Study of glycopyrrolate dry powder behavior in new single dose inhalers under generic product development

Abstract

With increasing environmental pollution and tendency to smoking, the number of patients suffering from chronic obstructive pulmonary disease is increasing and a demand for generic products for the treatment of chronic obstructive pulmonary disease (COPD) is growing. The long process of generic formulation development can be accelerated by using an inhaler with suitable fluid dynamics features. This paper presents a study of a newly patented single-dose Memmatec Mora® inhaler in two versions: with grid openings 1.0 (A) and 0.5 mm (B), using Seebri Breezhaler® as a reference product. The studies were conducted with inhalation powders containing 44μg glycopyrronium bromide placed in a capsule. The manuscript presents studies during the selection of a generic inhaler within the course of inhalation powder development by a pharmaceutical company. The fluid dynamics features of the inhalers and the dose delivered were determined. The aerodynamic particle size distribution (APSD) and the inhalable dose were tested using a cascade impactor. The delivery dose for the Breezhaler, Mora A and Mora B inhalers for a volumetric flow of 100 L×min-1 was 38.5, 40.5 40.3μg, respectively. Fine particle fraction of the inhalers tested was 22.3, 24.6 25.5μg, respectively. Results of the study indicate that increase of the glycopyrronium bromide inhalation dose can be achieved not only by changes in the manufacturing technology of inhalation powder, hard capsule technology or addition of best quality raw materials, but also by the use of a properly selected inhaler with specific fluid dynamics features.