Nested Capsule Design for Delayed Release of Acid-Unstable Drugs
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Solution Overview
Problem
Existing capsule designs for delayed release of pharmaceuticals are limited by their size and structure, which do not effectively enhance the release of acid-instable active substances, leading to issues such as premature disengagement and inefficient use of space within the capsule.
Innovation Solution
A multi-part capsule design featuring an outer and inner capsule configuration where the inner capsule is inverted, creating a 3- or 4-wall configuration along the length, minimizing the gap between capsules and maximizing the inner volume for a larger active substance load, while using acid-resistant materials like HPMC and gellan gum for enhanced delayed release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a single capsule shell is used for delayed release, then the capsule structure is simple, but the delayed release effect is insufficient and space utilization is poor
Solution Approach 1:
The patent employs a nested capsule structure where an inner capsule is placed inside an outer capsule. The inner capsule contains the active substance and is made of acid-resistant material for delayed release, while the outer capsule provides additional protection and structural support. This nested configuration maximizes the use of internal space and enhances the delayed release effect without excessive complexity.
Solution Approach 2:
The capsule is divided into distinct segments: an inner capsule containing the active substance and an outer capsule providing additional protection. This segmentation allows each layer to perform specific functions - the inner capsule provides acid resistance and delayed release, while the outer capsule offers mechanical protection and can be made of different materials optimized for its specific role.
2Reliability
If multiple two-piece capsules are stored within one another, then delayed release is improved, but the overall size increases and handling becomes difficult
Solution Approach 1:
The inner capsule is nested within the outer capsule in a compact arrangement that minimizes the overall volume. The telescopic engagement between the inner and outer capsules allows for tight fitting with minimal gaps, reducing the overall size while maintaining the delayed release functionality of the nested structure.
3Volume of moving object
If capsule components are tightly fitted, then space is maximized, but premature disengagement may occur during handling
Solution Approach 1:
The capsule components feature curved surfaces that facilitate smooth telescopic engagement. The rounded geometry allows the inner capsule to be easily inserted into and engaged with the outer capsule while maintaining a tight fit that maximizes internal volume. The curved surfaces distribute mechanical stresses evenly, reducing the risk of premature disengagement during handling.
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 design ensures effective delayed release of acid-instable substances without increasing the overall size of the capsule, improving stability and homogeneity of the release profile, and facilitating easier handling and swallowing.
Implementation Method 1
delayed release in capsule technology is highly desirable since it permits to store within the capsule active materials that are normally acid instable
Data Source
AI summary
A comestible dosage form article for administration to a target subject, the dosage form comprising: an outer capsule comprising a first cap telescopically engageable with a first body; and an inner capsule, within the outer capsule, comprising a second cap telescopically engageable with a second body, wherein the inner capsule is inverted with respect to the outer capsule such that, in an assembled state, the second cap is proximal to the first body and distal to the first cap.