• November 26, 2018

This article focuses on the informative chapters that are either official text or are in draft, and fall under the remit of the sub-committee: <1601>, <1602>, <1603> and <1604>. The information provided on draft chapters and is based on previously published Stimuli articles, and should therefore be construed as only being indicative of likely content, […]

  • March 26, 2018

The Aerosols Sub-Committee (SC) of the General Chapters—Dosage Forms Expert Committee revises United States Pharmacopeia (USP) chapters to reflect scientific developments and stakeholder input, as well as to align them with current and evolving regulatory requirements. The general chapters of United States Pharmacopeia –National Formulary (USP–NF) are subdivided. Those with numbers below <1000> are generally […]

  • December 15, 2017

The Abbreviated Impactor Measurement (AIM) and Efficient Data Analysis (EDA) concepts have been developed in parallel, as ways in which to improve the collection and analysis of data associated with the size characterization of aerosols emitted from orally inhaled products (OIPs). This article explains why they are both important developments and provides advice on ways […]

This article looks at the noticeable shift from standard pharmacopeial quality control testing to more realistic end-user-driven testing by incorporating clinically appropriate methods. It also looks into development of more advanced technologies for OIP-generated particle size distribution assessment. Finally, it briefly mentions testing of APSD for OIPs containing formulations that incorporate nanoparticles.

  • December 14, 2017

Getting a drug onto the market is a long, complex and costly process. Companies developing new therapeutics and formulations must be able to make the process as simple and efficient as possible. Quality by design, or QbD, is an approach that could help, by putting the focus on commercialization right from the early steps of […]

  • December 12, 2017

Caused by impaction of the delivered dose and the rapid evaporation of any remaining propellant (and in some cases, volatile co-excipients as well), the cold freon effect strongly influences the efficiency of drug delivery. It may, for example, cause the patient to abort or be unsuccessful in completing the inhalation manoeuvre. Quantifying this phenomenon is […]

  • November 29, 2017

APSD testing is still one of the best in vitro indicators of expected in vivo effectiveness, but from a QbD perspective, analytical variability and increased testing requirements to create robust datasets present a barrier to progress. Understanding and controlling critical analytical method parameters is fundamental to device performance and the foundation of robust analytical testing. […]

Recently, regulatory agencies have put greater emphasis on the need to understand pharmaceutical process, product quality and risk management to ensure that patient needs continue to be met. The United States Food and Drug Administration (FDA) Quality by Design (QbD) initiative encompasses these considerations, building on previous concepts covered in the International Conference on Harmonization […]

  • November 20, 2017

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; […]