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.
In conclusion of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, reviews and compares current Phase 3 and Registration-stage products with products first approved since 2014 in the United States, Japan, or Europe.
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
Marc Brown, PhD, Jon Lenn, PhD, and Jeremy Drummond, PhD, believe it is essential the lead (and potentially a back-up formulation depending on any risk factors identified) has been optimized and characterized to demonstrate it will maintain its quality and performance as well as provide the best chance of measurable success in the clinical setting.
Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.
Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, offers a short overview of drug delivery and formulation transactions and includes some of the numbers that color the trends of 2018 along with some thoughts on notable transactions and technologies.
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.
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…..