Prosolv tech in API development pact

The Prosolv technology platform essentially enhances the characteristics of APIs and other ingredients, resulting in a number of favourable features in the finished tablet. According to JRS, the technology can help stabilise certain difficult APIs, as well as offering manufacturing benefits through Prosolv products' high compactability, improved blending properties and enhanced lubrication efficiency. The proprietary technology platform allows manufacturers to incorporate the features of tableting excipients into the API. JRS claims that using Prosolv technology early in the development process can result in early market entry, direct compression formulas and smaller, consumer-friendly tablets. Under the terms of the agreement between the two companies, CoreRX will undertake formulation and development work for drugs that have been co-processed using the Prosolv technology. The company will be evaluating a number of generic drug candidates to determine potential performance and stability improvements using Prosolv, covering therapeutic areas including cardiovascular, anti-infectives, and anti-cancer therapies. JRS's Prosolv platform has already been applied in its Prosolv SMCC (silicified microcrystalline cellulose) product, a high functionality ingredient that has been approved for use in major pharmaceutical markets including Europe, the US, Japan, Mexico and Australia. After initially using the ingredient in herbal extracts such as ginseng and St John's wort, JRS found that it afforded some moisture protection to active ingredients. Further development has allowed the company to incorporate its technology into spray-drying procedures common in the pharma industry, which, when applied to certain APIs, results in enhanced moisture stability whilst maintaining dispersion and disintegration properties. "It's a very effective tool to disperse small particle sized actives through an excipient matrix,"​ vice president of R&D Alen Guy explained to in-PharmaTechnologist.com, while also highlighting the extremely high content uniformity achieved using the system. Prosolv SMCC is now formulated in hundreds of products worldwide, and requires less complex processing with high inherent functionality which JRS says is imparted to the drug formula. In this way, co-processing with Prosolv SMCC has brought significant benefits to working with 'difficult' APIs, and the JRS-CoreRX collaboration hopes to be able to being the same benefits to other problematic but important drugs. "API co-processing allows manufacturers the opportunity to formulate active ingredients possessing excipient-like tableting properties; more compressible, more freely flowing, and offering the best possible content uniformity,"​ said Stephen Bert, senior vice president of JRS. "We are not creating complexity, we are simplifying formulation development and manufacturing processes." ​ The long-term agreement between JRS and CoreRX will apply the Prosolv technology to a number of targets, initially focusing on Prosolv SMCC but with eight or nine other active ingredients on the list. This is a significant move for JRS, well-known as a market-leader in excipients but sailing into new territory with the CoreRX collaboration. However, combining JRS' excipient expertise with CoreRX' formulation and analytical skills could lead to a winning combination. "There are a number of problematic actives out there,"​ said Guy. "We are hoping to open the door to new and improved dosage forms with enhanced stability that can offer opportunities for life-cycle management for potential future partners." ​ Work on the first active ingredient on the companies' list will begin by the end of this month, with the first proof of principle study scheduled to be complete during the fourth quarter 2007.