Dosage Forms

Angie Drakulich was editorial director of Pharmaceutical Technology.

Articles

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

Physical-Chemical Identifiers: A Q&A with FDA on the Final Guidance

The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.

Assessing Tablet-Sticking Propensity

Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.

Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.

Multilayer-Tablet Technology

Multilayer tablets can be challenging, but meeting regulatory expectations is crucial. We speak with Vilayat Sayeed from the FDA, to find out more about the critical factors that need to be fully understood.

Multilayer Tablets: Critical Factors To Consider

This risk-management case study focuses on assessing empty capsules.

PQRI Case Study (4): Process Deviation and Empty Product Capsules

The author prepared and analyzed a detailed design of experiments for the manufacture of a simple tablet formulation. The aim was to test whether tablet hardness and weight could be controlled during the compression process by adjusting certain machine parameters.

A Design of Experiments for Tablet Compression

A Q&A with Joe Cascone, director of potent pharmaceutical development at Metrics, moderated by Patricia Van Arnum. Discussion of the key considerations made in facility design, equipment selection, and operations to achieve desired levels of containment.

Achieving Containment in High-Potency Manufacturing: A Case Study for Solid Dosage Manufacturing

FDA published a draft guidance that lists recommendations to follow, data to provide, and criteria to meet and describe in new drug applications and abbreviated new drug applications for scored tablets.

FDA Publishes Draft Guidance on Tablet Scoring

Xevo TQD provides ultimate consistency between analyses; instrument to instrument, lab to lab; both the advanced technology of the ACQUITY UPLC System and the robust universal ion source architecture on the Xevo TQD guarantee flexibility and dependability.

Rapid identification of Genotoxic Impurities in Tablets with Xevo TQD

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The solid form of an API plays a crucial role in drug quality, and advancing methods for screening, detection, and characterization is key.

Solid/Semi-Solid Dosage