Alchem International solves stability dilemma for micronized Digoxin
prnewswire | April 15, 2019
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; our stability batches show Alchem manufactured digoxin to be stable with no change in the impurity profile and other properties either in long term stability or accelerated stability tests providing a clear advantage for handling and formulation".