Interaction of Formulation and Device Factors Determine the In Vitro Performance of Salbutamol Sulphate Dry Powders for Inhalation. Issue 11 (28th July 2015)

• Record Type: Journal Article
• Authors: Muddle, Joanna; Murnane, Darragh; Parisini, Irene; Brown, Marc; Page, Clive; Forbes, Ben
• Is Part Of: Journal of pharmaceutical sciences. Volume 104:Issue 11(2015:Nov.)
• Page Start: 3861
• Page End: 3869
• Publication Date: 2015-07-28
• Subjects: Pharmacy -- Periodicals; 615.1
• DOI: 10.1002/jps.24599
• Languages: English
• ISSNs: 0022-3549

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <p>A variety of capsule‐based dry powder inhalers were used to evaluate formulation‐device interaction. The <italic>in vitro</italic> deposition of salbutamol sulphate (SS) was compared directly to published data for salmeterol xinafoate (SX). A 3<sup>2</sup> factorial design was used to assess the effect of SS formulations with three blends of different grade coarse lactose supplemented with different levels of fine lactose. These formulations were tested for homogeneity and evaluated for their <italic>in vitro</italic> deposition using Aeroliser, Handihaler and Rotahaler devices. The performance of the SS‐lactose formulations differed across the grade of lactose and amount of fine lactose used compared to the same powder compositions blended with SX. SX had a greater fine particle fraction than SS for most of the comparable formulations, probably because of the different cohesiveness of the drugs. A head‐to‐head comparison of 'matched' SX and SS formulations when aerosolised from the same three devices demonstrated that formulation–device interactions are as critical in determining the <italic>in vitro</italic> deposition of drug–lactose blends as the identity of the active pharmaceutical ingredient. This work has revealed the limitations of the interpretative value of published <italic>in vitro</italic> performance data generated with a single device (even at equivalent aerosolisation force), when designing formulations for a different device. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 104:3861–3869, 2015</p> </abstract>