• November 25, 2019

In this second article, we continue defining the path to necessary and sufficient impactor quality specifications. We introduce the need for a careful definition of sufficiency. This definition, in turn, necessarily introduces the concept of acceptable risk. We have therefore set out the philosophy of establishing impactor quality specifications that are sufficient for meeting the […]

Reducing the variability associated with inhaler testing, notably cascade impaction testing, is a critical, ongoing activity for the industry. Experience suggests that the complete automation of testing is not always the best solution due to the complexity, risk and investment involved. Rather, best practice centers on semi-automation, the use of proven, modular, easy-to-validate automation solutions […]

  • September 23, 2019

Physicochemical properties such as particle size, particle density, aerodynamic particle size, degree of crystallinity, particle shape, surface morphology and chemical composition need to be characterized for inhalable solid-state particles that are designed to target select regions of the respiratory tract.

Dr. Priya Muralidharan and Dr. Maria Acosta discuss techniques from the original article they wrote with their colleagues, as well as new approaches used to evaluate complex macromolecules that could be delivered via inhalation. Click here for original article

  • July 29, 2019

This first article in a three-part series takes a “fundamental” or “grassroots” look at the question of how to create both necessary and sufficient quality requirements for cascade impactors that are used for batch release testing of a specific drug product. The thought process applies to devising meaningful impactor quality requirements when testing an existing […]

  • March 21, 2019

Automated SEM-EDS can provide high-magnification images and elemental information, as well as detailed morphological and shape information in a quantitative method for easier comparison of two products. Depending on the drug type and preparation method, it can detect particles in the submicron range. It also enables efficient collection of large data sets in a matter […]

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.

  • January 28, 2019

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.

As with standard solid dosage forms, commercial DPIs are typically labeled with a label claim, which, in simple terms, is essentially the strength or dose of the product. For DPIs, however, the understanding of dose is more complex than for standard solid dosage forms because the entire labeled dose never reaches the target region of […]

  • July 23, 2018

The method has the capacity to run multiple samples per day and is therefore highly suitable for routine support during formulation and process optimization and in stability studies. A critical factor for success, however, is that it must be performed in a laboratory that has the ability to control the relative humidity.