Composite Capsule Formulation with Conforming Tablet
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Solution Overview
Problem
Current composite formulations for treating chronic cardiovascular diseases face challenges in patient compliance due to the need for multiple medications, difficulty in adjusting drug amounts, and chemical interactions that reduce stability, as well as swallowing difficulties caused by large capsule sizes.
Innovation Solution
A composite formulation comprising a tablet encapsulated in a hard capsule with a shape conforming to the internal space, allowing for a high charge rate and improved stability, where the tablet is prepared by compression with pharmaceutically acceptable excipients and can be coated to prevent interactions, enabling efficient administration and enhanced therapeutic effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If multiple separate medications are administered to treat chronic cardiovascular diseases, then therapeutic efficacy is improved through synergistic effects, but patient compliance deteriorates due to the inconvenience of taking multiple drugs
Solution Approach 1:
The patent combines multiple separate medications (capsule containing atorvastatin, ramipril, and enteric-coated aspirin tablet, plus metoprolol tablet) into a single composite formulation package that patients must administer together as one unit, thereby maintaining synergistic therapeutic effects while improving compliance by eliminating the inconvenience of managing multiple separate drugs
2Quantity of substance
If the amount of drugs in a hard capsule is increased to provide high dose therapy, then therapeutic efficacy is improved, but capsule size increases causing swallowing difficulties
Solution Approach 1:
The patent nests a tablet (containing compressed active ingredients and excipients) inside a hard capsule. The tablet is shaped to conform to the capsule's internal space, allowing efficient use of available volume. This nesting approach enables high drug dosing while maintaining manageable capsule size by optimizing the internal geometry and eliminating voids between the tablet and capsule wall
Solution Approach 2:
The patent changes the physical state and density parameters of the drug formulation by compressing active ingredients into a tablet with high density and eliminating voids. The tablet is shaped to match the capsule's internal geometry, maximizing the charge rate (amount of drugs per capsule volume). This parameter optimization allows high drug content in smaller capsules that are easier to swallow
3Ease of operation
If active ingredients are combined in a single capsule to simplify administration, then patient convenience is improved, but chemical interactions may reduce drug stability
Solution Approach 1:
The patent segments the composite formulation into distinct components: a hard capsule containing a tablet with multiple active ingredients (atorvastatin, ramipril, aspirin) and a separate metoprolol tablet. This segmentation allows the active ingredients to be physically separated into different compartments, preventing harmful chemical interactions while maintaining the convenience of a composite formulation that can be administered together
Solution Approach 2:
The patent uses a tablet matrix as an intermediary carrier that holds multiple active ingredients in a controlled environment. The tablet structure acts as a physical barrier and controlled-release mechanism, preventing direct chemical interactions between incompatible drugs while allowing them to be administered together as a unified formulation
4Ease of manufacture
If conventional charging methods are used to fill hard capsules with drugs, then manufacturing is simple, but voids remain reducing charge rate and increasing capsule size
Solution Approach 1:
The patent applies preliminary action by pre-shaping the compressed tablet to conform precisely to the capsule's internal geometry before charging. The tablet is molded with a shape that matches the capsule's internal space, eliminating voids and maximizing the charge rate. This preliminary shaping action is integrated into the tablet manufacturing process, maintaining ease of manufacture while dramatically improving charging efficiency
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 formulation achieves a high charge rate, improved stability, and enhanced therapeutic effects by efficiently filling the capsule space without voids, reducing capsule size, and maintaining stability through separation of active ingredients, thus improving patient compliance and convenience.
Implementation Method 1
the tablet is prepared by compression with pharmaceutically acceptable excipients
Implementation Method 2
the tablet can be coated to prevent interactions
Data Source
AI summary
The present invention relates to a hard capsule composite formulation comprising a capsule having a hemispherical closure at each end and an interior space; and one or more tablets encapsulated in the capsule, wherein the tablet or the tablets as a whole have a shape conforming to the internal space of the capsule. The hard capsule composite formulation can efficiently charge pharmaceutical compositions inside the limited interior space of the capsule, and hence, it allows packing a high-dose of pharmaceutical composition in a relatively small-sized capsule, which increases productivity and patient compliance. Also, the composite formulation exhibits good dissolution rate because pharmaceutically active ingredients contained in the capsule are separated from one another, and thus, the ingredients are less affected by the dissolution rate of one another, allowing good storage stability which can optimize the therapeutic effects.