Ilaprazole Composition With Controlled Derivatives for Stable Quality
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Solution Overview
Problem
Current formulations of ilaprazole, including oral tablets and injectable powders, are inadequate for effectively controlling acute gastric mucosal lesions and bleeding due to multiple trauma or severe stress reactions, with a lack of research on more reliable and stable quality formulations.
Innovation Solution
A pharmaceutical composition comprising ilaprazole or its salts with controlled amounts of ilaprazole derivatives and a specific pH range, combined with a pharmaceutically acceptable carrier, is developed to enhance stability and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If ilaprazole is formulated as oral enteric-coated tablets or microparticles, then the formulation is suitable for treatment of peptic ulcer, but it cannot effectively control acute gastric mucosal lesion bleeding and severe stress reactions
Solution Approach 1:
The patent changes the formulation parameters from oral solid dosage forms to intravenous injection powder, enabling the drug to be administered directly into the bloodstream. This parameter change allows ilaprazole to rapidly achieve effective concentrations in severe acute gastric mucosal lesion bleeding cases where oral administration would be insufficient or impossible, thereby improving both adaptability to different patient conditions and efficacy reliability.
2Ease of operation
If existing ilaprazole injection powder formulations are used, then intravenous administration is available for severe patients, but the quality stability and reliability of the formulation are insufficient
Solution Approach 1:
The patent optimizes the formulation parameters of the injection powder, specifically controlling the content of ilaprazole derivatives within defined ranges. This parameter optimization ensures the stability and reliability of the formulation quality while maintaining the convenience of intravenous administration for severe patients who cannot take oral medications.
3Stability of the object's composition
If higher amounts of ilaprazole derivatives are present in the formulation, then the formulation may be more stable, but the purity and quality of the main active ingredient decreases
Solution Approach 1:
The patent establishes specific parameter ranges for ilaprazole derivative content (0.1-5.0 wt%) that balance formulation stability with main ingredient purity. By controlling the derivative content within this optimized range, the formulation achieves sufficient stability while maintaining the purity and quality requirements for the active ingredient, resolving the contradiction between stability and precision.
Data Source
AI summary
The present invention relates to a pharmaceutical composition containing ilaprazole or a salt thereof, and a preparation method therefor. The pharmaceutical composition contains or consists of ilaprazole or a salt thereof, and a ilaprazole derivative, wherein the amount of the ilaprazole derivative in the pharmaceutical composition is not higher than 1.3 wt % (less than or equal to 1.3 wt %). The composition can be used for treating peptic ulcer bleeding and stress ulcer and preventing upper gastrointestinal hemorrhage caused by severe diseases.