Evaluation of different parameters that affect droplet‐size distribution from nasal sprays using the Malvern Spraytec®

Dayal, Pankaj; Shaik, Madhu Sudhan; Singh, Mandip

doi:10.1002/jps.20090

Cited by 96 publications

(80 citation statements)

References 13 publications

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“…Of the four factors, stroke length and actuation velocity are related to the actuation performance of the nasal spray pump; the concentration of CMC and Tween-80 are the dominant factors which influence the formulation viscosity and surface tension, respectively. Selection of the range of these factors was based on previous studies (8,9). A nonlinear quadratic model of nasal spray droplet velocity generated by regression of the experimental factor values on the measured response is expressed as follows:…”

Section: Influence Of Actuation Parameters and Formulation Propertiesmentioning

confidence: 99%

“…The drug delivery performance of a nasal spray product is greatly influenced by both the formulation properties and the device capabilities (8)(9)(10). In previous studies, design of experiments (DOE) methodology was used to elucidate interactions between four factors (actuation stroke length, actuation velocity, concentration of gelling agent, and concentration of surfactant) with respect to their influences on nasal spray shot weight, DSD, spray pattern, plume geometry, and impaction force (5,11).…”

Section: Introductionmentioning

confidence: 99%

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Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA)

2011

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Abstract. Droplet velocity is an important parameter that can be used to characterize nasal spray products. In this study, a phase-Doppler anemometry (PDA) system was used to measure the droplet velocities of nasal sprays. A survey of seven commercial nasal spray products showed a range of droplet velocities from 6.7 to 19.2 m/s, all significantly different from each other. A three-level, four-factor BoxBehnken design of experiments (DOE) methodology were applied to investigate the influences of actuation parameters and formulation properties on nasal spray droplet velocity using a set of placebo formulations. The DOE study shows that all four input factors (stroke length, actuation velocity, concentration of the gelling agent, and concentration of the surfactant) have significant influence on droplet velocity. An optimized quadratic model generated from the DOE results describes the inherent relationships between the input factors and droplet velocity thus providing a better understanding of the input factor influences. Overall, PDA provides a new in vitro characterization method for the evaluation of inhalation drugs through assessment of spray velocity and may assist in product development to meet drug delivery equivalency requirements.KEY WORDS: design of experiments; droplet velocity; nasal spray; phase-Doppler anemometry.

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Section: Influence Of Actuation Parameters and Formulation Propertiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA)

2011

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“…The delivery performance of any aerosolized droplets introduced via the nasal cavity depends on many factors, such as the design of the pump, the physical properties of the formulation, and the position of administration. (21)(22)(23)(24)(25) In this present work, we have examined the effects of PBS versus sodium chloride (NaCl) diluents on stability and potency of NE-based vaccines when stored at room temperature (accelerated conditions). We have also evaluated the ability to deliver NE-based vaccines using standard nasal spray devices.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Stability and Nasal Delivery Systems for Immunization with Nanoemulsion-Based Vaccines

Makidon

Nigavekar

Bielinska

et al. 2010

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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Background: Many infectious diseases that cause significant morbidity and mortality, especially in the developing world, could be preventable through vaccination. The effort to produce safe, thermally stable, and needlefree mucosal vaccines has become increasingly important for global health considerations. We have previously demonstrated that a thermally stable nanoemulsion, a mucosal adjuvant for needle-free nasal immunization, is safe and induces protective immunity with a variety of antigens, including recombinant protein. The successful use of nanoemulsion-based vaccines, however, poses numerous challenges. Among the challenges is optimization of the formulation to maintain thermal stability and potency and another is accuracy and efficiency of dispensing the vaccines to the nasal mucosa in the anterior and turbinate region of the nasal cavity or potentially to the nasopharynx-associated lymphoid tissue. Methods: We have examined the effects of different diluents [phosphate-buffered saline (PBS) and 0.9% NaCl] on the stability and potency of nanoemulsion-based vaccines. In addition, we have determined the efficiency of delivering them using commercially available nasal spray devices (Pfeiffer SAP-62602 multidose pump and the BD Hypak SCF 0.5 ml unit dose Accuspray TM ). Results: We report the stability and potency of PBS-diluted ovalbumin-nanomeulsion mixtures for up to 8 months and NaCl-diluted mixtures up to 6 months when stored at room temperature. Significant differences in spray characteristics including droplet size, spray angle, plume width, and ovality ratios were observed between the two pumps. Further, we have demonstrated that the nanoemulsion-based vaccines are not physically or chemically altered and retain potency following actuation with nasal spray devices. Using either device, the measured spray characteristics suggest deposition of nanoemulsion-based vaccines in inductive tissues located in the anterior region of the nasal cavity. Conclusions: The results of this study suggest that nanoemulsion-based vaccines do not require specially engineered delivery devices and support their potential use as nasopharyngeal vaccine adjuvants.

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“…1 In brief, droplet size analysis of nasal aerosols was conducted by laser diffraction using a Malvern Spraytec with RT Sizer software (Malvern Instruments Ltd, Worcestershire, UK). InnovaSystems nasal actuation station (Moorestown, NJ) with "Might Runt" software was used to actuate the nasal pumps.…”

Section: Determination Of Droplet Size Distribution From Test Formulamentioning

confidence: 99%

“…Low viscosity or shear-thinning vehicle systems were effectively atomized into small droplets using different nasal pump sprays, as previously reported. 1 There have been many reports that solutions of mixtures of certain polymers, surfactants, and excipients can exhibit molecular interactions that affect the rheological and physicochemical properties of the solutions. 2 The nature of these interactions can affect the ability of the solution to be aerosolized into small droplets and may alter the stability and liberation of the active components.…”

Section: Introductionmentioning

confidence: 99%

Box-Behnken experimental design in the development of a nasal drug delivery system of model drug hydroxyurea: Characterization of viscosity, in vitro drug release, droplet size, and dynamic surface tension

et al. 2005

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The purpose of the research was to investigate the changes in physicochemical properties and their influence on nasal formulation performance using 5-factor, 3-level BoxBehnken experimental design on the combined responses of viscosity, droplet size distribution (DSD), and drug release. Gel formulations of hydroxyurea (HU) with surface-active polymers (hydroxyethylcellulose [HEC] and polyethylene-oxide [PEO]) and ionic excipients (sodium chloride and calcium chloride) were prepared using BoxBehnken experimental design. The rheology and dynamic surface tension (DST) of the test formulations was investigated using LV-DV-III Brookfield rheometer and T60 SITA tensiometer, respectively. Droplet size analysis of nasal aerosols was determined by laser diffraction using the Malvern Spraytec with the InnovaSystems actuator. In vitro drug release studies were conducted on Franz diffusion cells. With PEO gel, calcium chloride increased the viscosity and DSD and retarded drug release, while sodium chloride decreased the viscosity, DST, and DSD and accelerated the release of HU. With HEC gel, the addition of the above salts resulted in less significant changes in viscosity, DSD, and DST, but both salts significantly increased the release of HU. Droplet size data obtained from a high viscosity nasal pump was dependent on type of polymer, polymer-excipient interactions, and solvent properties. The applications of Box-Behnken experimental design facilitated the prediction and identified major excipient influences on viscosity, DSD, and in vitro drug release.

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Evaluation of different parameters that affect droplet‐size distribution from nasal sprays using the Malvern Spraytec®

Cited by 96 publications

References 13 publications

Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA)

Assessment of the Influence Factors on Nasal Spray Droplet Velocity Using Phase-Doppler Anemometry (PDA)

Characterization of Stability and Nasal Delivery Systems for Immunization with Nanoemulsion-Based Vaccines

Box-Behnken experimental design in the development of a nasal drug delivery system of model drug hydroxyurea: Characterization of viscosity, in vitro drug release, droplet size, and dynamic surface tension

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