Intas Pharmaceuticals has been granted a patent for an extended release pharmaceutical composition of Clozapine. The composition, provided as a reservoir type dosage form, achieves bioequivalence criteria compared to immediate release Clozapine when dosed once daily. It aims to improve patient compliance and reduce side effects, while also lacking any significant food effect on oral administration. The composition includes specific polymers and coatings to achieve the desired extended release properties. GlobalData’s report on Intas Pharmaceuticals 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 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 granted patent (Publication Number: US11648207B1) describes an extended-release oral pharmaceutical composition of Clozapine, a medication used to treat schizophrenia. The composition is designed to achieve bioequivalence with immediate-release Clozapine dosed twice per day.
The composition consists of granules, pellets, beads, or spheroids containing Clozapine and other excipients. It includes multiple layers, including a first seal coat layer with a hydrophilic polymer, an acidic coating with an acidic substance, a second seal coat layer with a hydrophilic polymer, an extended-release coating with a water-insoluble polymer and a water-soluble polymer, and a third seal coat layer with a hydrophilic polymer.
The amounts of each layer in the composition are specified, with the seal coating ranging from 2-20%, the acidic coating from 20-40%, and the extended-release coating from 2-20%. The hydrophilic polymer can be selected from various options such as hydroxypropyl methylcellulose, HPMC, Hypromellose, and others. The water-insoluble polymer can be Chitosan, polyurethanes, ethyl cellulose, cellulose acetate, or waxes, while the water-soluble polymer can be hydroxypropyl methylcellulose, HPMC, Hypromellose, and others.
The patent claims that when the extended-release composition is dosed once daily to a patient, it achieves steady-state plasma concentrations of Clozapine that fall within the 80 to 125% bioequivalence criteria compared to immediate-release Clozapine dosed twice per day at the same total daily dose. The patent specifies various parameters for bioequivalence, including the area under the time/plasma concentration curve (AUC0-24h), the maximum drug concentration in plasma (Cmax), and the minimum drug concentration in plasma (Cmin).
The patent also mentions that the composition, which contains 200 mg of Clozapine, provides a minimum drug concentration in plasma at steady state (Cmin) ranging from 20 ng/ml to 1070 ng/ml, a maximum drug concentration in plasma at steady state (Cmax) ranging from 130 ng/ml to 2280 ng/ml, and an AUC0-24h ranging from 2130 ng/ml to 35630 ng/ml. Additionally, it states that the composition provides an average minimum drug concentration in plasma at steady state (Cmin-avg) from about 150 ng/ml to 400 ng/ml, an average maximum drug concentration in plasma at steady state (Cmax-avg) from about 550 ng/ml to 750 ng/ml, and an average AUC0-24h (AUC0-24h,avg) from about 8000 to 12000 ng·h/ml.
The patent also mentions that the pharmaceutical composition can be dispensed or compressed into tablets or mini-tablets or filled into capsules for oral administration.
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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
