Amphipathic Lipid Sustained Release Chewable Compositions
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Solution Overview
Problem
Existing chewable sustained release compositions either inhibit sustained release upon chewing or have an unacceptable taste, leading to uncontrolled drug release and decreased patient compliance, particularly in veterinary and human medicine for patients with swallowing difficulties.
Innovation Solution
A chewable sustained release composition comprising one or more active ingredients, amphipathic lipids, and bulking or spheronizing agents, encapsulated within a matrix that maintains sustained release properties even when fragmented, without requiring heating above the melting points of the lipids, thus reducing production costs and minimizing active ingredient degradation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If wax-based agents are used to provide sustained release and taste-masking properties, then the composition can maintain sustained release characteristics, but the composition requires heating to temperatures exceeding the melting points of the wax-like agents, increasing production costs and potentially damaging the encapsulated drug or active ingredient
Solution Approach 1:
The invention changes the physical state parameter of the amphipathic lipid from solid to liquid by heating to a temperature above its melting point but below the degradation temperature of the active ingredient. This allows the lipid to encapsulate the active ingredient effectively without requiring excessive heat that would damage the drug. The key is modifying the temperature parameter to a specific range that achieves encapsulation while preserving drug integrity.
Solution Approach 2:
The invention uses a composite system combining amphipathic lipids with other compatible materials to form a matrix that provides sustained release properties. This composite approach allows the use of materials with lower melting points compared to traditional waxes, reducing the heating temperature required during manufacturing while maintaining the sustained release characteristic.
2Ease of operation
If most sustained release compositions are chewed, then they become suitable for patients with swallowing difficulties, but chewing inhibits their ability to slowly release the drug or active ingredient, resulting in an uncontrolled burst of the drug
Solution Approach 1:
The invention creates a dynamic matrix system where the amphipathic lipid matrix can adapt its structure in response to mechanical stress from chewing. The matrix maintains its sustained release properties through its viscoelastic characteristics, allowing it to deform under chewing forces while progressively releasing the active ingredient rather than disintegrating completely and causing a burst release.
Solution Approach 2:
The amphipathic lipid matrix is pre-formulated with specific structural characteristics that anticipate mechanical stress from chewing. The matrix is designed to resist complete breakdown during chewing while allowing controlled drug release, preparing the structure in advance to maintain sustained release properties even when fragmented in the oral cavity.
3Ease of operation
If most sustained release compositions are chewed, then they can be administered to patients with swallowing difficulties, but the composition has an unacceptable taste when chewed, decreasing patient willingness to accept such tablets
Solution Approach 1:
The amphipathic lipid matrix acts as an intermediary barrier between the active ingredient and the patient's taste receptors. The lipid structure encapsulates the active ingredient, preventing direct contact with taste buds and masking unpleasant tastes. This intermediary layer allows the composition to be chewed while maintaining acceptable taste characteristics.
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 composition achieves a controlled and sustained release of active ingredients over an extended period, maintaining release characteristics and taste-masking properties when chewed, with an in vitro dissolution rate that meets USP criteria, ensuring effective and prolonged drug delivery.
Implementation Method 1
comprising one or more active ingredients, one or more amphipathic lipids, and at least one bulking or spheronizing agent. The active ingredients are encapsulated within a matrix comprising the amphipathic lipids and the bulking or spheronizing agent.
Data Source
AI summary
Chewable sustained release compositions and their methods of production are provided. The sustained release compositions contain amphipathic lipids and matrix-forming polymers, which are used to encapsulate various drugs and active ingredients. The chewable sustained release compositions can maintain their sustained release properties even after being fragmented into a plurality of pieces.