Formulation Development
PEGYLATION – PEGylation – Three Decades of Product Approvals & Technology Development
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
CDMO CASE STUDY – AJILITY: Streamlining Drug Product Manufacturing
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
DRUG DELIVERY – Recognizing the Patient Potential for Transdermal Drug Delivery
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
EXECUTIVE INTERVIEW – Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
DEVICE DEVELOPMENT – Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES – Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
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.
SPECIAL FEATURE – Injection Devices: Will COVID-19 Deliver Growth to the Market?
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
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.
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