Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.

Purpose: The article provides an overview of the European Union Incident Management plan (EU-IMP) and reviews its first 10 years of operation. It outlines its scope, objectives, triggers, principles, and components.

Methods: Records were extracted from the European Pharmacovigilance Issues Tracking Tool and a separate tracking system for the period August 20, 2009 to August 19, 2019.

Supporting Innovation through Regulation and Science: Ireland as an Innovation Hub for Health Products.

New technologies and our ever-increasing knowledge provide an exciting potential to develop innovative health products that can address challenges such as chronic diseases and ultimately improve outcomes for patients. Ireland has a strategic focus on supporting innovation and offers an ideal environment for health product innovation. This is due to the expertise and experience that is available within the life sciences sector and an established national infrastructure which supports the translation of research into health products in a collaborative manner.

Modification of the solid-state nature of sulfathiazole and sulfathiazole sodium by spray drying.

Solid-state characterisation of a drug following pharmaceutical processing and upon storage is fundamental to successful dosage form development. The aim of the study was to investigate the effects of using different solvents, feed concentrations and spray drier configuration on the solid-state nature of the highly polymorphic model drug, sulfathiazole (ST) and its sodium salt (STNa). The drugs were spray-dried from ethanol, acetone and mixtures of these organic solvents with water.

Particle engineering of materials for oral inhalation by dry powder inhalers. II-Sodium cromoglicate.

Sodium cromoglicate is an antiasthmatic and antiallergenic drug used in inhalation therapy and commonly administered by a dry powder inhaler. In the present study we sought to examine the feasibility of producing nanoporous microparticles (NPMPs) of this hydrophilic material by adaptation of a spray drying process previously applied to hydrophobic drugs, and to examine the physicochemical and in vitro deposition properties of the spray dried particles in comparison to a commercial product. The storage stability of successfully prepared NPMPs was assessed under a number of conditions (4°C with dessicant, 25°C at 60% relative humidity and 25°C with dessicant).

Excipient-free nanoporous microparticles of budesonide for pulmonary delivery.

The aim of this study was to investigate the application of a spray-drying process for the production of nanoporous microparticles (NPMPs) to budesonide, and to characterise the particles produced in terms of their suitability for pulmonary delivery. Budesonide was spray dried with and without ammonium carbonate from ethanol/water or methanol/water solutions. The solid-state characteristics and micromeritic (particle size, density, surface area) properties of spray dried powders were assessed.