Dosage Forms

Articles

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

PharmTech Annual Event Highlights Process Optimization, Product Quality

Predictable outcomes lead to greater manufacturing efficiency and speed time to value.

Better Process Understanding Improves Quality, Lowers Risk

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The biggest single recent trend in outsourcing solid-dosage processing has been the movement toward discovery and synthesis of more potent active pharmaceutical ingredients. 

Outsourcing Solid Dosage Manufacturing

Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed. 

Process Considerations for Cell-Based Influenza Vaccines

Implementing a PAT Strategy

Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.

Effects of Initial Average Particle Size on Tableting: Evaluating Predictive Tools for Crystal Engineers and Formulators

The pharmaceutical industry's focus on process understanding, monitoring, and control is driving manufacturers to take greater steps toward identifying possible manufacturing bottlenecks earlier in the development process. For tablet, capsule, and excipient producers, such efforts include taking a closer look at the flow-ability of their powders.

Developments in Powder Flow Testing

Using a novel automated microfilling system, the authors demonstrate that roller compaction followed by milling is a viable preprocessing technique for high-dose chemical-in-capsule dosage forms. The process results in higher bulk and tapped densities for drug substances compared with milling alone.

Enhancement of Xcelodose Capsule-Filling Capabilities Using Roller Compaction

Though dissolution testing has been under scrutiny, it is still a powerful test method.

Challenges to the Dissolution Test Including Equipment Calibration

This article discusses the advantages and disadvantages of using solid-state NMR spectroscopy for the analysis of pharmaceutical solids.

Solid/Semi-Solid Dosage