Segmented Core Coated Dosage Forms for Controlled Release
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Solution Overview
Problem
There is a need for simple and reliable controlled release dosage forms that can release active agents at predetermined times, rates, and durations, which can be manufactured with ease and at an acceptable cost, while avoiding coating rupture during drug release.
Innovation Solution
A controlled release dosage form is designed with a core having a surface topography that controls the release by rupturing in an aqueous medium, creating passageways for controlled access and release of the active agent, using a subcoat like hydroxypropylmethylcellulose and a coating that ruptures to expose the core, allowing for prolonged release over several hours.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prolonged release coating is applied to control drug diffusion, then the release profile is controlled and rupture is avoided, but the manufacturing complexity and cost increase
Solution Approach 1:
The core is segmented with surface structures (protrusions, indentations, or combinations) that create localized stress points in the coating. This segmentation allows the coating to rupture at specific locations rather than requiring complex multi-layer coating systems to achieve controlled release.
Solution Approach 2:
The surface structures are pre-formed on the core before coating application. These pre-formed structures predictably control where the coating will rupture during dissolution, eliminating the need for complex post-coating modifications or multiple coating layers.
2Manufacturing precision
If plasticizers and pore formers are included in the coating system, then the target release profile is achieved, but the manufacturing ease and cost acceptability decrease
Solution Approach 1:
Different regions of the coating have different properties due to the underlying surface structures. Areas above protrusions experience different stress and dissolution rates compared to areas above indentations, creating localized release characteristics without requiring different materials throughout the coating.
Solution Approach 2:
The release profile is controlled by changing the physical parameters of the core surface (topography, protrusion height, indentation depth, spacing) rather than changing the chemical composition of the coating with multiple plasticizers and pore formers.
3Ease of manufacture
If the coating is designed to rupture to provide direct access, then simple manufacturing processes are used, but the risk of rapid release and overdose increases
Solution Approach 1:
The coating rupture occurs at specific localized positions above surface structures rather than uniformly across the entire surface. This localized rupture provides controlled direct access while maintaining coating integrity in other areas, preventing rapid complete release.
Solution Approach 2:
The coating partially ruptures at predetermined locations rather than completely failing. This partial rupture provides sufficient direct access for therapeutic effect while leaving portions of the coating intact to prevent excessive or rapid release.
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
This approach enables controlled release of active agents for extended periods, improving manufacturing ease and cost-effectiveness, while minimizing the risk of rapid release and overdose, and allowing for once-daily administration due to reduced size and prolonged action.
Implementation Method 1
the coating is prepared such that it provides the target release and that a rupture of the coating during the release is avoided. Typically the target release is achieved by including plasticizers and/or pore formers in the coating system to control drug diffusion through the coating.
Implementation Method 2
The subcoat preferably adheres to the core throughout the perimeter of the dosage form.
Data Source
AI summary
Dosage forms having a core having a surface having means for controlling release(s) on an active agent(s); methods of manufacturing, tools used in manufacturing; and uses of the dosage forms are described.