Package making – With means responsive to a sensed condition – Of individual contents or group feed or delivery
Reexamination Certificate
2001-05-02
2001-11-06
Smith, Scott A. (Department: 3721)
Package making
With means responsive to a sensed condition
Of individual contents or group feed or delivery
C053S493000, C053S539000, C053S543000
Reexamination Certificate
active
06311462
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to an apparatus for handling and packaging pharmaceutical dosage forms, particularly fragile dosage forms.
BACKGROUND OF THE INVENTION
The present invention can be applied to systems or assemblies for packaging essentially any dosage form. Such systems may include a forming device such as a tablet press, an infeed structure, a laning structure, robotic devices for handling or carrying dosage forms, and a packaging machine. A series of conveyor belts and ramps transport the dosage forms through the packaging system. After the dosage forms are made, they proceed through the system and are controlled and organized for receipt by a packaging machine. A robotic handler may be used to transport dosage forms to the packaging machine. If the system packages dosage forms into blister packages, a robotic handler may be used to transport dosage forms to a sheet of packaging material, which will be sealed with a second sheet of material to form packages of the dosage forms.
The dosage forms travel through the packaging system rapidly and in large volumes. As many as 800 to 1,440 tablets per minute, or more, may be assembled into 240 packages of tablets per minute, or more. Hence, a displaced machine part, one of the dosage forms, or other debris anywhere in the system can cause dosage forms to break and improperly formed packages. Some systems must be shut down so that the jammed product or other debris may be cleared manually. This results in a loss of the product in large numbers before the system can be interrupted and the problem remedied.
The foregoing problems are exacerbated where the dosage forms are particularly susceptible to damage. This is true for packaging systems for relatively soft tablets. Such soft tablets include certain embodiments described in commonly assigned U.S. Pat. Nos. 5,178,878 and 5,223,264, the disclosures of which are hereby incorporated by reference herein. These tablets include, in addition to the active ingredients, an effervescent composition so that when the tablet is orally administered to a patient, it disintegrates. The tablets are very soft with a hardness typically below about 20 Newtons and in some cases below 10 Newtons. As a result, the packaging system must take into account the fragile nature of the product by providing means for avoiding jamming and backing up within the system and adequate arrangement of the product for packaging. Despite efforts in the art, still further improvements would be desirable.
SUMMARY OF THE INVENTION
The present invention addresses these needs.
One aspect of the present invention provides an assembly for handling and packaging pharmaceutical dosage forms. The assembly in accordance with this aspect includes an infeed structure for accepting a series of dosage forms including a surface movable in a downstream direction, a laning structure defining a plurality of lanes extending in the downstream direction and having a downstream end, and a plenum structure extending from the infeed structure to the laning structure, including a guide portion for guiding dosage forms carried by said surface into the laning structure. A form handling device is provided for receiving dosage forms and transporting dosage forms from the laning structure to a packaging device. A dump gate has a closed position in which the dump gate blocks the lanes at the downstream ends of the lanes. In the closed position, dosage forms will accumulate in the lanes. The dump gate also has an open position in which the dump gate does not block the lanes. A timed controller is provided for opening the dump gate after the handling device receives dosage forms so that debris will be carried downstream out of the laning structure after the form handling device receives dosage forms from the laning structure. This aspect of the invention provides a dosage form handling assembly which clears the laning structure of debris without excessive loss of undamaged dosage forms. The timed controller is preferably arranged so that debris is carried out of the laning structure and the dump gate is brought into its closed position before undamaged tablets escape the laning structure. The timed controller preferably comprises a computer communicating with the form handling device and the dump gate.
In preferred embodiments, a guide wall structure defines the guide portion which preferably includes a curved portion. The guide wall structure also preferably defines the plenum structure which preferably includes a plenum entry. In preferred embodiments, the guide wall structure is shaped to guide dosage forms entering the plenum structure so that the dosage forms enter the plenum entry adjacent a first side of the laning structure and travel in a first direction transverse to the downstream direction toward a second side of the laning structure before entering the lanes of the laning structure. In certain preferred embodiments, the curved portion of the guide wall structure includes a member adjacent the plenum entry. A biasing means or biasing device is provided in certain preferred embodiments for vibrating the member to agitate the dosage forms and relieve jamming of dosage forms. The biasing means may comprise a shaker for vibrating the member. The guide wall structure and moveable member is provided to guide fragile dosage forms from the infeed structure to the laning structure for organizing the dosage forms to be placed into packages. The transition between the infeed structure and the laning structure in this aspect of the invention is shaped to prevent jamming or a bottleneck effect in this transitional area which may result in damage to or destruction of the dosage forms.
The laning structure preferably includes a surface for supporting the dosage forms. This surface, in certain preferred embodiments, slopes in the downstream direction to the dump gate so that debris is carried out of the laning structure when the dump gate is in the open position.
Another aspect of the invention provides a packaging device, comprising a top plate and a bottom plate for engaging a packaging material and a lid stock therebetween to seal the packaging material and the lid stock to one another. At least one of the top plate and bottom plate is comprised of a plurality of blocks and a base for supporting the plurality of blocks thereon. The blocks are floatably supported by the base and individually moveable with respect to the base so that pressure applied to the package material and the lid stock by the top and bottom plates is evenly distributed. This aspect of the invention provides a more evenly and more reliably sealed package.
In preferred embodiments, each of the blocks is free to tilt relative to the base in all directions. The base may include a ball-like member for each block and each block may include a corresponding circular cavity formed at a second surface of each block opposite to the first surface on which the packaging material is engaged. The cavity receives the ball-like member so that the block is floatably supported by the base. In preferred embodiments, either the top plate, the bottom plate or both are heated for sealing the package material and the lid stock together to form a package for the dosage form.
Another aspect of the invention provides an assembly for guiding pharmaceutical dosage forms in a packaging assembly, comprising a surface movable in a downstream direction, a laning structure extending in a lateral direction transverse to the downstream direction and defining a plurality of laterally spaced lanes extending in the downstream direction. The assembly also comprises guide wall structures including a curved portion and a wall structure defining a plenum upstream of the laning structure. The curved portion guides the dosage forms carried by said surface so that dosage forms enter the plenum structure at a plenum entry adjacent a first side of the laning structure and travel laterally toward a second side of the laning structure before entering the lanes. The assembly preferably includes a for
Amborn Jerry
Tiger Vernon
Cima Labs Inc.
Huynh Louis
Lerner David Littenberg Krumholz & Mentlik LLP
Smith Scott A.
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