Development

Fiera Milano Rho Exhibition Centre, Milan, Italy 2–4 October 2007

The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.

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

The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.

This article investigates how the industry can test inhalers in a way that is most representative of typical use.

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.

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.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Identifying polymorphs is a crucial part of the drug-development process as researchers forward select methods to improve detection.

Contract manufacturers and pharmaceutical ingredient suppliers proceed with select investments in biologics manufacturing, small-molecule synthesis, and formulation as the industry prepares for CPhI Worldwide in Milan.

Single-enantiomer drugs represent an increasingly large share of new chemical entities, leading to approaches in asymmetric synthesis.

Irish researchers have developed a method that could be used to deliver controlled amounts of drugs to diseased tissues while minimizing side effects by shining light on the target.

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

The company begins production at a new $100-million manufacturing facility for prefilled injection systems, plans further investment in packaging facilities, and targets both early-phase development and commercial manufacture.

Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.

During the past 30 years, manufacturers developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics, including quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and delivery systems as technology and drug development advance.

Catalytic routes to producing atorvastatin and sitagliptin are recent advancements.

The author reviews advancements in formulation that Pharmaceutical Technology has chronicled during the past 30 years. During this time, many novel solutions were investigated and finally became common and accepted techniques. The author also looks ahead to future developments in formulation and drug delivery methods.

Double-digit growth is projected for the US generic drug market, and the industry positions for opportunities in biosimilars.

Pfizer CentreSource is proceeding with a new plan for the supply of steroids and steroid intermediates through a recently signed pact with two Asian contract manufacturing organizations.

Nanotechnology is emerging as a tool for resolving challenges in delivering poorly water soluble and highly potent drugs.

The racemic compound (R, S)-(±)-ibuprofen is a popular and well understood active pharmaceutical ingredient, but it has several disadvantageous formulation properties such as poor solubility, low melting point, and potential esterification with excipients containing an hydroxyl group. The authors investigate the use of an (R, S)-(±)-ibuprofen salt to evaluate these problems using various analytical methods to determine the polymorphism, crystallinity, and drying scheme.

The Active Pharmaceutical Ingredients Committee (APIC) - a sector group of Conseil European des Federations de l'Industrie Chimique (CEFIC) - first voiced the need for EU GMP API legislation in 1993 to help ensure the safety of medicines. In 2000, the International Conference on Harmonisation (ICH) finalized the harmonized API GMP Guideline Q7, which became legal in the US and Japan in 2001. The EU adopted a directive in March 2004 that includes the requirement for APIs in medicines for the EU market to comply with ICH/Q7A. Member States are transposing the directive into their national law: about half of them have completed this process, seven more are well on their way to completion, while seven others are still in earlier stages of adoption.

Fluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.

Predicting the flow characteristics of powders during manufacture is especially important for the pharmaceutical engineer. Getting the powder flow wrong can be highly disruptive to plant performance and productivity, particularly where equipment has to be taken off-line and stripped down for cleaning out blockages. The flow behaviour of the individual ingredients may be well known, but as these are blended and reacted their flow properties can change.

Cells function as highly accurate quality control (QC) machines to ensure that only correctly folded proteins are released into the physiological milieu to perform their designated functions. The efficient removal of damaged or incorrectly folded/misfolded proteins at the correct time keeps a cell viable and functioning.

Reflecting strong growth prospects for certain biologic-based drugs, the biotechnology and pharmaceutical majors are proceeding with a strategy of expanding their internal manufacturing networks and partnering with select contract manufacturing organizations (CMOs).

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's annual analysis of the biotechnology industry.