Nano-Order Metal Oxide Coating for Photostable Solid Preparations
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Solution Overview
Problem
Conventional pharmaceutical solid preparations coated with film coatings often experience delayed drug elution and insufficient light shielding, as the polymer-based coatings can increase disintegration time and may not adequately protect against photodegradation.
Innovation Solution
A sputtering technique is used to apply a metal oxide coating in the nano-order thickness range of 1 nm to 500 nm, specifically with iron oxide or titanium oxide, to create a light-shielding layer on pharmaceutical solid preparations, eliminating the need for polymer compounds and enhancing photostability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If film coating is applied to protect the drug from light and moisture, then photostability is improved, but disintegration time is prolonged and drug elution is delayed
Solution Approach 1:
The invention changes the coating thickness parameter from conventional film coating (micrometer order) to atomic layer deposition (nanometer order, specifically 1-10 nm). This parameter change allows the coating to provide adequate light shielding for photostability while being thin enough to not significantly delay disintegration and drug elution
Solution Approach 2:
The invention replaces the conventional film coating mechanism (polymer-based, micrometer thickness) with atomic layer deposition (ALD), a vapor-phase deposition technique that creates ultra-thin metal oxide layers. This substitution enables precise control of coating thickness at the nanometer scale, resolving the contradiction between protection and disintegration
2Object-affected harmful factors
If a light shielding agent is coated using film coating with polymer compounds, then light protection is achieved, but the coating adds complexity and may affect drug release
Solution Approach 1:
The invention extracts only the essential light-shielding function from conventional film coatings by using ultra-thin metal oxide layers deposited via ALD. This eliminates the need for polymer compounds and complex coating systems while maintaining adequate light protection through the nanometer-thick metal oxide layer
Solution Approach 2:
The invention changes the coating approach from micrometer-thick polymer films to nanometer-thin metal oxide layers deposited by atomic layer deposition. This parameter change in thickness and material composition simplifies the coating system while achieving the same or better light shielding effect
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 results in pharmaceutical solid preparations with disintegration properties comparable to uncoated tablets while providing effective light shielding and improved photostability, reducing the formation of decomposition products under light irradiation.
Implementation Method 1
a method in which an inert gas (e.g., argon) is introduced in a vacuum, a negative voltage is applied to the target (plate-shaped film forming material) to generate a glow discharge, the inert gas atom is ionized, the gas ions are made to collide with the surface of the target at a high speed and hit it violently, and the particles (atoms and molecules) of the film-forming material constituting the target are vigorously ejected and vigorously adhered and deposited on the surface of the base material/substrate
Implementation Method 2
the surface of the solid preparation is coated with a light shielding agent or a metal oxide... to protect a drug from light
Data Source
Figure 1~2
AI summary
The main object is to provide a novel pharmaceutical solid preparation containing a pharmaceutically active ingredient, wherein the solid preparation is coated with a light shielding agent in a nano-order thickness. The present invention can include a pharmaceutical solid preparation containing at least one pharmaceutically active ingredient, wherein the surface of the solid preparation is coated with a light shielding agent or a metal oxide to a thickness in a range of 1 nm to 500 nm to form a coating layer, or is coated with a light shielding agent or a metal oxide which is present in a range of 5 × 10-6 mg/mm2 to 3 × 10-3 mg/mm2 to form a coating layer, and a process for producing a solid preparation containing at least one pharmaceutically active ingredient, comprising a step of coating a light shielding agent or a metal oxide by sputtering on the surface of the solid preparation to a thickness in a range of 1 nm to 500 nm.