Drug Delivery
Albireo Announces Positive Topline Data from Phase 1 Study of A3907
Albireo Pharma, Inc recently announced positive topline results from its Phase 1 clinical trial of A3907, the first oral systemic apical sodium-dependent bile acid transporter…
BioXcel Therapeutics Initiates Pivotal Phase 3 Program of BXCL501 for Acute Treatment of Agitation in Patients With Alzheimer’s Disease
BioXcel Therapeutics, Inc. recently announced the initiation of its pivotal Phase 3 program for BXCL501, the company’s proprietary, orally dissolving thin film formulation of dexmedetomidine,…
SWK Holdings’ Subsidiary, Enteris BioPharma, Receives $5-Million Milestone Payment From Cara Therapeutics
SWK Holdings Corporation recently announced its wholly owned subsidiary, Enteris BioPharma, received a $5- million milestone payment from Cara Therapeutics related to the license agreement for Peptelligence….
WACKER & CordenPharma Develop Solutions for Formulating Lipid Nanoparticles, Expanding Their Portfolio for Advanced Medicines
WACKER and CordenPharma have signed a development partnership in the field of Lipid Nanoparticle formulation. The two companies announced they plan to jointly develop know-how…
Immunic, Inc. Publishes Positive Results From the Single & Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
Immunic, Inc. recently announced positive unblinded safety, tolerability and pharmacokinetic (PK) results from Part A (single ascending doses, SAD) and Part B (multiple ascending doses, MAD)…
Vaccitech Acquires Avidea Technologies to Expand Product Pipeline & Strengthen Scientific Leadership in Immunotherapies & Vaccines
Vaccitech plc recently announced that it has acquired US-based Avidea Technologies, Inc. The consideration to Avidea’s existing shareholders is $40 million….
Arrivo BioVentures Emerges From Stealth Mode With a Robust Pipeline & Promising Data
After launching the company over 5 years ago with a team of seasoned serial entrepreneurs, $49 million in committed capital, and the promise to assemble…
Fareva & ApiJect Sign Licensing Agreement to Create a France-Based 500-Million Unit Annual Capacity for Single-Dose Prefilled Vaccine Injections
Fareva and ApiJect Systems, Corp. recently announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and….
WHITE PAPER: Molly Modular Autoinjector Platform by SHL Medical
White Paper: A Systematic Review of Molly’s Integrated and Flexible Device Design and Development Model SHL Medical has redefined the conventional platform model by…
Innovative Inhaled Drug Delivery Developer Aerami Therapeutics to Merge With Special Purpose Acquisition Company FoxWayne Enterprises Acquisition Corp. to Become Public Company
Aerami Therapeutics Holdings, Inc. and FoxWayne Enterprises Acquisition Corp. recently announced they have entered into a definitive business combination agreement…..
Fortress Biotech, Cyprium Therapeutics & Sentynl Therapeutics Announce the Initiation of Rolling Submission of an NDA for Treatment of Menkes Disease
Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. partner company, with support from its licensing partner Sentynl Therapeutics, Inc., a wholly owned subsidiary of Cadila Healthcare Limited, recently announced the initiation of a rolling submission of a New Drug Application….
SCYNEXIS Announces Agreement With FDA on Innovative Strategy for Approval of Oral Ibrexafungerp for Treatment of Invasive Candidiasis
SCYNEXIS, Inc. recently announced initiation of a global Phase 3 study to evaluate the efficacy, safety, and tolerability of oral ibrexafungerp as a step-down therapy…
Biofrontera Inc. Enrolls First Subject in Phase 1 Safety Study Evaluating Photodynamic Therapy With Three Tubes of Ameluz
Biofrontera Inc. recently announced the first subject has been enrolled in a Phase 1 study to evaluate the safety and tolerability of photodynamic therapy (PDT)…
Ventyx Biosciences Announces First Patient Dosed in Phase 2 Clinical Trial of VTX002 for the Treatment of Moderate-to-Severe Ulcerative Colitis
Ventyx Biosciences, Inc. recently announced the first patient has been dosed in a Phase 2 randomized, placebo-controlled trial of VTX002 for the treatment of moderate-to-severe ulcerative colitis (UC)…..
Progenity Announces New Patent for Single-Molecule Detection Technology
Progenity, Inc. recently announced a new patent related to its single-molecule detection platform under development. The USPTO has issued U.S. Patent No. 11,186,863 titled Methods,…
Adare Pharma Solutions Acquires Frontida BioPharm to Expand Leading CDMO Offerings
Adare Pharma Solutions recently announced the acquisition of Frontida BioPharm, a vertically integrated CDMO focused on oral formulations. The acquisition reinforces….
BioXcel Therapeutics Announces Extension of FDA Review Period of its NDA for BXCL501 for the Acute Treatment of Agitation Associated With Schizophrenia & Bipolar Disorders
BioXcel Therapeutics, Inc. recently announced the US FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the New Drug Application (NDA) of BXCL501 for the acute treatment of….
Vaxart Announces Acquisition of Second GMP Manufacturing Facility
Vaxart, Inc. has entered into an agreement with Kindred Bioscience, Inc. for the purchase of KindredBio’s manufacturing equipment and sublease of its GMP (Good Manufacturing…
2022 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Amorphous Nanoparticles for Drug Delivery of Poorly Water-Soluble Compounds
Jim Huang, PhD, says a thorough understanding of their amorphous stabilization and nano colloidal properties in relationship to in-vitro and in-vivo performance will help advance this interesting dosage form into human clinical testing and commercialization.
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.