SPECIAL FEATURE – Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System
Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.
DELIVERY DEVICE – Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways
Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.
NASAL SPRAY BIOEQUIVALENCE – Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
Sebastien Cordier, Bruno Morchain, and Estelle Verger review how PremiumCoat combines state-of-the art elastomer formulation with market-proven film-coating technology to create a highly advanced stopper solution.
In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.
WEARABLE PLATFORM – Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
PRECLINICAL TESTING – Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
Contributor Cindy Dubin explores how device developers and parenteral contract development and manufacturing organizations (CDMOs) are addressing current challenges, as well as advancements in customized device design, the continuous effort to incorporate safety and human factors, and how COVID-19 is shaping the future of the market.
DRY-POWDER THERAPEUTICS – Respiration Inspiration: Local Treatment of Lung Cancer by Dry-Powder Inhaler
Philip Kuehl, PhD, and Kimberly B. Shepard, PhD, describe the formulation and manufacturing considerations for development of dry-powder therapeutics for local treatment of lung cancer. Two case studies are presented in which two approved drugs are successfully formulated for DPI administration to the lung.
Raffaele Pace, MMe, MBA, reviews how today’s drug delivery devices must be more mobile, less intrusive, and simpler than ever before – all while remaining cost competitive.
EXCLUSIVE ONLINE CONTENT
Longeveron Partners With Kinesiometrics to Create & Implement Cutting-Edge Smart Phone App to Measure Physical Responses to Cell Therapy
Longeveron Inc. has entered into an agreement with Kinesiometrics Inc., to provide a cutting-edge, digital data-driven solution for objective real-time measurement of functional capacity and quality….
Impel NeuroPharma Announces US FDA Approval of TRUDHESA Nasal Spray for the Acute Treatment of Migraine
Impel NeuroPharma, Inc. recently announced the US FDA approved TRUDHESA (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura….
Aptar Pharma Granted Exclusive License Option by Pharmaxis to Develop & Promote High Payload Dry Powder Inhaler
Aptar Pharma recently announced it has entered into an agreement with Pharmaxis under which Aptar Pharma has the option to acquire the worldwide rights to….
Evonik has acquired German biotech company JeNaCell. The acquisition expands Evonik’s biomaterials portfolio to provide biotechnologically derived cellulose. The nature-identical material developed by….
Pharmaceutics International, Inc. to Platform West Pharmaceutical Services, Inc.’s Daikyo Crystal Zenith Container-Closure Components for Aseptic Fill-Finish
Pharmaceutics International, Inc. (Pii), a contract development and manufacturing organization (CDMO) will include Daikyo Crystal Zenith (CZ) container-closure components, offered by West Pharmaceutical Services, Inc…..