Bioavailability & Solubility
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.
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.
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.
Marshall Crew, PhD, focuses on considering what might be achieved if we borrow best practices and processes that have assisted other industries facing growing complexity, in fact, much of the advances in accelerating our solubilization processes are already borrowed from other industries, in many cases even the technologies.
David Shoemaker, PhD, says the origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.
Marshall Crew, PhD, explores some of the key features of people and organizations that lead to the innovations and products, and hopes that by example, insights can be acquired that will be useful in his colleagues respective organizations and that might ultimately lead to more innovation in the industry.
Archana Gangakhedkar, MS, and Jyothi Thundimadathil, PhD, indicate peptide-based linkers are promising counterparts in ADCs, providing tumor-specific cleavable and stable circulating linkers, and a new emerging class of PDCs is proving to be useful toward a broad spectrum of indications when compared to ADCs.
Wilfried Andrä, PhD, Pieter Saupe, and Matthias E. Bellemann, PhD, indicate the greatest obstacle on the road to targeted drug delivery in the GI tract was, until now, the lack of a practicable method to localize the capsule.
BIOAVAILABILITY ENHANCEMENT – Diffusion of Innovation & the Adoption of Solubilization Technologies: Observations of Trends & Catalysts
Marshall Crew, PhD, says that although diffusion processes of innovative products and services have been studied extensively for nearly 45 years, it seems reasonable that we might learn from others’ observations, and the frameworks they’ve developed to model diffusion of technology for the adoption of bioavailability platforms.
Drug Development Executive: Rod Ray, former Bend Research CEO and now a member of Capsugel’s Scientific and Business Advisory Board, talks about the enhanced capabilities of Capsugel DFS and the advantages offered to companies developing new and/or enhanced medicines.
EXCLUSIVE ONLINE CONTENT
Aptose Biosciences Inc. recently announced the G3 formulation of luxeptinib, designed for rapid and efficient absorption, demonstrates approximately an 18-fold improvement in oral bioavailability….
Zerion Pharma & Hovione Extend Partnership to Cover Use of Dispersome Technology Platform in Nutraceuticals
Hovione and Zerion Pharma A/S (Zerion) recently announced an extension of their collaboration on Zerion’s Dispersome technology into the nutraceutical/dietary….
Lonza Strengthens Micronization Portfolio With the Introduction of X-Ray Powder Diffraction Capability
Lonza has expanded the range of particle engineering services offered by its Monteggio (CH) site through the introduction of X-ray powder diffraction (XRPD). This rapid analytical technique provides additional….
Catalent, Inc. recently announced it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in….
Starton Therapeutics Reports Positive Results From Phase 1 Study Evaluating Continuous Delivery Lenalidomide
Starton Therapeutics Inc. recently announced positive results from high-level data from its Phase 1 study of STAR-LLD, evaluating the pharmacokinetics (PK) and safety of the company’s continuous delivery….
MARKET NEWS & TRENDS
Join our experts Dr. Mandar Kodgule, Dr. Rahul Aware, and Dr. Agnivesh Shrivastava live as they take you through compelling case studies, current trends and developments, and insights on mastering the design of hot-melt granulation process.
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Access our webinars on solubility strategies & pediatric drug development….
Read about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery.
This white paper will introduce the concept of dissolution and discuss how poloxamers are a simple yet powerful formulation approach that can enhance dissolution rate, while minimizing resource requirements.
Outsourcing Drug Development & Production: Technology-Driven Drug Delivery Systems for Small Molecules at Losan Pharma
Due to the increasing demand for drug delivery systems that are able to improve the properties of low soluble, poor permeable, or highly dosed new and existing drug substances, technology-driven CDMOs can offer a wide range of technology platforms to overcome such challenges….