• November 20, 2017

This article reviews the capabilities of breathing simulators and their application in nebulizer, dry powder inhaler (DPI) and pMDI testing, clearly differentiating between that which is specified by the pharmacopeias and that which remains optional but potentially valuable. The focus is delivered dose uniformity (DDU) testing and aerodynamic particle size distribution (APSD) measurement. Delivered dose […]

This article briefly reviews the application of organotypic in vitro tissue culture models for assessing drug disposition, toxicity and efficacy of inhalable formulations intended for administration via the proximal airways.

  • November 17, 2017

Confirming particle size and ensuring that suspended drug particles are evenly dispersed within a thixotropic solution creates a number of challenges. This article will discuss the issues that formulators have to address when creating a thixotrophic suspension and the types of analyses that are available to determine the extent to which the nasal spray has […]

The majority of active pharmaceutical ingredients (APIs) are crystalline materials, whose crystal lattice structure determines, to a large extent, the fracture patterns leading to particle size reduction upon milling. In this investigation, the integrity of the crystal after mechanical stress was studied on a model compound to show the evolution of properties of crystalline solids […]

  • November 16, 2017

A variety of techniques are reviewed for use in solid phase identification and quantification; particle morphology imaging and particle density estimations; surface property and interparticle interaction investigations; and predicting thermal activity and long-term physical and chemical stability.

Understanding the mechanisms by which changes to particle size occur and monitoring such changes through ongoing stability testing may be vital to the commercial success of a product. Failure to consider particle size stability in the early stages of drug development can lead to costly setbacks, batch rejection and delays in clinical trials. It is […]

It is now widely recognized that coating of particle collection surfaces prior to impactor measurements is often necessary to avoid bias caused by particle re-entrainment of solid particles. The amount of re-entrainment is dependent on the particle and collection surface characteristics, but in most cases can be reduced or eliminated by applying a sticky material […]

DPIs offer ease of coordination with the respiratory cycle compared to pMDIs and a reduced amount of drug trapped in the oropharynx. In addition, devices that do not use chlorofluorocarbon propellants are better for the environment. Within the sphere of DPIs, HPMC-capsule-based DPIs are a compelling alternative due to capsule properties of puncturing, powder aerosolization, […]

This article lays the groundwork for a re-think concerning the ways in which the patient or caregiver is intended to use OIPs and related devices. A case is made for advocating an approach by all stakeholders in the OIP life-cycle that ultimately results in simple-to-use and “patient-friendly” OIPs and related devices that will prove to […]

Focusing the early stages of development programs on obtaining regulatory approval and expecting that marketing efforts will convince physicians and patients to use the product, a paradigm that worked over the past several decades, now represents a strategic error, contends Balekdjian. US payers now play such an important role in the pharmaceutical marketplace that you […]