Drug Delivery
APEIRON Respiratory Therapies Announces Positive Results From Phase I Trial of Inhaled APN01
APEIRON Respiratory Therapies GmbH recently announced positive final results from a Phase 1 clinical trial of inhaled APN01 (alunacedase alfa), a soluble recombinant version of…
TFF Pharmaceuticals Announces Collaboration With Aptar Pharma to Explore & Develop Intranasal Delivery of Dry Powder Vaccines & Dry Powder Therapeutics
TFF Pharmaceuticals, Inc. recently announced a collaboration with Aptar Pharma aimed at developing and testing the administration of dry powder vaccines utilizing….
WHITEPAPER WORKSHOP - Soft Mist Inhalers
Soft mist inhalers (SMIs) are a versatile technology suitable for the delivery of both small and complex large molecules, optimising lung deposition whilst minimising oropharyngeal deposition…..
Gerresheimer & Merck KGaA Transform Primary Packaging Into Digital Twins
Gerresheimer AG and Merck KGaA, Darmstadt, Germany, jointly developed a digital twin solution to further ensure traceability and trust in crucial steps along the pharmaceutical…
Enteris BioPharma Presents Study of Ovarest® Demonstrating Oral Delivery Comparable to or Exceeding Injectable Leuprolide
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…
VacV Biotherapeutics Emerges From Stealth Mode to Bring Ground-Breaking Cancer Immunotherapies to the Clinic
VacV Biotherapeutics recently emerged from stealth mode to advance its promising pipeline of preclinical assets with best-in-class potential, toward the clinic…..
Lonza joins GENEGUT Project to Develop a Capsule Delivery Solution for an Innovative Crohn's Disease Treatment
Lonza recently announced its participation in the GENEGUT project to develop an innovative functional capsule-based delivery solution for therapies targeting….
BD, Biocorp Sign Agreement to Bring Connectivity, Traceability to Self-Administered Injectable Drugs
BD (Becton, Dickinson and Company) and Biocorp recently announced they have signed an agreement with the aim of using connected technology to track adherence for self-administered drug therapies….
Comera Life Sciences Announces Favorable Preclinical Results of Lead SQore Excipient in SEQURUS-2 Study
Comera Life Sciences Holdings, Inc. recently announced favorable results from its recently completed SEQURUS-2 study. Together with the SEQURUS-1 study, the preclinical results showed that Comera’s…
Bora Pharmaceutical Makes Strategic Appointment to Strengthen Global Manufacturing Capabilities
Bora Pharmaceuticals, a full-service contract development and manufacturing organization (CDMO), recently appointed Don Liscombe as its Vice President and General Manager to lead its flagship…
Aragen to Operationalize Cutting-Edge Formulation Manufacturing Facility
Aragen recently announced it will operationalize its state-of-the-art formulation manufacturing facility in the Mallapur campus, Hyderabad, India, by January 2023. The 12,000-sq-ft new facility will…
Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients With Krabbe Disease
Forge Biologics recently announced Chief Medical Officer Maria Escolar, MD, MS, presented updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the company’s…
FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia
Silo Pharma, Inc. recently announced it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as….
Opiant Pharmaceuticals Announces Completion of Enrollment in Phase 2 Clinical Trial of Nasal Naltrexone in Patients With Alcohol Use Disorder
Opiant Pharmaceuticals, Inc. recently announced the last patient has been enrolled in the Phase 2 clinical trial of OPNT002, nasal naltrexone, for patients with….
MBX Biosciences Advances Phase 1 Clinical Trial of Long-Acting Parathyroid Hormone Peptide Prodrug
MBX Biosciences, Inc. recently announced it has initiated the multiple ascending dose portion of its ongoing Phase 1 clinical trial of MBX 2109. MBX 2109,…
Nutriband & Kindeva Drug Delivery Demonstrate Enhanced Abuse-Deterrent Characteristics for Aversa Fentanyl
Nutriband Inc. and Kindeva Drug Delivery have demonstrated enhanced abuse deterrence kinetics of the company’s patented lead product, Aversa Fentanyl, an abuse-deterrent fentanyl transdermal system….
EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector
Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group, discuss their collaboration in producing the innovative Aidaptus auto-injector.
EXCIPIENT COMPACTION STUDY - Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator
Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.
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.