Archive for the 'Formulation' Category

Omega-3s Prescription Products: A Case Study of Innovation

Patricia Van Arnum PharmTech editor Innovation is the cornerstone of the pharmaceutical industry. The challenge to innovation not only entails identifying drugs with clinical efficacy but also in being able to produce and deliver the desired drug compound. An upcoming Pharmaceutical Technology webcast, Omega-3 Innovations in Pharmaceutical and Diagnostic Markets, will examine the latest developments for omega-3 prescription drug products, their regulatory status, and recent advances in softgel drug-delivery technologies for omega-3 products. Read more »

Borders on Intellectual Property

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines. PharmTech’s Asia correspondent, Jane Wan, reports that India has set a high bar for patent approval that Western drug manufacturers are finding frustrating.

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Bioavailability Enhancement through Lipid-Based Drug Delivery

Patricia Van Arnum PharmTech editor Improving bioavailability of poorly water-soluble drugs is an ongoing challenge for formulation scientists and is of crucial importance to advance clinically promising drug candidates. A Pharmaceutical Technology webcast, Bioavailability Enhancement through Lipid-Based Drug Delivery, will examine advances in lipid-based drug delivery systems for enhancing the bioavailability of absorption-limited small and large molecules. Read more »

Thirty-Five Years in the Pharmaceutical Sciences and Counting

Patricia Van Arnum PharmTech editor A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »

Making it Skin Deep

Patricia Van Arnum PharmTech editor 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 »

Optimizing Topical Drug Formulations and Manufacturing

Patricia Van Arnum PharmTech editor 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 »

Tackling the Problem of Poorly Water-Soluble Drugs

Patricia Van Arnum PharmTech editor 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 »

QbD in Theory and Practice

Erik Greb PharmTech editorThe 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 »

The Weight of the Matter: Revising Children’s OTC Labeling

Angie Drakulich PharmTech editorFDA 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 »

When Drug Makers Strive to Make Patients Dislike Their Products

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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