Microencapsulated Probiotic Softgel Capsule Manufacturing Process
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Probiotic bacteria in softgel capsules face challenges in maintaining viability and stability during storage at room temperature due to high water activity and physical stress during the manufacturing process, leading to rapid decline in colony-forming units (CFU) and ineffective colonization.
Innovation Solution
A process involving microencapsulating probiotic bacteria with a vegetable lipid coating having a melting point between 35°C and 75°C, suspending them in a formulation, mixing at low intensity and temperature, reducing agglomerates, and encapsulating in a softgel capsule to maintain coating integrity and viability, while controlling oxygen exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If probiotic bacteria are placed in softgel capsules for oral delivery, then they can reach the large intestine, but they rapidly lose viability during storage at room temperature due to high water activity and physical stress during manufacturing
Solution Approach 1:
The probiotic bacteria are pre-coated with a protective lipid coating before encapsulation in the softgel capsule. This preliminary coating action creates a protective barrier that prevents direct contact with the harsh internal environment of the capsule and protects during storage, thereby maintaining viability throughout the shelf life period.
Solution Approach 2:
A lipid coating serves as an intermediary layer between the probiotic bacteria and the softgel capsule environment. This intermediate coating protects the bacteria from physical stress during manufacturing and from the high water activity inside the capsule, enabling both oral delivery and long-term storage at room temperature while maintaining viability.
2Stability of the object's composition
If the softgel capsule manufacturing process involves mixing and encapsulation steps, then the probiotic bacteria can be delivered in a stable form, but physical stress during processing compromises cell viability and shelf life
Solution Approach 1:
The lipid coating is applied to the probiotic bacteria before they are subjected to the mixing and encapsulation processes. This preliminary protective action prevents physical stress during processing from directly affecting the bacterial cells, thereby maintaining cell viability while still achieving stable formulation through the subsequent manufacturing steps.
3Duration of action of stationary object
If a protective coating is applied to probiotic bacteria to enhance stability, then shelf life is improved, but the coating must be designed to release probiotics at the appropriate delivery site in the body
Solution Approach 1:
The lipid coating is designed with specific physical parameters including a melting point between 35°C and 75°C. This parameter change approach allows the coating to remain stable during storage and manufacturing at lower temperatures, while automatically melting and releasing the probiotic bacteria at body temperature in the gastrointestinal tract, thus achieving both long shelf life and appropriate release without complex manufacturing.
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 process results in a stable softgel capsule with enhanced viability and shelf life of at least 24 months at room temperature, maintaining a high percentage of viable probiotic bacteria for effective colonization.
Implementation Method 1
microencapsulated probiotic bacteria with at least one coating comprising at least one vegetable lipid having a melting point of between 35° C. and 75° C.
Implementation Method 2
encapsulating the de-agglomerated fill in a softgel capsule
Data Source
AI summary
A softgel capsule containing microencapsulated probiotic bacteria is manufactured such that the softgel capsule is stable for at least about 24 months at room temperature.