Drug Development

Phase II of FDA's GMP modernization plan may involve revising regulations to fit new policies and inspection and review programs.

The implementation of a total organic carbon (TOC) method into the United States Pharmacopeia (USP) has its origins in the early 1990s, when the Water Quality Committee (WQC) of the Pharmaceutical Manufacturers Association (PMA, later renamed PhRMA) debated improvements in the testing of purified water (PW) and water-for-injection (WFI). The resulting inclusion of modern analytical techniques replaced much older methods - some of which had been listed in the USP for more than 150 years. Finally, two new regulations were put in place: Chapter for conductivity, which replaced a series of individual ion tests; and Chapter which replaced the oxidizable substances test with a TOC method.

Information retrieval (IR) deals the representation, storage, organization of unstructured applying natural-language processing,semantic relationships, linguistic analyses,behavioral histories, and “fuzzy” statistical techniques to help human quickly find and retrieve the information they seek.

This article describes a novel approach to a scale-up management system, based on a holistic view of the scale-up lifecycle and an accompanying electronic development record of the information created.

The author argues that information technology solutions will play a major part in confirming-by experimental and statistical validation-that bioprocesses may be interchangeable and therefore generic. The bioprocessing ANDA will define both in-house and contract manufacturing.

Pharmaceutical science and technology news

Pharmaceutical science and technology news

Freeze pelletization is a new and simple technique for producing spherical pellets for pharmaceutical use.

The authors review current industry practices and regulatory expectations for the aseptic processing of sterile drugs. They compare and outline critical issues in current manufacturing technology and capabilities with regulatory requirements.

Using dimensionless analytical models, the authors establish the relationships among the essential parameters of a kneading complexation process.

FDA and industry discuss proposals for regulating combination diagnostics, medical devices, and pharmacogenomic-based drug products.

By enhancing stability and in vitro drug-release characteristics, limonene enantiomers are a natural-source alternative for developing and characterizing self-nanoemulsified drug delivery systems.

Big Pharma is ramping up capital spending in parenteral manufacturing at the same time that contract manufacturers are completing their own major investment programs.

Transdermal drug technology specialists are meeting demands for methods that can painlessly deliver larger molecules in therapeutic quantities.

Steaming-in-place (SIP) is a widely adopted method for the in-line sterilization of processing equipment. The main advantage of SIP relies on manipulation reduction and aseptic connections that might compromise the integrity of the downstream equipment.

Single-use products enhance sterile filtration by making it easier to maintain sterility and reduce cross-contamination risks.

FDA's recently released initiative has made process analytical technology (PAT) a hot topic in the life science industry. PAT describes the application of process analytical chemistry tools, feedback process control, information management tools, and product and process optimization strategies for the development and manufacture of pharmaceuticals. In this article, the author explores the impact PAT will have on the pharmaceutical industry.

The process of extrusion/spheronization used to produce spherical granules frequently relies on formulations containing microcrystalline cellulose (MCC). This excipient can hold water, even when pressure is applied, and form "pastes" that have suitable rheological properties, which allow both extrusion and subsequent spheronization to produce uniform spherical granules. This article describes a new approach to providing paste systems with appropriate characteristics. This can be achieved by incorporating glyceryl monostearate (GMS) into the formulation. It was found that the inclusion of GMS in formulations provides a useful alternative to MCC as an effective excipient to aid the preparation of spherical granules, allowing the incorporation of drug loads as high as 90%.

Excel File

FDA is re-engineering the CMC review process for innovator and generic drugs and backing risk-based ICH quality standards.

Pharmaceutical Science & Technology News

The authors suggest a design strategy for an aseptic process simulation that focuses on the basic repeating unit of the process, establishing alert and action criteria for the unit itself, and using worst-case simulations to establish routine operational parameters for the manufacturing process.

A straightforward approach reveals how the probability of passing the USP content uniformity test can be calculated for tablets and capsules.

In this final part of a series of three articles, the results from experiments involving cohesive materials are discussed in terms of mixing performance, agglomerate comminution, and lubrication of powder mixtures.

Customers are placing high demands on pharmaceutical manufacturers to produce sensitive, cost-effective and regulatory compliant inspection technology. This article examines how metal detection equipment suppliers can combine forces with manufacturers to provide state-of-the-art inspection systems, giving particular consideration to cleaning processes and regulatory issues.