessary tests and possible in vitro alternatives to repeating clinical trials for the following potential product changes can save significant time and money.
Nasal drug delivery is an attractive, growing niche, in part because devices can confer added value compared to generics and clinically are able to deliver fast onset with non-invasive administration of systemically-acting drugs, including biologics. Development efforts are focusing on reformulation and repackaging of successful, existing systemic drugs. Regulatory pathways in Europe and in the […]
Market opportunities include use of unit-dose and bidose devices and preservative-free formulations while unmet needs include treatment of CNS diseases. Product lifecycle management and nose-to-brain delivery are also discussed.
Novel advances in intranasal delivery technologies are broadening the nasal route as a viable solution for systemic delivery of a wide range of drugs, biologics and vaccines.1 Nasal delivery offers compelling advantages including bypass of hepatic first-pass metabolism, reduced nausea, reduced toxicity and rapid onset. In addition, non-invasive nasal delivery systems eliminate the risk of […]
Intranasal vaccination, used successfully in veterinary medicine for years, has the potential to gain a reasonable share of the vaccination market within a few years. Intranasal delivery has a number of advantages over intramuscular and oral vaccines, particularly for special patient populations such as children and the elderly. Despite the introduction of fine hypodermic needles […]
While the relationship between certain spray characteristics and the therapeutic effect of a product is still under investigation, the FDA currently requires numerous techniques for characterizing the nasal spray drug product for New Drug Applications (NDAs). Submissions of Abbreviated New Drug Applications (ANDAs) also require a subset of these tests to demonstrate in vitro bioequivalence […]
A reliance on in vitro testing could aid in the timely approval of generics and could reduce time and expense for the development of novel products. Cost effective and efficient methods to establish bioequivalence would benefit the development of both brand-name and generic pharmaceuticals, saving both companies and consumers significant amounts of money. Much of […]
The Human Factors Engineering (HFE) process is based on user studies to identify risks and improve the device design accordingly. HFE also considers competence and user satisfaction to be equally important in ensuring patients’ adherence to their treatment. Verifying both a safe and user-friendly device eventually relies on a combination of very different factors, ranging […]