Dosage Forms

The US Food and Drug Administration issued a rule that clarifies its requirements for current good manufacturing practices for aseptic processing, water standards, and verifications standards.

To keep up with applications, FDA promotes new testing and administrative methods.

Individualized dosing for specific patient needs has been the goal of medical and pharmacotherapy specialists since they first envisioned pharmacogenetic evaluation. With the measurement of individual levels of metabolism, the optimum dose can be calculated for each individual patient.

The authors analyzed the effects of complexation as well as the levels of ammonium bicarbonate and crospovidone on tablet wetting time (WT), disintegration time (DT), and percent dissolution efficiency at 60 min (%DE60).

Incorporating quality and economy into downstream purification processes can expedite first-in-human clinical trials, product licensure and technology transfer. Experience in the chromatographic purification of biopharmaceuticals enables the use of downstream processing heuristics to produce target molecules in cost-effective processes suitable for regulatory scrutiny.

Sanofi-aventis entered into an agreement with Chinese authorities allowing Sanofi to construct a vaccine-manufacturing plant in Shenzhen municipality.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Market demand for cytotoxic drugs is leading CMOs to expand their API manufacturing and formulation services.

Natural gums and mucilage have been widely explored as pharmaceutical excipients. The goal of this study was to extract mucilage from the leaves of Aloe barbadensis Miller and to study its functionality as an excipient in pharmaceutical sustained-release tablet formulations.

Vaccines are needed against old and new infectious disease threats - polio and other childhood illnesses, bioterrorism and pandemic flu. They are also emerging for cancer immunotherapy and for treating addiction. While vaccines are among some of the most successful biotech products, their large-scale manufacture involves some special demands, such as maintaining a good working cell bank and gearing up for production on an 'as needed' basis.

The crystalline structure of pharmaceutical solids can sometimes be altered during processing. X-ray powder diffraction and near infrared spectroscopy can be used to determine the amorphous and crystalline content of a model substance. The two techniques' precision, accuracy, detection limit and the speed of analysis are compared.

The pharmaceutical market is undergoing a major transformation with companies moving more and more toward the generics business, according to a new report.

Ranbaxy received full market approval from the US Food and Drug Admnistration for its anti-infective agent ?Clarithromycin? oral suspension.

Transdermal delivery takes up once-forbidden compounds, reviving markets and creating formulation opportunities.

The preferred route of administration for an injected therapeutic agent is subcutaneous (SC), but SC injections are generally limited to no more than 1-2 mL in volume, representing a major challenge, especially for large protein biologics.

Last year, a monoclonal antibody, TGN1412, led to potentially fatal adverse effects in a small group of Phase I volunteers in London. In the wake of this incident, EMEA has drawn up new guidelines that could lead to demands for more data on novel biologics. They may have implications for both manufacturing and clinical trials of biopharmaceuticals that are considered to pose a high risk to patients.

The UK, with its high quality educational capabilities in bioscience, has an opportunity to become the global hub of bioscience training, but must act quickly to secure this position.

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

The scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

A new economical method for producing fast-melting lamina-like dosage forms.

In biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.

This article describes how rapidly disintegrating tablets containing a large quantity of an intensely bitter drug were successfully developed with a suitable level of masking, tablet hardness, disintegration property, dissolution profile and mouth feel.

Getting from a cell culture to a purified biotech product is a demanding exercise involving many operations. Increasing productivity in the upstream part of biotech production is placing new demands on the purification process, which may lead to adopting new technologies.

A new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.

The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.

Microbix Biosystems has established a team of experts to help manufacturers boost their production of influenza vaccine.

Johnson & Johnson consolidates operations, Xceleron leases new facility, more