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Macsen Labs group’s Methylene Blue Synthesis Process granted a patent from Indian patent office


Delhi: The Indian patent office granted a patent to Mr. Achal Agrawal, a researcher and a pharma entrepreneur. The patent relating to the field of chemistry is titled “Novel Improved Method for Synthesis of Diaminophenothiazine Compounds”. The patent concerns a novel process for synthesizing the compound “Methylthioninium Chloride” or “Methylene Blue”.

Methylene Blue is the first phenothiazine compound that was developed more than 140 years ago. It has a plethora of medicinal applications that have been under research since. The compound is already approved for treating a blood disorder called methemoglobinemia. Methylene Blue is currently under clinical trial for its experimental use in the treatment of Alzheimer’s disease. In 2008, a Phase II clinical trial concluded that a purified form of methylene blue slowed cognitive decline in people with mild to moderate Alzheimer’s disease. Antimalarial use of the drug has recently been revived. It is also being studied as a photosensitizer for non-invasive photodynamic therapy of cancers.

“I have been successfully using nebulized methylene blue for over a decade to treat lung infections and fibrosis for my patients. During the first and the second wave of COVID-19, I extensively used methylene blue based on my past experience. In low dosage, methylene blue works against COVID-19 as a prophylactic as well as a treatment for mild to moderate COVID patients when administered sublingually & through nebulization.” Says Dr. Deepak Golwalkar, Veteran Pulmonologist.

“Methylene Blue being such an old compound having a history of more than a hundred years is hardly available in required pharmaceutical grade and purity. Even in developed countries like the United States, there is only a single source of this life-saving medicine. It is really difficult to synthesize methylene blue in high purity because of the degradants formed during the oxidation process. Looking at a large number of upcoming pharmaceutical applications of this compound, the new short process for yielding a high purity compound will be really beneficial for our industry.”, says Mr. Achal Agrawal, CEO of Macsen Labs, and inventor of the patented process.

The inventive process which has been patented yields a high purity compound in minimal steps and has eliminated lengthy purification procedures. Also, the process employs water-based chemistry that excludes the use of harmful chemical solvents, thus further eliminating the probability of occurrence of known or unknown impurities. The methylene blue compound that is obtained from Mr. Agrawal’s inventive process is of 99% purity and meets the Global Pharmacopoeia quality requirements established by compendiums such as United States Pharmacopoeia and European Pharmacopoeia (Ph. Eur.).

During the second wave of COVID-19, Macsen group also applied for emergency use of this drug with the CDSCO, but the emergency use was not granted without conducting clinical trials. Methylene Blue is not yet approved for any other disease apart from Methemoglobinemia, and it is a prescription drug that should not be consumed without advice from a medical professional.

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