Biphasic Controlled-Release Tablet for Rapid Onset and Zero-Order Release
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Solution Overview
Problem
Existing drug delivery systems struggle to provide a biphasic release profile that allows for both rapid onset and sustained, stable drug release, which is crucial for addressing specific pathological conditions, while maintaining efficacy and reducing adverse responses.
Innovation Solution
A biphasic controlled-release preparation comprising a drug-containing immediate-release layer, a drug-containing sustained-release layer, and a drug-free blocking layer, designed to achieve rapid drug release followed by near-zero-order release over an extended period, utilizing specific ratios and components for each layer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Speed
If a traditional immediate-release preparation is used, then the drug takes effect quickly, but it cannot maintain efficacy for a long time
Solution Approach 1:
The preparation is segmented into distinct layers: an immediate-release layer containing drug and a sustained-release layer containing drug, allowing each layer to perform its specific function independently. The immediate-release layer provides rapid drug release for quick onset, while the sustained-release layer maintains drug release over an extended period, thereby resolving the contradiction between quick onset and long-lasting efficacy.
Solution Approach 2:
The invention transitions from a single homogeneous preparation to a multi-layered structured preparation with distinct functional zones. By adding the dimension of spatial structure (layers), the system can simultaneously achieve rapid release (from the immediate-release layer) and sustained release (from the sustained-release layer), resolving the time-based contradiction.
2Duration of action of moving object
If an ordinary sustained-release dosage form is used, then the drug release is maintained for a long time, but it cannot take effect quickly
Solution Approach 1:
The preparation is segmented into distinct layers: an immediate-release layer containing drug and a sustained-release layer containing drug, allowing each layer to perform its specific function independently. The immediate-release layer provides rapid drug release for quick onset, while the sustained-release layer maintains drug release over an extended period, thereby resolving the contradiction between quick onset and long-lasting efficacy.
Solution Approach 2:
The invention transitions from a single homogeneous preparation to a multi-layered structured preparation with distinct functional zones. By adding the dimension of spatial structure (layers), the system can simultaneously achieve rapid release (from the immediate-release layer) and sustained release (from the sustained-release layer), resolving the time-based contradiction.
3Reliability
If a double-layer or multi-layer tablet system is used to achieve biphasic release, then the drug release profile is controlled, but the formulation and production process becomes complex
Solution Approach 1:
The preparation is segmented into distinct layers: an immediate-release layer containing drug and a sustained-release layer containing drug, allowing each layer to perform its specific function independently. The immediate-release layer provides rapid drug release for quick onset, while the sustained-release layer maintains drug release over an extended period, thereby resolving the contradiction between quick onset and long-lasting efficacy.
Solution Approach 2:
The invention transitions from a single homogeneous preparation to a multi-layered structured preparation with distinct functional zones. By adding the dimension of spatial structure (layers), the system can simultaneously achieve rapid release (from the immediate-release layer) and sustained release (from the sustained-release layer), resolving the time-based contradiction.
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 biphasic formulation ensures rapid drug action with stable, uniform release over time, reducing adverse responses and enhancing patient compliance by achieving a zero-order release rate within 1-10 hours.
Implementation Method 1
the immediate-release layer is rapidly dissolved and released in a zero-order mode within 1-10 h
Implementation Method 2
rapid drug release followed by near-zero-order release
Implementation Method 3
maintain their efficacy for a long time, while ordinary sustained-release dosage forms cannot take effect quickly
Implementation Method 4
near zero-order release at a uniform speed for a long time
Implementation Method 5
the drug-containing sustained-release layer (SR) is wrapped between the drug-containing immediate-release layer (IR) and the blocking layer (BL)
Data Source
AI summary
The present invention relates to a biphasic controlled-release preparation and preparation thereof. The biphasic controlled-release preparation can take effect quickly in vivo, quickly reach a peak value of blood drug concentration, then keep stable release, maintain stable blood drug concentration and reduce the fluctuation between wave peaks and wave valleys. The controlled-release preparation consists of three parts, namely an immediate-release layer, a tablet core layer and a blocking layer. The immediate-release layer is rapidly dissolved in vitro, and the combination of the remaining tablet core layer and the blocking layer can maintain the zero-order release in vitro.