The authors suggest that impaction data is fundamentally flawed and ineffective because individual stage groupings do not adequately account for both dimensions of the size-fractionated mass comprising the APSD, and their combined use compounds this weakness to dramatic effect. Clearly, they say, stage groupings cannot be relied upon for batch-disposition decisions and are therefore a […]
It is in the best interest of all key stakeholders to have inhaled medications accessible and affordable to all who need them. At the same time, it is necessary to continue to reward companies and individuals who work with innovator products for their efforts and investments that bring better inhaled medications to patients. Both innovator […]
Now, more than ever, healthcare economics are providing the impetus for innovation and consequently we will see some non-obvious disease states being treated using the nasal route. As we better understand the relationships of particle size, delivered gas, patient anatomy, and inspiratory patterns across patient populations, we expect more optimized pulmonary delivery efficiency, expanding trans-nasal […]
Trees whose isoprene production was genetically suppressed “did not suffer ill effects in terms of photosynthesis or ‘biomass production.’”They produced cellulose, (used in biofuel production) and grew as well as trees that were not modified. Because isoprene has a protective effect in stressful climates, the results were surprising. “The suppression of isoprene production triggered alternative […]
The insensitivity of FPD to shifts in inhaler APSD is illustrated and underlying causes have been discussed. Data from eight different products are examined. In conclusion, FPD cannot be used alone as a metric for APSD quality control. FPD can be used to control the mass-dimension of the APSD, but must be used in conjunction […]
The findings provide an overview of patient-reported levels of access to prevention, diagnosis, care and empowerment. In addition, the report provides recommendations for healthcare providers and systems, policy makers and payers, as well as patients and researchers.
It is inevitable that small- and medium-sized pharmaceutical companies outsource key research and chemistry, manufacturing and control (CMC) functions to contract research organizations (CROs) when it does not make financial sense to build internal capabilities for activities that are infrequent and/or require large capital or headcount investments to establish expertise. For inhalation product development, there […]
The authors provide a brief history of dry powder inhalers then discuss considerations for future development such as formulation, dose storage, moisture protection and metering, de-aggregative processes, counters, the environment, patient considerations and non-respiratory indications.
In this article, we look at recent changes in the regulatory framework, summarizing changes in United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, the pharmacopeias, and in localized regulations from regions of growing importance for drug development and manufacture, such as Brazil and China.
The author suggests opportunities exist in treating additional diseases, getting involved with patients, determining aerodynamic particle size distribution, managing oropharyngeal deposition, improving nasal delivery and targeting orally inhaled products with narrow therapeutic indices.