Bioavailability & Solubility
FORMULATION FORUM – Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
MULTI-PARTICULATE MANUFACTURING – How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
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….