Macsen Drugs granted a patent from Indian Patent office for Novel Fluorescein Sodium Synthesis Process

The Indian patent office has granted a patent to Macsen Drugs, a unit of Macsen Labs group. The patent relating to the field of chemistry is titled “Process for the preparation of crystalline fluorescein Sodium from diacetylfluorescein or Fluorescein”. The patent concerns a novel process for synthesizing the compound Fluorescein Sodium.

Fluorescein sodium is the sodium salt of fluorescein and a synthetic organic fluorescent dye. It comes in a dark orange/red powder that is water and alcohol soluble. It is used extensively as a diagnostic tool (through fluorescein angiography) in the field of ophthalmology, vascular neurosurgery, retinal disease macular degeneration, diabetic retinopathy, inflammatory intraocular conditions, and intraocular tumours. During open-heart surgery, a diluted form of Fluorescein Sodium is used to localise multiple ventricular septal defects. It is also used as a biomarker.

As fluorescein sodium is used in injectables and sterile ophthalmic solutions, it should be of high purity and meet all the pharmacopeial requirements. But it is very difficult to achieve the abovesaid as Fluorescein Sodium has a strong affinity for water (hygroscopic) and it immediately binds water molecules during synthesis, purification or handling. The addition of water decreases the potency of fluorescein sodium and it becomes lumpy/tarry and changes its colour. It may also expire and therefore disobey the specifications mentioned in Pharmacopoeia norms.

Thus, the research and development team of Macsen Labs has invented a novel process of making fluorescein sodium in which the resultant product is almost free of water, is of high purity and has a free-flowing bright orangish colour/ appearance. The inventive process which has been patented yields a high purity compound in minimal steps with 99.50% purity or above and meets the Global Pharmacopoeia quality requirements established by compendiums such as United States Pharmacopoeia and European Pharmacopoeia (Ph. Eur.).

Macsen Laboratories was started as a household unit on a rooftop in the old quarters of the historic walled city of Udaipur, by Dr. Mohanlal Agrawal, Mr.Puranmal Agrawal & Mr. Chandra Sen Agrawal in 1952. It is engaged in the manufacturing of niche active pharmaceutical ingredients, pharmaceutical application dyes, compounds of precious and rare earth metals, and other speciality inorganic compounds. Currently, Macsen Labs group is headquartered in Udaipur (Rajasthan, India), and has various manufacturing units in and around Udaipur.

Mr. Achal Agrawal is the current CEO of Macsen Group. He is the fourth-generation entrepreneur of the family-owned Macsen Labs Group and has been leading the organization since 2008. He has studied Chemical Engineering at Pune University, and he holds a keen interest in practical science, research, robotics, and aviation. Under his leadership, Macsen Labs which was a single manufacturing unit has become a group of industries, and the group’s turnover has increased substantially.

Macsen Labs is a manufacturer and supplier of several grades of Fluorescein Sodium such as:-

Resources on Fluorescein Sodium:-

Fluorescein Sodium | The Sodium Salt of Fluorescein

Various uses of Fluorescein Sodium | Medical & Scientific

Fluorescein Sodium Injection for Ophthalmology | Usage, Dosage, Brands & SIde effects

Everything you need to know about Fluorescein Sodium Ophthalmic Strips

Common & Rare Side Effects of Fluorescein Sodium & Precautions to be taken