Calcium-Treated Pectin Softgel Capsules for Enteric Shell Strength

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Solution Overview

Problem

Existing methods for preparing softgel capsules face challenges in improving pH tolerance in enteric dissolution and disintegration, as well as the robustness of the shell, due to electrostatic attraction and complex coacervate formation in acidic conditions.

Innovation Solution

A method involving treatment of softgel capsules with a solution containing calcium salts, such as calcium chloride, along with hydrochloric acid and dextrose, to initiate ionotropic gelation and enhance the enteric functionality and physical robustness of the capsule shell.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional enteric polymers are added in the capsule shell to protect contents from gastric conditions, then enteric functionality is improved, but electrostatic attraction occurs leading to complex coacervate formation that reduces shell robustness

Engineering Contradiction:
Improveenteric functionalityVSAvoidshell robustness
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The patent applies parameter changes by treating the capsule shell with a calcium salt solution (1-25 wt%) at controlled pH (less than 3) and temperature conditions. This treatment modifies the physical-chemical parameters of the shell materials, inducing ionotropic gelation that transforms the shell structure to achieve both enteric functionality and mechanical strength without coacervate formation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite shell structure by combining conventional enteric polymers with gelatin and applying calcium salt treatment. This composite approach allows the shell to exhibit both enteric properties (from the polymers) and enhanced mechanical strength (from the calcium-induced gelation network), resolving the contradiction between functionality and robustness.

Inventive Principle:
Principle #40Composite materials

2Strength

If the capsule shell is made more robust to withstand gastric conditions, then shell strength is improved, but pH tolerance in enteric dissolution and disintegration deteriorates

Engineering Contradiction:
Improveshell strengthVSAvoidpH tolerance in enteric dissolution
Core Design Contradiction:
StrengthVSAdaptability or versatility

Solution Approach 1:

The patent applies preliminary action by pre-treating the capsule shell with calcium salt solution before final formulation completion. This preliminary calcium treatment establishes a stable gelation network that provides mechanical strength while preserving the shell's ability to respond to pH changes during dissolution, preventing premature hardening that would compromise enteric functionality.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements dynamics by creating a shell structure that adapts its properties in response to environmental pH changes. The calcium-treated shell maintains structural integrity at low pH (gastric conditions) through the gelation network, but remains capable of dissolution at higher pH (intestinal conditions), achieving both strength and pH tolerance through dynamic responsiveness.

Inventive Principle:
Principle #15Dynamics

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 results in capsules that maintain integrity in acidic environments, demonstrating improved burst strength and controlled disintegration in neutral to basic pH conditions, ensuring effective delivery of active ingredients.

Implementation Method 1

treating a softgel capsule with a solution comprising a calcium salt... to initiate ionotropic gelation and enhance the enteric functionality and physical robustness of the capsule shell

Methodology Applied
Scientific EffectIonotropic gelation: Gel

Implementation Method 2

electrostatic attraction may occur in such capsules shell such that a complex coacervates may form in the shell

Methodology Applied
Scientific EffectElectrostatic attraction: Electrostatics

Data Source

PatentUS20250367124A1Softgel capsules and a method for preparing the softgel capsules
Publication Date: 2025.12.04 R P SCHERER TECH INC
  • US20250367124A1 patent drawing

AI summary

Disclosed herein is a method for preparing a softgel capsule including treating a softgel capsule with a solution including a calcium salt, wherein the softgel capsule includes a fill material and a shell composition including pectin.