Poster presented at the Novel Nasal Formulation and Delivery Summit; 2023 May 17 – 18, San Diego, California, USA. Proveris® Scientific Corporation, Hudson MA USAContinue reading
Unit dose nasal sprays: method effects of setting stroke length on spray characteristics
Poster presented at AAPS Annual Meeting and Exposition 2015.
Shaw, C., Smith, M., Richiuso A., Kulkarni V. – DPT Laboratories Ltd., Newcomb A. – Proveris Scientific Corp.
INTRODUCTION: The formulation properties (viscosity, surface tension and density) and automated actuation parameters (velocity, stroke length, force and acceleration) affect the spray characteristics of unit dose nasal spray devices. During method development, various actuation mode techniques are used to determine actuation parameters. In this study, three actuation modes were compared by assessing the spray characteristics of various formulations to establish the optimal method for actuating unit dose devices.
Determination of the influencing factors on in vitro performance of a marketed OTC nasal spray product using a Quality by Design (QbD) and Design of Experiments (DOE) approach
Poster presented at Respiratory Drug Delivery Conference Asia 2014.
Farina DJ, Pitluk Z, Mayer WJ, Falatico M, De S; RDD Asia 2014. Volume 1, 2014: 215-220.
INTRODUCTION: Determining the influencing factors related to in vitro performance of nasal sprays is essential for establishing robust release specifications, label claims, and product understanding consistent with current Food and Drug Administration (FDA) and International Conference on Harmonization (ICH Q8,R2) guideline [1,2]. The main purpose of this work was to show how as a systematic approach with modern design of experiments (DoE) and quality by design (QbD) practices can yielda wealth of product knowledge on a marketed nasal spray product for shot weight, spray pattern, and droplet size distribution in vitro performance. Moreover, with the 2013 FDA Advisory Panel recommendation to allow Nasacort AQ nasal spray (Triamcinolone) to be available as an over the counter product (OTC), deeper product knowledge gained from the approach shown in this poster could help regulatory, quality assurance, and business people when making the Rx-OTC transition  (e.g testing of the contain closure system in a way that simulates actual product usage [2, Section 2.4].
Using a predictive design of experiments approach to investigate the in vitro performance sensitivity of a unit dose nasal spray
Poster presented at Respiratory Drug Delivery 2016
Shaw CJ, Smith M, Newcomb A, Farina DJ, Kulkarni VS; Respiratory Drug Delivery 2016. Volume 2, 2016: 299-302.
INTRODUCTION: Unit dose nasal sprays are an attractive alternative to multi-dose devices for delivery of nasal therapies to treat conditions such as migraine pain (Imitrex® and Zomig®), cancer pain (Lazanda®), vitamin B12 deciency (Nascobal®), and heroin overdose reversal (Narcan®). Multi-dose nasal sprays have been studied using design of experiments (DoE) techniques to determine and predict their in vitro performance (e.g., shot weight, spray pattern, droplet size distribution) sensitivity to process settings (e.g., actuation velocity and stroke length) and formulation variables (e.g., viscosity, surface tension) . However, little literature has been published on the in vitro performance sensitivity of unit dose nasal spray products. This study leveraged the established multi-dose DoE methodologies to investigate the spray pattern and droplet size distribution (DSD) performance sensitivity of a popular unit dose device to controlled changes in key process settings and formulation properties.
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
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.