Dosage forms and methods of use thereof

摘要

Pharmaceutical dosage forms with external or internal features to complicate counterfeiting and support authentication are described. External features include surface texture, surface markings defined by patterns of physical or chemical markers, or complex interlocking shapes. Internal features also include physical or chemical markers in two or three-dimensional patterns observable after sectioning, or after breaking along designed fracture lines. Methods of manufacture using solid freeform fabrication (SFF) techniques such as three-dimensional printing (3DP) are described. Method of authentication using dosage form patterns and batch codes are also described.

主权项

1. A three-dimensionally printed dosage form comprising:
a. a three-dimensionally printed solid matrix comprising a blend of at least one active ingredient and at least one inactive ingredient; and b. at least one or more chemical markers, wherein said one or more chemical markers define one or more internal three-dimensional patterns in said matrix that cannot be fully observed when the dosage form is intact and that may be used to authenticate the dosage form, wherein said one or more chemical markers is comprises dye, pigment, color-shift substance, UV-active substance, fluorescent substance, or another inactive pharmaceutical ingredient, wherein said one or more internal patterns includes logo, batch code, lettering, numbering, a dot pattern, or a bar code, and wherein the internal pattern is non-concentric or asymmetric.