Manufacturing

Articles

The increasing popularity of orally disintegrating tablets has led to growing interest in the advantages of superdisintegrants. This article presents some practical considerations in selecting these ingredients.

Selecting Superdisintegrants for Orally Disintegrating Tablet Formulations

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

A Compliance Perspective on Dissolution Method Validation for Immediate-Release Solid Oral Dosage Forms on Automated Instrumentation

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

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

Fernando J. Muzzio, PhD, is a professor and the director of the pharmaceutical engineering program at the Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854-8058, tel. 732.445.3357.

Almost all pharmaceutical manufacturing processes require handling and processing cohesive powders. The application of sufficient shear (i.e., the total deformation that the bulk of granular material undergoes under applied shear stress) is an essential factor in such processes. Sufficient shear is required to mill and de-lump materials, achieve sufficient flow, and homogenize cohesive ingredients. Shear mixing plays a critical role in the blending of dry powders, particularly for those that contain a minor cohesive component such as a solid lubricant or a drug. This mechanism is necessary to achieve a satisfactory homogeneity and disintegrate possible agglomerates. Excessive shear can be disadvantageous, however, and can lead to electrostatic buildup, attrition, and overlubrication.

Manufacturing, Solid and Semi-Solid Dosage Drugs