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Pharmaceutical Technology-11-02-2019
Pharmaceutical Technology
QbD Takes Shape for Topical Pharmaceuticals
November 08, 2019
Quality/Regulations
43
11
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.
Optimizing Compression Coating for Pulsatile Release Tablets
November 08, 2019
Peer-Reviewed Research
43
11
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.
Advancing Transdermal Drug Delivery
November 02, 2019
Manufacturing
43
11
PATH’s Microarray Patch Center of Excellence aims to accelerate transdermal patch technology for public health needs.
The Emergence of Operational Technology as a Service
November 02, 2019
Manufacturing
43
11
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.
Residual Moisture Determination in Lyophilized Drug Products
November 02, 2019
Analytics
43
11
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.
Highest Shear Mixer Available
November 02, 2019
Product Spotlight
43
11
MegaShear from Ross is a patented ultra-high shear rotor/stator mixer for high-throughput emulsification, dispersion, and homogenization.
Powder Dosing Unit
November 02, 2019
Product Spotlight
43
11
Extrudor by MG America is a new powder dosing unit that only requires one dosing disk per capsule size, regardless of the dosage.
Innomech Benchtop Systems
November 02, 2019
Product Spotlight
43
11
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.
Automated Cotton Inserter
November 02, 2019
Product Spotlight
43
11
Deitz Company introduced the Pharmafill™ CS2 to its line of automated cotton inserters.
The Right Pieces for a Quality Program
November 02, 2019
Cover Story
43
11
An effective quality control unit is independent from manufacturing and ensures current standards are followed.
More Consistent Drug Inspection System on Horizon
November 02, 2019
Regulatory Watch
43
11
FDA readies more efficient oversight processes while advancing collaboration with Europe.
Signatures–What’s in a Name?
November 02, 2019
Ask the Expert
43
11
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.
Evaluating the Tech Transfer Process
November 02, 2019
Quality/Regulations
43
11
Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.
Developments in the Pharmaceutical Outsourcing Industry
November 02, 2019
Outsourcing
43
11
Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.
Breaking the Drug Shortage Cycle
November 02, 2019
From The Editor
43
11
FDA report says drug shortages are underappreciated and patients pay a price.
Adapting APIs for Specialty Dosage Forms
November 02, 2019
API Synthesis & Manufacturing
43
11
Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.
The Cost of Brexit
November 02, 2019
Quality/Regulations
43
11
Despite preparative work by the bio/pharma industry, any Brexit scenario will result in regulatory implications and increased costs.
Striking a Landmark Deal
November 02, 2019
From The Editor
43
11
After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.
Investigating NDMA Impurities at EMA’s Request
November 02, 2019
Regulatory Watch
43
11
Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.
Avoiding Bitter Taste
November 02, 2019
Formulation
43
11
Palatability is crucial for adherence and compliance to oral drug regimens.
Pharmaceutical Technology North America, November 2019 (PDF)
November 02, 2019
Issue PDF
43
11
Click the title above to open the Pharmaceutical Technology November 2019 issue in an interactive PDF format.