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Alchem International Solves Stability Dilemma for Micronized Digoxin and Files Patent for Novel Production Process
GENEVA, April 24, 2019 /PRNewswire/ -- Alchem International Private Limited ("Alchem"), a privately held pharmaceutical company focusing on the production of plant-derived active pharmaceutical ingredients (API); today announced the launch of its proprietary micronized digoxin platform.
Alchem's molecule is the sole micronized digoxin available globally that resolves the challenge of micro dosage formulation and the long-term stability and impurity issues with this specialist heart drug. Digoxin is commonly administered to treat various heart conditions including atrial fibrillation, atrial flutter, and heart failure. Micronization of digoxin, normally made for formulation homogeneity, dissolution and bioavailability, had previously led to an impractical and short shelf life (12 to 24 months) and the formation of impurities.
Speaking from Alchem's European offices in Geneva (Switzerland) Raman Mehta, Alchem CEO and President, commented, "Our process innovations mean that, for the first time since Boehringer Ingelheim announced in 2014 an end to production and supply of micronized digoxin to the market, drugmakers can be sure of supply and sure of the stability of this niche but important API." Raman Mehta continued, "Our customers are now able to formulate digoxin at the optimum particle size distribution (PSD) with a molecule that is stable for transport, stable for one-year storage at ambient temperatures (15 – 25 degrees Celsius) and stable for 4 years under cold storage (3 – 8 degrees Celsius). We fully expect the shelf life to be extended to 5 years in 2020 based on ongoing studies.
Alchem micronized digoxin EP, which has been developed by the company's R&D team using an inventive processing technique (patent filed), meets the strict EP monograph and is covered by European Certificate of Suitability (COS) issued by the European Directorate for the Quality of Medicines (EDQM). This inventive production technique has enabled us to match the PSD of the originator product Lanoxin at near the same production costs as our standard (non-micronized) digoxin. The state-of-the-art production site in Ballabhgarh, India has been audited and approved by ANSM (French Ministry of Health) for digoxin manufacturing on behalf of EDQM.
About Alchem International
Alchem International is a privately-owned company, founded in 1983. A pioneer in phytochemicals, it has nearly 40 years' experience in supplying plant-derived active ingredients to the pharmaceutical, nutraceutical and cosmetics industries worldwide.
Sales and Marketing Director - Alchem Europe SA