Dosage Forms

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Reformulation strategies can provide drug developers with a head start to achieve promising options that benefit the patient.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

A quick look at the history of OTC dosage form development shows the importance of patient-centered innovation.

Mannitol has been shown to improve patient perceptions of tablet flavor and mouthfeel, but its use can add to tableting challenges. SPI Pharma has developed new grades of material designed to make it easier to manufacture in patient-centered formulations.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

Risk levels should be considered when designing containment for pharmaceutical tableting equipment to enhance operator safety.

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

Understanding formulation properties early in development can prevent some costly issues later on.

OSD forms are popular within the industry due to the various advantages they offer, but there are specific considerations required to get the best OSD form possible.

This article examines multi-tip tool technology for pharmaceutical tablet compression and the process control and validation issues that must be carefully evaluated to assess the potential for success.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.

Johnson & Johnson announces clinical trial plans for COVID-19 vaccine candidate, as well as plans to produce 1 billion vaccine doses.

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

Assays can provide a useful tool in determining the potential toxicity of drugs throughout the development cycle.

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another.

Researchers at the Technical University of Munich (TUM) have discovered a way of continuously and precisely dosing active agents using an oil-hydrogel mixture.

Inhalation drug delivery company Vectura announces new organizational structure to drive innovation, customer focus, and growth.

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

Generic pharmaceutical company, Hikma Pharmaceuticals, and biopharmaceutical company, Arecor, have entered into an exclusive agreement for the development and commercialization of a ready-to-use injectable medicine.

FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.

Advanced dynamic process control of a fluid-bed granulation process using PAT data improves product quality.