Segmented Long-Acting Drug Delivery Device for Reduced Initial Burst
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Solution Overview
Problem
Long-acting drug delivery devices, such as intravaginal rings, experience an initial burst effect due to drug accumulation in the membrane, leading to an increased drug release in the first days after insertion, which is undesirable for drugs with high solubility in the polymer material.
Innovation Solution
The drug delivery device is designed with a specific segment sequence where the drug with better solubility in the polymer matrix is placed between segments containing a less soluble drug, and optionally includes an inactive segment to separate drug-containing segments, reducing the initial burst effect.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a drug delivery device uses a polymer membrane to encase the drug core, then drug release is controlled and extended over time, but an initial burst effect occurs due to drug accumulation in the membrane
Solution Approach 1:
The device is divided into multiple core segments (first core segment containing drug A, second core segment containing drug B) separated by an inactive membrane segment. This segmentation prevents drug accumulation in the membrane by creating distinct compartments, thereby eliminating the initial burst effect while maintaining controlled release over the desired duration.
Solution Approach 2:
An inactive membrane segment acts as an intermediary barrier between the drug-containing core segments. This inactive segment prevents direct drug-membrane interaction that would cause accumulation, serving as a mediator that maintains the benefits of membrane-encased controlled release while eliminating the harmful burst effect.
2Ease of manufacture
If drugs are mixed and equally distributed in the polymer matrix, then formulation is convenient and release rate is consistent, but drugs with high solubility accumulate in the membrane causing burst release
Solution Approach 1:
Instead of mixing drugs throughout the entire matrix, the invention segments the drug distribution into separate core segments. Each core segment contains specific drugs embedded in the polymer matrix, and these segments are separated by inactive membrane portions. This maintains manufacturing simplicity while preventing drug-membrane accumulation.
Solution Approach 2:
The inactive membrane segments are strategically positioned at specific locations between drug-containing core segments. This local modification creates zones where drug accumulation is prevented, applying the quality change only where needed (at membrane-drug interfaces) rather than requiring complete reformulation of the entire device.
3Device complexity
If the device is designed without a membrane or wall encasing the matrix, then the structure is simpler, but drug release is less constant during the wearing time
Solution Approach 1:
The device incorporates a membrane structure divided into active drug-containing core segments and inactive separating segments. This segmented approach maintains the structural benefits of membrane encasement for controlling release consistency while reducing overall complexity by having portions of the membrane serve dual purposes (structural support and drug separation barriers).
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 design results in a reduced initial burst and a more consistent drug release profile over the entire wearing period, independent of storage conditions, improving patient comfort and reducing the need for temperature-controlled storage.
Implementation Method 1
Intravaginal rings are devices made of flexible and drug-permeable polymers... that contains the active drugs release the active drug(s) from the polymer matrix material to the vaginal mucosa for a certain period of time at a defined rate
Implementation Method 2
Intravaginal rings are devices made of flexible and drug-permeable polymers... which provides controlled release of active ingredient(s) to the vagina over extended periods of time
Data Source
AI summary
The invention relates to a method for altering the release characteristics of a long acting drug delivery device containing at least two drugs in different segments, wherein the segments are arranged to a specific sequence.The invention furthermore relates to a drug delivery device with reduced initial burst containing two different drugs in different segments.The invention further relates to a delivery device manufactured according to the a.m. method and its use in contraception and gynecological therapies.