Drug Delivery
Caladrius Biosciences & Cend Therapeutics Announce Definitive Merger Agreement
Caladrius Biosciences, Inc. and Cend Therapeutics, Inc. recently announced the companies have entered into a definitive merger agreement under which Cend will merge with a wholly owned subsidiary of….
Sol-Gel Technologies & Galderma Announce FDA Approves First Topical Rosacea Treatment With Microencapsulated BPO
Sol-Gel Technologies, Ltd. recently announced the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY, a proprietary cream formulation of….
Starton Therapeutics Doses First Subjects in Phase 1 Clinical Trial of STAR-LLD Continuous Delivery Lenalidomide
Starton Therapeutics Inc. recently announced it has dosed the first subjects in a first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide,…
WHITE PAPER - Poloxamer: A Simple & Powerful Solution for Accelerating Dissolution
This white paper will introduce the concept of dissolution and discuss how poloxamers are a simple yet powerful formulation approach that can enhance dissolution rate, while minimizing resource requirements.
ProMed Pharma Announces Preclinical Rat Study to Assess Pharmacokinetics of Novel Long-Acting Contraceptive Implant
ProMed Pharma recently announce the initiation of preclinical evaluation of a novel fully resorbable contraceptive implant. The implant, developed in a project funded by the Bill & Melinda….
KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate
KemPharm, Inc. recently announced the first subject has been dosed in a Phase 1 clinical trial designed to assess the relative cardiovascular safety of serdexmethylphenidate…
TFF Pharmaceuticals Announces Safety & Pharmacokinetic Data From Phase 1 Study of Niclosamide Inhalation Powder
TFF Pharmaceuticals, Inc. recently announced safety and pharmacokinetic (PK) data from its Phase 1 study of Niclosamide Inhalation Powder, which is being developed for the…
Halozyme to Acquire Antares Pharma to Create a Specialty Product & Drug Delivery Leader
Halozyme Therapeutics, Inc. and Antares Pharma, Inc. recently announced the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for….
Geocann & Averix Bio Form Strategic Partnership to Supply Global Marketplace With Pharmaceutical API Phytocannabinoid Ingredients Formulated With Proven Delivery System
Geocann recently announced a strategic partnership with Averix Bio that will bring US-produced API phytocannabinoid ingredients and clinically proven bioavailable formulations to the global marketplace.…
Daré Bioscience Initiates Phase 1/2 Clinical Study of DARE-HRT1
Daré Bioscience, Inc. recently announced the initiation of a Phase 1/2 clinical study of DARE-HRT1. DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver…
WHITE PAPER: Controlled Synthesis of Lipid Nanoparticles Using the Automated Nanoparticle System
Particle Works’ leading microfluidic technology offers a unique automated nanoparticle generation platform for the production of homogeneous, controllable, and reproducible LNPs….
Matinas BioPharma & BioNTech Announce Exclusive Research Collaboration to Evaluate Novel Delivery Technology for mRNA-based Vaccines
Matinas BioPharma and BioNTech SE recently announced they have entered into an exclusive research collaboration to evaluate the combination of mRNA formats and….
Krystal Biotech Announces Home Dosing in B-VEC Open Label Extension Study
Krystal Biotech, Inc. recently announced it plans to offer patients with dystrophic epidermolysis bullosa (DEB), who are enrolled in the GEM-3 open label extension study,…
Eton Pharmaceuticals Announces FDA Approval of Cysteine Hydrochloride Injection
Eton Pharmaceuticals, Inc. recently announced it has received final approval from the US FDA for its cysteine hydrochloride abbreviated new drug application (ANDA), a bioequivalent generic of….
VectorBuilder to Expand With $500-Million Gene Delivery Research & Manufacturing Campus
VectorBuilder Inc. recently announced the construction of a new R&D and manufacturing center in Guangzhou, China. The Gene Delivery Research and Manufacturing Campus will significantly expand…
Enteris BioPharma Highlighted as Game Changer in Special Feature on Innovative Technologies for Improving Drug Solubility & Bioavailability
Enteris BioPharma, Inc., a biotechnology company developing innovative drug products based on its proprietary delivery technologies, and a wholly-owned subsidiary of SWK Holdings Corporation (Nasdaq:…
VYNE Therapeutics Announces Positive Phase 1b Efficacy Data From Phase 1b/2a Trial
VYNE Therapeutics Inc. recently announced positive efficacy results from the Phase 1b segment of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of…
FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
Arcutis Completes Enrollment in ARRECTOR Pivotal Phase 3 Trial of Topical Roflumilast Foam in Scalp & Body Psoriasis
Arcutis Biotherapeutics, Inc. recently announced the enrollment of the last subject in its ARRECTOR pivotal Phase 3 trial of topical roflumilast foam in adolescents and…
CELL & GENE THERAPY - State of the Industry – Where is C> Headed?
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
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.