According to modeling software company Simulations Plus, the FDA has awarded the company a contract for a project that is intended to improve models of pulmonary absorption of inhaled drugs, with a goal of creating "the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs." The company said that Rodrigo … [Read more...] about FDA provides funding for Simulations Plus and University of Florida project for validation of PBPK models for inhaled drugs
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TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
Copley Scientific launches new accessory for improved comparability between abbreviated and full resolution impactor measurements
OINDP testing experts Copley Scientific have announced the introduction of the new Volume and Resistance Compensator (VRC), which is designed to make abbreviated impactor measurements (AIM) more comparable to full resolution impactor measurements when measuring aerodynamic particle size distribution (APSD). According to the company, the VRC can be especially … [Read more...] about Copley Scientific launches new accessory for improved comparability between abbreviated and full resolution impactor measurements
Silgan Dispensing launches Gemini BE nasal pump
US-based device maker Silgan Dispensing has announced the launch of its new Gemini BE nasal pump. According to Silgan, the new pump is specifically designed to meet bioequivalence needs and "is adaptable to effectively match specific formulations for a perfect performance fit and quick time-to-market." The company says that the pump's spray characteristics can be … [Read more...] about Silgan Dispensing launches Gemini BE nasal pump
CDMO Micro-Sphere expands its inhalation capabilities
Swiss CDMO Micro-Sphere, which specializes in spray drying and capsule filling, has announced a greater than €5 million expansion of its Monteggio, Switzerland GMP manufacturing facility that includes new inhalation testing laboratory space as well as a containment system for handling high potency compounds. Micro-Sphere also announced that its manufacturing license … [Read more...] about CDMO Micro-Sphere expands its inhalation capabilities
Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
Transpire Bio, which previously announced deals with Recipharm for development of four inhaled products, announced a new deal with INTO (Inhalation Together) for development of three additional inhaled products: TRB-5, TRB-6 and TRB-7. INTO is a partnership between DFE Pharma, Sterling, and Harro Höfliger that was formed earlier this year to provide early development … [Read more...] about Transpire Bio announces development deal with INTO and names new Chief Scientific Officer
CoreRx adds particle engineering capabilities with Bend Bioscience deal
According to early stage CDMO Bend Bioscience, the company is now part of Florida-based CDMO CoreRx thanks to an equity investment by NovaQuest Private Equity, which acquired CoreRx in 2021. Bend Bioscience, which launched in 2021, will offer particle engineering and manufacturing services for a range of dosage forms, including dry powders for inhalation. Bend … [Read more...] about CoreRx adds particle engineering capabilities with Bend Bioscience deal
Ab Initio Pharma now able to manufacture OINDPs for clinical trials
Australian OINDP specialist CDMO Ab Initio announced that the Therapeutic Goods administration of Australia (TGA) has granted the company a license to manufacture finished inhalation products and nasal sprays, in addition to other dosage forms. Ab Initio says that the license allows it to offer services including manufacturing of finished products for clinical trials, … [Read more...] about Ab Initio Pharma now able to manufacture OINDPs for clinical trials
Honeywell begins large-scale production of medical grade Solstice Air HFO-1234ze MDI propellant
Honeywell has begun large scale manufacturing of Solstice Air HFO-1234ze(E), a low global-warming-potential (GWP) MDI propellant, at a facility located in Baton Rouge, LA, USA, the company said. In February 2022, AstraZeneca announced that it would reformulate Breztri budesonide/ glycopyrronium/ formoterol fumarate using Solstice Air as part of a partnership … [Read more...] about Honeywell begins large-scale production of medical grade Solstice Air HFO-1234ze MDI propellant
HCmed Innovations and AeroRx Therapeutics partner on nebulized LABA/LAMA for COPD
Startup inhaled drug developer AeroRx Therapeutics and nebulizer maker HCmed Innovations have announced that they will partner on development of a nebulized LABA/LAMA inhalation solution for the treatment of COPD. AeroRx is a spinoff of iPharma Labs, which was acquired by Kindeva Drug Delivery earlier this year. In March 2022, HCmed announced that it was partnering … [Read more...] about HCmed Innovations and AeroRx Therapeutics partner on nebulized LABA/LAMA for COPD