Direct Modified Release Coating on Band-Sealed Gelatin Capsules

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Solution Overview

Problem

Current methods for creating modified release coated capsules are inefficient, requiring additional preparation steps, high energy consumption, and increased costs due to imperfect adhesion of coatings on hard gelatin capsules, and existing solutions like precoatings or vacuum film coating have limitations in industrial applicability.

Innovation Solution

Applying a modified release coating directly onto a band-sealed capsule shell without a precoat, using a band to seal the gap between the capsule body and cap, which allows for reduced amounts of enteric polymer and thinner coatings, improving adhesion and manufacturing efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a precoating is applied to improve adhesion of modified release coating on hard gelatin capsules, then coating adhesion is improved, but preparation time and manufacturing costs increase

Engineering Contradiction:
Improvecoating adhesionVSAvoidpreparation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The invention removes the precoating step from the manufacturing process by directly applying the modified release coating to the capsule shell. This extraction of the unnecessary intermediate step reduces preparation time and manufacturing complexity while maintaining coating adhesion through optimized direct coating formulation and process parameters.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention performs preliminary surface preparation of the capsule shell through controlled moisture conditioning and surface activation before direct coating application. This preliminary action ensures the capsule shell surface is optimally prepared for direct coating adhesion without requiring a separate precoating layer.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a precoating is applied to improve coating adhesion, then coating stability is improved, but manufacturing complexity and costs increase

Engineering Contradiction:
Improvecoating stabilityVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention eliminates the precoating layer and associated manufacturing equipment requirements by implementing a direct coating process. This reduces manufacturing complexity while achieving comparable coating stability through optimized coating formulation and application parameters.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the coating process parameters including coating solution composition, application rate, drying conditions, and capsule shell pre-conditioning parameters to enable direct coating application with stability equivalent to precoated systems.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If vacuum film coating is used to eliminate precoating, then preparation steps are reduced, but technical complexity and industrial applicability are limited

Engineering Contradiction:
Improvemanufacturing efficiencyVSAvoidtechnical complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The invention replaces the complex vacuum film coating mechanical system with a conventional atmospheric spray coating system. This substitution maintains manufacturing efficiency by using widely available equipment while achieving the same goal of eliminating precoating requirements.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The invention optimizes coating process parameters for atmospheric spray application including aerosol formulation, spray pattern, deposition rate, and environmental conditions to achieve uniform coating quality without requiring vacuum equipment.

Inventive Principle:
Principle #35Parameter changes

4Object-affected harmful factors

If thicker enteric coating is applied to ensure acid resistance, then protection against stomach acid is improved, but capsule size and weight increase

Engineering Contradiction:
Improveacid resistanceVSAvoidcapsule weight
Core Design Contradiction:
Object-affected harmful factorsVSWeight of moving object

Solution Approach 1:

The invention changes the enteric coating formulation parameters including polymer molecular weight, copolymer composition ratio, and crosslinking density to achieve high acid resistance with reduced coating thickness. This reduces capsule weight while maintaining protection against stomach acid.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention uses composite enteric coating formulations combining multiple polymer types with complementary properties to achieve enhanced acid resistance at lower coating weights through synergistic material interactions.

Inventive Principle:
Principle #40Composite materials

Data Source

PatentUS11160762B2Modified release coated capsules
Publication Date: 2021.11.02 TILLOTS PHARMA AG
  • US11160762B2 patent drawing
  • US11160762B2 patent drawing
  • US11160762B2 patent drawing

AI summary

The present invention relates to a modified release coated capsule and a process to obtain that capsule.