Formulation and Drug Delivery

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

A company's contamination-control plan is an important document designed to formalize the rationale, methods, and validation of contamination-control procedures in a manufacturing facility. The author describes the role of bioburden in the contamination-control plan.

Improvements in analytical techniques may call for a re-evaluation of the biopharmaceutical industry saying that "the process is the product."

Dishman is giving a step further in its strategy to manufacture high potency (HiPo) Active Pharmaceutical Ingredients (APIs).

During the past few years, we've seen a growing interest in direct oral application products, evidenced by the large amount of products already available on the market.

Orally disintegrating tablets (ODTs) are growing in popularity and their market value could exceed $13 billion in sales by 2015, based on current global growth trends.

Biologics are large molecular weight molecules primarily formulated for parenteral administration; however, there are some smaller biomolecules that have been formulated for oral use.

Biopharmaceuticals commonly cannot be terminally sterilised, as such aseptic processing using sterilising grade filtration is essential.

The authors describe a new method for the production of personalised medicines utilising ultra-precise microdrop printing technology.

Gilead Sciences to Acquire Arresto Biosciences; Sartorius Appoints Head of Lab Business; and More.

The authors conducted an experiment to determine the type of extrusion that provides the best productivity and pellet quality. This article contains online bonus material.

Capable of great works, pharma as a whole still yields to the lesser angels of its nature.

Developments in RNAi, monoclonal antibodies, and more are boosting the biotech marketplace.

The manufacture of orally dissolving films is done by various methods such as solvent casting, hot-melt extrusion, semisolid casting, solid-dispersion extrusion, and rolling. The authors discuss these methods and the various parameters in which dissolving films are evaluated.

Poor organization makes it hard for readers to find the helpful information in a recent book.

Analysis of crospovidone as a superdistingrant.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

Supportive public policy is needed in order for innovation to flourish.

World AIDS Day 2010 reminds us that prevention and hope can help fight the disease.

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

The authors evaluated the effect of alcoholic beverages on the release profiles of sustained-release dosage forms containing metformin and diclofenac.

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.