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 […]
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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 […]
The pMDI looks set to continue as a very popular inhaler device. In the early 1990s, the pMDI was often seen as inefficient, somewhat old-fashioned, difficult to use correctly and environmentally unfriendly. Today, it is recognizable as the 1956 device, but it contains many modern enhancements and is viewed as durable, adaptable and cost-effective.
Several recent EPO Board decisions on inhalation patents give insight into how the EPO reviews the application and claims through the view of one of skill in art and how that affects patentability of the invention.
This article reviews the capabilities of breathing simulators and their application in nebulizer, dry powder inhaler (DPI) and pMDI testing, clearly differentiating between that which is specified by the pharmacopeias and that which remains optional but potentially valuable. The focus is delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement. Delivered dose […]
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 […]
After the U.S. Food and Drug Administration released its 1998 draft guidance on metered dose inhalers and dry powder drug products, a group of developers, manufacturers, and marketers of orally inhaled and nasal drug products (OINDP) joined together to provide a response. This ad hoc group developed a consensus response to the proposed guidance in […]
A variety of techniques are reviewed for use in solid phase identification and quantification; particle morphology imaging and particle density estimations; surface property and interparticle interaction investigations; and predicting thermal activity and long-term physical and chemical stability.