Pharmaceutical Technology-11-02-2019

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.

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

The pressure to improve operational technology performance combined with the rapid pace of technology change is driving adoption of new automation models in pharmaceutical manufacturing.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

MegaShear from Ross is a patented ultra-high shear rotor/stator mixer for high-throughput emulsification, dispersion, and homogenization.

Extrudor by MG America is a new powder dosing unit that only requires one dosing disk per capsule size, regardless of the dosage.

The new Innomech Benchtop Systems developed for and offered by Aston Particle Technologies (APT) combine two benchtop systems to organize small amounts of blended pharmaceutical powders for use in APT’s formulation development projects.

Deitz Company introduced the Pharmafill™ CS2 to its line of automated cotton inserters.

An effective quality control unit is independent from manufacturing and ensures current standards are followed.

FDA readies more efficient oversight processes while advancing collaboration with Europe.

It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

FDA report says drug shortages are underappreciated and patients pay a price.

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

Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.

After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.

Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

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

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