Drug Delivery
HiberCell Initiates Phase 1a Clinical Trial of HC-5404-FU, an ER Stress Modulator
HiberCell recently announced the initiation of a Phase 1a multicenter, open-label, dose escalation trial of its orally administered HC-5404-FU in patients with selected metastatic solid…
Noble Further Expands Capabilities of Its New Human Factors + Program
In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, recently announced the….
Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
Verrica Pharmaceuticals Inc. recently announced the US FDA has extended the review period for the New Drug Application (NDA) for VP-102 for the treatment of…
WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution
Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.
FORMULATION FORUM - Nanosuspension Dosage Forms: Product Development & Scale Up
In this month’s column on formulation development challenges, Jim Huang, PhD, discusses nanosuspensions prepared via the top-down process, ie, the wet milling process.
OPEN INNOVATION PLATFORM - Beyond the Rule of Five: Scouting for Novel Formulation Approaches to Enable the Subcutaneous Application of Molecules With Poor Drug-Like Properties in Preclinical Research – Facilitated Through opnMe.com
Ines Truebenbach, PhD; Menorca Chaturvedi, PhD; Markus Koester, PhD; and Achim Grube, PhD, are looking for proposals that would provide innovative formulation approaches to facilitate the subcutaneous application of bRo5 molecules in a preclinical setting.
DRUG DEVELOPMENT EXECUTIVE - Enteris BioPharma: How to Build a Preferred CDMO Partner
Dr. Paul Shields, COO of Enteris BioPharma, discusses the changing face of the CDMO industry and how his company plans to leverage its newly expanded CDMO operations to take advantage of a variety of growth opportunities to build deeper partnerships.
ORAL THIN FILMS - The Quest for a Magic Pill May Not Be a Pill at All
Robert Davidson says there have been significant advances in clinical development of this novel drug delivery system, and the technology is rapidly moving from just a theory to practical real-world application.
PRECLINICAL TESTING - Expanding Opportunities in Implantable Medical Devices With Optimized Preclinical Studies
Jaleel Shujath outlines the growing importance of implantable devices in clinical settings and our daily lives, highlighting the current state of preclinical testing and the regulatory barriers faced by device developers.
EXECUTIVE INTERVIEW - Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, Chief Executive Officer of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.
Microfluidics: An Alternative Method for Developing Nanoparticle Drug Delivery Systems
The encapsulation of drugs within purposely formulated liposome nanoparticles offers the potential for more controlled and sustained release, as well as reducing toxicity and….
Stevanato Group & Corning Incorporated Sign Licensing Agreement to Offer Corning Valor Glass Vials in Presterilized SG EZ-fill Packaging Configuration
Stevanato Group recently announced a licensing agreement with Corning Incorporated to offer a combined solution that will provide biopharmaceutical companies with improved levels of….
Evonik Markets New Enteric-Protected Ready-to-Fill Capsules for Fast, High-Performance Drug Development
Evonik recently launched the EUDRACAP platform of easy-to-handle capsules to help the pharmaceutical industry accelerate speed to market for complex oral drug products in early development stages…..
Ajinomoto Bio-Pharma Services Expands Fill Finish Capacity With New Multi-Purpose Fill Suite
Ajinomoto Bio-Pharma Services recently announced it will soon open a high-speed multi-purpose fill finish line in its state-of-the-art commercial manufacturing facility located in San Diego,…
Phillips-Medisize Unveils Aria Smart Autoinjector Platform to Drive Innovation & Sustainability in Digital Drug Delivery
Phillips-Medisize, a Molex company and leader in drug delivery, diagnostic, and MedTech devices, recently unveiled the Aria Smart Autoinjector platform to unlock innovation, differentiation, and sustainability in the digital drug-delivery device market….
Ocuphire Granted Two New US Patents Covering Late-Stage Drug Candidate
Ocuphire Pharma, Inc. recently announced the United States Patent and Trademark Office (USPTO) has issued two patents covering the company’s late-stage product candidate, Nyxol (phentolamine…
Advicenne Receives Positive Feedback From US FDA on Pathway to Approval & Amended Phase 3 Study Protocol
Advicenne recemtly announced the US FDA acceptance of the amended protocol of the company’s US-based Phase 3 pivotal trial of ADV7103 (Sibnayal) for the treatment…
BD to Build New Manufacturing Facility in Spain to Support Ongoing Strong Growth of Prefilled Drug Delivery Business
BD (Becton, Dickinson and Company) recently announced will build a $200-million high-tech manufacturing facility in city of Zaragoza, located in the Aragon region of Spain,…
Altimmune Announces New Preclinical Data for AdCOVID Demonstrating Sterilizing Immunity After a Single Intranasal Dose
Altimmune, Inc. recently announced positive results from a preclinical study of AdCOVID in a SARS-CoV-2 challenge model of infection. In this study, a single intranasal…
Proveris Laboratories Announces Expanded Services for Spray & Aerosol Characterization of Unit-Dose Nasal Drugs
Proveris Scientific Corporation, a leading provider of instrumentation and services to advance the science of aerosol and spray products, recently announced the expansion of contract…
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.