Formulation

The guidance provides recommendations for the development and quality information that should be included in NDA and ANDA applications.

A new sucrose product from MilliporeSigma has reduced nanoparticle impurities.

As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.

Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Palatability is crucial for adherence and compliance to oral drug regimens.

Start-up company, SeraNovo, has revealed that it has signed a license agreement with Carna Biosciences to expand the existing collaboration and jointly develop an oral formulation of Carna’s kinase inhibitor with increase bioavailability.

The companies will develop innovative formulations for drugs to treat rare diseases using Catalent’s oral disintegrating tablet technologies.

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

CHMP has recommended that Baqsimi (glucagon), a non-injectable treatment for severe hypoglycemia, be granted marketing authorization in the EU.

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.

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.

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.

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

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of AstraZeneca’s Qtrilmet (metformin hydrochloride, saxagliptin, and dapagliflozin) modified-release tablets for treating type-2 diabetes.

Colorcon Ventures looks to fund promising startups in drug manufacturing, delivery, and supply chain.

The companies have engaged in a manufacturing scale-up of LTX-03 tablets for clinical testing using LIMITx Technology.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Formulators of parenteral drugs must be cautious of specific considerations and challenges that arise during development and manufacture.

AstraZeneca has revealed that the CHMP of the European Medicines Agency has given a positive opinion to adding a self-administration option for Fasenra (benralizumab).

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.