Acid Resistant Banding for Two Piece Hard Capsules
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Solution Overview
Problem
Existing acid-resistant two-piece hard capsules face issues with body-cap separation and leakage during in vitro dissolution tests and in vivo acid resistance, as previous banding solutions fail to provide adequate protection against stomach acid conditions.
Innovation Solution
An acid-resistant banding composition comprising an acid-resistant polymer, an alkaline compound, and a mixture of organic solvent and water is used to create a robust seal between the capsule parts, with a preferred solvent-to-water ratio of 70:30 to 85:15, enhancing the acid resistance and reducing leakage and deformation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional banding solutions are used to seal capsule parts, then leakage prevention during storage is achieved, but acid resistance during in vitro dissolution tests and in vivo conditions deteriorates
Solution Approach 1:
The patent changes the chemical composition parameters of the banding solution by incorporating specific polymers (carbopol, hydroxypropyl methyl cellulose, hydroxypropyl cellulose) and alkaline compounds (ammonium hydroxide, sodium hydroxide, potassium hydroxide) in optimized concentrations. This chemical parameter modification enables the band to resist acid dissolution while maintaining sealing functionality, resolving the contradiction between leakage prevention and acid resistance.
Solution Approach 2:
The patent creates a composite banding material combining multiple polymers and alkaline compounds in a single banding solution formulation. This composite approach integrates the sealing properties of polymers with the acid-resistant properties of alkaline compounds, achieving both leakage prevention and acid resistance simultaneously rather than treating them as separate functions.
2Stability of the object's composition
If gelatin banding solution is used to prevent content leakage, then storage stability is improved, but deformation and separation under mechanical stress worsens
Solution Approach 1:
The patent modifies the physical-chemical parameters of the banding solution by selecting polymers with appropriate molecular weights and viscosities, and controlling the concentration of alkaline compounds. These parameter changes result in a band that maintains flexibility for sealing while developing sufficient mechanical strength to resist deformation and separation under dissolution test conditions, overcoming the limitations of conventional gelatin bands.
3Ease of manufacture
If traditional sealing methods are applied to acid-resistant capsules, then manufacturing simplicity is maintained, but in vivo acid resistance performance deteriorates
Solution Approach 1:
The patent introduces an intermediary substance - the alkaline compound-containing polymer band - that acts as a protective barrier between the capsule contents and the acidic dissolution medium. This intermediary band is applied using conventional banding equipment and procedures, maintaining manufacturing simplicity while providing the additional function of acid resistance that traditional sealing methods lack.
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 solution effectively prevents leakage and deformation, improving the acid resistance of the capsules during in vitro testing and in vivo conditions, while maintaining a visually appealing appearance.
Implementation Method 1
an acid resistant polymer, and an alkaline compound
Implementation Method 2
a mixture of organic solvent and water as solvent
Data Source
AI summary
The present disclosure relates to acid resistant banding solutions for two piece hard capsules endowed with acid resistant properties, and methods of making and using acid resistant banding solutions. The present disclosure also relates, in part, to methods for banding such acid resistant capsules which provides an acid resistant seal between the capsule parts and achieves acid resistance in vitro.