Drug Development

New maintenance models focused on efficiency improvements can deliver cost savings and enhanced service quality.

Reading the good automated manufacturing practice (GAMP 4) guide acquaints you with the now classic and almost famous V-model.1 The V-model, originally used for describing a validation workflow of IT and automated systems, is easy to understand and very good at ensuring that the requirements and design are built into the final solution. It is also extremely versatile and can be used for almost any type of validation task you could meet in a development phase.

The aim of this study was to analyse the process of tablet formation and the properties of the final tablets for six different carrageenans. The carrageenans used were based on the basic types of ?-, ?- and ?-carrageenan. Microcrystalline cellulose was used for comparison. Determination of material properties, compression analysis and tablet properties were described. Water content, particle size and morphology, glass transition temperature, and crystallinity were studied. The results show that the carrageenans are predominantly amorphous fibres, which are in the rubbery state during tabletting.

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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.)

Genentech Anticipates Full-Capacity Manufacturing

Molding Technique Improves Nanoparticle Production

Warning Letter: Pragmatic Materials

Development Collaboration for Ophthalmic Drugs Could Eliminate Injections

Warning letter: C&M Oxyfill

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.

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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).

Bioadhesive films cast from aqueous blends of PMVE/MA have diverse uses, such as a means of establishing an electrically conducting interface for bioelectrodes and as an adhesive drug delivery matrix.

HR-US is a nondestructive technique with enormous potential for the analysis of materials and formulations used in the pharmaceutical industry.

This high quality of pellet roundness is surprising in view of the high extrusion forces required to extrude the wet masses.

Glossary of computer and software terms.

New Excipient Guidance Doesn?t Fill Regulatory Gap

Recalls, Resignations, and Suspended Manufacturing Plague Able Labs

Compounding Pharmacies' Lawsuit Against FDA Will Continue