Abstract: A ready to use or ready to dilute for use, stable liquid Bendamustine solution formed of 90 to about 200 mg/mL Bendamustine Hydrochloride or a hydrate form thereof, and a co-solvent consisting of 1% v/v to 12% v/v water and 88% v/v to 99% v/v N,N-Dimethylacetamide (DMA). The liquid Bendamustine solution is room-temperature stable for at least 90 days. Optionally, 0.01 to about 0.5 mg/mL antioxidant, preferably, butylated hydroxytoluene is included in the solution.

Abstract: A tablet formed from a pre-lyophilization solution has a void in its bottom surface, with a void height that is about 60% to 100% of a depth of the tablet. A pharmaceutical dosage form includes a blister sheet having one or more cavities, each having a protrusion extending upwardly from the cavity floor, with a tablet formed in the cavity by lyophilization of a pre-lyophilization solution in each such cavity. The protrusion is a cylinder or tapered cylinder and the void has a corresponding shape. A film overlays the blister sheet to seal the tablet in the blister sheet cavities.

Abstract: A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.

Abstract: A pharmaceutically acceptable intranasal spray formulation includes about 0.01% w/v to about 5% w/v melatonin, about 0% w/v to about 50% w/v liquid solvent selected from the group consisting of alcohol, polyethylene glycol, propylene glycol and combinations thereof, a pH system in an amount effective to maintain a pH of the formulation at about 4.5 to about 6.5, at least one preservative, and water. An aqueous formulation of melatonin for nasal administration as an in-situ gel includes melatonin, water, at least one organic solvent, and at least one gelling agent.

Abstract: A three-dimensional printing system and equipment assembly for the manufacture of three-dimensionally printed articles is provided. The equipment assembly includes a three-dimensional printing build system, an optional liquid removal system and an optional harvester system. The build system includes a conveyor, plural build modules and at least one build station having a powder-layering system and a printing system. The equipment assembly can be used to manufacture pharmaceutical, medical, and non-pharmaceutical/non-medical objects. It can be used to prepare single or multiple articles.

Abstract: A three-dimensional printing system and equipment assembly for the manufacture of three-dimensionally printed articles is provided. The equipment assembly includes a three-dimensional printing build system, an optional liquid removal system and an optional harvester system. The build system includes a conveyor, plural build modules and at least one build station having a powder-layering system and a printing system. The equipment assembly can be used to manufacture pharmaceutical, medical, and non-pharmaceutical/non-medical objects. It can be used to prepare single or multiple articles.

Abstract: A method and system of forming a pharmaceutical dosage form within a portion of a blister packaging. The method includes the steps of providing a blister packaging for the dosage form with depressions. A predetermined amount of a drug-containing powder material comprising drug-containing particles is deposited into a substantially uniform powder layer within the depressions. A binding liquid is then deposited in a pattern on the powder layer within the depressions, to bind the particles of the powder layer and form an incremental wetted layer, Excess solvent in the binding material can be removed to form an incremental bound layer. These steps are repeated in sequence at least one or more times to form the pharmaceutical dosage form within the blister packaging.

Abstract: A method and system of forming a pharmaceutical dosage form within a portion of a blister packaging. The method includes the steps of providing a blister packaging for the dosage form with depressions. A predetermined amount of a drug-containing powder material comprising drug-containing particles is deposited into a substantially uniform powder layer within the depressions. A binding liquid is then deposited in a pattern on the powder layer within the depressions, to bind the particles of the powder layer and form an incremental wetted layer. Excess solvent in the binding material can be removed to form an incremental bound layer. These steps are repeated in sequence at least one or more times to form the pharmaceutical dosage form within the blister packaging.

Abstract: A method and system of forming a pharmaceutical dosage form within a portion of a blister packaging. The method includes the steps of providing a blister packaging for the dosage form with depressions. A predetermined amount of a drug-containing powder material comprising drug-containing particles is deposited into a substantially uniform powder layer within the depressions. A binding liquid is then deposited in a pattern on the powder layer within the depressions, to bind the particles of the powder layer and form an incremental wetted layer. Excess solvent in the binding material can be removed to form an incremental bound layer. These steps are repeated in sequence at least one or more times to form the pharmaceutical dosage form within the blister packaging.

Abstract: A lyophilization promoting element to facilitate the transfer of heat between a lyophilizer and a pre-lyophilization solution. The element includes a base plate with a plurality of apertures. The base plate is made of a thermally conductive material and the apertures are regularly arranged within the base plate, each aperture being sized to receive a pharmaceutical vial container containing a pre-lyophilization solution. A method of lyophilizing includes inserting one or more pharmaceutical vial containers into the plurality of apertures of the lyophilization promoting element and placing the lyophilization promoting element holding the one or more pharmaceutical vial containers on a shelf of a lyophilizer.

Abstract: A ready to use or ready to dilute for use, stable liquid Bendamustine solution formed of 90 to about 200 mg/mL Bendamustine Hydrochloride or a hydrate form thereof, and a co-solvent consisting of 1% v/v to 12% v/v water and 88% v/v to 99% v/v N,N-Dimethylacetamide (DMA). The liquid Bendamustine solution is room-temperature stable for at least 90 days. Optionally, 0.01 to about 0.5 mg/mL antioxidant, preferably, butylated hydroxytoluene is included in the solution.

Abstract: Liquid pharmaceutical formulation of Bendamustine that include bendamustine active pharmaceutical ingredient, N,N-Dimethylacetamide, and water in an amount of about 0.3% to 40%. The active pharmaceutical ingredient is Bendamustine, a pharmaceutically acceptable salt, and/or a hydrate form thereof, preferably Bendamustine HCl monohydrate. The formulations contain 20-200 mg/mL Bendamustine. The formulations are stable upon long term storage at refrigerated conditions. They can be administered to treat neoplastic conditions without reconstituting prior to administration.

Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.

Abstract: The present invention provides a method for designing a ferric pyrophosphate citrate complex composition containing pyrophosphate, citrate, ferric, sodium, and sulfate ions and calculating and adjusting each salt needed based on a choice of salts that contain the above ions and a desired concentration of each ion in the final product. The present invention also provides a process for preparing a pharmaceutical dosage form of ferric pyrophosphate citrate complex composition in liquid form which is ready to be administrated to patients in need and which maintains the mass balance of ion sources throughout the process.

Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.

Abstract: The present invention provides pharmaceutical formulations of lyophilized carmustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized carmustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with carmustine, such as neoplastic diseases.

Abstract: A kit for treating psychosis by administering a pharmaceutically acceptable liquid composition of Asenapine to oral mucosa includes a formulation having Asenapine, or a pharmaceutically acceptable salt or hydrate thereof, ethanol, and water and a multidose pump filled with the formulation. The Asenapine compositions are stable for an extended period of time at normal storage conditions.

Abstract: The invention provides a process for preparing stable, high API content, solid pharmaceutical dosage forms by direct compression or dry granulation, characterized in that the pharmaceutical tablets rapidly disintegrate in water or other aqueous solutions to produce a clear or almost clear solution. Also provided is a pharmaceutical carglumic acid tablet, which has improved manufacturing, dissolution, and stability properties, and is less expensive to produce, compared to the equivalent commercial product.

Abstract: A three-dimensional printing system and equipment assembly for the manufacture of three-dimensionally printed articles is provided. The equipment assembly includes a three-dimensional printing build system, an optional liquid removal system and an optional harvester system. The build system includes a conveyor, plural build modules and at least one build station having a powder-layering system and a printing system. The equipment assembly can be used to manufacture pharmaceutical, medical, and non-pharmaceutical/non-medical objects. It can be used to prepare single or multiple articles.

Abstract: Liquid pharmaceutical formulation of Bendamustine that include bendamustine active pharmaceutical ingredient, N,N-Dimethylacetamide, and water in an amount of about 0.3% to 40%. The active pharmaceutical ingredient is Bendamustine, a pharmaceutically acceptable salt, and/or a hydrate form thereof, preferably Bendamustine HCl monohydrate. The formulations contain 20-200 mg/mL Bendamustine. The formulations are stable upon long term storage at refrigerated conditions. They can be administered to treat neoplastic conditions without reconstituting prior to administration.