Drug Delivery
SPECIAL FEATURE - Injection Devices: Faster, Integrated, and Flexible for the IV to SC Transition
Contributor Cindy H. Dubin speaks with several companies who highlight how device developers are addressing various challenges while still ensuring precise dosage control and patient compliance.
SUBCUTANEOUS INJECTIONS - A New Dimension for an Enhanced Injection Experience
Enrico Barichello and Crystal Salvans explore the impact of market trends, focusing on the technical and clinical challenges associated with delivering large-volume, high-viscosity subcutaneous injections. They also highlight the need for optimized delivery systems that can accommodate these formulations without compromising usability or efficacy, as well as the potential advantages such systems may offer for non-viscous injections.
FORMULATION FORUM - Hot Melt Extrusion – An Enabling Technology for Poorly Soluble Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say in spite of many challenges, drug manufactures continue to look for non-conventional, and often novel, polymers to expedite the development of innovative molecules coming out of discovery when none of the conventional technologies do not meet the desired objectives.
PULMONARY DELIVERY - Development of Pulmonary Dosage Forms for the Successful Delivery of Complex Molecules
Richard Johnson, PhD, believes there is growing interest in next-generation pulmonary delivery devices that can overcome delivering drugs more efficiently into the deep lung and also delivering thermally sensitive drugs that are unstable in solution.
EXECUTIVE INTERVIEW - Lonza & Ethris: Advancing mRNA Vaccines: Room-Temperature Stable, Spray-Dried Formulations for Enhanced Mucosal Delivery
Kim Shepard, Director of Advanced Drug Delivery at Lonza, and Carsten Rudolph, PhD, Co-founder and Chief Executive Officer at Ethris, discuss the main objectives of the collaboration and the benefits of spray-dried mRNA vaccines.
WHITEPAPER - Drug Delivery – Recent Trends, Enabling Technologies, In-Vitro-In-Vivo Predictions & Personalized Medicine
Enabling technologies such as Nanotechnology, Amorphous Solid Dispersions, Self-emulsifying/nanoemulsifying drug delivery systems (SEDDS/SNEDDS) or Lipid Nano Particles (LNPs) for oral delivery are key elements for the development of complex and difficult to develop small molecules.
FORMULATION DEVELOPMENT - Innovative Drug Delivery Approaches for GLP-1 Agonists: Enhancing Medication Adherence & Treatment Outcomes
Nasrin Mahmoudi, PharmD, PhD, and Michael Baumann, highlight recent developments in GLP-1 agonist formulations and delivery methods, including advanced injectable formulations, novel oral delivery systems, and topical formulations.
STERILE INJECTABLE MANUFACTURING - Solving Complexity & Strategies for Commercial Success
Jennifer Gattari explores the key forces driving change in the SI space and outlines the core considerations manufacturers must address to deliver safe, effective therapies at commercial scale and the growing reliance on contract manufacturers to help navigate complexity with confidence.
Orexo's AmorphOX Technology May Pave the Way for Intranasal GLP-1 Medication
Orexo AB recently announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with the AmorphOX technology. In the in-vivo study, three different…
Medicus Pharma Ltd. Completes Acquisition of Antev Limited
Medicus Pharma Ltd., a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutic assets, and Antev Limited, a…
MannKind Announces Expansion of United Therapeutics Collaboration for Second Inhaled Therapy
MannKind Corporation recently announced United Therapeutics Corporation has exercised its option—granted under the companies’ 2018 license and collaboration agreement—to develop a second dry powder inhalation…
Clearside Biomedical Announces Multiple Presentations on Suprachoroidal Delivery
Clearside Biomedical, Inc. recently announced its SCS delivery platform and CLS-AX program will be highlighted in multiple presentations at the 25th EURETINA Congress from September…
MannKind to Acquire scPharmaceuticals, Accelerating Revenue Growth & Emerging as a Patient-Centric Leader in Cardiometabolic & Lung Diseases
MannKind Corporation and scPharmaceuticals Inc. recently announced the signing of a definitive merger agreement for MannKind to acquire scPharmaceuticals. This proposed acquisition marks MannKind’s strategic…
Biofrontera Announces Last-Patient-Out in Phase 2b Study of Ameluz Topical Gel for the Treatment of Moderate-to-Severe Acne Vulgaris
Biofrontera Inc. recently announced the final patient in its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of moderate-to-severe acne vulgaris…
Medicus Pharma Provides Update on D-MNA Clinical Development Program for the Treatment of Basal Cell Carcinoma
Medicus Pharma Ltd. recently announced, following the acceptance of the Type C meeting request by the USFDA, it has submitted its queries in writing and…
BioMed X & Novo Nordisk Launch New Collaboration in Oral Peptide Drug Delivery
BioMed X recently announced the launch of a new collaboration with Novo Nordisk, a leading global healthcare company headquartered in Denmark. This partnership aims to…
Upperton Pharma Solutions Awarded VaxHub Sustainable Grant to Advance Oral Vaccine Delivery in Partnership With the University of Oxford’s Pandemic Sciences Institute
Upperton Pharma Solutions, a leading UK-based contract development and manufacturing organisation (CDMO), has been awarded a grant as part of the first VaxHub Sustainable Platform…
Opus Genetics Announces FDA Clearance of IND Application for Gene Therapy Candidate
Opus Genetics recently announced the US FDA has accepted its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy for the treatment of bestrophin-1…
Tiziana Life Sciences Doses First Patient in Phase 2a Trial of Intranasal Foralumab for Multiple System Atrophy
Tiziana Life Sciences, Ltd. recently announced the first participant has been enrolled and dosed in its Phase 2a clinical trial evaluating intranasal foralumab in patients…
ON-DEMAND WEBINAR: Drug Product Design for Delivery of Challenging Molecules
In this talk we illustrate several case studies demonstrating how a fundamental understanding of molecular properties combined with a strategic vision for drug product design can lead to effective and advanceable formulations for even the most challenging drug products.
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.