Multilayered Mucosal Patch With Adhesive and Water-Repelling Backing
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Solution Overview
Problem
Current dosage forms for mucosal administration, such as oral films and disintegrating tablets, face challenges including short residence time, low drug bioavailability, sensitivity to environmental conditions, and difficulty in handling, especially for patients with physiological impairments, as well as limitations in loading multiple active pharmaceutical ingredients with tailored release profiles.
Innovation Solution
A multi-layered dosage form comprising an adhesive layer, a water-repelling backing layer, and one or more intermediate layers, where the active pharmaceutical ingredient is incorporated, providing controlled and unidirectional release, improved handling, and versatility in drug loading through techniques like electrospinning, freeze-drying, or spraying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral films and disintegrating tablets are used for mucosal administration, then the dosage form can be taken without water and avoids gastrointestinal degradation, but the residence time in the oral cavity is short and significant washout by saliva occurs
Solution Approach 1:
The dosage form is divided into multiple functional layers: a mucoadhesive layer for attachment, an intermediate layer containing the active pharmaceutical ingredient, and a water-repelling backing layer. This segmentation allows each layer to perform its specific function, with the backing layer preventing saliva penetration and the adhesive layer ensuring prolonged contact with the mucosa.
Solution Approach 2:
The patent uses composite material structures combining hydrophilic polymers in the adhesive layer with hydrophobic materials in the backing layer. This composite approach creates a dosage form that simultaneously exhibits mucoadhesive properties and water resistance, resolving the contradiction between ease of administration and prolonged residence time.
2Quantity of substance
If higher doses are incorporated to guarantee therapeutic effect, then sufficient drug delivery is achieved, but the dosage form becomes more sensitive to ambient conditions and mechanical properties deteriorate
Solution Approach 1:
The active pharmaceutical ingredient is localized in the intermediate layer, separated from the adhesive and backing layers. This local concentration allows high drug loading in a specific region without compromising the overall stability and mechanical properties of the entire dosage form structure.
3Adaptability or versatility
If multiple active pharmaceutical ingredients with tailored release profiles are incorporated, then versatile drug delivery is achieved, but the manufacturing complexity and difficulty of controlling release profiles increase significantly
Solution Approach 1:
Each active pharmaceutical ingredient can be incorporated into separate intermediate layers or different regions of the intermediate layer, allowing independent control of release profiles for each drug. This segmentation simplifies the manufacturing process compared to attempting to control multiple release profiles within a single homogeneous matrix.
4Duration of action of moving object
If electrospinning technique is used to prepare fiber layers for drug loading, then controlled release is achieved, but not all active pharmaceutical ingredients are compatible and loading capacity is limited
Solution Approach 1:
The intermediate layer acts as an intermediary between the electrospun fiber layer and the mucosa, providing a compatible matrix for incorporating various active pharmaceutical ingredients that may not be suitable for direct electrospinning. This intermediary layer expands the range of compatible ingredients while maintaining the controlled release benefits of the fiber structure.
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 multi-layered dosage form ensures efficient, controlled, and unidirectional release of active pharmaceutical ingredients, enhancing bioavailability and ease of use, while allowing for high drug loading and compatibility with various active ingredients, thus addressing the limitations of existing technologies.
Implementation Method 1
an adhesive layer capable of adhering to mucosa of the human or animal body
Implementation Method 2
a water-repelling backing layer
Implementation Method 3
the at least one intermediate layer is a porous semi-solid or solid material
Data Source
AI summary
A dosage form for application on mucosae for release of at least one active pharmaceutical ingredient, wherein the dosage form includes an adhesive layer, made of fibers, capable of adhering to the mucosae of the human or animal body, a water-repelling backing layer, and at least one intermediate layer positioned between the adhesive layer and the water-repelling backing layer. The active pharmaceutical ingredient(s) are incorporated in the intermediate layer(s) and/or in the adhesive layer.