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US 4,029,757 AGranted
Manufacture of pharmaceutical unit dosage forms
AssigneeHoffmann-La Roche Inc.
InventorsArthur Roman Mlodozeniec, Lawrence Samuel White
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AssigneeHoffmann-La Roche Inc.
InventorsArthur Roman Mlodozeniec, Lawrence Samuel White
Estimating the term…
Pharmaceutical dosage forms comprising an edible web having deposited thereon or at least partially thereon a particulate medicament, the webs being thereafter fabricated and finished to pharmaceutically elegant solid dosage forms having no medicament exposed on an exterior surface. The dosage forms have a consistency of release of medicament which can be controlled to exacting specifications. The disclosed solid dosage forms are prepared by high speed automated equipment and the process by which they are made is characterized by non-destructive quality control analysis and performance evaluation both conducted on-line and integrated into the manufacturing operation. Included in the scope of the disclosed invention are certain apparatus and methods of manufacture.
A method of preparing solid pharmaceutical unit dosage forms comprising loading one or more medicaments to a therapeutically inert, edible web, fabricating said web into a solid geometric form of predetermined dimensions having said medicament substantially internalized, said form being divisible into a plurality of unit dosage forms, unitizing said geometric form into said plurality of unit dosage forms and sealing said unit dosage forms to completely internalize said medicament wherein said procedures include at least one non-destructive testing operation to assure uniform quality of said unit dosage forms, wherein said fabrication procedure comprises fan folding a continuous web structure comprising at least one pair of layers of web having medicament loaded to the facing surfaces thereof and subjecting said stack to pressure to densify and shape same into a continuous rod-like geometric form.
Dependencies are inferred from the claim text.