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Article / Oct 26, 2018

The Coming of Age of Amorphous Solid Dispersions

Pharma's Almanac, 26 October, 2018

Although the majority of new drug candidates suffer from poor solubility and bioavailability, oral solid dosage forms remain the preferred route of administration due to their ease of use and convenience for patients and caregivers. In recent years, numerous drugs formulated as amorphous solid dispersions (ASDs) have been successfully commercialized, confirming the effectiveness of these technologies for enhancing the dissolution of challenging APIs.

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Topics covered in the article:

  • Focus on Spray Drying

  • Addressing Solubility Issues

  • Benefits of ASDs

  • Two Leading ASD Technologies

  • Maintaining the Metastable Form

  • Dealing with Brick Dust

  • Facilitating ASD Development and Manufacturing

  • Greater Understanding for Rational Design

 

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With key expansions coming to fruition on either side of the pond, specialist CDMO Hovione is making sure that drugmakers can access its particle engineering expertise across multiple geographies.  That flexibility will be key for the Portugal-based company in the coming years as the pharmaceutical industry continues to embrace more regional supply chains. In a recent interview, Hovione's David Basile, VP of technical operations for the Americas, discussed this trend and the manufacturer's expansion project, which is set to come online in New Jersey next month.  In the coming weeks, Hovione plans to debut a new spray drying expansion at its campus in East Windsor, New Jersey. The company has invested $100 million to expand its campus, including new construction and the acquisition of an additional facility and greenfield land.  Specifically, one of two pharmaceutical spray drying-3 units, or PSD-3 units, will come online in the coming weeks to tackle amorphous active pharmaceutical ingredients (APIs) and amorphous solid dispersions, according to the company. With some 80% of new small molecules in development insoluble in water, Hovione’s particle engineering and amorphous solid dispersion platform helps medicine developers improve the solubility, bioavailability, and, in some cases, the stability of their drug candidates, Basile said.  The company boasts spray dryers from the lab scale to PSD3 at its original facility in East Windsor, in addition to the pair of large-scale machines about to be activated at the campus' new facility.  “We’re going for a single, unified site with capabilities across the campus to do drug substance through finished drug product under one governance and quality system,” - Basile told Fierce.   Read the full article at FiercePharma.com

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