Drug Delivery
FORMULATION FORUM - Nanoparticle Technologies Used in Ocular Drug Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, describe the basic understanding of eye diseases, challenges in ocular drug delivery, and the future trends in development of innovative drugs.
DRUG DELIVERY - EUDRACAP® Select - Examining a Case From Development to Clinical Trial
Lucas Paulo Cusin, Kamlesh Oza, PhD, and Steven Smith, et al focus on the development of a customized functional coated capsule for the delivery of live biotherapeutics and demonstrate its effectiveness in the oral delivery of a sensitive proprietary microbiome ecosystem while simplifying the drug development process.
PBPK MODELING - Critical Parameters for Simulating Oral Absorption Using PBPK Models
Deanna Mudie, PhD, says with an increasing number of drugs posing absorption challenges, the ability to predict how a new molecule will behave in vivo is important, and being able to predict and mitigate absorption problems before they arise should help the project progress with fewer delays.
Apalutamide Study Again Demonstrates the Advantages of Nanoforming Over Traditional Cancer Treatment Formulations
Nanoform Finland Plc recently announced it had received positive results from its own preclinical, in-vivo study of a nanocrystalline-enabled apalutamide oral formulation, which shows potential…
Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD
Silo Pharma, Inc. recently announced positive results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress…
MoonLake Immunotherapeutics Announces Positive Feedback From FDA & EMA on Regulatory Path for Phase 3 Program
MoonLake Immunotherapeutics recently announced the successful outcome of its end-of-Phase 2 interactions with the US FDA as well as positive feedback from its interactions with…
Biora Therapeutics Announces Successful Completion of Single-Ascending Dose Cohorts of Phase 1 Clinical Study of BT-600
Biora Therapeutics, Inc. recently announced completion of the single-ascending dose (SAD) cohorts for its Phase 1, first-in-human clinical study of BT-600 in healthy adult volunteers.…
Aptar Digital Health Announces Acquisition of Healint to Reinforce Digital Health Portfolio & Drive Future Growth
Aptar Digital Health recently announced it has acquired Healint, a digital health company recognized for their virtual clinical studies, real-world evidence and patient registries platform,…
Evonik Partners With University of Mainz to Commercialize New Class of PEG Lipids for Nucleic Acid Delivery
Evonik and the University of Mainz have signed a license agreement to commercialize randomized polyethylene glycols (rPEGs), a new class of PEGs. Evonik intends to use….
Silo Pharma’s Ketamine Implant Demonstrates Successful Drug Delivery
Silo Pharma, Inc. recently provided a positive update on SP-26, its novel time-released, dose-controlled formulation of ketamine initially targeted for fibromyalgia. A preclinical research study…
MiNK Therapeutics' AgenT-797 Shows Promising Results in the Treatment of Severe Acute Respiratory Distress
MiNK Therapeutics, Inc. recently announced the publication of results in Nature Communications from a Phase 1/2 study of agenT-797 in patients with moderate-to-severe acute respiratory…
BioXcel Therapeutics Announces USPTO’s Allowance of Patent Application for Method of Treating Agitation in Alzheimer’s Disease Using Oromucosal Formulations of Dexmedetomidine
BioXcel Therapeutics, Inc. recently announced the United States Patent and Trademark Office (USPTO) has allowed US Patent Application No. 17/496,470 with claims pertaining to a…
Studies Validate Advantages of Administering Drugs to Pets Via IntelGenx’s VetaFilm Platform
IntelGenx Corp. recently announced positive results from a proof-of-concept (POC) study to assess the palatability, owner-perceived acceptability, and ease of repeated administration of IntelGenx’s VetaFilm…
Denali Therapeutics Announces Presentations on its Investigational Blood-Brain Barrier-Crossing Enzyme Replacement Therapies
Denali Therapeutics Inc. recently announced upcoming presentations from its Enzyme Transport Vehicle (ETV) development programs, tividenofusp alfa (DNL310) and DNL126 (ETV:SGSH), to be given at…
AustinPx Partners With Microsize on KinetiSol Technology, Partnership Strengthens Commercialization Options for AustinPx’s Clients
AustinPx and Microsize recently announced the strategic partnership to accelerate the commercial application of AustinPx’s KinetiSol Technology platform. The collaboration will enable….
Kindeva Drug Delivery Launches New Analytical Services Global Business Unit
Kindeva Drug Delivery recently announced the expansion of its analytical services capabilities — launching a new global business unit offering integrated and stand-alone analytical support to…
Cristalia Products With Nemera’s Reusable Pen Injector Commercialized in Brazil
Cristalia’s human growth hormone will be administered with CRISPEN. Approved by ANVISA1, CRISPEN is part of Nemera’s state-of-the-art pen injector platform PENDURA AD……..
Jnana Therapeutics Announces Positive Clinical Proof of Concept Achieved With Potential First-in-Class Oral Treatment for PKU
Jnana Therapeutics recently announced positive, statistically significant interim results from its ongoing clinical study of JNT-517 in individuals with phenylketonuria (PKU). JNT-517, a small molecule inhibitor…
FORMULATION FORUM - Lipid Nanoparticles – Carriers for Nucleic Acids Delivery
Shaukat Ali, PhD, and Jim Huang, PhD, describe the role of individual components in aggregation, packing, stability, efficacy, and potency of nucleic acids, the understanding of which is important to achieve better designed and smarter formulations, and robust scale up and manufacturing of LNPs.
SPECIAL ROUNDTABLE - Leadership Panel: 4 Trends That Will Have the Most Impact on Drug Development in 2024
Contributor Cindy H. Dubin asked some of today’s life science leaders what they expect will have the greatest impact on drug development in 2024 and beyond.
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.