3D Printed Dosage Forms with Unique Authentication Patterns
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Solution Overview
Problem
Conventional methods for authenticating pharmaceutical products are inadequate, as they rely on chemical markers that can be easily detected and replicated, and RFID technology that can be tampered with, failing to provide direct verification for end-users, particularly patients.
Innovation Solution
The development of dosage forms with unique external and internal characteristics using solid freeform fabrication techniques, such as three-dimensional printing, which create complex geometries and patterns that are difficult to replicate, combined with methods for authenticating these features through matching patterns to reference standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chemical markers are used for authentication, then authentication capability is improved, but the markers can be easily detected and replicated by counterfeiters
Solution Approach 1:
The patent applies local quality by incorporating chemical markers at specific localized positions within the dosage form rather than uniformly throughout. Different regions of the dosage form contain different chemical markers or combinations of markers, creating a unique spatial pattern that is difficult for counterfeiters to replicate without sophisticated analysis and synthesis capabilities.
Solution Approach 2:
The patent employs asymmetry by using non-uniform distributions of chemical markers throughout the dosage form. The markers are positioned asymmetrically in specific regions, creating an irregular pattern that contrasts with the symmetric or uniform patterns often used in conventional dosage forms, thereby enhancing authentication capability while resisting counterfeit replication.
2Reliability
If RFID technology is used for tracking, then product authentication is improved, but the system can be tampered with and does not provide direct verification for end-users
Solution Approach 1:
The patent introduces an intermediary system that bridges the gap between sophisticated authentication technologies and end-users. This intermediary involves incorporating authentication features directly into the dosage form itself, such as visual patterns, colors, or physical characteristics that patients can directly observe and verify without requiring complex electronic systems or specialized equipment.
Solution Approach 2:
The patent enables self-service authentication by incorporating authentication features that patients can independently verify without requiring assistance from healthcare professionals or specialized equipment. The dosage form itself carries the authentication information through visible patterns, colors, or other direct characteristics that patients can examine themselves.
3Ease of manufacture
If conventional manufacturing processes are used, then ease of manufacture is maintained, but the dosage forms lack complex internal geometries needed for authentication
Solution Approach 1:
The patent applies segmentation by dividing the dosage form into distinct regions or layers, each containing specific chemical markers or authentication features. This segmentation allows conventional manufacturing processes to be used while still achieving complex internal geometries, as each segment can be independently controlled and positioned during the manufacturing process.
Solution Approach 2:
The patent employs the nesting principle by incorporating multiple levels of authentication features within the dosage form structure. Different regions contain different types of markers or features at different depths or layers, creating a nested arrangement that provides multiple authentication capabilities without requiring entirely new manufacturing processes.
Data Source
AI summary
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.