Formulation

InformexUSA, San Francisco (Feb. 14)-NPIL Pharma unveiled a $100-million investment program in formulation development and manufacturing services.

InformexUSA, San Francisco (Feb. 14)-Almac Sciences plans to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky.

The same phenomena that create lightning and thunderstorms are around us every day, producing incredibly high voltages, which cause sparks and shocks. Static electricity is a mighty force. Each year excessive electrical charge build cause explosions in the grain industry.1 Look around any flammable storage area and you will see both grounding bars on the wall and cables, from the grounding bars connected to the drums of solvents. Take any material safety data sheet (MSDS) for a powder and look in section V; it highlights that any dry powder has the potential to attract and store a charge.

Raman spectroscopy has become a commonly used technique for physicochemical analysis that possesses many advantages over other analytical techniques. It is a very attractive characterization tool, not least because it enables measurements in water. However, very few examples of its application in an aqueous environment exist in literature. This paper provides some recent applications of Raman spectroscopy in pharmaceutical material and process characterization when water is present.

Terpenes are widely used in topical preparations. This paper focuses on the skin penetration of terpenes depending on their physicochemical properties and influence of the type of dermatological vehicle that was used. The structure of human skin and the skin penetration process is also briefly described.

The recent struggles of Cardinal Health's and Patheon's contract dose manufacturing businesses offer a lesson on good business practices.

Water interacts with pharmaceutical solids at virtually all stages of manufacture, from synthesis of raw materials to the storage of the final dosage form. The interactions of water with powders is, therefore, a major factor in the formulation, processing and product performance of solid pharmaceutical dosage forms.

Nanoparticulate drug carriers include a class of particles made of polymers or lipids that - because of their size and chemical composition -permit systemic and local treatment.

Dublin, OH (Nov. 30)-Cardinal Health has announced plans to divest its Pharmaceutical Technologies and Services (PTS) segment, "a business that manufactures or packages 100 billion doses of medication every year for pharmaceutical and biotech firms, employs approximately 10,000 at more than 30 facilities worldwide and generates $1.8 billion in revenue," according to a company statement.

Makers of injectable drugs can increase their market share and stay competitive by devising a product life-cycle management strategy.

Research Triangle Park, NC (Nov. 13)-Eisai Inc. broke ground here for a new pharmaceutical production and formulation research and development facility for parenteral oncology drugs.

Dublin, Ireland (Nov. 6)-Merck Sharp & Dohme (Ireland) Ltd., a wholly owned subsidiary of Merck & Co, Inc. plans to establish a formulation-research-and-development and manufacturing facility at its plant in Ballydine, Ireland, according to the Industrial Development Agency Ireland.

Yet again, FDA's ability to regulate drugs is under fire. At the core of this latest round of scrutiny is whether the agency has the resources to properly control the safety of new nanotech-based drug products.

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

The trend towards developing pharmaceutical products and their manufacturing processes in tandem supports optimized production. Such developments rely on gathering process-relevant information at an early stage and being able to draw on past and current processing experience. Here, we discuss how powder rheometers can make a real difference in building a database of powder properties and removing subjectivity.

This article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).

The specialty excipients market in the United States, Western Europe, and China is valued at nearly $800 million. The authors discuss the opportunities and challenges in these markets by examining the product mix, supply base, and preferred production methods.

Plastic has emerged gradually as a viable packaging material, even for sterile products. Acceptance of plastics has been encouraged by blow–fill–seal (BFS) technology, which provides scientific and commercial benefits. BFS technology has, however, brought new challenges for formulation-development scientists. This article highlights the specific concerns for the development of sterile liquid products and the formulation strategies to address these concerns.

The authors investigated the influence of various particle size fractions of Tamarind seed polyose (TSP) on indomethacin (IND) release from matrix tablets. They assessed the TSP fractions for swelling, density, and flow properties and the IND matrix tablets for tensile strength, friability, and release profile. Release kinetics was evaluated using Higuchi and Peppas equations. The density and flow properties showed that the size fraction affects the suitability of TSP as an entrapment polymer. The release profile showed that the release of IND from TSP matrix is swelling dependent, thereby affecting the kinetics of release.

Protein formulation specialists have long sensed that something big could be just around the corner. Over the past few decades, countless companies have attempted to bring to market new protein therapeutics that offer improvements-be they more patient friendly, more effective, or easier to manufacture-over traditional formulations. Earlier this year, the launch of Pfizer's "Exubera" pulmonary insulin met this anticipation head on. The fast-acting, inhaled-powder form of recombinant human insulin brought hope to the millions of diabetic patients waiting for an alternative to injections.

The increasing popularity of orally disintegrating tablets has led to growing interest in the advantages of superdisintegrants. This article presents some practical considerations in selecting these ingredients.

Mefenamic acid has variable bioavailability and tabletting issues because of its hydrophobic nature and poor material characteristics. Recrystallization of mefenamic acid was performed from three different solvent–solvent mixtures under differing conditions. The crystals obtained were screened for the existence of new crystal properties or polymorphic forms, then characterized further.

The presence of very low levels of residues (including solvents) in excipients is becoming an important issue for users, and the presence of very low levels of ?non-lactose? species in DPI lactose may pose challenges to suppliers and users.

Baltimore, MD (Sept. 10)-Researchers at Johns Hopkins University have devised a new controlled-delivery system that applies an electrical pulse to release drug molecules, nanoparticles, biopolymers such as peptides and proteins, and protein assemblies such as viruses from thin fabricated gold electrodes. Developers hope the technique will allow biocompatible implantable chips for precisely dispensing small amounts of drug into the body.

As the pace of product development accelerates, the approach to dissolution-method development must advance beyond a manual method and an assay. A natural progression of the method-development process must include the transfer of the manual method onto automated instrumentation.

Biovail Corporation is demanding that the US Food and Drug Administration (Rockville, MD) enforce the proper criteria for determining bioequivalence of extended-release generic versions of bupropion products.

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

Aegis Therapeutics (San Diego, CA) has launched a new formulation technology to increase the stability of proteins and peptides.

Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.

Formulation development can involve several complex technical challenges, but an approach incorporating design of experiments can help address these difficulties.