Aurobindo Pharma has patented a binder-free stable pharmaceutical composition containing amorphous canagliflozin, ensuring chemical and polymorphic stability. The composition, devoid of canagliflozin hemihydrate, exhibits comparable dissolution and bioavailability to INVOKANA® tablets, lasting at least 6 months in harsh conditions. GlobalData’s report on Aurobindo Pharma gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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According to GlobalData’s company profile on Aurobindo Pharma, Nanoparticle drug conjugates was a key innovation area identified from patents. Aurobindo Pharma's grant share as of February 2024 was 89%. Grant share is based on the ratio of number of grants to total number of patents.

Stable pharmaceutical composition of amorphous canagliflozin

Source: United States Patent and Trademark Office (USPTO). Credit: Aurobindo Pharma Ltd

A recently granted patent (Publication Number: US11857559B2) discloses a stable pharmaceutical composition comprising amorphous canagliflozin, lactose, microcrystalline cellulose, polysorbate 80, croscarmellose sodium, and magnesium stearate. This composition, prepared using a fluidized bed processor with two granulating fluids, is free of canagliflozin hemihydrate and remains stable for a minimum of 6 months at 40°C/75% RH. Importantly, it demonstrates comparable bioavailability to commercially available canagliflozin hemihydrate tablets.

The composition, as outlined in the patent claims, consists of specific weight percentages of each ingredient, with amorphous canagliflozin ranging from 30-50% w/w, lactose and microcrystalline cellulose at 30-50% w/w, croscarmellose sodium at 10-20% w/w, polysorbate 80 at 1-3% w/w, and magnesium stearate at 0.5-2% w/w. Additionally, the use of granulating fluids, specifically a solution of polysorbate 80 in water and lactose in water, is highlighted in the patent for the preparation of this stable pharmaceutical composition. Furthermore, the option to coat the composition with a coating agent is also mentioned in the claims, potentially offering additional benefits in terms of stability and drug release profiles.

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GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies