Specialty Dosage Drugs

In this sponsored podcast, Adam Stuart, Senior Design Engineer at 3M Drug Delivery Systems, discusses the role of dose counters for metered dose inhalers and the technical challenges companies can face when adding this feature to their inhaler products.

Stada licenses 3M's transdermal technology for a fentanyl patch.

Intertek is now offering comprehensive services for the development of orally inhaled and intranasal drug products (OINDPs) for both small molecules and biologics.

Bend Research adds powder-filling technology.

In this episode, we?ll discuss how an aging global population and the need for continual innovation in the pharmaceutical industry factor into drug delivery systems that move beyond traditional pills and capsules into transdermal drug delivery.

3M Drug Delivery will manufacture transdermal patch for ProStrakan.

Mylan completes expansion of its transdermal patch facility in Vermont.

Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

Australian team develops method for making ultrafine particles for more efficient drug delivery.

The challenge of developing orally inhaled nasal drug products (OINDPs) is complicated by the interplay between drug-delivery devices and formulation.

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

Micronization can be performed with a jet mill or bead mill.

New systems that combine Raman spectroscopy with automated imaging support the efficient gathering of such data, including information concerning size and shape distributions for individual components within a formulation.

Orphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division.

The authors discuss the analysis of the resulting data, focusing on methods for the calculation of mass median aerodynamic diameter, one of the metrics routinely used for comparative testing.

Emerging methods could provide alternative ways of producing inhalable drug particles.

The author reviews key considerations for formulating powders for use in inhalers. This article is part of a special Drug Delivery issue.

The author reviews advances in technology that may soon allow transdermal delivery of two of the fastest growing drug classes on the pharmaceutical market. This article is part of a special Drug Delivery issue.

Although there are no regulatory requirements or established pharmacopoeial techniques for the dissolution testing of inhaled drugs, such testing can potentially open up the opportunity to tailor formulation properties.

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

The pharmaceutical industry?s increasing interest in inhaled drugs has prompted several researchers to propose standard dissolution-testing methods for these products.

The authors demonstrate that sustained-release delivery can help avoid the risk of sudden higher-blood concentration of a drug to avoid toxicity.

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

The European Organisation for Rare Diseases (EURORDIS) has predicted that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year.

Mark Copley discusses the methods used for DPI testing and the challenges presented by the current regulatory framework.

An inhaler mouthpiece that optimizes drug delivery to the lungs and reduces the amount of wasted medication has been developed by US researchers.

For the first time, cancer treatments accounted for 5% of overall drug spending in the first half of 2009, said Medco Health Solutions in a press release last week.

Formoterol presents formulators and manufacturers in the asthma and chronic obstructive pulmonary disease marketplace many challenges.

Teva Pharmaceutical Industries and Barr Pharmaceuticals (Montvale, NJ) signed a definitive agreement under which Teva will acquire Barr, the fourth-largest generic-drug company in the world. Teva will buy each share of Barr common stock for $39.90 in cash and 0.6272 Teva shares. Based on the closing price of Teva?s shares on July 16, 2008, the price per share of Barr common stock is $66.50, and the total value of the acquisition is $7.46 billion. Teva will assume Barr?s outstanding net debt of approximately $1.5 billion.