Enteric Seamless Soft Capsule Gelatin Pectin Viscosity
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Solution Overview
Problem
Conventional capsules with gelatin or agar shells disintegrate in acidic stomach environments, limiting their use for acid-labile substances and requiring the development of enteric capsules with acid resistance to release active ingredients effectively in the intestines.
Innovation Solution
Manufacturing enteric seamless soft capsules using a capsule shell liquid composed of gelatin and low methoxy pectin with a degree of esterification of 0 to 40% and a degree of amidation of 0 to 25%, achieving a viscosity of 60 to 127 mPa•s at 50°C, which allows for effective encapsulation and acid resistance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If conventional gelatin or agar shells are used, then the capsule is easy to manufacture, but the shell disintegrates in acidic stomach environment preventing use of acid-labile substances
Solution Approach 1:
The capsule shell uses a composite material system combining gelatin with enteric coating agents (methacrylic acid-methacrylate copolymer and cellulose acetate phthalate) to achieve both ease of manufacture and acid resistance. The enteric coating layer protects the gelatin core from acidic environments while maintaining manufacturing simplicity through a two-layer structure.
Solution Approach 2:
The invention changes the chemical and physical parameters of the shell material by applying enteric coating agents with specific molecular weights and esterification degrees. The coating layer transforms the shell's response to pH conditions, enabling it to resist acid dissolution at stomach pH while dissolving at intestinal pH.
2Reliability
If enteric coating is applied to achieve acid resistance, then acid-labile substances can be protected, but the manufacturing process becomes more complex
Solution Approach 1:
The enteric coating is applied in advance during the capsule manufacturing process itself, rather than as a separate post-processing step. The coating is applied to the formed capsule shell before filling, integrating the acid resistance function into the base manufacturing流程 and reducing overall process complexity.
Solution Approach 2:
The invention uses specific enteric coating agents as intermediaries between the gelatin shell and the acidic stomach environment. These coating agents (methacrylic acid-methacrylate copolymer and cellulose acetate phthalate) act as protective mediators that allow the shell to withstand acid without requiring complex structural modifications.
3Strength
If low methoxyl pectin with high degree of esterification is used, then the capsule shell has good film-forming properties, but the viscosity becomes too high for seamless capsule formation
Solution Approach 1:
The invention precisely controls the degree of esterification of low methoxyl pectin within 2-15% and degree of amidation within 0-20%, optimizing the balance between film-forming strength and viscosity. This parameter optimization enables the shell liquid to maintain sufficient viscosity for seamless capsule formation while achieving adequate film strength.
Solution Approach 2:
The invention applies different functional requirements to different components of the shell liquid: low methoxyl pectin provides film strength and structural integrity, while gelatin provides flexibility and processability. This local quality differentiation allows each component to optimize its specific function without compromising the other.
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 method produces enteric seamless soft capsules that are excellent in formulation properties, effectively encapsulating acid-labile substances and preventing bad breath and flavor reversion, ensuring reliable release in the intestines without disintegration in the stomach.
Implementation Method 1
preparing an enteric capsule shell liquid comprising gelatin and low methoxyl pectin having a degree of esterification of 0 to 40% and a degree of amidation of 0 to 25%
Implementation Method 2
The present inventors focused on the degree of amidation and the degree of esterification of pectin used in a capsule shell and the viscosity of the shell liquid
Implementation Method 3
the enteric capsule shell liquid having a viscosity at 50°C of 60 to 127 mPa•s
Implementation Method 4
Enteric capsules are capsules whose shells have acid resistance, therefore do not disintegrate in the stomach, but disintegrate in the intestines to release the capsule fills
Implementation Method 5
preparing an enteric capsule shell liquid comprising gelatin and low methoxyl pectin having a degree of esterification of 0 to 40% and a degree of amidation of 0 to 25%
Data Source
AI summary
An object is to provide a method of manufacturing a seamless soft capsule that is enteric and excellent in formulation properties. An enteric seamless soft capsule is manufactured by the following steps (a) and (b): (a) preparing an enteric capsule shell liquid comprising gelatin and low methoxy pectin having a degree of esterification of 0 to 40% and a degree of amidation of 0 to 25%, the enteric capsule shell liquid having a viscosity at 50°C of 60 to 127 mPa•s; and (b) encapsulating capsule fills with the enteric capsule shell liquid prepared in the step (a) by dripping. Preferably, the jelly strength of the gelatin is 180 to 330 Bloom, an aqueous solution of the low methoxy pectin at a concentration of 2 mass% has a viscosity at 35°C of 8 to 15 mPa•s, and the enteric capsule shell liquid comprises 10 to 20 parts by mass of the low methoxy pectin per 100 parts by mass of gelatin.