Abstract: This disclosure is in the field of mini-softgel capsules, particularly softgel capsules containing naproxen salt as an active ingredient. It relates generally to softgel capsules containing high concentration formulations of naproxen sodium.

Abstract: A system and method for promoting and safeguarding the wellbeing of patients in relation to a fluid injection may obtain patient data; determine, based on the patient data, an initial risk prediction for a patient for a fluid injection to be administered to the patient, the initial risk prediction including a probability that the patient experiences at least one adverse event in response to the fluid injection; provide, to a user device, before the fluid injection is administered to the patient, the initial risk prediction; determine, after the fluid injection is started, sensor data associated with the patient; determine, based on the sensor data determined after the fluid injection is started, a current risk prediction including a probability that the patient experiences the at least one adverse event in response to the fluid injection; and provide, to the user device, the current risk prediction.

Abstract: This disclosure is in the field of mini-softgel capsules, particularly softgel capsules containing naproxen salt as an active ingredient. It relates generally to softgel capsules containing high concentration formulations of naproxen sodium.

Abstract: A fluid injector system has at least one reciprocally operable piston having a piston head, and a plunger engagement mechanism associated with the piston head. The plunger engagement mechanism has a cam sleeve disposed within the piston head and movable relative to the piston head, the cam sleeve having one or more tracks defining a cam surface. The plunger engagement mechanism further has an actuator operatively connected to the cam sleeve for moving the cam sleeve relative to the piston head, and one or more pins disposed within the cam sleeve. The one or more pins are movable within the one or more tracks with movement of the cam sleeve between a first or withdrawn position, wherein the one or more pins are radially withdrawn into the piston head and a second or extended position, wherein the one or more pins protrude radially outward relative to an outer surface of the piston head.

Abstract: A fluid control valve for use in a fluid delivery system for delivering fluid to a patient includes a valve body defining an internal chamber, a first inlet port for receiving a first inlet tube, a second inlet port for receiving a second inlet tube, an outlet port, and a sliding valve member slidably disposed in the internal chamber. The first inlet tube defines a first inlet lumen axially aligned with the internal chamber. The second inlet tube defines a second inlet lumen axially aligned with the internal chamber. The sliding valve member includes a first sealing end and second sealing end. The sliding valve member is positionable in a first operating state, a second operating state, and a third operating state based on a flow differential between the first inlet lumen and the second inlet lumen.

Abstract: A fluid injection system and a fluid verification system for confirming that a syringe, containing a fluid for injection, is fully filled with fluid and neither has free space (i.e., air) near the distal end thereof when the syringe is provided in an upright position nor contains air bubbles. Imaging processing techniques and systems are also provided to determine various injection parameters and to verify the type and certain properties of fluid that is present within a syringe.

Abstract: The present disclosure relates generally to bilayer tablets comprising a combination of two active pharmaceutical ingredients, and more specifically to bilayer tablets comprising acetylsalicylic acid, pseudoephedrine, and a dissolution aid. The bilayer tablets utilize a combination of granulated and non-granulated acetylsalicylic acid along with a unique distribution of sodium carbonate as a dissolution aid that provide acetylsalicylic acid and pseudoephedrine in a single dosage form having rapid dissolution and long-term storage stability (low degradation). The present disclosure also provides methods of preparing and of using the bilayer tablets.

Abstract: An apparatus (300) for suspending air bubbles in a fluid path of a fluid injector system includes an internal chamber (320) having a curved interior wall (322) defined within the housing (310), an inlet fluid pathway in fluid communication with the internal chamber, and an outlet fluid pathway in fluid communication with the internal chamber. The inlet fluid pathway extending into the chamber at a tangent to the curved interior wall, and the outlet fluid pathway spaced from the inlet fluid pathway such that fluid flowing into the internal chamber via the inlet fluid pathway is directed away from the outlet fluid pathway. The internal chamber is configured to create an internal fluid vortex in an injection fluid entering the internal chamber from the inlet fluid pathway, and wherein the internal fluid vortex at least temporarily suspends air bubbles in the fluid in the internal vortex and delays the passage of the air bubbles to the outlet fluid pathway.

Abstract: A cap for intake and delivery of a fluid from a syringe is described. The cap includes an outer cap assembly comprising a fluid inlet path and a fluid outlet path and an inner cap assembly configured for insertion into a fluid nozzle of the syringe and to provide selective fluid communication between an interior of a syringe and the fluid inlet path or the fluid outlet path. The outer cap assembly is slidable relative to the inner cap assembly between a first filling position, where the interior of the syringe is in fluid communication with the fluid inlet path, and a second delivery position, where the interior of the syringe is in fluid communication with the fluid outlet path. Syringes including the cap are also described.

Abstract: A fluid injector system for delivering a multi-phase fluid injection to a patient and methods of fluid delivery is disclosed. Methods of creating and using a multi-aspect fluid path impedance model of the injector system are used. Modeling and adjustment of factors that affect impedance and prevent or reduce backflow, reduce the likelihood of fluid flow rate spikes and provide more accurate flow rates and mixing ratios of fluids may be repeated or happen essentially continuously during an injection. The adjustments may be determined before the injection or determined and/or adjusted during the injection. The determination may include sensor feedback commonly used in injectors such as pressure and position feedback as well as other sensors. In all cases, the user can be notified of adjustments through on-screen notices and/or through the recordation of the injection data by a control device of the injector at the conclusion of the injection.

Abstract: The present disclosure provides improved methods for calibrating the zero position of at least one drive member of an injector system is disclosed. Automated methods of position calibration of the drive member of a fluid injector are disclosed. These methods address sources of error in positional accuracy and fluid delivery inaccuracies, such as disposable syringe tolerance and injector wear over time. According to other embodiments of the present disclosure, methods and fluid injector systems for determining and correcting for the amount of slack in a fluid injection apparatus are described. An understanding of the calibration and the amount of slack in a fluid injection system allows a processor to correct for the slack, thereby ensuring more accurate fluid delivery to the patient and more accurate imaging processes.

Abstract: A method for dynamic pressure control during a multiphase injection is described wherein the pressures of fluids in the various reservoirs of a fluid delivery system are controlled to provide desired fluid delivery parameters. The methods include advancing the first drive member to expel the first fluid from the first reservoir into a conduit, wherein the fluid is pressurized to a first fluid pressure; measuring the first fluid pressure to provide a target value; while the second reservoir is in fluid isolation from the conduit, advancing or retracting the second drive member to increase or decrease the fluid pressure of the second fluid in the second reservoir to the target value; placing the second reservoir in fluid communication with the conduit; and advancing the second drive member to expel the second fluid from the second reservoir into the conduit.

Abstract: Provided are topical analgesic gel compositions having relatively high payloads of menthol and camphor by micro-emulsion technology and methods of preparing topical analgesic gel compositions having relatively high payloads of menthol and camphor. Topical analgesic gel compositions may include from 12 to 16 wt. % menthol; from 4 to 8 wt. % camphor; from 0.1 to 2 wt. % carbomer; and 60 to 70 wt. % solvent. Topical analgesic gel compositions can have a viscosity from 60,000 to 110,000 centipoise.

Abstract: Provided herein, in some embodiments, are materials and methods for treating hemophilia A in a subject ex vivo or in vivo. Also provided herein, in some embodiments, are materials and methods for knocking in a coding sequence encoding a synthetic FVIII having a B domain substitute into a genome.

Abstract: Provided is an apparatus, system, and method for a nested syringe assembly. The nested syringe assembly includes a first syringe having a cylindrical body defining an inner diameter and a second syringe having a cylindrical body defining an outer diameter. The outer diameter of the second syringe is less than the inner diameter of the first syringe. At least a portion of the cylindrical body of the second syringe is disposed within the cylindrical body of the first syringe.

Abstract: A syringe including a syringe body extending from a proximal end to a distal end, and a stabilizing element provided on the distal end of the syringe body, a portion of the stabilizing element extending substantially perpendicular to a longitudinal axis of the syringe body. A multi-use disposable set (MUDS) includes a plurality of syringes, each syringe having a syringe body, a proximal end, a distal end spaced apart from the proximal end along a longitudinal axis of the syringe body, a stabilizing element provided on the distal end, a portion of the stabilizing element extending substantially perpendicular to the longitudinal axis of the syringe body, and a manifold in fluid communication with the distal end of each of the plurality of syringes.

Abstract: Provided is a method for delivering a medical fluid. The method includes delivering a fluid volume, which includes contrast and/or a flush fluid, at a preselected total volumetric flowrate during a first duration of a fluid delivery procedure. The amount of the contrast agent and the flush fluid in the fluid volume can be controllably varied during the first duration of the fluid delivery procedure so as to substantially maintain a preselected total volumetric flowrate throughout the first duration of the fluid delivery procedure. Also provided is a fluid delivery system capable of performing this method.

Abstract: A syringe for a fluid delivery system includes a pressure jacket having a distal end, a proximal end, and a throughbore therebetween. The syringe further includes a rolling diaphragm having a proximal end with an end wall for engaging a plunger, a distal end received within the throughbore of the pressure jacket. The distal end of the rolling diaphragm has a nozzle and a sidewall extending between the proximal end and the distal end of the rolling diaphragm along a longitudinal axis. At least a portion of one of the sidewall and the end wall has non-uniform thickness. At least a portion of the sidewall is flexible and rolls upon itself when acted upon by the plunger such that an outer surface of the sidewall at a folding region is folded in a radially inward direction as the plunger is advanced from the proximal end to the distal end of the rolling diaphragm.