Biphasic Calcium Composition for Controlled Release
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Solution Overview
Problem
Current calcium supplements have low bioavailability and cause gastric side effects due to variations in pH and absorption rates in the gastrointestinal tract, leading to inadequate calcium delivery and compliance issues in patients.
Innovation Solution
A biphasic, controlled-release oral composition comprising a first portion for immediate release of calcium compounds like calcium carbonate and a second portion for extended release of calcium compounds like calcium citrate, optimized with pharmaceutically acceptable excipients and polymers for sustained delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If immediate-release calcium formulations are used, then high calcium delivery is achieved, but gastric side effects and hypercalcemia occur due to rapid absorption
Solution Approach 1:
The calcium supplement is divided into multiple dosage forms with different release characteristics (immediate-release and extended-release formulations). This segmentation allows the calcium to be delivered in controlled amounts over different time periods, preventing rapid absorption that causes hypercalcemia and gastric side effects while still providing adequate total calcium delivery.
2Object-affected harmful factors
If extended-release calcium formulations are used, then gastric side effects are reduced, but inadequate calcium absorption occurs due to slow release
Solution Approach 1:
The extended-release formulation is designed to release calcium gradually over time, providing a sustained supply that avoids the gastric side effects of immediate-release formulations. The segmented release profile ensures that calcium is delivered at manageable rates throughout the dosing interval, improving tolerance while maintaining adequate absorption.
3Quantity of substance
If high amounts of elemental calcium are present in immediate-release formulations, then calcium supplementation effectiveness is improved, but undissolved calcium remains in the GI tract causing side effects
Solution Approach 1:
The total calcium dose is segmented between immediate-release and extended-release formulations. The immediate-release portion provides rapid calcium delivery for effectiveness, while the extended-release portion delivers the remaining calcium gradually, preventing undissolved calcium accumulation in the GI tract and associated side effects.
Solution Approach 2:
The formulation changes the release rate parameter of calcium over time. By using different release kinetics (fast initially, then slower), the system maintains high calcium availability for absorption while preventing the saturation of absorption mechanisms that leads to undissolved calcium remaining in the GI tract.
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
Enhances calcium absorption and bioavailability, reducing toxicity and gastric side effects, thereby improving patient compliance and ensuring consistent calcium levels.
Implementation Method 1
A first phase of release, such as immediate release of a calcium compound such as calcium carbonate, may be released immediately and absorbed mostly or fully in acidic media
Implementation Method 2
A second phase of release, such an extended release of a calcium compound, such as calcium citrate, may be released
Data Source
AI summary
Orally administrable compositions comprising calcium, methods of administration, and methods of making the same.