Formulation and Drug Delivery

Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.

The agency announced it has approved 1171 generic drugs in fiscal year 2019.

A complete understanding of primary packaging physicochemical properties is necessary in the formulation and development of biologics.

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

On Wednesday Nov. 6, 2019, Gregor Deutschle and Dr. Nicolas Eon, both from Schott, will share insights into ready-to-use solutions for complex biotech drugs.

The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval.

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Changing regulatory guidance on generic topical products is expected to lead to an increase in the number of market approvals in the near future.

Establishing OEL data and ensuring appropriate engineering controls are crucial aspects of safe handling.

Research into peginterferon alfa-2b’s degradation pathways suggest that drug substance be immediately and continuously converted to drug product when the material is in liquid form.

High-throughput platforms can be used to develop tertiary phase diagrams, which can be leveraged to identify the most stable SEDDS formulations and excipients for lipid-based drug delivery systems.

Technological advancements can address the formulation and dissolution challenges of HPMC polymers.

In this article, the contents of a stimulus article produced by the joint subcommittee of the USP Expert Committees on Dosage Forms, Physical Analysis, and Excipients and relevant comments from a workshop session are summarized.

This article seeks to encourage continued dialogue among stakeholders to achieve consensus regarding excipient additives and processing aids.

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.

GSK’s expanded R&D and manufacturing facility in Upper Merion, PA houses a new analytical lab and flexible manufacturing equipment, including single-use bioreactors.

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.