Manufacturing

Mark Copley is Sales Director at Copley Scientific.

Articles

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

Improving Inhaled Product Testing: Methods for Obtaining Better In vitro-In vivo Relationships

New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.

Combining Spectroscopy with Automated Imaging: A New Analytical Solution to Meet Regulatory Requirements for Inhaled Products

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

Inhaled Product Characterization

The author reviews key considerations for formulating powders for use in inhalers. This article is part of a special Drug Delivery issue.

Considerations and Approaches for Filling Dry-Powder Inhalers

Yoen-Ju Son is Visiting Research Scientist at College of Pharmacy, University of Texas at Austin (TX, USA).

Jason McConville is Assistant Professor, Director of InstrUcTex, at College of Pharmacy, University of Texas at Austin (TX, USA)

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.

Dissolution Testing For Inhaled Drugs

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

Seeking a Dissolution-Test Solution for Inhaled Drugs

Angie Drakulich was editorial director of Pharmaceutical Technology.

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

FDA Removes Last CFC Inhalers from the Market

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.

Regulatory challenges of inhaler testing

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers.

Optimizing drug delivery to the lungs

Formoterol presents formulators and manufacturers in the asthma and chronic obstructive pulmonary disease marketplace many challenges.

Manufacturing, Inhalation Drugs