Treatments for respiratory disorders are a major area of interest for the generics sector.
An April IMS Health survey showed that although the number of inhalables prescribed in the US grew in 2013, total revenue generated fell 5%, primarily as a result of the greater proportion of lower cost products.
Further evidence for this interest is provided by the issuance of various new monographs and guidance documents setting out bioequivalence testing requirements for companies trying to develop non-branded inhalable products.
Product specific
Copley Scientific cited this trend when it launched its new testing systems this week, explaining that the techs “make it possible to develop generics for treating respiratory conditions in accordance with new US Pharmacopeia (USP) product specific monographs for Fluticasone Propionate (FP) Inhalation Powder and Inhalation Aerosol.
“Product-specific monographs and regulatory guidance help generic manufacturers to identify appropriate testing equipment and methods to robustly demonstrate bioequivalence with named drug products.”
The UK firm said that, because the monographs are product-specific, the recommended testing equipment and methods reflect those used for the originator product rather than those specified in general guidelines for inhaled products.
Copley’s new systems include a glass sample collection apparatus to assess delivered dose uniformity (DDU) and a preseparator for the Andersen Cascade Impactor (ACI) which is used for aerodynamic particle size distribution (APSD) measurements for fluticasone propionate.
The firm explained that: “For FP Inhalation Aerosols, there is a separate Glass Sample Collection Apparatus and an FP Inlet Cone for use with the ACI. The new FP Induction Port is common to both powder and aerosol APSD testing.”
“All these components are developed in accordance with the new USP 36 Second Supplement monographs for FP Inhalation Powders and Aerosols with the FP Induction Port, Preseparator and Inlet Cone being modified versions of those already specified in USP Chapter <601> and European Pharmacopoeia (Ph.Eur.) Chapter 2.9.18.”
“In combination with the BAC 2000, a timer-controlled solenoid valve used as part of the system for determining the APSD of PF Inhalation Powders, these accessories enable standard test equipment, including the Andersen Cascade Impactor, to be tailored to meet the specifications of the new monographs.”
The firm has also introduced the BP MDI Content Uniformity Apparatus to support the testing of metered dose inhalers (MDIs), originally developed using test methods specified in the British Pharmacopoeia (BP),
Copley said that: “Although the BP and European Pharmacopoeias are essentially harmonised for inhaled products, this simple accessory is uniquely referenced in the BP. It enables a modified test set-up for measuring DDU, which, like APSD, is a performance-defining parameter for inhaled products.”