Devices
Respiratory Drug Development eBook – Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
PARENTERAL DEVELOPMENT – Considerations in Developing Complex Parenteral Formulations
Iain MacGilp, PhD, says the path to delivering stable, apparently simple solution, suspension, or emulsion formulations is multi-faceted and requires a constant focus on key control measures through pre-formulation development to commercialization.
DEVICE DESIGN – Quality-by-Design Approach to Enable High-Dose Drug Delivery With Autoinjectors
Patrick Le Gal explains how his company deployed a quality by design approach to manage all the unavoidable competing requirements and to propose a solution that balances performance, robustness, and usability.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
SMART DEVICES – Add-On Connectivity Facilitates New Generation of Smart Inhalers
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
EXECUTIVE INTERVIEW – Vetter: Insights on Insourcing Versus Outsourcing in the World of Injectable Manufacturing
Oskar Gold, Vetter’s Senior VP, Key Account Management and Marketing/Corporate Communications, offers his insights on aseptic manufacturing and why careful thought and consideration of different criteria must be applied.
DEVICE REGULATIONS – The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
EXECUTIVE INTERVIEW – BD Integrated Systems: From Innovation to Integration
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
WEARABLE INJECTORS – BD Wearable Drug Delivery Devices: An Attractive Proposal
Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.
SPECIAL FEATURE – Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
EXCLUSIVE ONLINE CONTENT
Enable Injections Enters Strategic Partnership With Sanofi
Enable Injections, Inc. recently announced it has entered into a multi-product development agreement with Sanofi S.A.
Japan’s Medical Device Market Set to Reach $74.7 Billion in 2025
The Japanese medical device market is set to reach from $54.5 billion in 2018 to $74.7 billion in 2025, growing at a compound annual growth rate (CAGR) of 4.6% says GlobalData, a leading data and analytics company.
Hovione Technology Announces Acquisition of Global Rights to New Pulmonary Inhaler Device
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Industry Trends: Vigilance is Critical for Future Success
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).