Manufacturing

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.

Why spray drying processes offer a range of particle engineering possibilities.

The emerging markets represent an attractive investment opportunity for the pharmaceutical industry because of the countries' growing economies and unmet medical needs.

The pharmaceutical industry must understand its responsibilities to improve the safety of chemicals as defined by the REACH initiative.

A new automated factory in Boston (MA, USA) has been developed that uses non-genetically modified green plants to quickly produce large quantities of vaccines and therapeutics.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

The Society of Chemical Manufacturers and Affiliates is raising concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act.

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2010 edition from Camfil Farr and K-Tron.

The green movement promises to make life-sciences manufacturing processes more environmentally friendly.

If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.

Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs, according to market analysts Frost & Sullivan.

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.

The US Food and Drug Administration held a public meeting in Rockville, Maryland, on April 12, 2010, to solicit stakeholders' comments about the Prescription Drug User Fee Act program.

Orphan drugs may help pharmaceutical companies reduce the effect of revenue loss caused by patent expirations of blockbuster drugs, according to Frost and Sullivan.

sanofi-aventis outlined an investment plan for adapting its chemical and biotechnology manufacturing facilities in France during the next four years.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

CMOs' business model has all of the flaws of the captive model it is meant to replace.

Collaboration has been key to the pharmacopeia's achievement.

Tablets and capsules are mainstay product forms, so what are the spending and innovation trends for solid-dosage manufacturing equipment and machinery?

As drug manufacturing and standards grow, pharmacopeias must adapt to meet new challenges.

In Part I of this article, which appeard in the March 2010 issue, the authors describe their approach for constructing form spaces for carbamazepine, cimetidine, and phenylbutazone by initial solvent screening to evaluate the feasibility of spherical crystallization. Part II of this article discusses their findings.

As the industry continues to evolve, do we know where we're headed?

An established show has several new programs that reflect the industry's current challenges.