Impact of actuator design on multi-dose nasal spray characteristics

Impact of actuator design on multi-dose nasal spray characteristics

Poster presented at Respiratory Drug Delivery Conference 2018.

Chauhan H, Liu-Cordero S, Liao L, Werbeck J; Respiratory Drug Delivery 2018. Volume 2, 2018: 497-502.

INTRODUCTION: Developing a successful multi-dose nasal spray can be a difficult process. A number of components and critical parameters need to be precisely controlled to achieve desired dose delivery. Numerous studies have focused on the effects of formulation aspects (viscosity, surface tension)1,2 on the drug performance. However, device components, including the nozzle/actuators, pump assembly, and dip tube also play a significant role. This study focuses on differences between specific components within the nasal spray device. The pump is responsible for metered delivery of the dose and thereby determines the shot weight of the product. The spray characteristics (spray pattern, plume geometry, and Droplet Size Distribution) of the nasal spray are influenced by formulation, as well as the device, especially the actuator (consisting of the nozzle orifice and swirl chamber). (Figure 1). This study focuses on the effect of different actuators by keeping the pump consistent across water and a drug formulation. Understanding the effects of actuator design and formulation on spray pattern can have a significant impact on successful product development.

Evaluating spray characteristics of multi-dose nasal spray devices across different actuator designs

Evaluating spray characteristics of multi-dose nasal spray devices across different actuator designs

Poster presented at Respiratory Drug Delivery Conference Asia 2018.

Chauhan H, Liu-Cordero S, Jones D, Okorodudu B; RDD Asia 2018. Volume 1, 2018: 199-204.

INTRODUCTION: This paper explores how a design of experiments (“DoE”) approach was employed to provide a foundational understanding of the effects of shaking on dose content uniformity (“DCU”) and spray pattern performance of commercially available albuterol pressurized metered dose inhaler (“pMDI”) products. The pMDIs tested were suspension formulations with different excipients that are all known to be sensitive to shaking based on their respective usage instructions for patients (i.e. the instructions only include language such as “…shake well before each use…”). The DoE focused on controlling and systematically varying the duration, angle, and frequency of shaking immediately prior to automated actuation and measuring the resultant DCU and spray pattern performance of the emitted aerosols. DCU was selected as an obvious output for in vitro performance based on accepted regulatory guidance documents. Specific optical spray pattern measurements were included in the DoE to see if such measurements could be correlated to the shaking conditions, and if so, how these measurements could be used to build an alternative model for efficient, high resolution, in vitro performance prediction for through life testing of pMDIs. The results indicate that the pMDIs tested have statistically significant differences in their performance sensitivities to shaking and that these differences should be explained to patients for optimal benefit.