Articles by Mark Copley - Pharmaceutical Technology

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Articles by Mark Copley

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

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.
Feb 2, 2013

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.

Inhaled Product Characterization

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median środynamic diameter, one of the metrics routinely used for comparative testing.
Nov 1, 2011

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.

Dissolution Testing For Inhaled drugs

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. The authors explain how a new technique using standard dissolution test equipment in combination with US Pharmacopeia methods for the dissolution testing of solid dosage forms can be used to differentiate the solubility of orally inhaled products.
Nov 1, 2010

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.

Regulatory challenges of inhaler testing

Nov 1, 2009

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

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