Abstract: In one general aspect, a method is disclosed for processing a pharmaceutical substance in a pharmaceutical processing system that includes lyophilizing a plurality of containers provided in a nest. A first controlled environment enclosure in the pharmaceutical processing system is isolated against an external environment, and a controlled environmental condition is established in the first controlled environment enclosure. The pharmaceutical substance is deposited into at least a portion of the plurality of containers in the first container nest at a filling station within the first controlled environment enclosure. The deposited pharmaceutical substance is lyophilized in the first container nest.

Abstract: An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

Abstract: In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligined concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest.

Abstract: A hermetically sealed multi-axis articulated arm apparatus for use within a sealable isolator chamber is disclosed. In one general aspect, it comprises a rotational shaft that passes through an opening in the chamber, a sealing member disposed within the chamber for sealing the shaft to an inner surface of the chamber, interconnected hermetically sealed arm segments operably attached to the linear motion shaft; an end effector operably attached to a terminal arm segment among the arm segments, and at least one fully enclosed drive system for driving and controlling the shaft and the arm segments. The rotational shaft can further be a linear motion shaft for which the sealing member is a bellows. The materials for the parts of the apparatus exposed to the atmosphere of the chamber can be compatible with an aseptic and cleanable environment and the surfaces of the arm segments can be shaped to avoid pooling of contaminants.

Abstract: The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active, metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.

Abstract: Systems and methods are disclosed, which permit filling containers with a product. A filling arm is disposed within a chamber and an optical sensor is configured to sense openings of the containers within the chamber. Locations of the sensed openings are used to guide the filling arm to fill the containers with a product.

Abstract: The invention provides an encapsulated unit dosage form for picoplatin that is adapted for oral administration of the picoplatin containing a substantially dry powder with about 20 to 55 wt % picoplatin in the physical form of a picoplatin particulate wherein an average picoplatin particle diameter is less than about 10 microns. The picoplatin particles are dispersed within the powder of the formulation which includes a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate and an effective amount of up to about 5 wt % of a lubricant.

Abstract: The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox- active metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the pieoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.

Abstract: The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.

Abstract: The invention provides formulations for the organoplatinum anticancer drug picoplatin. Self emulsifying compositions, stabilized nanoparticulate compositions, solid dispersions, and nanoparticulate suspensions in oils are provided, along with methods for preparation of the formulations. The formulations can provide improved oral availability of picoplatin relative a to a simple solution of picoplatin such as in water or normal saline solution and can be used in combination therapy.

Abstract: Methods for stabilizing aqueous solutions of picoplatin are provided. Such stable, preferably aseptic solutions are particularly useful for preparing unit dosages of picoplatin for oral or intravenous administration, preferably in combination with at least one additional non-platinum anti-cancer agent.

Abstract: The invention provides an encapsulated unit dosage form for picoplatin that is adapted for oral administration of the picoplatin containing a substantially dry powder with about 20 to 55 wt % picoplatin in the physical form of a picoplatin particulate wherein an average picoplatin particle diameter is less than about 10 microns. The picoplatin particles are dispersed within the powder of the formulation which includes a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate and an effective amount of up to about 5 wt % of a lubricant.

Abstract: Systems and methods permit filling containers with a product. A filling arm is disposed within a chamber. An optical sensor is configured to sense openings of the containers within the chamber. Locations of the sensed openings are used to guide the filling arm to fill the containers with a product.