Dosage Forms

A coalition establishes a secure, direct link between a physical tablet and a digital backend for supply chain integrity.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.

The key is to ensure that excipients only interact with APIs via desired mechanisms.

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

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.

PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.

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

Intertek has announced that it has expanded its center of excellence for biopharmaceutical services in Manchester, United Kingdom, to support the development of biologics and gene therapies.

Lincoln Pharmaceuticals has received a patent, which is valid for 20 years, from the Government of India for its liquid diclofenac metered-dose rectal spray.

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.

Improving operator skills using flexible, online training benefits pharmaceutical tableting operations.

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.

Optima Packaging explains its approach to process design.

Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.

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).

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

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

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.

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.