Cipla. has filed a patent for a stable ready-to-use extended release injectable pharmaceutical formulation containing Aripiprazole. The formulation is designed for the treatment of schizophrenia and related disorders. The patent also includes a method for preparing the formulation. The formulation must meet specific criteria, including containing no more than 1.0% total impurity when stored for 6 months in a sealed, sterile container at 60% relative humidity and a temperature of 25°C. GlobalData’s report on Cipla 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 Cipla, Peptide pharmacophores was a key innovation area identified from patents. Cipla's grant share as of September 2023 was 38%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230310417A1) describes a stable ready-to-use extended release formulation of aripiprazole, a medication used to treat schizophrenia. The formulation consists of aripiprazole or its pharmaceutically acceptable salt, along with various excipients. The patent claims that this formulation remains stable when stored for 6 months in a sealed, sterile container at 60% relative humidity and a temperature of 25°C, with no more than 1.0% total impurity as measured by HPLC.
The formulation includes aripiprazole monohydrate as the pharmaceutically acceptable salt, with a concentration of about 200 mg/mL of the total formulation. The particle size of the aripiprazole monohydrate ranges from about 10 µm to about 100 µm. The formulation is in the form of a suspension and contains suspending agents, surfactants, a buffer system, and an aqueous vehicle as the pharmaceutically acceptable excipients.
The suspending agents used in the formulation include alginates, colloidal silicon dioxide, agar, calcium stearate, magnesium aluminum silicate, guar gum, acacia, tragacanth, xanthan gum, bentonite, carbomer, carrageenan, gelatin, polyethylene glycol, povidone, dextrin, medium-chain triglycerides, sucrose, chitosan, polyoxyethylene, polyoxypropylene ethers, and combinations thereof. The concentration of the suspending agent ranges from about 10 mg/mL to about 100 mg/mL of the total formulation.
The surfactants used in the formulation include polysorbate 80, polysorbate 20, sorbitan ester, polyoxyethylene hydrogenated castor oil, and poloxamer 188. The concentration of the surfactant ranges from about 0.1 mg/mL to about 30 mg/mL of the total formulation.
The buffer system consists of sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, citric acid, sodium hydroxide, hydrochloric acid, or combinations thereof. The pH of the formulation ranges from 3.0 to 9.0, with a preferred range of 3.0 to 7.0.
The vehicle used in the formulation is water for injection. The formulation provides extended release of aripiprazole or its pharmaceutically acceptable salt over at least a 28-day period.
The patent also describes a method of treating schizophrenia by administering the ready-to-use formulation directly to the patient. Additionally, a process for the preparation of the stable pharmaceutical preparation is outlined, involving the dissolution of suspending agents, surfactants, and buffer in a solvent, followed by the dissolution of aripiprazole or its pharmaceutically acceptable salts to obtain a suspension. The pH of the composition is adjusted, and the suspension is filled into suitable containers/closures to obtain a ready-to-use preparation. Optional sparging with inert gas can be performed during the preparation process.
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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
