Drug Delivery
4DMT Receives FDA Regenerative Medicine Advanced Therapy Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD
4D Molecular Therapeutics recently announced the US FDA has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet…
Biora Therapeutics Announces New Patent for its NaviCap Targeted Oral Delivery Platform
Biora Therapeutics, Inc. recently announced it received an Issue Notification from the US Patent and Trademark Office for a patent related to the treatment of…
Ethris Initiates First-in-Human Dosing in Phase 1 Study for the Treatment of Virus-Induced Asthma
Ethris GmbH recently announced the dosing of the first healthy participant in its first-in-human study of lead candidate ETH47, which was developed using Ethris’ Stabilized…
Successful Transfer of NDA Acknowledged by FDA From Former Zosano Pharma to Emergex for Investigational Microneedle-Based Drug Delivery Patch
Emergex Vaccines Holding Limited recently announced the company has transferred ownership, as of May 2023, of the existing US FDA New Drug Application (NDA) of the investigational MAP originally intended….
Global Confidence in Drug Delivery Innovation Remains at Record Highs According to Pharmapack
The annual Pharmapack Drug Delivery Innovation Index is released ahead of Europe’s premier drug delivery and packaging event, Pharmapack Europe 2024 (January 24-25) – held at the Paris Expo, Porte de Versailles (Hall 7.2). The results showed….
Roche Completes Acquisition of Telavant From Roivant, Including Rights to Novel TL1A Directed Antibody for Inflammatory Bowel Disease Treatment
Roivant recently announced the completion of the previously announced acquisition by Roche of Telavant, for an upfront payment of approximately $7.1 billion…..
Rani Therapeutics Announces Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist
Rani Therapeutics Holdings, Inc. recently announced pharmacodynamic data of an incretin triagonist of the GLP-1, GIP, and glucagon receptors delivered transenterically, which mimics the RaniPill…
Aptamer Group Signs Material Agreement With Genetic Medicines Company
Aptamer Group plc, the developer of novel Optimer binders to enable innovation in the life sciences industry, recently announces it has entered into a material…
Clene Announces Publication Describing CNM-Au8 Brain Target Engagement in Neurodegenerative Diseases
Clene Inc. and its wholly owned subsidiary Clene Nanomedicine Inc. recently announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8, the…
Biora Therapeutics Announces New Research Collaboration for the BioJet Systemic Oral Delivery Platform
Biora Therapeutics, Inc. recently announced a new research collaboration with a large pharmaceutical company for its BioJet Systemic Oral Delivery Platform. The new agreement provides funding….
ProQR Therapeutics Announces Transaction Completed for Théa to Acquire Sepofarsen & Ultevursen Ophthalmic Assets
Agreement provides ProQR with initial payment of €8M and up to €165M in earn-out payments, as well as potential double-digit royalties based on commercial sales in the US and EU….
Recipharm Announces Collaboration With Oz-UK to Accelerate the Development of Low Global Warming Potential pMDIs Utilizing HFA-152a Propellant
Recipharm recently announced a collaboration with Oz-UK to accelerate the development and manufacture of “green” pressurized metered dose inhalers (pMDIs). The pMDIs will utilize valves…
Colorcon Unveils Corelease - A Unified Brand for Novel Controlled-Release Formulated Systems
Ready formulated systems approach simplifies the development and manufacturing for controlled release…..
2024 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM – Nanosuspensions - An Enabling Formulation for Improving Solubility & Bioavailability of Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the role of excipients and methods for preparation and application of nanosuspensions in injectable, ocular, topical, and oral drug delivery.
REGULATORY AFFAIRS - Rethink the Regulatory Dynamic: A Better Approach for Being Your Product’s Best Advocate
Nick Smalley says as drug device combination products grow more complex, regulations increase commensurately. However, to implement and enforce appropriate regulatory standards and truly ensure product safety, regulators must understand what it is they are regulating.
LIPOSOMAL PEPTIDE THERAPEUTICS - Revolutionizing Oncology: Unleashing Innovative Strategies to Tackle Challenging, High-Value Drug Targets
Natalia Zisman, Krishna Allamneni, PhD, and Stacy W. Blain, PhD, explain how targeting downstream signaling proteins offers a promising approach to effectively mitigate the emergence of drug resistance that precision oncology therapies leave behind.
CARBOMER CHEMISTRY - Breaking Ground in Controlled Release
Nicholas DiFranco, MEM, believes by working alone or alongside other well-established excipients for controlled release such as HPMC, the power of carbomer chemistry can help drug developers to overcome common challenges associated with controlled-release formulations without resorting to more complex techniques.
Tiziana Life Sciences Announces Foralumab Dosing of Four New Patients in the Expanded Access Program for Multiple Sclerosis
Tiziana Life Sciences Ltd. recently announced it has successfully enrolled and dosed four new patients with non-active secondary progressive multiple sclerosis (na-SPMS) in the Brigham…
Hovione Expands Nasal Drug Delivery Capabilities With Development of Nasal Powder Delivery Device Technology in Collaboration With IDC
Hovione and Industrial Design Consultancy (IDC) have entered into a joint development of an innovative nasal powder delivery device technology supporting local, systemic, and nose-to-brain drug delivery….
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.