To achieve a true step-change in nebulization, next-generation nebulizers need to be designed in such a way that they (1) are inconspicuous during patient use, (2) allow for the patient to conveniently carry the device in everyday life, (3) administer the dose in a shorter time, and (4) preferably do so with only one or […]
Recent developments related to laboratory testing methods are helping to shape an additional form of robust OIP testing that has clinical realism as its prime objective, rather than test method simplicity.
For some time, it has been evident that the USP/Ph.Eur. inlet may not provide the most accurate in vitro realization of aerosol transport through the upper respiratory tract. Recent research undertaken at the University of Alberta on this problem resulted in the development of an “idealized” adult throat geometry from which a new inlet accessory […]
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 […]
Elastomers have been used in OINDPs for more than 50 years. Constituting an integral part of OINDP container closure systems (CCSs) and/or delivery devices (DDs), they are important to the safety and performance of drug products. The quality of elastomeric components and their construction is essential for ensuring that a CCS/DD functions according to its […]
ECs share a common purpose with conventional pharmaceutical inhalation devices: they produce aerosols intended to be orally inhaled into the respiratory tract. They seemingly serve the same goal of pulmonary delivery so it is worthwhile to examine ECs from the viewpoint of inhalation drug development and explore what can be learned from them.
Lung cancer is the leading cause of cancer-related deaths in the world. While novel targeted therapeutics are making their way into the clinic, chemotherapeutics remain a mainstay of lung cancer therapies. Delivering chemotherapeutics through inhalation shows promise as a new delivery method with which to treat cancer. The goal of this work was to develop […]
An innovative approach to the problem of linking medication delivery to patient inspiration has been adopted in the mechanically-operated, breath-actuated jet nebulizer (BAN). By virtue of its design, it also takes advantage of air entrainment during the inhalation portion of each breathing cycle to help increase delivery of respirable fine particles. The AeroEclipse-II BAN (Trudell […]
Challenges associated with adherence to prescribed medication are compounded by the possibility that the older patient, as well as having multi-morbidities, may lack manual dexterity due to commonly encountered diseases such as arthritis or Parkinsonism. The patient may have cognitive difficulties to a varying extent, and as a result is likely to be difficult to […]
In July 2011, Pharmacopeial Forum published an in-process revision of Chapter , under a changed title “Product Performance Tests—Nasal and Inhalation Aerosols, Sprays, And Powders,” with significantly revised content and with a new companion Chapter , entitled “Inhalation and Nasal Drug Products—General Information and Product Quality Tests.” Accordingly, the International Pharmaceutical Aerosol Consortium on Regulation […]