Dosage Forms

When it comes to developing a robust lyophilization process, formulators can "pay now or pay later," says Jeff Schwegman, PhD, founder and chief scientific officer for BioConvergence. Because 30% of new drugs in clinical trials are biotech-based therapeutics (compared with 7% 10 years ago), more than ever, the US Food and Drug Administration is paying close attention to lyophilization data and questioning pharmaceutical companies about their development cycles, especially cycle development transfer, shelf-temperature mapping, dryer-to-dryer comparison studies, formulation time, process validation, and cycle deviation. Consequently, this is pushing formulators to optimize formulation variables, conduct additional testing during early-stage development, and understanding critical process parameters, equipment qualifications, and manufacturing conditions that can influence formulation behavior at a large scale. Not taking the time or effort to achieve these goals during early development could lead to redundancies in formulation work - a reality observed too often in today's practices.

The authors focus on the effects of cellulosic materials during the performance qualification validation of a transfer barrier isolator used for the purpose of sterility testing.

The common crystal form of ibuprofen was changed to optimize processing and manufacturing properties. Six modified crystal forms were prepared and assessed for dissolution, morphology, particle size, density, thermal characteristics, powder x-ray diffractometry, flow properties, and tabletability.

Biomanufacturing managers believe the current lack of adequately trained personnel is one of the most serious problems facing the biomanufacturing industry.

Industry, FDA, and World Health Agencies Boost Pandemic Preparedness

Roche Plans New US Manufacturing Facility for Tamiflu while Cipla Prepares to Market Generic

Collaboration Targets Single-Shot Japanese Encephalitis Vaccine

A radiotracer technique is a simple, fast, and sensitive technique for analyzing the integrity of clinical supply packages to water.

This review article discusses orally disintegrating tablets and their manufacturing technologies, development issues, and future trends.

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

A fleet of pharmaceutical manufacturers have green lighted new bar coding and e-pedigree pilots using electronic barcodes. But is Industry ready for full-scale RFID?

Pharmaceutical science and technology innovation

Genecor Wins Vaccine-Development Contract

FDA Proposes Question-Based-Review System for Generics

FDA Calls Chiron Facility Acceptable; GSK Gets Green Light For Flu Vaccine

New Guidance May Speed Generic Approvals

The tablet formation of six different carrageenans was analysed by 3D modelling, Heckel analysis, the pressure–time function and energy calculations. It was found that the fibres experienced plastic deformation, which was accompanied by a great deal of elasticity. Measurement of elastic recovery in dependence on maximum relative density and time showed that relaxation is completed a considerable amount of time after tabletting. Shrinking of the fibres occurred in parallel with elastic recovery as a result of the reorganization of the fibre structure. The tabletting behaviour of carrageenans makes them suitable for the soft tabletting of pressure sensitive materials.

Contract manufacturers serving the biopharmaceutical market add capacity in a bet on renewed growth for biomanufacturing.

Bavarian Nordic Sues Acambis for Patent Infringement

Acambis and Bavarian Nordic Vie for Smallpox Vaccine Contract

GSK Releases Flu Vaccine Production Strategies

US Government Orders 2M Doses of Avian Flu Vaccine

Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.

Various systems and measures can be used to safely handle and process explosive pharmaceutical compounds in a range of manufacturing procedures.

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.

Microbioreactor Array System Boost Cell Culture Capacity

Protein Refolding Technology Improves Yields

Able Labs Files for Chapter 11

Chiron Cuts Supply of Flu Vaccines Made in Germany; Liverpool Plant Under Inspection

Able Interim Chief Resigns Amid Drug Recall