Issue link: https://www.e-digitaleditions.com/i/1500880
News about companies that support development of orally inhaled and nasal drug products (OINDPs), including regulatory approvals, new partnerships, new products and services and results of clinical studies. 8 June 2023 Inhalation ing service to help pharmaceutical companies efficiently bring orally inhaled and nasal drug products (OINDPs) to market. A compa- ny news release stated the service builds on the company's exper- tise in analytical testing and its in-depth understanding of aero- sol and inhalation science, while offering the added benefit of work- ing with a fully integrated testing, consulting and compliance service provider. e inhalation testing service is aimed at pharmaceuti- cal companies, generic drug man- ufacturers looking to reformulate existing products for inhalation devices and device manufactur- ers. It will focus on formulation and device testing for dry pow- der inhalers (DPIs), pressurized metered dose inhalers (pMDIs), soft mist inhalers (SMIs), nasal sprays, breath-actuated devices and novel inhaled devices. A range of services will be offered, includ- ing early-stage production char- acterization and analysis, device selection and testing, small-scale manufacturing support, manufac- turing scale-up, analytical meth- od development and validation, on-site stability storage, extract- ables and leachables (E&L) testing and toxicology support. Horiba Scientific named Fritsch's exclusive American distributor IRVINE, CALIFORNIA—Fritsch has selected Horiba Scientific as their exclusive distributor through- out the Americas for their Analy- sette 28 ImageSizer. e Analysette 28 is a dynamic image analyzer for applications that require measure- ments of particle size and shape of powders and bulk solids, (mea- suring range 20 μm to 20 mm) as well as suspensions and emulsions, (measuring range 5 μm to 3 mm). An Horiba news release described the agreement as an important step for Horiba's particle char- acterization business, providing the company's customers with an established technology for deter- mining accurate [particle] size and Copley Scientific introduces two-in- one instrument NOTTINGHAM, UNITED KINGDOM—Copley Scientific has announced the introduction of the Impactor Genie™ IG 200i, a semi-automation tool for reg- ulatory and compendial aerody- namic particle size distribution (APSD) measurement with either the Andersen Cascade Impac- tor (ACI) or Next Generation Impactor (NGI). It combines the functionality of the company's Impactor Coater™ IC 200i for collection plate and cup coating and the enhanced Gentle Rocker™ GR 200i for drug dissolution. A company news release noted that coating impaction surfaces with a tacky, viscous solution mini- mizes the risk of particle bounce, a known cause of inaccurate mea- surement, in particular for dry powder inhalers (DPIs). In addi- tion, following size fractionation of the delivered dose, drug is recov- ered from each collection plate or cup of an impactor by dissolution to generate an APSD for the active pharmaceutical ingredient(s), a manually intensive process that can cause variability in the result- ing data. Using the two-in-one instrument, the impactor coater can standardize the application of coating solution to each impaction surface, decreasing the inherent variability associated with man- ual coating processes while help- ing enhance lab productivity and throughput. e gentle rocker can promote easy and fully repeatable dissolution of the drug present on impaction surfaces, enabling spe- cific, reproducible drug recovery and easy method transfer, increas- ing the reliability of results and decreasing analytical workload. Broughton launches new inhalation testing service EARBY, LANCASHIRE, UNIT- ED KINGDOM—Broughton, a scientific consultancy and contract research organization (CRO), has announced a new inhalation test- INDUSTRY NEWS Catalent and Harm Reduction Therapeutics sign commercial supply agreement SOMERSET. NEW JERSEY AND PITTSBURGH, PENNSYLVA- NIA —According to Catalent and Harm Reduction Therapeutics, the companies have signed a com- mercial supply agreement, under which Catalent will manufacture Harm Reduction Therapeutics' over-the-counter naloxone nasal spray, RiVive™ (3.0 mg), for the emergency treatment of known or suspected opioid overdose. e agreement comes after the United States Food and Drug Administra- tion (FDA) granted Harm Reduc- tion erapeutics priority review status for its New Drug Applica- tion (NDA) in December 2022. e companies' news release stated that FDA approval is anticipated in July 2023 and a US launch early in 2024. "e opioid epidemic is an ongoing national tragedy, and for OTC naloxone to address this unmet need we needed a manu- facturing partner with the capa- bility and bandwidth to help make naloxone much more widely and easily accessible to save lives that will otherwise be lost to opioid overdose," said Michael Hufford, PhD, co-founder and chief exec- utive officer of Harm Reduction Therapeutics. "This agreement marks a major milestone for Harm Reduction erapeutics and is also a significant step forward in tack- ling a major public health issue in the US," said Carla Vozone, vice president of inhalation strategy at Catalent. "Our company is driven by a 'patient-first' culture, which is synergistic with the goals and mis- sion of our partner on this project, and we take great pride in being associated with such a potentially life-changing program." continued on page 34