Brivaracetam Modified Release Tablet Composition
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Solution Overview
Problem
Existing modified release formulations of brivaracetam face challenges in achieving consistent therapeutic plasma concentrations, reducing adverse effects, and improving patient compliance due to issues with flowability, content uniformity, and dissolution profiles.
Innovation Solution
A modified release tablet composition comprising brivaracetam and at least one diluent (32.0% to 55.0% by weight) with a release rate-controlling membrane coating, using a process such as direct compression or dry granulation to ensure stability and desired pharmacokinetic profiles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If brivaracetam is formulated with high diluent content (32.0% to 55.0% by weight) and release rate-controlling membrane coating, then controlled and prolonged release is achieved, but manufacturing complexity increases
Solution Approach 1:
The tablet is segmented into functional layers: a core layer containing brivaracetam and diluent, and an outer release rate-controlling membrane coating layer. This segmentation allows independent optimization of each layer's properties and simplifies manufacturing by enabling separate preparation and assembly of components.
Solution Approach 2:
The formulation uses composite materials combining brivaracetam (active substance) with specific diluents in optimized ratios (32.0% to 55.0% by weight), covered by a release rate-controlling membrane coating. This composite structure enables controlled release while maintaining manufacturing feasibility through standardized coating processes.
2Stability of the object's composition
If brivaracetam is formulated for modified release, then therapeutic plasma concentration is maintained over prolonged periods, but flowability and content uniformity deteriorate
Solution Approach 1:
The formulation optimizes the diluent content parameter within a specific range (32.0% to 55.0% by weight) to balance content uniformity and release characteristics. This parameter optimization ensures adequate mixing and distribution of brivaracetam while maintaining manufacturability and content uniformity.
Solution Approach 2:
Diluents serve as intermediary substances that facilitate uniform distribution of brivaracetam throughout the tablet matrix. The specific diluent selection and concentration range (32.0% to 55.0% by weight) act as mediators to achieve both content uniformity and controlled release profile.
3Productivity
If brivaracetam is formulated for modified release, then dosing frequency is reduced, but dissolution profile control becomes more difficult
Solution Approach 1:
A release rate-controlling membrane coating is applied as a thin film over the tablet core. This flexible coating layer provides controlled release functionality while being amenable to standard pharmaceutical coating processes, making dissolution profile control achievable through established manufacturing techniques.
Solution Approach 2:
The formulation utilizes specific diluent concentrations (32.0% to 55.0% by weight) to modulate the dissolution profile. By adjusting diluent content within this range, the release characteristics can be optimized to achieve prolonged release while maintaining ease of manufacture through conventional processing.
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 solution achieves a controlled and prolonged release of brivaracetam, enhancing therapeutic efficacy by maintaining constant plasma concentrations, reducing dosing frequency, minimizing adverse effects, and improving patient compliance and convenience.
Implementation Method 1
a modified release tablet composition comprises brivaracetam and at least one diluent wherein the amount of diluents is 32.0% to 55.0% by weight in the total composition and further comprising a release rate-controlling membrane coating
Data Source
AI summary
The present invention relates to a modified release tablet composition comprises brivaracetam and at least one diluent wherein the amount of diluents is 32.0% to 55.0% by weight in the total composition and further comprising a release rate-controlling membrane coating. Furthermore, the tablet is also obtained by using an effective process which is simple, rapid, cost effective, time-saving and industrially convenient process.