CONTAINER CLOSURE SYSTEM – Recent Prefillable Syringe Developments Mirroring Increasing Biotech Drug Product Demands
Stefan Verheyden says the container closure system has become a decisive factor for sustained market success, with autoinjectors and injection pumps as growing areas of interest.
Degenhard Marx, PhD, and Günter Nadler discuss the treatment of sore throats via a pump spray and explore the considerations to be made when developing a reliable spray product.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
Boris Stoeber, PhD, Sahan Ranamukha, PhD, and Rory St. Clair describe the Microdermics technology and its improvements over the conventional subcutaneous route of administration.
SPECIAL FEATURE – Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
Chris Evans explains how it is important that pharmaceutical companies and their drug delivery system partners proactively address the forgetting curve by rethinking how patients learn to use self-administration systems.
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
DEVICE REGULATIONS – Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations
Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.
EXCLUSIVE ONLINE CONTENT
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.
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, 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).
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.