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Gamma Scintigraphic Evaluation of a Novel Budesonide Dry Powder Inhaler Using a Validated Radiolabeling Technique

Warren, Simon, Taylor, Glyn, Smith, Jeffrey, Buck, Helen and Parry-Billings, Mark 2002. Gamma Scintigraphic Evaluation of a Novel Budesonide Dry Powder Inhaler Using a Validated Radiolabeling Technique. Journal of Aerosol Medicine 15 (1) , pp. 15-25. 10.1089/08942680252908548

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Abstract

A scintigraphic study was carried out to compare the lung deposition of budesonide delivered via Clickhaler® and Turbuhaler® dry powder inhalers in healthy volunteers. Validation of Technetium-99m (99mTc) radiolabeling of the budesonide/lactose blend used in the Clickhaler and excipient-free budesonide used in the Turbuhaler was carried out using a multistage liquid impinger, and compared with reference unlabeled devices. Budesonide was quantified using high-performance liquid chromatography and 99mTc by scintillation counting. The percentages (SD) of fine particles (<5.5 μm diameter) from radiolabeled and unlabeled devices were not significantly different (p > 0.05). Mean values for drug and radiolabel, respectively, were 34.6% (2.5) and 31.6% (3.8) for the Clickhaler, and 29.8% (5.5) and 31.4% (5 6) for the Turbuhaler. Fifteen healthy male volunteers received a single dose (2 × 200 μg actuations) from both devices in a double-blinded, double dummy, crossover study. During dosing, each inhalation maneuver was recorded using a computer-linked pressure transducer. To permit accurate determination of radiolabeled drug deposition, the lung margins of each volunteer were determined by Krypton-81m (81mKr) gas imaging. Mean [SD] lung deposition for the Clickhaler (26.8% [6.8], RSD 25.2) was significantly greater (p < 0.001) than for the Turbuhaler (15.8% [6.6], RSD 42.2). Inspiratory flow rate parameters were similar for both devices with peak and mean values of 73 and 51 L/min for the Clickhaler, and 73 and 47 L/min for the Turbuhaler, respectively. These results indicate that, in healthy volunteers, budesonide lung deposition was higher and more consistent with the Clickhaler than with the Turbuhaler.

Item Type: Article
Date Type: Publication
Status: Published
Schools: Pharmacy
Subjects: R Medicine > RM Therapeutics. Pharmacology
R Medicine > RS Pharmacy and materia medica
Publisher: Mary Anne Liebert
ISSN: 0894-2684
Last Modified: 04 Jun 2017 04:55
URI: http://orca.cf.ac.uk/id/eprint/46441

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