Multilayer Solid Dosage Form for Vitamin Stability in Neuropathy Treatment
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Solution Overview
Problem
Existing formulations of pyrimidine and/or purine derivatives and B-group vitamins suffer from stability issues due to humidity and acidic conditions, leading to vitamin degradation and the need for strict storage conditions, limiting the effective dosage and efficacy in treating peripheral neuropathies.
Innovation Solution
A multilayer pharmaceutical or nutraceutical solid dosage form is developed, comprising separate layers of pyrimidine/purine derivatives and B-group vitamins, enhancing chemical stability and allowing for higher doses without the need for preservatives or stringent storage conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pyrimidine and purine derivatives are combined with B-group vitamins in existing formulations, then the therapeutic effect for peripheral neuropathies is improved, but the stability of the formulation deteriorates due to vitamin degradation under humidity and acidic conditions
Solution Approach 1:
The formulation is divided into separate layers: a first layer containing pyrimidine and purine derivatives, and a second layer containing B-group vitamins. This segmentation prevents direct contact between the two components, eliminating the chemical interaction that causes vitamin degradation while maintaining the therapeutic benefits of both substances when administered together.
Solution Approach 2:
A pH buffer system is introduced as an intermediary component to neutralize acidic conditions generated by pyrimidine and purine derivatives. The buffer maintains a neutral pH environment, preventing acid-catalyzed degradation of B-group vitamins while allowing the therapeutic agents to coexist in the same formulation.
2Quantity of substance
If high doses of pyrimidine and purine derivatives are administered, then the treatment efficacy for peripheral neuropathies is improved, but the storage conditions become more restrictive due to increased instability
Solution Approach 1:
By segmenting the formulation into separate layers, high doses of pyrimidine and purine derivatives can be administered without compromising stability. The physical separation prevents degradation reactions, allowing the formulation to maintain stability even at higher dosage levels without imposing strict storage restrictions.
Solution Approach 2:
The pH of the formulation is modified by introducing a buffer system that maintains neutral conditions. This parameter change prevents acid-catalyzed degradation, allowing the formulation to remain stable under normal storage conditions even when containing high doses of pyrimidine and purine derivatives.
3Reliability
If pyrimidine and purine derivatives are formulated with B-group vitamins, then the therapeutic benefit is enhanced, but the formulation requires preservatives and stringent storage conditions
Solution Approach 1:
The formulation is segmented into separate layers, eliminating the need for preservatives and complex storage requirements. This simple physical separation maintains therapeutic benefits while reducing formulation complexity by removing the need for additional stabilizing agents and strict storage protocols.
Solution Approach 2:
A pH buffer is introduced as a simple intermediary component that neutralizes acidic conditions. This single addition prevents vitamin degradation without requiring preservatives or complex storage conditions, thereby enhancing therapeutic benefit while minimizing formulation complexity.
Data Source
AI summary
The present invention relates to a multilayer pharmaceutical or nutraceutical solid dosage form comprising at least one pyrimidine derivative, purine derivative or any salt or solvate thereof and least one B-group vitamin. It also provides three methods for producing said multilayer pharmaceutical or nutraceutical solid dosage forms. Furthermore, the present invention is also related to therapeutic uses of said multilayer pharmaceutical or nutraceutical solid dosage forms, particularly for the treatment and/or prevention of peripheral neuropathy.