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November 17, 2022
1 Min Read
Image courtesy of Silgan Dispensing
For pharmaceutical companies looking to introduce new nasal spray formulations, the recently launched Gemini BE nasal pump is nothing to sneeze at.
Available in the US, the device, which was developed with Silgan Dispensing’s bioequivalence (BE) program, is adaptable to specific formulations and customizable with more than 40 different spray configurations.
The company’s five-stage custom process comprises project identification, pre-study initial characterization, BE alignment testing, smart selection for BE, and official BE for filing. Throughout the process, Silgan Dispensing works with the client to customize the Gemini BE so that it performs equivalently with a reference pump’s spray attributes, such as spray pattern, plume geometry, and droplet size distribution. This is achieved through a combination of mathematical modeling, statistical calculations, and design experiments with a variety of spray orifices. The pump can be further customized by having all typical closure types available, precisely adjustable delivered dose, different finger pads, and even colors, if needed.
Additional pump benefits include cleanroom, pharma-grade, and ISO-certified production; high-dosing accuracy; low strokes to prime; and capability to match existing reference listed drug devices across a range of formulations.
Silgan Dispensing’s BE program is aligned with Food and Drug Administration (FDA) and European Union (EU) methods and supported by the company’s regulatory team. The company is working on several bioequivalence projects with its customers using the new nasal pump technology; however, it declined to provide additional information now about these projects.
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