Testosterone Spray Coating for Consistent Immediate Oral Release
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Solution Overview
Problem
Existing methods struggle to provide a reliable and consistent immediate release of testosterone and other active ingredients in drug delivery systems, particularly at industrial scales, leading to inconsistent amounts and undesirable taste or texture.
Innovation Solution
An industrial process involving spray coating at controlled temperatures (35-45°C) with specific polymer and solvent combinations, ensuring precise and immediate release of testosterone and other active ingredients, such as sildenafil or buspirone, in a dual drug delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If spray coating is performed at higher temperatures to improve drying efficiency, then productivity increases, but manufacturing precision deteriorates due to inconsistent testosterone amounts
Solution Approach 1:
The patent applies parameter changes by optimizing the drying temperature to a specific range (35-45°C) that balances drying efficiency with manufacturing precision. This temperature parameter was selected to prevent testosterone degradation while ensuring adequate drying, thereby achieving both productivity and consistent drug amounts in the coating.
2Reliability
If more testosterone is applied in the coating to ensure sufficient release, then the therapeutic effect improves, but object-generated harmful factors worsen due to undesirable taste and texture
Solution Approach 1:
The patent uses parameter changes by optimizing the testosterone content in the spray coating to a precise range (0.5-5% w/w). This parameter optimization ensures sufficient therapeutic effect while minimizing excessive amounts that would cause undesirable taste and texture, thus resolving the contradiction between efficacy and sensory quality.
Solution Approach 2:
The patent applies local quality by ensuring uniform distribution of testosterone within the coating layer through controlled spray coating parameters. This localized uniformity prevents both under-dosing (insufficient therapy) and over-dosing (bad taste/texture) in specific areas of the tablet.
3Quantity of substance
If a thicker coating layer is used to provide sufficient testosterone dose, then the quantity of substance increases, but device complexity increases due to difficulties in achieving uniform distribution
Solution Approach 1:
The patent applies periodic action by using multiple sequential spray coating passes rather than a single thick coating application. This approach allows the coating to be built up layer by layer with proper drying between passes, ensuring uniform distribution of testosterone throughout the coating thickness and simplifying the overall process control.
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
Achieves reliable and consistent release of testosterone and other active ingredients, improving stability and taste, with at least 50% of testosterone released within 1 minute and maintaining therapeutic efficacy.
Implementation Method 1
spray coating at controlled temperatures (35-45°C)
Implementation Method 2
spray coating at controlled temperatures (35-45°C) with specific polymer and solvent combinations
Data Source
AI summary
The invention relates to a process for preparing a time controlled, immediate release drug delivery system for oral administration of a first active ingredient to a subject in need thereof. The invention additionally relates to a dual drug delivery device, comprising the time controlled, immediate release drug delivery system according to the invention, further comprising a spray coating comprising a testosterone.