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).
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final 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.
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
OPEN INNOVATION PLATFORM – Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
Dr. Paul Shields, COO of Enteris BioPharma, discusses the changing face of the CDMO industry and how his company plans to leverage its newly expanded CDMO operations to take advantage of a variety of growth opportunities to build deeper partnerships.
EXCLUSIVE ONLINE CONTENT
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….
Vifor Pharma & Cara Therapeutics Announce US FDA Approval of Injection for Treating Moderate-to-Severe Pruritus in Hemodialysis Patients
Cara Therapeutics and Vifor Pharma recently announced the US FDA has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with….
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….
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…..
DisperSol & Catalent Collaborate to Establish KinetiSol Technology Manufacturing Hub for DisperSol Pharmaceutical Pipeline
DisperSol Technologies and Catalent recently announced a strategic manufacturing collaboration to accelerate the development of multiple DisperSol pharmaceutical products…..