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Primary break-up and atomization characteristics of a nasal spray.

ABSTRACT: The primary objective of this research was to extract the essential information needed for setting atomization break up models, specifically, the Linear Instability Sheet Atomization (LISA) breakup model, and alternative hollow cone models. A secondary objective was to gain visualization and insight into the atomization break up mechanism caused by the effects of viscosity and surface tension on primary break-up, sheet disintegration, ligament and droplet formation. High speed imaging was used to capture the near-nozzle characteristics for water and drug formulations. This demonstrated more rapid atomization for lower viscosities. Image processing was used to analyze the near-nozzle spray characteristics during the primary break-up of the liquid sheet into ligament formation. Edges of the liquid sheet, spray break-up length, break-up radius, cone angle and dispersion angle were obtained. Spray characteristics pertinent for primary breakup modelling were determined from high speed imaging of multiple spray actuations. The results have established input data for computational modelling involving parametrical analysis of nasal drug delivery.

SUBMITTER: Shrestha K

PROVIDER: S-EPMC7406034 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Primary break-up and atomization characteristics of a nasal spray.

Shrestha Kendra K Van Strien James J Singh Narinder N Inthavong Kiao K

PloS one 20200805 8

The primary objective of this research was to extract the essential information needed for setting atomization break up models, specifically, the Linear Instability Sheet Atomization (LISA) breakup model, and alternative hollow cone models. A secondary objective was to gain visualization and insight into the atomization break up mechanism caused by the effects of viscosity and surface tension on primary break-up, sheet disintegration, ligament and droplet formation. High speed imaging was used t ...[more]

PMID: 32756567

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Project description:Anxiety disorders (AD) are the most common mental conditions affecting an estimated 40 million adults in the United States. Amiloride, a diuretic agent, has shown efficacy in reducing anxious responses in preclinical models by inhibiting the acid-sensing ion channels (ASIC). By delivering amiloride via nasal route, rapid onset of action can be achieved due to direct "nose-to-brain" access. Therefore, this study reports the formulation, physical, chemical, and microbiological stability of an extemporaneously prepared amiloride 2 mg/mL nasal spray. The amiloride nasal spray was prepared by adding 100 mg of amiloride hydrochloride to 50 mL of sterile water for injection in a sterile reagent bottle. A stability-indicating high-performance liquid chromatography (HPLC) method was developed and validated. Forced-degradation studies were performed to confirm the ability of the HPLC method to identify the degradation products from amiloride distinctively. The physical stability of the amiloride nasal spray was assessed by pH, clarity, and viscosity assessments. For chemical stability studies, samples of nasal sprays stored at room temperature were collected at time-points 0, 3 hr., 24 hr., and 7 days and were assayed in triplicate using the stability-indicating HPLC method. Microbiological stability of the nasal spray solution was evaluated for up to 7 days based on the sterility test outlined in United States Pharmacopoeia (USP) chapter 71. The stability-indicating HPLC method identified the degradation products of amiloride without interference from amiloride. All tested solutions retained over 90% of the initial amiloride concentration for the 7-day study period. There were no changes in color, pH, and viscosity in any sample. The nasal spray solutions were sterile for up to 7 days in all samples tested. An extemporaneously prepared nasal spray solution of amiloride hydrochloride (2 mg/mL) was physically, chemically, and microbiologically stable for 7 days when stored at room temperature.

Dataset Information

Primary break-up and atomization characteristics of a nasal spray.

Publications

Primary break-up and atomization characteristics of a nasal spray.

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