Drug Delivery
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
ADVANCED DELIVERY DEVICES - Design & Evaluation of a Polymer-Based Prefillable Syringe for Biopharmaceuticals With Improved Functionality & Performance
Sagarika Bose, PhD, and Kevin Constable address the design of a new commercially available polymer-based prefillable syringe with enhanced performance features when combined with complex biopharmaceutical drug products.
EXECUTIVE INTERVIEW - SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development
Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.
EXECUTIVE INTERVIEW - Gerresheimer: Plastic Perfection
Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.
LIPID-BASED DELIVERY SYSTEMS - New Approaches for Macromolecule Oral Delivery, Abuse Deterrence & Bioavailability Enhancement
Julien Meissonnier reviews the development of a broad range of advanced oral drug delivery technologies, including a toolkit of technologies based upon the broad application of lipid-based drug delivery systems for optimum solubility enhancement.
FORMULATION DEVELOPMENT - A QbD Approach to Develop Extended Release Softgels
INTRODUCTION Soft gelatin capsules (softgels) continue to be the oral solid dosage form preferred by consumers.1 Understandably, as they are easy to swallow and digest,…
GASTRORETENTIVE DELIVERY - Box-Behnken-Designed Gastroretentive Floating Tablets of Famotidine
Mohit Kumar, MPharm, Parijat Pandey, and Harish Dureja, PhD, develop and characterize a single-unit, floating controlled drug delivery system of famotidine hydrochloride using a blend of natural polymer and synthetic polymer along with a gas-generating agent by applying Box-Behnken design.
ADVANCED DELIVERY DEVICES - Self-Administration Device Training: Incorporating New Technologies to Reduce Device Errors
Craig Baker says at its core, the ultimate goal of device training is to improve the patient experience and create value for HCPs and industry stakeholders, and improved training technologies can allow brands to engage patients and provide personalized training content based on individual patient needs and performance.
NANOSCALE PARTICLES - VAULT: A Novel Nanofrontier in Drug Delivery
ABSTRACT Novel nanoscale particles (Vaults) as first described in 1986, exist in the multiples of thousands in most eukaryotic cells. Having an intricate shape composed…
MARKET BRIEF - Miniaturizing Healthcare - From Microelectronics to Nanobiosensing
Cecilia Van Cauwenberghe, MS, Technical Insights Senior Research Analyst, Frost & Sullivan, reports that the proliferation of lower cost microfluidics-based genomics tools offering improved capabilities and allowing more access to end-users is expected to drive this technology for pharmaceutical and biomedical research throughout the next 5 years.
SPECIAL FEATURE - Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation
Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.
COMBINATION PRODUCTS - Human Factors & Combination Products
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
EXECUTIVE INTERVIEW - Ascendia Pharmaceuticals: Sophisticated Formulations for Poorly Soluble Drugs
Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.
TOPICAL DELIVERY - The Importance of the Right Formulation in Topical Drug Development
Vijendra Nalamothu, PhD, reports that the importance of the right formulation and delivery method in topical pharmaceuticals is critical. It can mean the success or failure of drug substance, and getting the preparation right from the outset saves money and time.
ADVANCED DELIVERY DEVICES - Innovation Without Change: What is it & What Can it Mean for Pharmaceutical Manufacturers?
John A. Merhige, MEM, and Dan Thayer believe a rigorous, risky development and regulatory process forces pharmaceutical manufacturers into a bad compromise between advances in delivery systems and the time, cost, and risk associated with those advances.
GLOBAL DELIVERY MARKET - Advanced Drug Delivery Systems: mAb, RNAi, & Breaking the Blood-Brain Barrier
Kevin James, Shalini Dewan, MS, Kim Lawson, and Usha Nagavarapu believe advances in understanding human biology and diseases are opening new and exciting possibilities in the biotechnology industry. R&D spending, along with increasing competition, patent expiries, and new and emerging technologies will continue to shape growth in this market for the foreseeable future.
NANOTECHNOLOGY MARKET - Nanotechnology Markets in Healthcare & Medicine
Kevin James, Jackson Highsmith, and Paul Evers report the global market for nanoparticles in the life sciences is estimated at over $29.6 billion for 2014. This market is forecast to grow to more than $79.8 billion by 2019, to register a healthy compound annual growth rate of 22%. The biggest increase will come in the area of drug delivery systems.
FORMULATION DEVELOPMENT - Solumerized(TM) Trans-Resveratrol, Bridging the Bioenhancement Gap to Drug Delivery Between Pharmaceuticals & Dietary Supplements
Amir Zalcenstein, PhD, Galia Temtsin Krayz, PhD, and Sabina Glozman, PhD, discuss the example of Resveratrol, a supplement with a solid body of scientific data attesting to its efficacy in enhancing lifespan and treating a variety of medical conditions, which yet remains short of its true market potential due to stability, bioavailability, and cost issues.
NANOEMULSION FORMULATIONS - Nanoemulsion Formulations for Injection & Oral Administration
Troy M. Harmon, MS, MBA, and Jingjun Huang, PhD, use Ascendia’s EmulSol technology to develop a novel oil-in-water nanoemulsion formulation of clopidogrel whereby the free-base form of clopidogrel has acceptable solubility in the oil phase, and is protected from chemical degradation.
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.