Ramipril Oral Solution Buffering for Stability and Taste Masking
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Solution Overview
Problem
Existing pharmaceutical compositions for oral delivery, particularly for pediatric and geriatric patients, face challenges such as stability issues, solubility problems, and palatability concerns, which affect patient compliance and bioavailability.
Innovation Solution
The development of pharmaceutical solutions comprising a water-soluble active pharmaceutical ingredient, a buffering agent, and water, with a pH range of about 5 to 8, which enhances stability, solubility, and palatability, thereby improving patient compliance and bioavailability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If oral liquid dosage forms are formulated to improve patient compliance and dosage control, then patient acceptability is improved, but stability and solubility challenges increase
Solution Approach 1:
The patent applies parameter changes by adjusting the pH of the oral liquid formulation to a specific range (pH 3.0-5.0) to optimize both stability and solubility of the active pharmaceutical ingredient. This parameter optimization resolves the contradiction by creating conditions where the drug remains stable in solution while maintaining adequate solubility for dosing accuracy.
Solution Approach 2:
The patent employs composite materials by combining the active pharmaceutical ingredient with specific excipients including buffering agents, solubilizers, and stabilizers in a formulated mixture. This composite formulation approach addresses the stability-solubility contradiction by using synergistic combinations of components that collectively maintain drug stability while ensuring adequate solubility.
2Reliability
If multiple excipients are added to oral liquid formulations to address solubility and stability, then drug delivery performance is improved, but formulation complexity increases
Solution Approach 1:
The patent applies universality by selecting excipients that perform multiple functions simultaneously. For example, buffering agents serve both to maintain pH for stability and to enhance solubility, while solubilizers also contribute to masking bitter tastes. This multi-functionality approach improves drug delivery performance while minimizing the number of separate components needed.
3Reliability
If pH is adjusted to optimize solubility and stability, then drug bioavailability is improved, but taste masking becomes more difficult
Solution Approach 1:
The patent uses composite materials by formulating a combination of pH-adjusting buffering agents with taste-masking excipients such as sweeteners and flavoring agents. This composite approach allows the formulation to maintain the optimized pH range for bioavailability while simultaneously addressing the bitter taste through the synergistic action of multiple taste-modifying components.
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 proposed solution achieves prolonged stability and improved bioavailability, making it suitable for pediatric and geriatric patients, while also masking bitter tastes with sweeteners and flavoring agents, thus enhancing patient acceptability.
Implementation Method 1
The composition comprises an active pharmaceutical ingredient, a buffering agent, and water, wherein the pH of the composition is between about pH 5 to about pH 8
Data Source
AI summary
This disclosure relates to pharmaceutical compositions in the form of a solution for oral delivery. Particularly, the pharmaceutical compositions comprise an active pharmaceutical ingredient, a buffering agent, and water. In some embodiments, the pH of the composition is from about pH 5 to about pH 8. In some embodiments, the active pharmaceutical ingredient is selected from ramipril, solifenacin, vigabatrin, losartan potassium, warfarin, and melatonin.