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.
Jim Huang, PhD, reviews how injectable solutions offer an attractive alternative to oral dosage form due to fast onset, reproducible PK/efficacy profile, high bioavailability as a result of bypassing the oral absorption barrier, and suitability of administration under hospital setting.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2020
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
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.
Dai Hayward, CEO at Micropore, discusses his company’s expertise and underpinning technology in the development of safe, efficient, and scalable continuous manufacturing of drug delivery solutions.
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
John Docherty, President of Lexaria, discuess how the company’s recent uplist to the NASDAQ has resulted in its largest capital injection to date, which will allow it to focus on preclinical and clinical testing programs for DehydraTECH formulations across three main areas of interest.
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.
Alex Kerr, Sam Trotter, and Poppy Maley explain how recent advances in biopolymers and manufacturing technology now enable formulation of injectable drug products to be tailored at will to achieve a target bioavailability in a shorter development time with robust and low cost of manufacture.
Contributor Cindy Dubin speaks with several innovative excipient companies that assert novel excipients – agglomerated, co-processed, and multifunctional – actively and safely affect formulation stability, solubility, and bioavailability as well as foster faster drug disintegration.
GLOBAL REPORT – 2020 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery and Formulation Product Approvals of 2020
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
Jim Huang, PhD, discusses how understanding the properties of ASDs and their relationship to downstream product scale up, stability, and in-vivo performance is critical to successfully utilize them for drug delivery of insoluble drugs in early development and commercialization in a timely and cost-effective manner.
Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.
BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
With the development of ILC Dover’s new Aseptic Isolator system new opportunities have opened up for many organizations who were previously able to conduct fill finish activities due to facility restraints or expensive closed barrier systems. This new technology….
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FORMULATION FORUM – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid
In this study, the authors monitor acetylsalicylic acid (ASA) hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of the ASA.
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….
In this Whitepaper, Solo Containment (now part of ILC Dover) walks you through their process, from concept-to-development, for creating a fully disposable Grade-A aseptic fill/finish isolation system.
ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…
Developing a new pharmaceutical product is one of the most interesting and rewarding activities to partake in, it is also extremely challenging. It is a given that drug development projects will not….
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Vectura & Inspira Pharmaceuticals Sign Agreement to Develop Potential Inhaled Treatment for COVID-19
Vectura Group plc and Inspira Pharmaceuticals Limited recently announced an agreement to develop an inhaled formulation of Inspira’s lead drug candidate for the potential treatment of….
Takara Bio Europe AB & PanCryos Announce Licensing Agreement to Enable Development of Cell-Based Therapy for Diabetes
Takara Bio Europe AB (TBEAB) and PanCryos recently announce they have reached a licensing agreement surrounding TBEAB’s clinical-grade human embryonic stem (hES) cell lines…..
With SensAIR, Gerresheimer presents for the first time a new platform for on-body infusion pumps that can deliver drugs of higher viscosity, such as monoclonal antibodies (mAbs), with precise dosing and safety….
Catalent Acquires Additional Facility at its Gosselies, Belgium, Campus for Commercial-Scale Plasmid DNA Manufacturing
Catalent and Promethera Biosciences recently announced that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its….
Rentschler Biopharma and Vetter, two globally operating Contract Development and Manufacturing Organizations (CDMOs), recently announced their strategic collaboration has taken key steps….
Daré Bioscience, Inc. recently announced that data from the DARE-BVFREE Phase 3 study of DARE-BV1, a thermosetting vaginal gel for the treatment of bacterial vaginosis, was….
InveniAI LLC recently announced a multi-target drug discovery collaboration with Shionogi & Co., Ltd.; the multi-year collaboration will combine InveniAI’s AI platform….
AavantiBio and Catalent recently announced a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA)….
Genedata recently announced a long-term partnership agreement with MacroGenics, a biopharmaceutical company and an emerging leader in developing and commercializing innovative immune-oncology therapeutics…..
Agenus Submits Balstilimab Biologics License Application to the US FDA for Patients With Recurrent or Metastatic Cervical Cancer
Agenus Inc. recently announced the submission of a Biologics License Application (BLA) to the US FDA for the accelerated approval of….