Drug Delivery
Celsion Reports Data Safety Monitoring Board Unanimous Recommendation to Continue Dosing Patients in the Phase 2 Portion of the OVATION 2 Study With GEN-1 in Advanced Ovarian Cancer
Celsion Corporation recently announced that following a pre-planned interim safety review of 81 as treated patients randomized in the Phase 1/2 OVATION 2 Study with….
Skye Bioscience Reports Positive Results for SBI-100 in GLP Toxicology Study
Skye Bioscience, Inc. recently announced it has completed a good laboratory practice (GLP) nonclinical toxicology study of its SBI-100 ophthalmic nanoemulsion in support of the company’s….
OKYO Pharma Announces Successful Completion of Pre-IND Meeting With FDA on the Development of OK-101 to Treat Dry Eye Disease
OKYO Pharma Limited recently announced the successful completion of a pre-IND (Investigational New Drug) meeting with the US FDA regarding the development plans for OK-101…
Opiant Pharmaceuticals Announces Positive Pharmacokinetic, Safety & Tolerability Results From a Multi-Dose Study for OPNT003, Nasal Nalmefene
Opiant Pharmaceuticals, Inc. recently announced positive topline results from a multi-dose pharmacokinetic (PK) study for OPNT003, nasal nalmefene, an investigational treatment for opioid….
Berkshire Sterile to Offer Formulation, Lyophilization & Method Development Services
Berkshire Sterile Manufacturing (BSM) MA, has recently added formulation, lyophilization, and method development capabilities to complement their clients’ drug productions…..
Eyenovia Concludes Type A Meeting With FDA Related to MydCombi NDA Resubmission
Eyenovia, Inc. recently announced that the company successfully completed a Type A meeting with the US FDA related to the refiling of the NDA for…
Silo Pharma Extends Exclusive Option Agreement for Homing Peptides
Silo Pharma, Inc. recently announced it has extended its exclusive option agreement with the University of Maryland, Baltimore, to explore a novel invention generally known as….
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)…
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.