Multi-compartment Controlled Release Dosage Form for Targeted GI Delivery
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Solution Overview
Problem
Oral drug administration often results in low bioavailability due to limited absorption in the gastrointestinal tract, particularly in the stomach and large intestine, leading to ineffective treatment and increased risk of drug side effects when higher doses are administered to compensate.
Innovation Solution
A drug dosage form comprising a shell with multiple compartments made of materials soluble at specific gastrointestinal sites (stomach, small intestine, or large intestine) to control drug release and absorption, ensuring targeted delivery and increased bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral drug administration is used, then the drug can be easily administered and absorbed in the gastrointestinal tract, but the bioavailability is low due to limited absorption in the stomach and large intestine
Solution Approach 1:
The dosage form is divided into multiple compartments, each containing drugs targeted for specific gastrointestinal sites. The shell is segmented into different sections with distinct release characteristics, allowing simultaneous targeted delivery to multiple locations in the GI tract while maintaining ease of oral administration.
Solution Approach 2:
Different compartments of the shell are designed with specific properties tailored to their target GI sites. Each compartment contains materials with appropriate solubility and release characteristics for its intended location, enabling localized optimization of drug absorption while maintaining overall system simplicity.
2Reliability
If higher doses are administered to compensate for low bioavailability, then the effective amount of drug may be achieved, but the risk of drug side effects increases
Solution Approach 1:
By segmenting the dosage form into targeted compartments, the total drug dose can be distributed to specific GI sites where it is most needed. This reduces the need for high systemic doses and minimizes side effects while ensuring effective treatment at the target locations.
Solution Approach 2:
The multi-compartment shell acts as an intermediary delivery system that transports drugs to their target sites in the GI tract. This intermediary structure enables precise drug placement, reducing waste and minimizing the need for excessive dosing that would increase side effect risk.
3Ease of manufacture
If conventional oral dosage forms are used, then the manufacturing process is simple, but the drug concentration at specific gastrointestinal sites is low
Solution Approach 1:
The dosage form is constructed with multiple compartments that can be filled with different drug formulations during manufacturing. This segmentation allows for targeted drug placement at specific GI sites while using conventional manufacturing techniques, maintaining ease of production despite the enhanced targeting capability.
Solution Approach 2:
Multiple drug-containing compartments are nested within a single outer shell structure. This nested design consolidates multiple targeted deliveries into one manufacturable unit, simplifying the manufacturing process while achieving high local drug concentrations at multiple specific GI sites simultaneously.
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
Enhances bioavailability by allowing controlled release and absorption of drugs at specific gastrointestinal sites, potentially reducing the need for higher doses and minimizing side effects.
Implementation Method 1
a shell defining a first compartment and a second compartment, wherein said shell comprises a first material soluble at a first gastrointestinal site, and a second material soluble at a second gastrointestinal site
Data Source
AI summary
The present disclosure provides a dosage form of controlled release at specific gastrointestinal sites. The dosage form includes a shell defining a first and a second compartment, a first active pharmaceutical ingredient (API) loaded in the first compartment, and a second API loaded in the second compartment, wherein the first API and the second API can be the same or different. The shell includes a first material soluble in a first gastrointestinal site and a second material soluble in a second gastrointestinal site.