Proveris Scientific has announced that it now has the ability to conduct in vitro testing of unit dose nasal drugs in multiple orientations, which is necessary for intranasal products such as opioid overdose reversal drugs, seizure medications, or sedatives that are designed for administration by emergency personnel or clinicians where the patients could be in various positions. The company’s custom designed hardware allows for product characterization, performance, safety, and bioequivalence testing of such unit dose nasal sprays in compliance with regulatory guidance.
Proveris VP of Technical Services and Proveris Laboratories Alberto Correia said, “Developers of intranasal branded and generic drugs for the treatment of conditions such as overdose reversal and seizures will benefit from Proveris’s simple and precise setup to be able to test their products in multiple orientations, mimicking how these products will actually be administered in real-life situations. Additionally, the unit-dose configuration in our Viota software allows each device to be actuated properly using a force limited methodology ensuring full dose delivery. Force profiles generated from each actuation can help to confirm dose delivery. This is critical for unit dose devices designed for use in combatting life-threatening events such as drug overdose and seizures, as well as for potent drugs where exceeding the dosage limit is dangerous.”
In May 2020, Proveris launched cGMP-compliant OINDP testing services, and the company offers both cGMP and non-GMP testing services for unit dose nasal spray pumps using its Sprayview spray characterization systems and Ergo actuation technology.
Read the Proveris Scientific press release.
