Improving drug delivery is an important consideration in new drug development and in managing the product life cycle of existing drugs. Delivery mechanisms that can improve patient compliance, facilitate administration, and target delivery of an active are crucial goals. Drugs that are delivered topically provide an opportunity to realize these objectives, and an upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

Improving the solubility of poorly water-soluble drugs is of crucial importance for developing and successfully commercializing new drug compounds. Combinatorial chemistry and high-throughput screening methods in drug discovery has increased the number and diversity of molecules of potential interest in drug development. That larger pool of candidates, although potentially beneficial, also creates challenges, namely more compounds  of poor solubility. According to some industry estimates, approximately 70% of new chemical entities under development may be classified as BCS Class II compounds (i.e., high permeability and low solubility) (1). An upcoming webcast by Pharmaceutical Technology examines one technology to address low bioavailability: pharmaceutical melt extrusion. Read more »

The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

FDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the agency, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, recommended a change for children’s OTC medicines that contain acetaminophen, such as Tylenol. The labeling issue has been a concern for many years now, and has gained attention since January 2008, when postmarket adverse events were reported for McNeil Consumer Healthcare’s pediatric formulations of Tylenol, Motrin, Zyrtec, and Benadryl. Read more »

Deaths from unintentional overdoses of prescription drugs have reached epidemic proportions in the US, outnumbering deaths from motor vehicle crashes or suicides in 20 states. Approximately 27,500 people died from unintentional drug overdoses in 2007, driven to a large extent by prescription opioid overdoses. This is according to a press release from the University of North Carolina (UNC), referring to a publication in the Journal of Clinical Psychiatry describing the phenomenon, and offering advice to prescribers on how to deal with it.

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This blog post was written by Amy Ritter.

Drug maker KV Pharmaceuticals has been in the news concerning pricing of its newly approved drug, Makena.  Makena, while newly approved, is a version of a very old drug, synthetic progesterone, which had previously been available to consumers for as little $10-$15 a treatment through specialty pharmacies that compounded the drug on site.   Read more »

Patients who take biological drugs traditionally have had little choice but to submit to injections. Yet needlephobes should take heart. Several partnerships are developing other ways to deliver large molecules that seem to show promise. Read more »

Next week, the US Pharmacopeia (USP) is hosting the 10th International Symposium on Pharmaceutical Reference Standards in Rockville, MD. The annual PDA-FDA meeting also happens to be taking place next week in Washington, DC, so industry has much to hope for in terms of regulatory news. Read more »

Pharmaceutical companies sometimes explain their unimpressive pipelines by saying that it’s become harder to discover and develop new drugs. Believing that the low-hanging fruit has been picked already, manufacturers are focusing on serving small patient populations. But a new paper suggests that the industry may be overlooking the potential of a particular class of drugs to treat tens of millions of patients. Read more »