Drug Delivery
Evoke Pharma & EVERSANA Extend Commercialization Partnership to Further Support GIMOTI
Evoke Pharma, Inc. and EVERSANA Life Science Services, LLC recently announced the extension of their agreement to continue collaborating on the commercialization and distribution of….
Arcutis Completes Enrollment of STRATUM Pivotal Phase 3 Trial of Topical Roflumilast Foam in Individuals With Seborrheic Dermatitis
Arcutis Biotherapeutics, Inc. recently announced the enrollment of the last subject in its STRATUM Phase 3 pivotal trial for topical roflumilast foam in patients with….
Owen Mumford Announces on Market Release of UniSafe 1-mL Safety Device for Pre-filled Syringes Featuring Industry-First Spring-less Mechanism
Owen Mumford Pharmaceutical Services recently announced its UniSafe 1-mL safety device for pre-filled syringes has been approved as a combination product in Asia. In Europe,…
Enable Injections Announces $215-Million Financing
Enable Injections, Inc. recently announced $215 million in Series C financing. Magnetar Capital (Magnetar) led the financing along with new institutional investments from….
Cocrystal Pharma Selects Two Lead Antiviral Drug Candidates for its COVID-19 Oral Drug Program
Cocrystal Pharma, Inc. has selected two investigational novel antiviral drug candidates for further development as oral treatments for SARS-CoV-2, the virus that causes COVID-19…..
TFF Pharmaceuticals Completes Enrollment in Phase 1 Study Evaluating Inhaled Formulation of Niclosamide to Treat COVID-19
TFF Pharmaceuticals, Inc. recently announced it has completed enrollment of 40 healthy subjects in its Phase 1 clinical trial (CT.gov identifier NCT05168644) of a dry…
Lyra Therapeutics Announces Initiation of LYR-210 Pivotal Phase 3 ENLIGHTEN Program in Surgically Naïve Chronic Rhinosinusitis Patients
Lyra Therapeutics, Inc. recently announced the initiation of the Phase 3 ENLIGHTEN I clinical trial of LYR-210 in adult, surgically naïve chronic rhinosinusitis (CRS) patients, with trial sites open for….
Starton Therapeutics Successfully Demonstrates Continuous Drug Delivery of Lenalidomide From a Transdermal Patch in an In Vivo Nonclinical Study With STAR-LLD
Starton Therapeutics Inc. recently announced it successfully obtained promising results in a non-GLP rabbit pharmacokinetic (PK) and skin irritation study of….
Soleno Therapeutics Provides Regulatory Update on DCCR for the Treatment of Prader-Willi Syndrome
Soleno Therapeutics, Inc. recently provided an update following recent interactions with the US FDA regarding the development of once-daily DCCR (diazoxide choline) extended-release tablets for….
WuXi STA Launches its First Parenteral Formulation Manufacturing Line
WuXi STA recently announced its first parenteral formulation manufacturing line at the Wuxi city site is now in commission. This wholly automatic sterile manufacturing line operates…
Enteris BioPharma Launches Enhanced Website Showcasing Full Suite of Bench to Market™ Services
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: SWKH), recently announced the launch….
Enteris BioPharma to Participate in Biotech Showcase Virtual & BIO Partnering at JPM During J.P. Morgan Week 2022
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, recently…
First Patient Dosed in IntelGenx’s Resumed BUENA Montelukast VersaFilm Phase 2a Clinical Trial in Patients with Mild to Moderate Alzheimer’s Disease
IntelGenx Corp. recently announced patient dosing has resumed in the ongoing Phase 2a (BUENA) clinical trial in patients with mild to moderate Alzheimer’s Disease (AD)…
Spero Therapeutics Awarded up to an Additional $12.9 Million by BARDA to Support the Development of Orally Administered Tebipenem Pivoxil in Pediatric Patients
Spero Therapeutics, Inc. recently announced the company and the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US….
Revive Therapeutics Provides Update on Phase 3 Clinical Trial for Bucillamine in COVID-19
Revive Therapeutics Ltd. recently provided an update on the company’s US FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with….
VYNE Therapeutics Announces Phase 1b Data for FMX114 From Phase 1b/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis
VYNE Therapeutics Inc. recently announced it has completed the Phase 1b portion of a Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate…
Catalent Launches New Xpress PharmaceuticsT Service to Expedite Development of Oral Drugs for Adaptive Phase 1 Clinical Trials
Catalent recently announced the launch of its new Xpress Pharmaceutics service, designed to accelerate the development of oral drugs through Phase 1 clinical studies. By integrating formulation….
FORMULATION FORUM - Formulation & Process of Lipid Nanoparticles for Delivery of Small Molecules & Biologicals
Jim Huang, PhD, explains how recently, lipid nanoparticles have emerged as a drug delivery system for biologicals, especially for the COVID-19 mRNA vaccines in which LNPs play a vital role in transporting mRNA into the target cells.
EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
Evelo Biosciences Presents Data on EDP1815 Mechanism of Action & Supporting Ongoing Clinical Development for Inflammatory Diseases
Evelo Biosciences, Inc. recently announced data for EDP1815, the company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis…..
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.