Proveris Laboratories announces the availability of services utilizing a new approach to IVIVC for inhalation drug products

Hudson, MA, May 24, 2019 – Proveris Scientific Corporation, a leading provider of services and technology to advance the science of respiratory drug delivery products, today announced the addition of new services to accelerate product characterization, performance, safety and bioequivalence testing of inhalation drug products by measuring the aerosolization process, regional deposition and bioavailability under more human realistic conditions than existing methods.

These services are aligned with recent efforts to establish in-vitro/in-vivo correlation (IVIVC) and support the FDA’s newly released draft guidance on Beclomethasone Dipropionate that promotes alternate in-vitro studies in lieu of clinical endpoint.

Based on an innovative new proprietary technology, these services have been developed in collaboration with key industry leaders and are now being offered through Proveris Labs.

“We are very excited to offer our customers access to this new technology” comments Alberto Correia, Vice President of Technical Services, “we believe we will provide our customers tremendous insight into the performance of their products and enable a new approach to IVIVC.”

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 their expertise, experience and core technologies. With customers’ success as their central motivating force, Proveris Scientific adds value to a global customer base with “complete solutions” that include product innovation, technical services, systems, consumables and educational training. Since its founding in 1995, the company has accelerated the development of the 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 on its technology issued in United States, Europe, and Asia. For more information, please visit www.proveris.com.

OINDP companies get together to create new event series

Led by inhaler device platform designer and supplier Merxin and by Nanopharm, a CRO specializing in inhaled and nasal drugs, a group of companies that offer products and services for OINDP development has come together to put on a new event series called Inspire Me. The first event will take place on June 4 and 5, 2019 in San Francisco, CA, USA, with the first day devoted to dry powder inhalers and the second day to soft mist inhalers.

The companies, which represent a comprehensive range of expertise in OINDP technology, also include filling and packaging company Harro Höfliger; DPI capsule and spray drying experts Lonza (Capsugel); particle analysis specialists Malvern Panalytical; lactose manufacturer Meggle; human factors researchers MedHF; generic device developer, and spray analysis experts Proveris Scientific.

Merxin Chief Business Officer Philippe Rogueda explains the reasoning behind creating the new event: “InspireMe events are meant to be educational, to teach people how to make inhaler products from API to registration. This sort of overview and product building is sometimes taught at university by non-practitioners, but not in main stream conferences by industrialists with a wealth of experience. This event aims to teach how to make inhalers from a purely industrial perspective: from the best in the industry with current live experience.”

“Soft-mist and dry powder inhalers are emerging as the preferred delivery system by offering several benefits, such as, non-invasive, propellant free, easy to handle, easy to operate, and gradual release profile,” adds Ben Okorodudu, VP of Sales for Proveris Scientific; “However, the variations in design, formulation, and use present significant challenges in the development, and manufacturing of a successful drug products. A focused conference that delves into the challenges, and opportunities for DPI, and SMI creates a platform for addressing relevant science, technology, and tools for achieving safe, effective, commercially viable respiratory drug delivery.”

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UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA

UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.

NAYZILAM® (midazolam) nasal spray* is a nasally administered benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older.

NAYZILAM allows for administration by a non-healthcare professional in patients actively seizing when and where a seizure cluster occurs.

Approval of NAYZILAM adds to UCB’s already existing anti-epilepsy drug portfolio, reinforcing the company’s position as a global leader in epilepsy.

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