Segmented Bioerodible Drug Delivery System for Controlled Release
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Solution Overview
Problem
Conventional drug delivery systems fail to provide controlled and tailored release profiles for active pharmaceutical ingredients, leading to excessive API concentrations and potential toxicity, especially for APIs with a narrow therapeutic window, and do not allow for complex release patterns or simultaneous administration of multiple APIs with specific profiles.
Innovation Solution
A bioerodible drug delivery system with a base component and a separate first component, where the first component is inhomogeneously arranged within the base component, allowing for controlled and customized release profiles without the need for osmotic agents, enabling precise administration of APIs based on their specific therapeutic requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the API is homogeneously distributed throughout the tablet, then the manufacturing process is simple and consistent, but the release profile cannot be controlled and leads to excessive API concentrations
Solution Approach 1:
The tablet is segmented into distinct zones with different API concentrations. The API is not homogeneously distributed but rather concentrated in specific regions (e.g., center or periphery) of the tablet, allowing different parts of the tablet to dissolve at different rates and provide controlled release profiles
Solution Approach 2:
Different regions of the tablet are assigned different API concentrations based on their intended release function. The core or specific zones contain higher API concentrations while other regions contain lower concentrations or excipients only, enabling spatially differentiated release behavior
2Speed
If the tablet dissolves quickly to release API, then the onset of action is rapid, but the API concentration exceeds the therapeutic window and causes toxicity
Solution Approach 1:
The tablet is designed to release API in periodic phases rather than all at once. Different zones dissolve at different rates, creating a staged release pattern where API is released over an extended period, maintaining concentrations within the therapeutic window while avoiding toxicity
Solution Approach 2:
The tablet structure is pre-designed with zones that dissolve at different rates, so that the release profile is predetermined and controlled from the outset. This preliminary structuring ensures that API release follows a safe profile without requiring active regulation during dissolution
3Device complexity
If a single API is administered, then the dosage form is simple, but complex therapeutic regimens requiring multiple APIs with different release profiles cannot be achieved
Solution Approach 1:
The tablet is designed as a multi-functional dosage form that can simultaneously administer multiple APIs with different release profiles. Different zones of the tablet can contain different APIs or the same API with different concentrations, enabling a single tablet to fulfill multiple therapeutic functions
Solution Approach 2:
Multiple APIs with different release requirements are merged into a single tablet through zoned distribution. Each API is placed in specific zones where its release characteristics match its therapeutic requirements, combining multiple drug delivery functions in one dosage form
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system achieves controlled and optimized pharmacokinetics and pharmacodynamics by varying API concentrations throughout the delivery system, reducing side effects and allowing for tailored release profiles, including constant, intermittent, or phased releases of multiple APIs, effectively managing API concentrations within the therapeutic window.
Implementation Method 1
The drug delivery system comprises a base component which is soluble in body fluids
Data Source
AI summary
The present invention relates to a drug delivery system, in particular for a controlled administration of one or more active pharmaceutical ingredients to a body, and further in particular for oral administration of one or more active pharmaceutical ingredients to a body. The system thereby comprises a base component soluble in body fluids and a separate first component soluble in body fluids. The first component thereby comprises a therapeutically effective amount of a first active pharmaceutical ingredient.