ALD Coating for Pharmaceutical Substrates
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Solution Overview
Problem
Current pharmaceutical coating methods are complex, costly, and inefficient, particularly for drugs with poor flow properties and compressibility, leading to low product yields and stability issues, especially in the dissolution and controlled delivery of poorly soluble pharmaceuticals.
Innovation Solution
The use of Atomic Layer Deposition (ALD) to coat pharmaceutical substrates before processing into a solid dosage form, allowing for a thin, dense, and uniform coating that improves processability and stability without the need for excipients, and enables controlled release formulations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional coating methods are used, then coating can be applied to pharmaceutical substrates, but the process becomes complex, costly, and inefficient with low product yields
Solution Approach 1:
The patent replaces conventional mechanical spray coating systems with a fluidized bed coating system. The fluidized bed approach uses fluid dynamics to suspend particles and deliver coating material uniformly, eliminating the need for complex spray pattern control, nozzle spacing adjustments, and drop size management while achieving superior coating uniformity and reduced process complexity
Solution Approach 2:
The invention changes the fundamental operating parameters of the coating process by transitioning from contact-based spray coating to fluidized bed coating. This parameter change enables continuous coating application, improves coating uniformity, and simplifies process control by eliminating the need to precisely control multiple spray-related parameters simultaneously
2Reliability
If conventional coating methods are used, then coating can be applied to pharmaceutical substrates, but the process becomes costly and results in low product yields
Solution Approach 1:
The fluidized bed coating process enables continuous coating application without the interruptions inherent in conventional batch spray coating. The fluidized state of particles allows for uninterrupted coating material deposition, improving product yield by reducing coating material waste and eliminating the need for multiple coating passes, thereby reducing overall processing costs
Solution Approach 2:
The fluidized bed system utilizes the natural fluidization of particles to achieve uniform coating distribution. The coating material is delivered through the fluidized particle stream, which automatically distributes the coating uniformly across the pharmaceutical substrates without requiring complex external control systems, thereby reducing operational costs and improving productivity
3Reliability
If conventional coating methods are used, then coating can be applied to pharmaceutical substrates, but dissolution and controlled delivery of poorly soluble pharmaceuticals remains challenging
Solution Approach 1:
The fluidized bed coating system enables precise control over the local coating environment, allowing different regions of the coating to have tailored properties. The fluidized state facilitates uniform distribution of coating materials with varying dissolution characteristics, enabling the creation of coatings with specific local properties that control drug release while maintaining manufacturing feasibility through a single integrated process
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
ALD coating enhances the manufacturing process by improving the flow and compressibility of pharmaceuticals, ensuring uniform dosage forms, protecting against moisture and oxygen, and allowing for tailored release profiles, while reducing coating costs and eliminating the need for solvents and plasticizers.
Implementation Method 1
a method wherein a layer of protective material is applied on the surface of a pharmaceutical substrate using an ALD (Atomic Layer Deposition) method
Implementation Method 2
Coating can also been used to work as a barrier against atmospheric stress e.g. humidity, UV-light and oxygen to increase physical and chemical stability of the active agent
Data Source
AI summary
The present invention relates to the field of coating pharmaceutical substrates. In particular, the invention relates to methods of coating of pharmaceutical substances, pharmaceutical ingredients or a blend of them. The invention also provides a method of making a pharmaceutical formulation which may be processed into a pharmaceutical dosage form, which utilizes solid pharmaceutical particles and a pharmaceutical formulation obtained by the method. The methods of the invention utilize atomic layer deposition technology. The novel methods allow difficult, moisture sensitive and electrically charged pharmaceutical substrates to be easily processable.