Oil-Proof Coated Statin Tablet in Omega-3 Capsule
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Solution Overview
Problem
Existing oral complex preparations face stability issues and content uniformity problems due to the interaction of statin-based drugs with external environmental factors when coated with omega-3 fatty acids, leading to instability and increased related substances.
Innovation Solution
An oral complex preparation is developed with a capsule containing a fat-soluble first drug, such as omega-3 fatty acid, and a solid preparation with a statin-based drug embedded inside, coated with an oil-proof material to prevent external factor interference.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the solid preparation containing statin-based drug is coated with omega-3 fatty acid, then the complex preparation can be manufactured, but the stability deteriorates and related substances increase due to interaction with external environment
Solution Approach 1:
The invention divides the complex preparation into separate functional layers: an inner layer containing the statin-based drug and an outer layer containing the omega-3 fatty acid. This segmentation prevents direct contact between the statin and omega-3, eliminating the stability issues and formation of related substances while still allowing both drugs to be administered together in a single capsule.
Solution Approach 2:
The invention introduces an intermediate barrier between the statin-based drug and omega-3 fatty acid. This barrier prevents the harmful interaction between the two substances while allowing both to coexist in the same preparation, thus maintaining manufacturing simplicity without compromising drug stability.
2Productivity
If the surface area of the preparation is increased to improve drug release, then the elution pattern can be adjusted, but the stability decreases due to greater exposure to external environment
Solution Approach 1:
By segmenting the preparation into distinct inner and outer layers with different surface areas, the invention allows the outer layer to provide sufficient surface area for effective drug release while the inner layer containing the statin remains protected with minimal exposed surface area, thus maintaining stability without compromising release efficiency.
3Device complexity
If the statin-based drug is uniformly coated on the outer layer, then the preparation can be simplified, but the content uniformity decreases and hardness control becomes difficult
Solution Approach 1:
The invention segments the drug distribution into separate layers, with the statin-based drug confined to the inner layer and omega-3 in the outer layer. This segmentation ensures uniform content distribution within each layer while maintaining a relatively simple overall structure, thus achieving both manufacturing precision and structural simplicity.
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 oil-proof coating layer maintains the stability of the statin-based drug, prevents penetration of the omega-3 fatty acid into the solid preparation, and ensures appropriate elution and disintegration times, enhancing the therapeutic effect while maintaining the convenience of a single medication administration.
Implementation Method 1
it has been confirmed that the fat-soluble first drug does not have an effect on the hardness of the solid preparation since the fat-soluble first drug does not penetrate a tablet containing the second drug when coating the surface of the solid preparation containing the second drug with an oil-proof material
Data Source
AI summary
The present invention relates to an oral complex preparation comprising: a capsule containing a fat-soluble first drug; and a solid preparation containing a second drug, the solid preparation being embedded into the capsule and including an oil-proof material coating layer on the surface thereofThe oral complex preparation of the present invention prepared by embedding the solid preparation including the oil-proof material coating layer on the surface thereof and containing the second drug into the capsule containing the fat-soluble first drug enables two types of drug ingredients to be simultaneously administered. At this time, the oral complex preparation of the present invention can independently transfer each of two types of the active ingredients to a desired region without loss of the active ingredients since the oral complex preparation by enabling the oil-proof material coating layer on the surface of the solid preparation to block elution of the active ingredients of the solid preparation by the fat-soluble first drug or occurrence of side effects with the fat-soluble first drug.