Dosage Forms

A stepwise, process risk-assessment approach can facilitate the identification and understanding of critical process parameters, quality attributes, and in-process controls. This approach can lead to more use of science- and risk-based regulatory practices to simplify the regulatory requirements for changes to synthetic processes and to support the underlying quality systems that ensure compliance.

Can macromolecular processes learn from small-molecule experience? Burdened by exploding bioreactor productivity, architects of downstream bioseparation technology are looking into the drug industry's past for inspiration, while small-molecule companies adopt techniques pioneered by biotechnology. (The first of three articles on the current state of separations.)

FDA Posts Q5E Biotech and Biological Products Comparability Guideline

Self-Assembly Nanotechnology Improves Microencapsulation

Once considered mainly an afterthought in a company's lifecycle-management strategy, controlled-release dosage forms are now positioned at the forefront of many formulation strategies. In contrast to drug discovery, formulation work focuses not only on the intricacies of the active pharmaceutical ingredient (API), but also on fine-tuning the excipients, the release profile, and the delivery mechanism to provide optimal therapeutic benefit. Because of their wide range of applications and functionalities, especially in controlled-release therapies, polymers are among the most widely used excipients.

Wet granulation is a size-enlargement process in which a liquid is used to achieve the agglomeration of solid particles. Agglomeration improves particles' tableting properties by rendering them free-flowing, nonsegregating, and suitable for compression (1).

Vaccine developers are using novel drug delivery methods that offer advantages over traditional techniques such as improved immunogenicity, better stability, specific control over antigen release, and a wider pool of targeted diseases.

Vaccine developers are wrking on new drug delivery systems that offer improved immune responses, better stability, and a wider pool of targeted diseases.

A ready-to-fill closed vial can improve aseptic filling quality and reduce process complexity.

Pure water is a raw material of particular importance to the pharmaceutical industry. Drinking water is the basis for the treatment of water for pharmaceutical applications; it is the starting point for the production of the various pharmaceutical water qualities, such as purified water, highly purified water and water for injection.

The complete elimination of human-derived contamination is possible only with the elimination of human intervention.

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination.

Crucell and NIH Sign Ebola Vaccine Manufacturing Contract

HHS Awards $97-Million Vaccine Development Contract

The principles of direct compression haven’t changed in more than a century. So why can the topic still pack a ballroom?

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage.This article describes the basic principles of the technique and provides examples of its potential applications.

An increasing number of new compounds are being introduced into pharmaceutical pilot plants.The knowledge base for these compounds regarding their toxicities,physical handling, and cleaning is limited.The authors examine various approaches for addressing the cleaning validation of new compounds and discuss the role of determining appropriate visible residue limits.

To meet the requirements of the USP ^755& Minimum Fill and ^698& Deliverable Volume tests, target fill levels greater than 100% must be established.This article proposes a criterion for establishing an appropriate target fill level such that a sample will have a 95% probability of passing these USP tests at 95% confidence.

The authors argue that chlorine dioxide (CD) is a safe and effective decontaminating agent that can be used for challenging applications.The effectiveness of CD gas for sterilizing complex isolator systems is studied.

The authors study the effects of sweet potato and cocoyam starches on the compressional and mechanical characteristics of a paracetamol tablet formulation using cornstarch BP.

Innovators and generics makers are staking out positions on follow-on proteins and other manufacturing issues.

X-ray microtomography has great potential for improving the understanding of the structural features of solid dosage forms and the changes in those features during manufacturing, handling, and storage. This article describes the basic principles of the technique and provides examples of its potential applications.

"Stable Liquid" Technology Permits Heptavalent Vaccine Against Botulism

UK MHRA Okays Chiron Flu Vaccine Plant; FDA Approval Still to Come

Big Pharma Companies Team Up to Develop Once-Daily, Triple-Combination HIV Drug

This article outlines a comprehensive approach for organizing a firm's aseptic operations, including planning for routine and nonroutine interventions, establishing effective process simulations, and determining which vials to incubate.

New fixed-dose combination drugs aim to enhance safety and efficacy, while regulators clear a path for more drug–device combination products.

The author points out some major obstacles to effective scale-up and describes methods available to pharmaceutical scientists for addressing scalability issues.

In the manufacture of many pharmaceutical products, dry-particle blending is a critical step that directly affects content uniformity.