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, […]
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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 […]
This article provides an overview of the considerations for the formulation development of inhaled biologics and the various excipients that are routinely investigated for use in dry powder formulations of biologics intended for oral inhalation, with particular emphasis on protein stabilization. Carbohydrates, including simple sugars, complex sugars and sugar alcohols; amino acids and surfactants are […]
This article describes legislative and commercial drivers for propellant change and potential propellants, as well as the Respitab® technology platform, which provides a novel approach to formulation and manufacturing of lower global warning potential (GWP) pMDIs. Studies are presented and manufacturing and considerations for its use are discussed. There is a clear need for alternatives […]
The Pulmonary Fibrosis Foundation maintains a database of molecules and clinical programs in development for IPF. As of June 2021, while it may not be comprehensive, it listed 33 programs, yet shows only five via the inhaled route. Why then, given the availability of the technology and manufacturing knowledge, and the inherent medical advantages of […]
Impaction-based methods for determining the aerodynamic particle size distributions (APSDs) of aerosolized drug products intended for oral and nasal inhalation are preferred by regulatory authorities because they can be used to directly classify the APSD in terms of the drug substance content of the sampled drug product. One such impactor, the Next Generation Impactor (NGI), […]
The need for accurate thermophysical property prediction for diverse formulation mixtures is expected to grow, as next-generation formulations with low global warming potential (GWP) are introduced and as usage of predictive simulation increases during pMDI development. This need can be supported by appropriate experimental measurement campaigns for formulation mixtures, spanning the full range of temperature, […]
For many years, the nasal route of administration has been used very successfully for the non-invasive delivery of small molecule drugs. The anatomy and physiology of the nasal cavity have been exploited to deliver 1) locally acting medications, to combat ailments such as seasonal and year-round allergies, 2) systemically delivered drugs, via the highly vascularized […]
Production of inhalable drug particles traditionally involves milling, spray drying, spray freeze drying and supercritical fluid processes. Many of these processes expose the formulation to thermal or mechanical stresses, leading to changes in the particles’ surface and physicochemical properties. Among various particle properties (particle size and size distribution, surface properties, hygroscopicity, electrostatic charge and relative […]