Enteric Soft Gel Capsule Formulation with Intrinsic Acid Resistance
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Solution Overview
Problem
Existing methods for manufacturing enteric soft gel capsules are time-consuming, costly, and require a separate coating process, which can damage the soft gels and result in an opaque shell. Additionally, soft gelatin capsules are not resistant to gastric juice, limiting the formulation of acid-sensitive active pharmaceutical ingredients.
Innovation Solution
A method for manufacturing enteric soft gel capsules involves dissolving a gelling polymer and a plasticizer in water to form a polymer mixture, followed by titrating an acid-insoluble polymer dispersion with an alkali agent to determine the stoichiometric amount needed for neutralization. This neutralized polymer dispersion is then mixed with the polymer mixture and heated to form an enteric gel mass, which is used directly for encapsulation, eliminating the need for a separate coating process.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate coating process is used to provide enteric properties, then the soft gel capsules gain acid resistance, but the process becomes time-consuming, costly, and damages the soft gels resulting in an opaque shell
Solution Approach 1:
The patent combines the enteric coating function with the soft gel formulation by incorporating acid-insoluble polymer directly into the gel mass during encapsulation. This merging eliminates the separate coating step, reducing manufacturing time and cost while avoiding damage to the soft gel structure. The acid-resistant properties are intrinsic to the capsule wall itself rather than being applied as a separate coating layer.
Solution Approach 2:
The patent performs preliminary action by pre-formulating the gel mass with acid-insoluble polymer before encapsulation. This preliminary incorporation of the enteric component into the gel matrix ensures that acid resistance is built-in from the start, eliminating the need for subsequent coating operations and reducing overall manufacturing time.
2Reliability
If a separate coating process is used to provide enteric properties, then the soft gel capsules gain acid resistance, but the process becomes costly and damages the soft gels
Solution Approach 1:
The patent merges the enteric coating function with the soft gel formulation by incorporating acid-insoluble polymer directly into the gel mass during encapsulation. This eliminates the separate coating step, reducing manufacturing complexity and cost while avoiding damage to the soft gel structure. The acid-resistant properties are intrinsic to the capsule wall itself rather than being applied as a separate coating layer.
3Ease of manufacture
If conventional soft gelatin capsules are used, then the capsules are easy to manufacture, but they are not resistant to gastric juice limiting the formulation of acid-sensitive active pharmaceutical ingredients
Solution Approach 1:
The patent uses composite materials by combining gelatin or vegetarian gelling agent with acid-insoluble polymer in a single gel mass formulation. This composite structure maintains the ease of manufacture of soft gel capsules while conferring intrinsic acid resistance through the polymer component, enabling formulation of acid-sensitive APIs without complex coating processes.
4Reliability
If acid-insoluble polymer is added to the gel mass, then the capsules gain intrinsic acid resistance, but the formulation process becomes more complex
Solution Approach 1:
The patent performs preliminary action by pre-formulating the gel mass with acid-insoluble polymer before encapsulation. This preliminary incorporation of the enteric component into the gel matrix ensures that acid resistance is built-in from the start, simplifying the overall process by eliminating the need for separate coating operations despite the additional formulation step.
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 clear, acid-resistant enteric soft gel capsules with intrinsic resistance to gastric juice, eliminating the need for a separate coating process. This results in a more efficient, cost-effective, and aesthetically pleasing product with improved stability and shelf life.
Implementation Method 1
titrating a sample of an acid insoluble polymer in an aqueous dispersion with an alkali agent to obtain a titration curve; determining a first equivalence and a second equivalence from the titration curve, whereby the second equivalence is used to calculate a stoichiometric amount of alkali agent needed to neutralize a bulk amount of an acid insoluble polymer dispersion to become translucent
Implementation Method 2
adding the bulk amount of the translucent acid insoluble polymer dispersion to the polymer mixture while mixing and heating at 70° C. until the enteric gel mass forms
Data Source
AI summary
A method of manufacturing an enteric gel capsule and the enteric gel capsules produced by this method. The method of manufacturing the enteric gel capsule involves: dissolving a gelling polymer and a plasticizer into water to form an polymer mixture; mixing a bulk amount of acid insoluble polymer dispersion with a calculated amount of alkali agent to form a bulk amount of translucent acid insoluble polymer dispersion, the amount of alkali agent determined from a titration curve prepared by titrating a sample of the acid insoluble polymer; and adding the bulk amount of translucent acid insoluble polymer dispersion to the polymer mixture while mixing and heating at 70° C. until a gel mass forms.