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.
New Delhi: Alchem International Private Limited (“Alchem”), a privately held pharmaceutical company focusing on the production of plant-derived active pharmaceutical ingredients (API); recently 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; 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”.
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).
The state-of-the-art production site in Ballabgarh, India has been audited and approved by ANSM (French ministry of health) on behalf of EDQM.
Expanding on the company’s long-term production commitment and the challenge faced to overcome the stability issues, Raman Mehta provided more detail, “Alchem has been involved in the production and supply of digoxin for the past 20 years. We have invested heavily in manufacturing capabilities and a robust supply chain to ensure supply security for our customers, and we habitually hold safety stock to meet at least five year’s demand.”
“The challenge we faced was to add a stable micronized digoxin molecule to our product portfolio that met the strict EDQM regulatory requirements on micronized APIs and was not cost prohibitive to manufacture. We had undertaken various experiments in the past with post-production micronizing but rejected this approach as this practice is no longer accepted by EDQM and produced an unstable molecule as well as a significant loss in manufacturing yields,” Mehta added.
“The novel process developed by our R&D team overcomes these barriers and achieves the optimum particle sized distribution (PSD) as part of the normal production method. 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. As a result, our customers can achieve better tablet homogeneity and enhanced dissolution and bioavailability at close to the same cost as standard (non-micronized) digoxin,” he further added.