Dosage Forms

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary.

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

Sample preparation-specifically, API extraction and dilution-can introduce errors. Use of best practices and automation can reduce variability.

Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

Pharmaceutical companies are developing new strategies to address the ever-increasing development costs for new drug therapies and maximize the value of their existing drug portfolio.

This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.

Jean-Yves Balfin, product manager at Korsch AG, speaks to Pharmaceutical Technology about the ins and outs of multilayer tableting.

Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.

Low-temperature chemistry enables performance of more challenging and selective chemistry.

Increasing dwell time can improve tablet production.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

The acquisition will place Cambrex into the finished dosage form CDMO market.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

With the right excipients, formulators can control when, where, and how an API is released.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

GW Research’s Epidiolex, which treats two forms of epilepsy, receives FDA’s approval; spurs FDA reminders about unapproved products.

Recipharm adds inhalation drug manufacturing capacity with the acquisition of Sanofi’s Holmes Chapel, UK site.

Cambrex expands its generic API research and development capabilities at its Milan, Italy site.

MilliporeSigma targets emerging biotechs with US development center and global grants.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Bosch Packaging Technology will introduce its newest R&D device for continuous oral solid dosage production at Achema 2018.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Cambrex Corporation has announced facility, equipment, and instrument upgrades at its High Point, NC facility and updated progress on expansions in Cedar City, IA.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.