In spray-dried formulations, various excipients or carriers are incorporated to improve the aerosolization behavior, stability and mechanical properties of active pharmaceutical ingredients (APIs) as well as to modify the pharmacokinetics and pharmacodynamics of APIs. Sugars are the most common excipients used as diluents and flow enhancers. In addition, sugars can provide hydrogen bonding and act […]
Archives
With the increasing prevalence and use of digital technologies applied to drug delivery devices and software solutions to support inhaled therapeutics, there are multiple considerations that patients, healthcare professionals, payors and pharmaceutical manufacturers can and should observe. Key considerations include identifying the stakeholders required, value to deliver to each stakeholder, system design and the laws […]
The SABINA study of SABA inhaler usage and risk of asthma exacerbations, funded by AstraZeneca, is the largest real-world observational data analysis of asthma inhaler therapy and has evaluated more than one million patients across 40 countries. In addition, at Queen Mary University of London, a study of more than 700,000 patient records evaluated SABA […]
Local treatment of lung cancer by the inhalation route is an emerging therapeutic area, particularly for early stages of the disease when the cancer is localized in the lung tissue. This article outlines manufacturing and formulation considerations for local treatment of lung cancer by dry powder inhaler and highlights three recent case studies. The article […]
The earliest reference to therapeutic dry powder inhalation may also be the earliest reference to “engineered particles,” dating from 1849, in London. An initial article looks at the history of dry powder inhalers, including devices and formulations, and discusses considerations for future DPIs. Then an interview takes a new look at current challenges and opportunities […]
CFD modeling for product development requires knowledge of the capabilities of state-of-the-art software and the adoption of a well-controlled simulation workflow. This article will review previous work in this area, illuminating CFD capabilities and the processes and considerations required to create a trusted, useful, predictive simulation to support the product development process. This article shows […]
The four parts of a dry powder formulation (the formulation, excipient, composition and processing) must be thoroughly understood in order to develop and optimize adhesive mixtures for inhalation. In addition, their interactions can be highly complex. This article gives examples and discusses the complex interaction between the formulation and the device. The articles in this […]
Dry powder inhalation (DPI) products basically consist of a powder formulation and a device. The formulation, which contains active pharmaceutical ingredient(s) (APIs) micronized to inhalable particle size and a few excipients may, at first glance, appear simple. However, a large number of factors are critical to the performance of dry powder formulations for inhalation. Furthermore, […]
Considering flow conditions in the DPI test system has led to understanding more about why experts have improved the pharmacopeial protocol over time. Still, there are aspects of the fundamentals that are not yet clarified but worth understanding and accommodating in the protocols. The authors believe these include specifications for the solenoid valve, the effect […]
A large gap exists between the relatively straightforward robust methods in the pharmacopeias, developed primarily for product release, and the more elaborate approaches to assist in understanding how inhalers are likely to perform in the hands of the patient or caregiver. The authors propose that there is a middle way forward and believe it is […]