Enteric Soft Capsule Shell Formulation with Alkaline Agents
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Solution Overview
Problem
Existing enteric soft capsule manufacturing processes face challenges with brittle and viscous gel masses, requiring additional plasticizers and volatile alkaline agents, which complicate the manufacturing process and pose safety concerns.
Innovation Solution
The development of enteric soft capsules with gastric-resistant polymer compositions that include film-forming polymers like gelatin and acid-insoluble polymers, such as acrylic and methacrylate acid copolymers, which reduce the need for plasticizers and eliminate the use of volatile alkaline agents, enhancing manufacturing efficiency and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If integrated enteric polymers are used in capsule shell formulation, then enteric properties and surface homogeneity are improved, but gel mass becomes brittle and viscous requiring additional plasticizers
Solution Approach 1:
The patent changes the chemical parameters of the gel mass formulation by incorporating alkaline agents (ammonium hydroxide, sodium hydroxide, or potassium hydroxide) at controlled concentrations (0.1-10% w/w). This parameter change modifies the gel mass properties to achieve optimal balance between enteric resistance, elasticity, and manufacturability, resolving the contradiction between improved enteric properties and manufacturing complexity
Solution Approach 2:
The patent creates a composite gel mass formulation combining film-forming polymers (gelatin, HPMC, or carrageenan), enteric polymers (acrylic/methacrylate copolymers), plasticizers, and alkaline agents. This composite approach integrates multiple functional components that work synergistically to provide both enteric properties and manufacturing flexibility without requiring excessive plasticizers
2Manufacturing precision
If integrated enteric polymers are used to eliminate coating defects, then surface homogeneity is improved, but volatile alkaline agents are required posing safety concerns
Solution Approach 1:
The patent carefully controls the concentration parameters of alkaline agents within specific ranges (0.1-10% w/w in gel mass, 1-20% w/w of enteric polymer weight) to achieve the necessary pH modification for polymer dissolution without excessive volatility. This parameter optimization reduces safety hazards while maintaining enteric functionality and surface homogeneity
Solution Approach 2:
The patent introduces alkaline agents as intermediary substances that facilitate the dissolution of enteric polymers at intestinal pH without requiring volatile alkaline compounds. The alkaline agents act as mediators between the enteric polymer matrix and the intestinal environment, enabling controlled drug release while improving manufacturing safety
3Ease of manufacture
If additional plasticizers are used to reduce gel mass viscosity, then ease of manufacturing is improved, but device complexity increases
Solution Approach 1:
The patent optimizes the plasticizer concentration parameter within specific ranges (5-50% w/w of gel mass) and combines it with controlled alkaline agent addition to achieve optimal gel mass viscosity and elasticity. This balanced parameter approach improves processability while minimizing the need for excessive plasticizers and reducing formulation complexity
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 new compositions result in enteric soft capsules with improved elasticity and enteric properties, increased compatibility with alkali-labile active substances, and simplified manufacturing, while maintaining enhanced stability and controlled release profiles.
Implementation Method 1
at least one or more acid-insoluble polymers
Implementation Method 2
formed from a gel mass composition comprising: (a) at least one or more film-forming polymers
Implementation Method 3
at least one or more plasticizers
Data Source
AI summary
Described herein are enteric soft capsules comprising gastric resistant polymers and gelatin and methods for manufacturing the same. The enteric soft capsules described herein have enhanced enteric and elastic properties and are simpler to manufacture and produce.