Drug Delivery
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
NASAL DELIVERY - Improving Nasal Drug Delivery With Permeation Enhancing Technology
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
EXECUTIVE INTERVIEW - Kytosan USA, Inc.: Blazing a Trail in Chitosan Manufacturing in the United States
Dr. Joseph F. Bristow, Chief Technology Officer for Kytosan USA, discusses chitosan and its impact on the pharmaceutical industry, as well as Kytosan USA’s production plans.
Catalent & TFF Pharmaceuticals Announce New Inhalation Dry Powder Development & Manufacturing Agreement
Catalent and TFF Pharmaceuticals, Inc. recently announced their collaboration agreement focused on the generation, testing, and manufacture of dry powder formulations for a range of…
Genevant Sciences & Arbutus Biopharma File Patent Infringement Lawsuit Against Moderna
Genevant Sciences and Arbutus Biopharma Corporation recently filed a lawsuit in the US District Court for the District of Delaware against Moderna, Inc. and an…
TFF Pharmaceuticals Announces Inhaled Niclosamide Significantly Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2
TFF Pharmaceuticals, Inc. recently announced that results from its recently completed in vitro neutralization and viral replication assays indicate that the company’s inhaled niclosamide product candidate completely….
WHITE PAPER: HPAPI Drug Solid Oral Dosage (SOD) Manufacturing – Ensuring Content Uniformity
What techniques should manufacturers employ when working with low-dose drug products? By: Thomas Daggs, MBA, Vice President, Product Development & Quality Control, and Angelo Consalvo,…
HiberCell Initiates its Phase 1a/b Clinical Trial in Patients With Advanced Solid Tumors
HiberCell has recently initiated a Phase 1a/b clinical trial of HC-7366, a first-in-class selective, orally bioavailable modulator of General Control Nonderepressible 2 (GNC2) for the…
Rani Therapeutics Unveils High-Capacity RaniPill Device for Oral Delivery of Biologics
Rani Therapeutics Holdings, Inc. recently announced the development of a high-capacity oral biologics device known as the RaniPill HC (High Capacity), capable of delivering up to….
Supernus Receives Notice Assigning Early October 2022 PDUFA for SPN-830 Apomorphine Infusion Device NDA
Supernus Pharmaceuticals, Inc. recently announced it received notice from the US FDA that the company’s New Drug Application (NDA) resubmission for its apomorphine infusion device…
Poseida Therapeutics Appoints New President, Gene Therapy
Poseida Therapeutics, Inc. recently announced Brent Warner has joined the company as President, Gene Therapy, effective February 21, 2022. “Brent brings deep pharmaceutical expertise and…
Hovione & Zerion Pharma Announce Strategic Partnership
Hovione recently announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement….
Enteris BioPharma Highlights Progress in Oral Feasibility Program
Enteris BioPharma, Inc. recently provided an update on its oral feasibility programs involving the company’s Peptelligence and ProPerma oral peptide and small….
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….
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.