In its draft guidance “Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action” (April 2003),4 the FDA highlights the use of laser diffraction for measurement of the particle size distribution of both nasal sprays and nasal aerosols. Cascade impaction is recommended for scrutiny of the finer end of the distribution. This […]
Recently, specially-designed devices have emerged that can target the delivery of sprays or powders to the olfactory region of the nose, thereby enabling delivery of the drug directly to the central nervous system. This article examines nasal spray formulation parameters and excipients and their influence on key in vitro tests.
Although nasal aerosol products to treat pain have been available for a number of years, recent developments have brought renewed interest to this market. In addition, estimated at over two billion dollars in 2009, the world market for nasally administered systemic drugs has seen strong growth in the last few years. This article will look […]
The past few years have seen the leveling off of new molecular entities (NMEs) reaching the market,1-3 partly as a result of increasing drug development costs and higher regulatory standards for drug approval. Yet many opportunities still exist in this changing pharmaceutical market for both innovator and generic pharmaceutical companies who are willing to seek […]
Quality by Design (QbD), the latest methodology for improving the safety and efficacy of drug products, presents pharmaceutical companies with an opportunity to revaluate the costs and, more importantly, the safety measures associated with achieving high quality overall. Given the increasingly complex and expensive drug products reaching the market, QbD arguably represents an essential strategy; […]
Confirming particle size and ensuring that suspended drug particles are evenly dispersed within a thixotropic solution creates a number of challenges. This article will discuss the issues that formulators have to address when creating a thixotrophic suspension and the types of analyses that are available to determine the extent to which the nasal spray has […]
Therapeutic advantages and potential improvements in patient care and patient compliance make the area of intranasal drug delivery attractive from a business perspective. As a consequence, the number and variety of drugs/biologics and devices explored and eventually marketed for intranasal delivery is likely to grow worldwide. The success of a given “drug idea”, however, depends […]
In the case of formulations under development for indications such as pain management, migraine, seizure and biologics such as vaccines, which require a delivery system with precision control over spray plume geometry and deposition to the nasal mucosa for systemic uptake, pharmaceutical manufacturers have turned their attention to unit-dose, aseptic intranasal drug products. This type […]
Nasal sprays are now showing great promise in the delivery of drugs for breakthrough pain relief and vaccines. Innovation is set to continue as electronic “smart” devices are being integrated into designs in order to increase patient compliance, a key market driver for nasal aerosols.
For the localization of formulation deposition within the nasal cavity, a nasal replica model can be used. Models in use are cadaver casts or are made from CT scan data or similar data of a vital nose. Casts representing a vital nose are preferred, although casts always represent an individual’s nose with its particular dimensions, […]