Bioavailability & Solubility
SPECIAL FEATURE – Improving Bioavailability & Solubility: Each Molecule Is Unique
Contributor Cindy H. Dubin speaks with several innovative companies to discuss novel approaches to improving bioavailability and solubility that have one commonality: they treat each molecule as an individual.
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.
FORMULATION FORUM – Oral Controlled Delivery of Poorly Water-Soluble 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.
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM – Age-Appropriate Pediatric Formulation Development
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.
EXECUTIVE INTERVIEW – Enteris BioPharma: Pioneers in Oral Formulation Development
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.
OSD FORMULATIONS – Dissolving Bioavailability & Solubility Challenges in Formulation & Development
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.
FORMULATION FORUM – Formulation Development Strategy for Early Phase Human Studies
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.
EXCLUSIVE ONLINE CONTENT
Molecular Templates Announces FDA Acceptance of IND Application for a PD-L1-Targeted Engineered Toxin Body Enabled With Proprietary Antigen Seeding Technology
Molecular Templates, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for MT-6402, a next-generation ETB targeting PD-L1 that is enabled with….
Gattefossé Continues International Development & Builds Production Site in Texas
Gattefossé is investing 30 million euros in its industrial operations and announced the construction of a brand new manufacturing plant in Lufkin, TX. This asset will produce lipid-based….
Novo Nordisk to Acquire Emisphere Technologies for $1.35 Billion
Emisphere Technologies, Inc. recently announced it has entered into a definitive agreement with Novo Nordisk, whereby Novo Nordisk will acquire Emisphere, on a cash-free, debt-free basis, for….
APPLY NOW ! – A Novel Approach for Incentivizing Drug Delivery Innovation
One of the most critical early steps in the development of novel drug delivery systems is to demonstrate convincing proof-of-concept. The dilemma is that while pharma companies can be interested in….
SeraNovo Enters Second License Agreement With Carna Biosciences
SeraNovo B.V. recently announced it has signed a second License Agreement with Carna Biosciences, Inc., a company engaged in the drug development of….