Intas Pharmaceuticals has filed a patent for stable extended release formulations and pharmaceutical compositions of Clozapine. The patent claims a composition with low impurities and a specific assay range of Clozapine after storage under specified conditions. The composition includes Clozapine with a small particle size for improved solubility. GlobalData’s report on Intas Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
Smarter leaders trust GlobalData
According to GlobalData’s company profile on Intas Pharmaceuticals, cancer treatment biomarkers was a key innovation area identified from patents. Intas Pharmaceuticals's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230181595A1) describes a stable extended release pharmaceutical composition of Clozapine, a medication used to treat schizophrenia. The composition includes one or more pharmaceutically acceptable excipients and has specific requirements for impurity levels and assay quantity.
According to claim 1, the total impurities in the pharmaceutical composition must not exceed 2% w/w of Clozapine. Additionally, the assay of the quantity of Clozapine in the composition should be between 95% and 105% after storage at 40±2° C. and 75±5% relative humidity (RH) for 6 months. The composition must also contain Clozapine with an effective particle size (D90) of less than about 10 microns, ensuring a solubility of at least 20 mg/ml in 0.1N hydrochloric acid.
Claim 2 further specifies that the individual impurity level in the composition should not exceed 0.2% w/w of Clozapine after the same storage conditions mentioned in claim 1.
Claim 3 introduces a different storage condition, stating that the assay of the quantity of Clozapine in the composition should be between 95% and 105% after storage at 25±2° C. and 60±5% RH for 6 months. The other requirements for impurity levels and particle size remain the same as in claim 1.
Claim 4, similar to claim 2, states that the individual impurity level in the composition should not exceed 0.2% w/w of Clozapine after the storage conditions mentioned in claim 3.
Claim 5 focuses on the dissolution profile of the composition. It specifies that the composition should have a dissolution profile where not more than 30% of the weight of Clozapine is dissolved in 30 minutes, between 40% and 70% is dissolved in 2 hours, and more than 80% is dissolved in 10 hours. The dissolution profile is measured using a specific apparatus and conditions.
Claims 7 and 8 describe the composition in different forms, either as multiparticulates or compressed into tablets or capsules for oral administration.
Claims 9 and 10 mirror claims 5 and 7, respectively, but with the storage conditions mentioned in claim 3.
Overall, this patent application describes a stable extended release pharmaceutical composition of Clozapine with specific requirements for impurity levels, assay quantity, particle size, and dissolution profile. The composition can be in the form of multiparticulates or compressed into tablets or capsules for oral administration.
To know more about GlobalData’s detailed insights on Intas Pharmaceuticals, buy the report here.
Data Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
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
