Dosage Forms

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Pharmaceutical Technology spoke with David Fitzhenry about the costs of specialty drugs.

PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.

Eppendorf’s Conical screw cap tubes in 15 mL and 50 mL complete a range of volume sizes that meet needs from 0.5 mL to 50 mL.

Will biosimilars share a compendial identity like generic drugs do?

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Gyrolab CHO-HCP Kit 1 detects and quantifies host cell proteins from Chinese hamster ovary cells.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or biopolar I disorder.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Appropriate feeding equipment can be selected to meet the challenges of dosing powders that are sticky or do not flow well.

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Medicago's new production facility will make plant-based vaccines and therapeutics.

CVS Health signed a definitive agreement to acquire Omnicare for $12.7 billion to expand its reach to assisted living and long-term care facilities.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

The new guideline replaces the previous version-CHMP/EWP/240/95 Revision 1.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Pall has agreed to be acquired by Danaher for $127.20 per share.

With acquisition of Oncaspar portfolio for leukemia from Sigma-Tau Finanziaria, Baxter BioScience adds an oncology infrastructure and biologic.

CombiLac is a lactose-based, co-processed excipient, designed to ease oral solid dosage form development and manufacture in direct compression.

The agency publishes draft guidance answering industry questions about the Biologics Price Competition and Innovation Act.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.