Proveris Laboratories announces expanded services for spray and aerosol characterization of unit-dose nasal drugs

Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, today announced the expansion of contract test services for product characterization, performance, safety, and bioequivalence testing of unit-dose nasal drugs.

Utilizing optimized hardware, Proveris Laboratories now offers the ability to perform in vitro characterization testing on unit-dose devices at multiple orientations, allowing developers to test products designed to be administered in a prone position by a physician, first responder, or caregiver. These new service offerings allow developers to not only comply with regulatory guidance, but also gain key insights early in the development process, with regards to device performance.

Proveris Scientific’s other patented technologies and methodologies allow for robust evaluation of unit-dose spray pumps, syringes, pressurized aerosol devices, and both liquid and powder formulations intended for systemic, nose-to-brain, and local delivery. cGMP-compliant and non-GMP test services include predictive modeling experiments using the Proveris by Design™ design of experiments (DoE) method, human actuation studies using Ergo™ technology, and product characterization studies performed on industry gold standard SprayVIEW® Measurement Systems. Vereo® Automated Actuators, which are at the center of most Proveris platforms, are powered by Viota® Software, including unit-dose capability to allow for proper actuation of single shot devices that often require specially tailored profiles to deliver the full dose. 

Alberto Correia, Vice President of Technical Services and Proveris Laboratories commented, “Developers of intranasal branded and generic drugs for the treatment of conditions such as drug 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.”

About Proveris Scientific

Proveris Scientific Corporation advances the science of respiratory drug delivery products by driving new technology development for high performance spray characterization, capture, and analysis, while leveraging its expertise, experience, and core technologies. With customer success as its central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” which include product innovation, technical services, systems, consumables, and educational training. Since its founding in 1995, the company has accelerated the development of top spray and aerosol drug products and has deployed its systems at more than 100 pharmaceutical development and manufacturing sites around the globe. Proveris’s systems are the industry standard and are used by the FDA, CFDA, and the pharmaceutical industry to generate submission-ready data. Proveris is certified to ISO 9001:2015 by TUV Rheinland of North America, Inc., and has more than 20 patents issued on its technology.

Recipharm invests in its US inhalation development service

The newly acquired system was installed alongside an environmental controlled aerosol collection chamber for inhalation testing and a metered dose inhaler (MDI) and dry powder inhaler (DPI) pilot process lab.

SprayVIEW® is a primary instrument for the characterisation of aerosols or sprays emitted from MDIs, soft mist inhalers and nasal sprays through the measurement of spray pattern and plume geometry. Both are important factors that affect spray performance and SprayVIEW® is an important tool that can visualise changes in other critical quality attributes (CQAs) of inhaled and nasal products.

Commenting on the investment, Lei Mao, Director Inhalation Science and Product Development at Recipharm said: “By employing the SprayVIEW® system and expanding our expertise in this technique, we are strengthening our capabilities in inhalation and nasal product development and manufacturing.”

Read news reported by: Recipharm…