Pharmaceutically Stable Soft Capsule with Immiscible Phases

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Solution Overview

Problem

Conventional soft capsules struggle to effectively combine two or more different pharmaceutical active ingredients in a single formulation without separate granules, leading to potential reactivity and stability issues during storage and release.

Innovation Solution

A pharmaceutically stable soft capsule formulation is developed, featuring a continuous first phase and a continuous second phase with distinct liquid or suspension bases, where the first phase and second phase are separated without an additional surfactant or physical layer, allowing for independent delivery of active ingredients with different solubility properties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If two or more different pharmaceutical active ingredients are combined in a single soft capsule formulation, then medication compliance and convenience are improved, but reactivity between ingredients increases and stability deteriorates

Engineering Contradiction:

Improvemedication complianceVSAvoidformulation stability

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The soft capsule is divided into multiple compartments, each containing a different pharmaceutical active ingredient in its own compatible base. The gelatin shell is segmented into separate chambers that physically isolate ingredients, preventing reactivity while maintaining a single-dose formulation for improved compliance.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Multiple composition units are nested within the gelatin shell structure, with each composition containing an active ingredient and its compatible base. The compositions are arranged in a nested configuration where each unit is self-contained, preventing interaction between different pharmaceutical agents while maintaining overall formulation integrity.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If separate granules are used for each active ingredient, then stability is improved, but device complexity and manufacturing complexity increase

Engineering Contradiction:

Improveformulation stabilityVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

Multiple separate composition units are merged into a single integrated soft capsule formulation. The gelatin shell encapsulates multiple compositions in one manufacturing process, eliminating the need for separate granule handling while maintaining the stability benefits of separation through compatible bases and physical compartmentalization.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The gelatin shell serves multiple functions simultaneously: it provides structural containment, creates physical barriers between compositions, and enables a single-dose delivery system. The formulation structure is designed to handle multiple active ingredients through a unified manufacturing process, reducing overall system complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of manufacture

If a single liquid phase is used for multiple active ingredients, then manufacturing simplicity is improved, but compatibility and stability deteriorate due to reactivity

Engineering Contradiction:

Improvemanufacturing simplicityVSAvoidingredient compatibility

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

Each composition within the soft capsule has its own locally optimized base that is specifically compatible with its active ingredient. Rather than using a single universal base, the formulation employs locally tailored bases in each compartment, ensuring chemical compatibility and stability for each pharmaceutical agent while maintaining manufacturing feasibility.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The formulation uses composite material structures where each composition consists of an active ingredient combined with its compatible base material. These composite compositions are then integrated into the gelatin shell, allowing each ingredient to be stabilized by its specific base while maintaining overall formulation manufacturability through the unified capsule structure.

Inventive Principle:

Principle #40Composite materials

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

This approach minimizes reactivity between active ingredients, ensuring stability and optimal bioavailability by maintaining phase separation, allowing for a synergistic effect and improved medication compliance.

Implementation Method 1

the first liquid phase and the second liquid phase are immiscible with each other and are present as separate phases

Methodology Applied

Scientific EffectImmiscibility:

Implementation Method 2

a gelatin shell formulation made of a gelatin, a plasticizer, and water

Methodology Applied

Scientific EffectGelatin gelation: Gel

Data Source

PatentUS20240293329A1Pharmaceutically stable soft capsule comprising two or more different compositions

Publication Date: 2024.09.05 COSMAXPHARMA CO LTD

AI summary

The present disclosure relates to a pharmaceutically stable soft capsule formulation containing two or more different compositions, wherein each single ingredient can be formulated as a composite formulation, and a formulation with improved stability can be provided by minimizing a reaction between two or more different compositions.