Dosage Forms

Demand for new therapies and vaccines spotlights production challenges.

Romaco Kilian's KTP 420X tablet press compresses up to 360,000 tablets an hour.

Fette Compacting America FE75 Tablet Press is designed to produce up to 1.6 million tablets per hour.

Weighing the pros and cons of hot-melt extrusion and spray drying.

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Advances in solid and liquid formulation techniques are providing more options.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

USP expresses its support for a consensus-based global approach to the naming of biologics.

I Holland, in collaboration with the University of Nottingham and experts from the Laboratory of Biophysics and Surface Analysis, United Kingdom, recently completed a two-year tableting science anti-stick research (TSAR) project, which sought to understand why certain formulations stick to tablet tooling.

Leading global tablet tooling manufacturer, I Holland has a range of multiple tip punches and dies optimised to meet the requirements of modern tablet production.

CALIXAR and VirPath use new manufacturing techniques to create a vaccine for the pandemic flu, influenza A (H1N1), available in 2015.

Texas A&M dedicates national pandemic influenza vaccine manufacturing facility.

Micronization and other processes are used to obtain optimal particle characteristics for pulmonary and oral solid-dosage delivery.

A GPhA report says generic drugs saved the US health system $239 billion in 2013.

Molecular Profiles has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the United Kingdom.

FDA approved XTANDI for the treatment of metastatic castration-resistant prostate cancer.

PDA will publish a technical report on quality risk management aspects of drug shortages in early 2015.

PDA surveys are designed to evaluate quality metrics practices at member organizations.

FDA gives NewLink Genetics approval to proceed to Phase 1 clinical studies of Ebola vaccine.

Conventional tablets may no longer be the go-to solution.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

A surge in generic drug applications is testing FDA?s ability to reduce the backlog of ANDAs.

The National Institute of Allergy and Infectious Diseases will begin the first in a series of trials for an Ebola vaccine during the week of Sept. 1.

Concerns about quality in overseas production may bring generic drug production back to the United States, concludes CPhI study.

The European system for assessing drugs will be used as a model internationally.

EMA has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of a module on the quality requirements.

Customers are looking to reduce risk, increase performance, and optimize productivity.

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.