What is a unit-dose nasal spray?
Sometimes referred to as a unispray or unidose device, unit-dose nasal spray devices deliver one 100uL spray of drug product.
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What is contract manufacturing in pharma?
Contract manufacturing in Pharma is a business model wherein you hire another company to produce assemblies, components, or goods.
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What is aseptic manufacturing?
Aseptic manufacturing is a manufacturing method that can produce bacteria-free products. Aseptic manufacturing is the key to keeping your patients safe from harmful bacteria.
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What is a Aptar bidose nasal spray device?
The Aptar bidose (BDS) nasal spray device is designed to accurately deliver two metered nasal spray doses. The device does not require priming and is disposed of after use.
Are nasal sprays drug-device combination products?
Nasal sprays are drug-device combination products, as defined in FDA 21 CFR 3.2(e): “A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity”.
What is a preservative-free nasal spray?
A preservative-free nasal spray is a nasal spray that is manufactured aseptically to prevent microbial growth rather than having a preservative included in its formulation.
What is a multi-dose preservative-free nasal spray device?
Multi-dose preservative-free nasal spray delivery devices are specifically designed to prevent the ingress of microbiological contamination for multiple doses.
Does Renaissance manufacture nasal spray devices?
No, Renaissance does not manufacture nasal spray devices. We work with our clients and their chosen nasal spray device to fill and assemble their final product.
What is a CDMO?
A CDMO is a Contract Development and Manufacturing Organization that accelerates how pharmaceutical companies bring drugs and therapies to market.
What is aseptic fill finish?
Aseptic fill finish is a process that fills drug product into its final primary packaging absent of microorganisms and pyrogens. During this single process, sterility is maintained from filling to packaging.
What aspects of formulation impact spray characteristics of nasal sprays?
Since nasal sprays are drug/device combination products, the effectiveness of the drug product itself is dependent also on the nasal spray delivery device. This requires special attention during formulation development in order to develop an effective product. These considerations include viscosity, surface tension, density, and particles.