Orellanine Aqueous Formulation With pH-Controlled IV Stability
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Solution Overview
Problem
Existing formulations of Orellanine are not stable enough for intravenous administration, necessitating the development of a stable pharmaceutical formulation that maintains effective concentrations for treating renal cancer.
Innovation Solution
A pharmaceutical aqueous solution formulation comprising Orellanine with a pH range of 7 to 8, using phosphate or citrate buffers, and adjusted osmolality to ensure stability and solubility, allowing for intravenous administration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If Orellanine is formulated for intravenous administration, then it can be used to treat renal cancer effectively, but the formulation stability is insufficient
Solution Approach 1:
The patent applies parameter changes by optimizing the pH of the formulation to a specific range (7.0-8.0) and controlling the concentration of buffering agents (10-200 mM phosphate or citrate buffer). These parameter adjustments resolve the contradiction by ensuring the formulation remains stable under intravenous administration conditions while maintaining the therapeutic efficacy of Orellanine for renal cancer treatment.
2Quantity of substance
If the pH of the formulation is adjusted to improve solubility, then Orellanine concentration can be increased, but formulation stability may be compromised
Solution Approach 1:
The patent resolves this contradiction by precisely controlling the pH parameter within the narrow range of 7.0-8.0 and adjusting the buffering agent concentration (10-200 mM). This parameter optimization allows achieving adequate Orellanine solubility and concentration (0.1-40 mg/ml) while maintaining formulation stability, as evidenced by the absence of precipitation or degradation during storage and administration.
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 stable and effective intravenous delivery of Orellanine, maintaining concentrations suitable for treating renal cancer, with solubility optimized through pH and osmolality control.
Implementation Method 1
a buffer; wherein the pH of the formulation is in the range of 7 to 8
Implementation Method 2
adjusted osmolality to ensure stability and solubility
Data Source
AI summary
A pharmaceutical aqueous solution formulation comprising Orellanine is disclosed.