Spray drying is used to produce engineered, inhalable dry powders and is a critical tool for new drug developers. It enables production of powders with a tightly controlled range of particle sizes and solid-state properties. Formulators have control over the crystalline and amorphous character and radial distribution of components and particle morphology. This comes from […]
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Much improvement has taken place in evaluating sources of variability in the measures of delivered dose uniformity (DDU) and aerodynamic particle size distribution (APSD). Methods described in the United States Pharmacopeia (USP) and European Pharmacopoeia (Pharm. Eur.) now include dimensions and diagrams for all components critical to their robustness. However, we show that there are […]
When selecting biological models for testing inhalation products, careful consideration must be made regarding the area of the respiratory tract that is the target site for a product. Once the appropriate cellular models are selected, there are several cell culture techniques that can be utilized to mimic the physiologically relevant conditions. Currently, several cellular models […]
Excipient enhanced growth (EEG) is progressing through toxicological studies and showing promise for treatment of asthma and lung cancer by delivering active molecules to target sites in the lungs. This article discusses development of two candidates, budesonide and gemcitabine, for local lung delivery using this formulation approach in combination with traditional spray drying for the […]
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 […]
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 […]