Abstract: The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.

Abstract: Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.

Abstract: The present invention relates to stable pharmaceutical compositions comprising apixaban or its pharmaceutically acceptable salts thereof. The present invention further relates to a capsule composition comprising a therapeutically effective amount of apixaban solubilized or dispersed in a pharmaceutically acceptable carrier, wherein the therapeutically effective amount of apixaban ranges from about 0.5 mg/unit dosage form to about 50 mg/unit dosage form. The present invention also provides manufacturing processes thereof and use of the said compositions for prevention, treatment or prophylaxis of disorders in human patients in need thereof.

Abstract: Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.

Abstract: Stable injectable compositions comprising glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof are disclosed. Preferably, the composition is provided in a sealed container, e.g., an ampoule, a vial, a pre-filled syringe or an auto-injector. Further, stable injectable solutions are disclosed, which comprise glucagon or a pharmaceutically acceptable salt, solvate, or hydrate thereof, and which are suitable for subcutaneous, intravenous or intramuscular administration. Methods for manufacturing stable injectable solutions of glucagon are also disclosed.

Abstract: Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, and which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine, or pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.

Abstract: The present invention relates to stable oral pharmaceutical compositions in the form of a solution comprising: hydroxyurea at a concentration of about 10 mg/mL to about 500 mg/mL; at least one pharmaceutically acceptable liquid vehicle; and one or more amino acids selected from the group consisting of glycine, alanine, glutamic acid, L-arginine, lysine, L-cysteine, methionine and mixtures thereof, wherein the level of carbamoyloxyurea in the solution is less than 0.5 % w/w as measured by HPLC when the solution is stored at 25° C./60% RH for at least 3 months. The invention further relates to processes for the production of the compositions, methods for their administration, and their use for treatment of diseases treatable by hydroxyurea.

Abstract: Stable, injectable pharmaceutical compositions are provided, which are useful as ready-to-dilute (RTD) or ready-to-use (RTU) liquid injectable compositions comprising bendamustine or a pharmaceutically acceptable salt thereof, which are suitable for intravenous administration. Preferably, solution formulations comprise (a) bendamustine or its pharmaceutically acceptable salts, solvates, or hydrates thereof, (b) at least one pharmaceutically acceptable non-aqueous solvent; (c) optionally, at least one pharmaceutically acceptable excipient, and (d) optionally, a pH adjuster, where the pharmaceutical composition is antioxidant-free, and formulated as a ready-to-dilute or ready-to-use liquid composition suitable for parenteral administration. The invention further relates to methods for manufacturing stable, antioxidant-free injectable solutions of bendamustine.

Abstract: The present invention relates to liquid pharmaceutical compositions of clonidine or its pharmaceutically acceptable salts thereof. Preferably, the liquid pharmaceutical compositions are suitable for oral administration, and are stable for extended periods of time. More specifically, stable liquid pharmaceutical compositions of clonidine at concentrations of 1 µg/mL or more are provided. The present invention further relates to stable oral liquid compositions of clonidine, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by clonidine.

Abstract: The present invention relates to stable liquid oral compositions of cyclophosphamide having extended stability, methods for their administration, processes for their production, and use of these compositions for treatment of diseases treatable by cyclophosphamide. The invention also relates to a kit comprising stable liquid oral compositions of cyclophosphamide.

Abstract: The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.

Abstract: Various implementations described herein are directed to a system and methods for validating data points associated with an integrated circuit. In one implementation, the method may include retrieving data table associated with an integrated circuit, wherein the data table includes characterized electrical data associated with one or more cells of the integrated circuit. Further, the method may include converting the data table to one or more relative matrices. The one or more relative matrices are analyzed to determine a trend formed by entries of the one or more relative matrices. Further, the method may include determining whether one or more entries of the one or more relative matrices deviate from the trend. In response to the determination, the data table is flagged.

Abstract: Various implementations described herein are directed to a system and methods for implementing a critical path architect. In one implementation, the critical path architect may be implemented with a system having a processor and memory including instructions stored thereon that, when executed by the processor, cause the processor to analyze timing data of an integrated circuit. The timing data may include transition times for cells along paths of the integrated circuit. The instructions may cause the processor to identify instances of timing degradation for the cells along the paths of the integrated circuit. The instructions may cause the processor to recommend changes for the instances of the cells along the paths having timing degradation.

Abstract: Various implementations described herein are directed to a system and methods for validating data points associated with an integrated circuit. In one implementation, the method may include retrieving data table associated with an integrated circuit, wherein the data table includes characterized electrical data associated with one or more cells of the integrated circuit. Further, the method may include converting the data table to one or more relative matrices. The one or more relative matrices are analyzed to determine a trend formed by entries of the one or more relative matrices. Further, the method may include determining whether one or more entries of the one or more relative matrices deviate from the trend. In response to the determination, the data table is flagged.

Abstract: The present invention relates to novel impurities of cyclophosphamide having structure V, VI or VII, stabilized form of these novel impurities, a process of preparing a stabilized form and isolating thereof. The invention also relates cyclophosphamide formulations which include cyclophosphamide, at least one pharmaceutically acceptable excipient, and a certain level of these impurities having structure V, VI or VII. The invention further relate to method of using such stable liquid formulations of cyclophosphamide for parenteral administration in treating various cancer disorders.

Abstract: Various implementations described herein are directed to a system and methods for implementing a critical path architect. In one implementation, the critical path architect may be implemented with a system having a processor and memory including instructions stored thereon that, when executed by the processor, cause the processor to analyze timing data of an integrated circuit. The timing data may include transition times for cells along paths of the integrated circuit. The instructions may cause the processor to identify instances of timing degradation for the cells along the paths of the integrated circuit. The instructions may cause the processor to recommend changes for the instances of the cells along the paths having timing degradation.

Abstract: Various implementations described herein are directed to a system and methods for implementing a critical path architect. In one implementation, the critical path architect may be implemented with a system having a processor and memory including instructions stored thereon that, when executed by the processor, cause the processor to analyze timing data of an integrated circuit. The timing data may include transition times for cells along paths of the integrated circuit. The instructions may cause the processor to identify instances of timing degradation for the cells along the paths of the integrated circuit. The instructions may cause the processor to recommend changes for the instances of the cells along the paths having timing degradation.

Abstract: Various implementations described herein are directed to a system and methods for implementing a critical path architect. In one implementation, the critical path architect may be implemented with a system having a processor and memory including instructions stored thereon that, when executed by the processor, cause the processor to analyze timing data of an integrated circuit. The timing data may include transition times for cells along paths of the integrated circuit. The instructions may cause the processor to identify instances of timing degradation for the cells along the paths of the integrated circuit. The instructions may cause the processor to recommend changes for the instances of the cells along the paths having timing degradation.

Abstract: A synchronizer flip-flop is provided, which is able to better respond to input values that are not provided for the necessary setup or hold times. The flip-flop includes a latch that includes inverter circuitry for producing a first signal and a signal in dependence on a value of an input signal at a node. A clocked inverter includes a first switch that is connected between a first reference voltage supply and an intermediate node and a second switch, which is connected between the intermediate node and a second reference voltage supply. The first switch is controlled by the first signal and the second switch is controlled by the second signal to produce an output signal at the intermediate node.

Abstract: A synchroniser flip-flop is provided, which is able to better respond to input values that are not provided for the necessary setup or hold times. The flip-flop includes a latch that includes inverter circuitry for producing a first signal and a signal in dependence on a value of an input signal at a node. A clocked inverter includes a first switch that is connected between a first reference voltage supply and an intermediate node and a second switch, which is connected between the intermediate node and a second reference voltage supply. The first switch is controlled by the first signal and the second switch is controlled by the second signal to produce an output signal at the intermediate node.