13 results about "Rivaroxaban" patented technology

The invention belongs to the technical field of medicine, and particularly discloses a rivaroxaban tablet and a preparation method and application thereof, the rivaroxaban tablet is composed of rivaroxaban and a ternary composite carrier; the ternary composite carrier is composed of vitamin E polyethylene glycol succinate, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol grafted copolymer and a crystal inhibitor; wherein the mass ratio of the rivaroxaban to the ternary composite carrier is 1: (3-7); the mass ratio of the vitamin E polyethylene glycol succinate to the polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol grafted copolymer to the crystal inhibitor in the ternary composite carrier is 1: 2: 3. According to the rivaroxaban tablet and the preparation method and application thereof, the preparation method is simple in process, good in production continuity, high in mechanization degree and suitable for industrial production, the rivaroxaban tablet prepared through the preparation method is high in dissolution rate, and the bioavailability of the rivaroxaban tablet is remarkably improved compared with that of a preparation on the market.

The application discloses a rivaroxaban concentration determination method based on anti-Xa factor activity, a determination reagent and a preparation method thereof, and relates to the technical field of biology, and comprises reagent R1, reagent R2 and a sample diluent.The reagent R1 comprises Xa factor, a buffer, a stabilizer and inorganic salt.The reagent R2 comprises a chromogenic substrate, a buffer, polyethylene glycol and inorganic salt.The sample diluent comprises a buffer, a stabilizer and inorganic salt and is used for diluting samples with a concentration higher than a preset threshold value.The application remarkably reduces the cost by adopting an optimized formula of bovine factor and domestic raw materials, ensures the detection accuracy of high-concentration samples, and has excellent sensitivity, specificity and stability, realizes a detection performance highly related to a gold standard method, and thus successfully overcomes the technical bottlenecks of high detection cost, limited linear range, inaccurate detection of high-value samples and lack of high-quality domestic reagents in the prior art.

This document discloses rivaroxaban tablets for oral suspension formulation for oral administration. Also disclosed is a method for preparing rivaroxaban tablets for oral suspension and a method of treating diseases.

Provided are an oral dissolving film composition of rivaroxaban, a method for preparing same, and use thereof. The oral dissolving film composition comprises one or more of rivaroxaban and a pharmaceutically acceptable salt, hydrate, and solvate thereof as an active ingredient, and a film-forming material. Also, the present invention features a simple process, no sedimentation during the preparation of film solutions, qualified content uniformity, high drug loading capacity, and improved patient compliance, and is particularly suitable for patients with dysphagia.

This invention provides an orally soluble film composition for rivaroxaban, its preparation method, and its applications. The rivaroxaban orally soluble film composition comprises an active pharmaceutical ingredient and a film-forming material; the active pharmaceutical ingredient is one or more of the following: 5-chloro-nitro-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholino)phenyl]-1,3-azolidin-5-yl}methyl)-2-thiophene-carboxamide, a pharmaceutically acceptable salt, hydrate, and solvate thereof, as shown in Formula I. The rivaroxaban orally soluble film composition provided by this invention has the advantages of good taste, stable properties, high dissolution, and immediate dissolution in the oral cavity without the need for drinking water, without a gritty feeling after dissolution in the oral cavity, and rapid oral absorption. Furthermore, the process of this invention is simple, no sedimentation occurs during the preparation of the film solution, the content uniformity meets requirements, the drug loading is high, and clinical patient compliance is improved, making it particularly suitable for patients with swallowing difficulties, and it has good market prospects.

Disclosed herein relates to an oral liquid formulation of rivaroxaban. The present invention is specifically related to an oral liquid suspension of rivaroxaban comprising therapeutically effective amount of rivaroxaban, a salt or prodrug thereof; one or more viscosifying agents; one or more buffering agents; at least one wetting agent; at least one vehicle, and one or more pharmaceutically acceptable excipients. Also disclosed herein relates to process of preparation of an oral liquid formulation of rivaroxaban and a method of using the same.

The application belongs to the technical field of pharmaceutical preparations, and particularly relates to a rivaroxaban tablet, a preparation method and use. The rivaroxaban tablet comprises a rivaroxaban inclusion compound, lactose, starch, low-substitution hydroxypropyl cellulose and magnesium stearate. The rivaroxaban is packaged by using trimethylamine modified methyl cellulose as a packaging material, and the preparation process is optimized. The problem of low drug loading and low encapsulation efficiency of the rivaroxaban inclusion compound in the prior art is solved. The rivaroxaban tablet with a rivaroxaban inclusion compound with high drug loading and high encapsulation efficiency is provided, and the delivery efficiency of the rivaroxaban inclusion compound is improved. Through verification, the rivaroxaban tablet provided by the application has high dissolution rate, few impurities and stability.

This application discloses a method for detecting related substances in rivaroxaban tablets and its application, belonging to the field of pharmaceutical analysis technology. The method employs high-performance liquid chromatography (HPLC) with a column packed with octadecylsilane-bonded silica gel. The column is 150 mm long, 34.0 mm in inner diameter, and has a particle size of 23 μm. Mobile phase A is a 0.095%-0.105% phosphoric acid aqueous solution, and mobile phase B is acetonitrile. Gradient elution is used. The flow rate is 0.95-1.05 ml / min. The column temperature is 3337℃. The detection wavelength is 230-250 nm. The injection volume is 1020 μl. This method is highly specific, sensitive, and accurate, and can simultaneously detect known and unknown impurities, including LFSB1 to LFSB13, in rivaroxaban tablets, making it suitable for the quality control of this formulation.

The application discloses a model for predicting the risk of rivaroxaban anticoagulation bleeding and application thereof, and belongs to the technical field of biological detection. The model comprises a data input unit of two independent risk factors of a CYP3A4 genotype and clinical bleeding history of a subject, an assignment unit, an efficacy prediction unit and a report output unit, a C&B scoring system is formed according to the units, the total score is 3 points, if the C&B score is less than or equal to 1 point, rivaroxaban can be used as a coagulation factor X inhibitor for anticoagulant therapy, and if the C&B score is greater than or equal to 2 points, warfarin can be selected for anticoagulant therapy. The model can be used for guiding a clinician to accurately select a coagulation factor X inhibitor, the result of predicting the risk of rivaroxaban bleeding is accurate and reliable, and balance between anticoagulation benefits and bleeding risks can be achieved.

The present application relates to a kind of rivaroxaban tablets and its preparation method, the rivaroxaban tablet includes 5-15 parts rivaroxaban, 2-10 parts disintegrating agent, 0.1-1 part binder, 0.1-1 part surfactant, 55-80 parts filling agent and 0.2-1.2 parts lubricant by weight fraction.The rivaroxaban tablet used in the present application is greater than 85% at 15min under different pH and different medium conditions Cumulative dissolution, dissolution behavior is fast, batch stability.The preparation method is simple, and the content of the obtained tablet is uniform, the dissolution rate of the tablet is fast, the impurity has no obvious increasing trend, the content and dissolution degree are basically unchanged, and the preparation stability is good.

According to the present invention, by selecting an appropriate range of rivaroxaban particle size and hydrophilic polymer content, it is possible to provide a rivaroxaban composition having bioavailability independent of food while using microscale rivaroxaban particles.

This invention relates to a solid dispersion and its formulation, wherein the solid dispersion contains the active ingredient rivaroxaban and a carrier, and the solid dispersion exhibits good stability, rapid dissolution rate, and the ability to improve the solubility of the active ingredient. The carrier is defined as described in the specification.

This document discloses rivaroxaban tablets for oral suspension formulation for oral administration. Also disclosed is a method for preparing rivaroxaban tablets for oral suspension and a method of treating diseases.