Abstract: A syringe assembly includes a syringe and a tamper evident cap disposed over a Luer connection of the syringe, the tamper evident cap having a main body that defines a proximal end defining an opening, a distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage to receive a tip cap and the Luer connection, where the tamper evident cap is spaced from the tip cap. The main body further defines a frangible connection between the proximal and distal ends of the main body. The frangible connection can break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap remains engaged with the syringe when the frangible connection breaks.

Abstract: Via communications with an association management resource, an operator of a respective fluid delivery system can associate a medical device (fluid pump) with a particular entity such as a patient, location, one or more other medical devices, the caregiver, etc. Thereafter, the operator of the fluid delivery system is able to better manage use of the fluid delivery system based on relevant medical information, which is accessible as a result of creating the association. For example, the association management resource gathers and stores information associated with the entity prior to the operator providing the input associating the fluid delivery system with the entity. After the operator of the fluid delivery system creates the association, the medical information associated with the entity is immediately available to the fluid delivery system and/or corresponding operator of the fluid delivery system.

Abstract: Devices and methods for use with syringes are disclosed. A plunger rod includes an outer housing having proximal and distal ends and a lumen between the ends, as well as an inner body axially slidable within the lumen between a first and second position. The inner body has a retention member extending therefrom. When the inner body is in the first position, the plunger rod has a first length, and, when the inner body is in the second position, the plunger rod has a second length greater than the first length. When the inner body is in the second position, the inner body is configured to be rotated relative to the outer housing until the retention member is received within the outer housing to preclude the inner body from moving in the axial direction.

Abstract: A fluid delivery apparatus includes controller hardware, a diaphragm pump, a positive displacement pump, and a fluid conduit extending between the diaphragm pump and the positive displacement pump. During operation, and delivering fluid to a downstream recipient, the controller hardware draws fluid into a chamber of the diaphragm pump from a fluid source container. The controller hardware applies pressure to the chamber of the diaphragm pump to output the fluid in the chamber of the diaphragm pump downstream through the fluid conduit to the positive displacement pump. During application of the pressure to the chamber and outputting the fluid in the chamber of the diaphragm pump downstream, the controller hardware activates the positive displacement pump to pump the fluid from the positive displacement pump to the downstream recipient.

Abstract: Provided are methods for analyzing and purifying degarelix or a pharmaceutically acceptable salt thereof containing at least one related impurity. Also provided are methods for analyzing and purifying degarelix or a pharmaceutically acceptable salt thereof containing compound A and/or compound D as an impurity. Further provided are degarelix or a pharmaceutically acceptable salt thereof prepared from and/or selected using the disclosed methods.

Abstract: A fluid delivery apparatus includes controller hardware, a diaphragm pump, a positive displacement pump, and a fluid conduit extending between the diaphragm pump and the positive displacement pump. During operation, and delivering fluid to a downstream recipient, the controller hardware draws fluid into a chamber of the diaphragm pump from a fluid source container. The controller hardware applies pressure to the chamber of the diaphragm pump to output the fluid in the chamber of the diaphragm pump downstream through the fluid conduit to the positive displacement pump. During application of the pressure to the chamber and outputting the fluid in the chamber of the diaphragm pump downstream, the controller hardware activates the positive displacement pump to pump the fluid from the positive displacement pump to the downstream recipient.

Abstract: A system includes: a fluid delivery pump and a network of multiple record management processing nodes. The fluid delivery pump is in communication with one or more of the record management-processing nodes in the network. At least a first record management processing node receives input indicating a fluid delivery event. The fluid delivery event indicates fluid delivery from the fluid delivery pump to a recipient. The record management-processing node identifies code pertinent to the fluid delivery event; the code includes criteria in which to validate the fluid delivery event. In response to validation of the fluid delivery event as specified by the criteria in the code, a resource such as the record management-processing node triggers a transaction associated with the fluid delivery event.

Abstract: The invention provides a fulvestrant composition comprising a pharmaceutically acceptable vehicle and not more than 2% total impurities and which, optionally, is free of a non-aqueous ester solvent. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.

Abstract: The present disclosure describes a syringe assembly including a syringe including a Luer connection and a tip, a plunger, a tip cap, a tamper evident cap disposed over the tip cap, and a film including a frangible connection. The film secures the tamper evident cap to the Luer connection, where the frangible connection can break under a force applied to the tamper evident cap such that the tamper evident cap disengages from the Luer connection when the frangible connection breaks.

Abstract: The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes a cyclodextrin, water, and an amine, and has a pH above the buffering range of the amine. The liquid formulation of the invention is stable and ready-to-use.

Abstract: The invention provides a fulvestrant composition comprising a pharmaceutically acceptable vehicle and not more than 2% total impurities and which, optionally, is free of a non-aqueous ester solvent. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.

Abstract: The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.

Abstract: The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes a cyclodextrin and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.

Abstract: The invention provides a method for analyzing a protamine sample for the presence or amount of at least one nucleotidic impurity. The invention also provides a method for the quantitation of peptides in a sample of protamine comprising four major peptides and at least one related impurity.

Abstract: The present disclosure describes a syringe assembly including a syringe and a tamper evident cap disposed over a Luer connection of the syringe, the tamper evident cap having a main body that defines a proximal end defining an opening, a distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage to receive a tip cap and the Luer connection, where the tamper evident cap is spaced from the tip cap. The main body further defines a frangible connection between the proximal and distal ends of the main body. The frangible connection can break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap remains engaged with the syringe when the frangible connection breaks.

Abstract: The present disclosure describes a syringe assembly including a syringe and a tamper evident cap disposed over a Luer connection of the syringe, the tamper evident cap having a main body that defines a proximal end defining an opening, a distal end opposite the proximal end along the axial direction, an outer surface, and an inner surface opposite the outer surface that defines a passage to receive a tip cap and the Luer connection, where the tamper evident cap is spaced from the tip cap. The main body further defines a frangible connection between the proximal and distal ends of the main body. The frangible connection can break under a force applied to the distal end of the tamper evident cap such that the proximal end of the tamper evident cap remains engaged with the syringe when the frangible connection breaks.

Abstract: The present invention is directed to a pharmaceutical product which includes a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.

Abstract: The present invention is directed to a liquid formulation comprising levothyroxine or a pharmaceutically acceptable salt thereof. The formulation of the present invention includes tromethamine, sodium iodide, and water and has a pH of about 9.0 to about 11.5. The liquid formulation according to the invention is stable and ready-to-use.

Abstract: The invention provides a fulvestrant composition comprising a pharmaceutically acceptable vehicle and not more than 2% total impurities and which, optionally, is free of a non-aqueous ester solvent. The composition may be used to treat hormone receptor positive metastatic breast cancer in a subject.

Abstract: A caspofungin composition includes caspofungin acetate and at least one amino acid, where the composition is a solid. The solid composition may be made by forming a liquid mixture including a solvent, caspofungin acetate and the amino acid(s), and lyophilizing the liquid mixture.