Layered Pharmaceutical Formulations with Dissolvable Intermediate Barrier
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Solution Overview
Problem
Multilayer pharmaceutical formulations face challenges in maintaining predictable dissolution profiles due to in vivo conditions, which can disrupt the intended release of drugs, leading to unpredictable drug delivery and potential interactions between different drugs within the tablet.
Innovation Solution
A layered pharmaceutical formulation comprising two or more pharmaceutical layers separated by an intermediate layer that dissolves in vivo, maintaining the integrity of the drug layers and ensuring a predictable dissolution profile similar to a singly compressed tablet, with the intermediate layer configured to dissolve quickly, exposing the drug layers to bodily fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple pharmaceutical layers are combined in a single tablet to treat multiple symptoms, then treatment efficiency is improved, but unpredictable drug delivery and potential drug interactions occur due to in vivo conditions disrupting the dissolution profile
Solution Approach 1:
The tablet is divided into multiple distinct pharmaceutical layers, each containing specific drugs for different symptoms. Each layer is separated by an intermediate layer that dissolves quickly, allowing each layer to dissolve independently and predictably while maintaining physical separation to prevent drug interactions. This segmentation enables multiple symptoms to be treated simultaneously with reliable, predictable dissolution for each layer.
2Object-affected harmful factors
If pharmaceutical layers are physically separated to prevent drug interactions, then drug safety is improved, but dissolution predictability may be compromised due to the presence of intermediate layers
Solution Approach 1:
An intermediate layer is positioned between adjacent pharmaceutical layers to physically separate them and prevent direct contact between different drugs. This intermediate layer is designed to dissolve quickly in vivo, which maintains the physical separation barrier during the dissolution process, ensuring that drugs from different layers do not interact while still allowing each layer to dissolve predictably and independently.
3Object-affected harmful factors
If an intermediate layer is added to separate pharmaceutical layers, then drug separation is improved, but the complexity of the formulation increases
Solution Approach 1:
The intermediate layer is designed to be a temporary, dissolvable barrier that is discarded (dissolved) quickly in vivo. This quick dissolution means the intermediate layer performs its separation function during the critical dissolution phase and then disappears, allowing the pharmaceutical layers to dissolve independently without long-term structural complexity. The temporary nature of the intermediate layer minimizes overall formulation complexity while maintaining effective drug separation.
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 configuration ensures that each pharmaceutical layer dissolves independently with a predictable dissolution profile, allowing for coordinated treatment of multiple symptoms with a single formulation, minimizing side effects and enhancing the bioavailability of drugs like bupropion and zonisamide for weight loss and obesity treatment.
Implementation Method 1
the intermediate layer is configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact
Data Source
AI summary
In one embodiment a layered pharmaceutical formulation includes two or more pharmaceutical layers and an intermediate layer disposed between at least two of the two or more pharmaceutical layers, the intermediate layer configured to dissolve in vivo to thereby leave the two or more pharmaceutical layers substantially intact. In one embodiment, an active pharmaceutical ingredient in at least one of the pharmaceutical layers is selected from bupropion, zonisamide, naltrexone, topiramate, phentermine, metformin, olanzapine and fluoxetine.