Stabilized Modified-Release Vitamin D Formulation for Storage Stability
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Solution Overview
Problem
Existing controlled release formulations of 25-hydroxyvitamin D compounds face issues with stability during storage, leading to undesirable fluctuations in vitamin D levels and increased catabolism, which can cause toxicity and require frequent patient monitoring.
Innovation Solution
A stabilized formulation comprising 25-hydroxyvitamin D compounds and a cellulosic compound, such as cellulose derivatives, maintains consistent vitamin D release and absorption, ensuring stability and bioavailability over extended periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If controlled release formulations of 25-hydroxyvitamin D are used, then vitamin D absorption is improved and blood levels are maintained, but stability during storage deteriorates leading to fluctuations in vitamin D levels
Solution Approach 1:
The patent introduces a stabilizer as an intermediary substance that mediates between the 25-hydroxyvitamin D compound and the storage environment. The stabilizer prevents degradation and maintains formulation integrity during storage, thereby preserving vitamin D level consistency without requiring changes to the controlled release mechanism itself.
Solution Approach 2:
The patent modifies the formulation parameters by adding stabilizing agents and adjusting compositional ratios to enhance storage stability. These parameter changes allow the formulation to maintain its controlled release properties while becoming resistant to storage-induced degradation, resolving the contradiction between reliability and stability.
2Object-affected harmful factors
If controlled release formulations are used to maintain constant blood levels, then toxicity risks are reduced, but storage instability increases leading to supraphysiological surges
Solution Approach 1:
The patent applies beforehand cushioning by incorporating stabilizers into the formulation during manufacturing, before storage begins. This preemptive measure cushions against potential degradation and prevents the formation of unstable products that could cause supraphysiological surges and toxicity, while preserving the intended controlled release profile.
Solution Approach 2:
The stabilizer acts as an intermediary that protects the 25-hydroxyvitamin D compound from storage-induced changes. This intermediary prevents the formation of degradation products that could lead to toxicity, while allowing the formulation to maintain its designed release characteristics for safe and effective therapy.
3Device complexity
If immediate release formulations are used, then formulation simplicity is maintained, but frequent patient monitoring is required due to supraphysiological surges
Solution Approach 1:
The patent creates a composite formulation by combining 25-hydroxyvitamin D with controlled release agents and stabilizers. This composite structure provides sustained release functionality and storage stability, eliminating the need for frequent monitoring while maintaining manageable formulation complexity through the use of established pharmaceutical excipients and processes.
Data Source
AI summary
A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation can comprise one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a stabilizing compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.