Drug Delivery
Apellis Announces US FDA Approval of the EMPAVELI Injector, a Device to Streamline Self-Administration
Apellis Pharmaceuticals, Inc. recently announced the US FDA has approved the EMPAVELI Injector, a compact, single-use, on-body device designed to enhance self-administration of….
Assembly Biosciences Nominates Development Candidate ABI-6250, an Orally Bioavailable HDV Entry Inhibitor
Assembly Biosciences, Inc. recently announced the selection of development candidate ABI-6250 to progress to IND-enabling studies. ABI-6250, an orally bioavailable small molecule entry inhibitor, is…
Evonik Strengthens Portfolio of Nanoparticle Technologies & Services for Parenteral Drug Delivery
Evonik is strengthening its platform of parenteral drug delivery solutions with three new standard PLA-PEG di-block copolymers and a new nanoparticle formulation service using….
DEVICE DEVELOPMENT - Connected Auto-Injector Development: How to Leverage Human Factors Engineering
Finola Austin examines the human factors process for such devices, including a detailed look at the recent development of the UniSafe® 1 mL auto-injector.
Biora Therapeutics Announces Submission of IND Application for BT-600 Program Featuring NaviCap Ingestible Drug Delivery Device
Biora Therapeutics, Inc. recently announced submission of an Investigational New Drug (IND) application with the US FDA that supports the next phase of development of…
ALSA Ventures Launches Novel Gene Therapy Portfolio Company Axovia Therapeutics
ALSA Ventures recently announced the acquisition of Axovia Therapeutics Inc and the launch of a new portfolio company Axovia Therapeutics Ltd. Axovia is developing the…
Rani Therapeutics Initiates Phase 1 Study of RT-111 (RaniPill Containing Ustekinumab Biosimilar, CT-P43)
Rani Therapeutics Holdings, Inc. recently announced the initiation of a Phase 1 clinical trial to evaluate the safety and tolerability of RT-111, an orally administered…
POINT Biopharma & Athebio Announce Partnership to Develop Designed Ankyrin Repeat Protein Targeted Radioligands
POINT Biopharma Global Inc. and Athebio AG recently announced a collaboration and license agreement to develop and commercialize DARPin-targeted radioligands (Radio-DARPins). DARPins are an attractive…
New Collaboration With Stevanato Group to Elevate mRNA Production With Nfinity Platform
Quantoom Biosciences recently announced a new collaboration with Stevanato Group, a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life science industries, with the goal of….
Evoke Pharma Receives Notice of Allowance from USPTO for First & Only FDA-Approved Nasal Formulation of Metoclopramide Commercially Available in the US
Evoke Pharma, Inc. recently announced it has been granted a Notice of Allowance from the US Patent and Trademark Office (USPTO) for patent application No.…
Immatics & Moderna Announce Strategic Multi-Platform Collaboration to Develop Innovative Oncology Therapeutics
Immatics, NV, and Moderna, Inc. recently announced a strategic research and development collaboration to pioneer novel and transformative therapies for cancer patients with high unmet….
Verona Pharma Announces FDA Has Accepted NDA Filing for Ensifentrine for the Maintenance Treatment of COPD
Verona Pharma plc recently announced the US FDA has accepted for review the company’s New Drug Application (NDA) seeking approval of ensifentrine for the maintenance…
Shape(TX) Collaborates With Otsuka to Develop Novel AAV Gene Therapies for Ocular Diseases
Shape(TX) and Otsuka Pharmaceutical Co., Ltd. recently announced a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular….
WEBINAR - Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
Palisade Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement With Giiant Pharma for Multiple Oral Drug Candidates Targeting Inflammatory Bowel Disease
Palisade Bio, Inc. recently announced it has entered into a licensing agreement with Giiant Pharma, Inc., providing the company with the exclusive worldwide rights to develop, manufacture, and commercialize….
CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success
Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.
SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance
Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.
EXECUTIVE INTERVIEW - Sever Pharma Solutions: Development & Manufacturing of High Potent Polymer-Based Dosage Forms
Tony Listro, Vice President of Technology and Site Lead for SPS’s North American site in Putnam, CT, discusses the company’s recent focus areas as well as current plans for expansion.
THERAPEUTIC FOCUS - Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients With Parkinson’s Disease
Joseph M. Palumbo, MD, says addressing Parkinson’s via the inflammatory pathway offers a unique perspective that was virtually unheard of only 10 years ago.
MEDICAL DEVICE TESTING - Breathing Component Biocompatibility: The Practical Application of ISO 18562
Luminita Moraru, MSc, explains how the medical devices industry has grown and is expanding daily and presents the key steps that need consideration when assessing breathing devices.
What are Drug Delivery Systems?
Drug delivery systems are engineered technologies for the targeted delivery and/or controlled release of therapeutic agents. The practice of drug delivery has changed significantly in the past few decades and even greater changes are anticipated in the near future. Drug delivery includes but is not limited to oral delivery, gene/cell delivery, topical/transdermal delivery, inhalation deliver, parenteral delivery, respiratory delivery, capsules, particle design technology, buccal delivery, etc.
The Evolution of Drug Delivery Systems
Drug delivery systems have greatly evolved over the past 6 decades. In the past 12 years specifically, there have been huge advancements in drug delivery technology. For instance, advanced medication delivery systems, such as transdermal patches, are able to deliver a drug more selectively to a specific site, which frequently leads to easier, more accurate, and less dosing overall. Devices such as these can also lead to a drug absorption that is more consistent with the site and mechanism of action. There are other drug delivery systems used in both medical and homecare settings that were developed because of various patient needs and researchers continue to develop new methods.
Drug Delivery System Market Size
The pharmaceutical drug delivery market size is studied on the basis of route of administration, application, and region to provide a detailed assessment of the market. On the basis of route of administration, it is segmented into oral delivery, pulmonary delivery, injectable delivery, nasal delivery, ocular delivery, topical delivery, and others.
The estimated global market size of drug delivery products was $1.4 trillion in 2020. Unfortunately, 40% of marketed drugs and 90% of pipeline drugs (mostly small molecules) are poorly soluble in water, which makes parenteral, topical, and oral delivery difficult or impossible. In relation, poor solubility often leads to low drug efficacy. Add in the fact that many other hurdles exist in the form of drug loading, stability, controlled release, toxicity, and absorption – it’s not hard to understand the difficulties in bringing new drug products to market. Additionally, biopharmaceuticals (proteins, peptides, nucleic acids, etc) and combination drug products possess many of these same problematic obstacles that affect efficacy. These challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel drug delivery platforms that overcome a great many bioavailability and delivery obstacles. By leveraging these platforms, pharmaceutical and biopharmaceutical companies can improve dosing accuracy, efficacy, and reproducibility in their drug discovery and drug delivery research.
Drug Delivery System Demand
The demand for pharmaceutical products worldwide is only going to increase in the coming years, as old and emerging diseases continue to threaten the well-being of people globally. Drug discovery efforts are expected to intensify, generating a large variety of active compounds with vastly different structures and properties. However, it is well known that despite tremendous output of the drug discovery process, the success rate of a candidate compound becoming an approved drug product is extremely low. The majority of candidate compounds are discarded due to various hurdles in formulation and preclinical testing (such as issues with solubility, stability, manufacturing, storage, and bioavailability) before even entering into clinical studies. Therefore, advances in formulation and drug delivery, especially the development of new and versatile biomaterial platforms as effective excipients, may salvage many “difficult,” otherwise triaged, drug compounds, and significantly enhance their chance of becoming viable products. Furthermore, breakthroughs in biomaterial platform technologies will also facilitate life cycle management of existing APIs through reformulation, repurposing of existing APIs for new indications, and development of combination products consisting of multiple APIs.