Moisture Buffer Layer for Gelatin Capsule Packaging
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Solution Overview
Problem
Hard gelatin capsules become brittle and prone to breaking when pressed out of blister packages due to moisture-related issues, as existing packaging technologies fail to maintain a stable, non-brittle state, especially when relative humidity is low.
Innovation Solution
A method involving a lid film and blister base with a moisture-regulating buffer layer containing hygroscopic salts, silica gel, or zeolites, which adjusts humidity within the package to a range of 10-50% relative humidity, preventing brittleness by maintaining a dry and non-brittle state of the capsules.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If hard gelatin capsules are packed in conventional blister packages without moisture regulation, then the packaging is simple and cost-effective, but the capsules become brittle and break when pressed out
Solution Approach 1:
A moisture-regulating buffer layer is introduced as an intermediary component between the capsule and the blister package environment. This buffer layer actively controls the microclimate around the capsule, maintaining optimal humidity levels to prevent brittleness while the capsule remains packaged.
Solution Approach 2:
The moisture-regulating buffer layer is pre-positioned within the blister package structure before the capsule is sealed inside. This preliminary arrangement ensures that moisture control is immediately effective from the moment of packaging, preventing brittleness development during storage and transport.
2Stability of the object's composition
If the relative humidity in the packaging is reduced to prevent moisture-related softening, then capsule softening is prevented, but the capsules become brittle and prone to breaking
Solution Approach 1:
The invention optimizes the moisture-regulating buffer layer composition with specific absorber material concentrations (1-60 wt.%) to achieve an ideal relative humidity range (10-50% r.h.). This parameter optimization balances moisture control to prevent both softening and excessive drying that would cause brittleness.
Solution Approach 2:
The moisture-regulating buffer layer creates a localized controlled environment around each capsule within the blister package. This local moisture control ensures that each capsule maintains its optimal humidity level independently, preserving both moisture stability and mechanical strength.
3Object-affected harmful factors
If existing packaging materials with strong moisture absorption are used, then moisture control is enhanced, but the capsules become too dry and brittle
Solution Approach 1:
The invention modifies the moisture absorption characteristics by precisely controlling the absorber material content (1-60 wt.%) and selecting appropriate types (hygroscopic salts, silica gel, or zeolites). This parameter control ensures the buffer layer provides sufficient moisture regulation without over-drying the capsules, preventing brittleness.
Solution Approach 2:
The moisture-regulating buffer layer is formulated as a composite material system combining polymer matrices with specific absorber materials. This composite structure provides balanced moisture regulation properties that control humidity within the optimal 10-50% r.h. range, preventing both moisture-related softening and excessive drying.
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 effectively prevents hard gelatin capsules from breaking when pressed out of the blister package by maintaining a stable humidity level, reducing the risk of brittle failure and ensuring reliable drug delivery.
Implementation Method 1
the moisture-regulating buffer layer (20), the lid film and/or the blister base comprising the buffer layer or a prelaminate for the lid film and/or the blister base comprising the buffer layer is exposed to a predefined moisture level, wherein the predefined moisture level of the buffer layer is such that it buffers the humidity in the space surrounding the hard gelatin capsule within the cavity closed by the lid film to lie in a range between 10 and 50 % r.h.
Implementation Method 2
the moisture-regulating buffer layer contain 1 to 60 wt.% of an absorber material which is either a hygroscopic salt, a silica gel or a zeolite or a mixture of any of said absorber materials
Data Source
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AI summary
A method for conditioning a hard gelatin capsule (50) having any moisture content to a dry and non-brittle state when packed for at least one week in a cavity (45) of a blister base (40) closed by a lid film (35) comprising an aluminium foil, wherein the hard gelatin capsule (50) is a hard starch capsule manufactured from collagen and the hard gelatin capsule (50) contains pharmaceuticals and wherein the dry state of the hard gelatin capsule (50) means a relative humidity of less than 50% at room temperature and the non- brittle state means that the hard gelatin capsule (50) does not break when pressed out of the cavity (45) of the blister base (40) through the lid film (35). The lid film (35) and/or the blister base (40) comprise/s a moisture-regulating buffer layer (20) with a predefined humidity. The moisture-regulating buffer layer (20) consists of a polymer or polymer mixture containing 1 to 60 wt.% of an absorber material which is either a hygroscopic salt, a silica gel or a zeolite or a mixture of any of said absorber materials, wherein the absorber material buffers the humidity in the space within the cavity (45) surrounding the hard gelatin capsule (50) to lie in a range between 10 and 50 % r.h.