Dissolution of fine particle fraction from truncated Anderson cascade impactor with an enhancer cell.

Abstract:

:Dissolution testing for inhalers were previously conducted either on unfractionated drug-carrier powders or drug of specific aerodynamic particle size. In this study, the collection of the full fine particle fraction (FPF) was attempted on a single stage. Capsules containing 30 mg of 2% salbutamol sulfate (SS) was tested to have a FPF of 9 ± 1% using the full set of Andersen cascade impactor (ACI) and a modified Rotahaler® capable of achieving 4.0 kPa pressure drop at 60 L/min air flow rate. A truncated ACI comprising the USP throat, pre-separator, stage 0, stage 4, stage F, polytetrafluoroethylene funnel (TF) and small collection plate (sCP) was found to be capable of achieving a FPF of 9% collected on TF and sCP. An adhesive tape was used to collect the FPF from the TF and sCP and held in place by an enhancer cell in a 200 mL round bottom vessel containing 50 mL Gamble's solution with 0.2 v/v, % Tween 80. Dissolution testing of SS and Seretide® showed burst release of SS and salmeterol while sustained release of fluticasone. This study demonstrated a reproducible method which may be used for evaluation of the full FPF of orally inhaled products.

journal_name

Int J Pharm

authors

Tay JYS,Liew CV,Heng PWS

doi

10.1016/j.ijpharm.2018.04.048

subject

Has Abstract

pub_date

2018-07-10 00:00:00

pages

45-50

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(18)30276-X

journal_volume

545

pub_type

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