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Sterile Basics: Intravenous Admixture Preparation Considerations, Part 5: pH Considerations
1International Journal of Pharmaceutical Compounding. lallen@ijpc.com.
International Journal of Pharmaceutical Compounding
|July 11, 2020
Summary
Understanding pH is crucial for parenteral drug formulation. Adjusting pH impacts drug solubility and stability, affecting precipitation and degradation, which is vital for intravenous admixtures and parenteral nutrition.
Area of Science:
- Pharmaceutical Sciences
- Drug Formulation
- Intravenous Admixtures
Background:
- The pH of parenteral dosage forms significantly influences drug solubility and stability.
- Intravenous admixtures often involve mixing components with varying pH values, complicating formulation.
- Compounding parenteral nutrition requires careful consideration of pH for solubility and stability of multiple ingredients.
Purpose of the Study:
- To introduce the fundamental principles of pH, pKa, and dissociation constants in relation to drug solubility and stability.
- To explain how changes in pH affect drug precipitation and degradation in parenteral formulations.
- To provide a foundation for understanding pH considerations in intravenous admixture preparation.
Main Methods:
- Review of physicochemical principles governing pH, solubility, and stability.
- Discussion of the impact of pH on drug characteristics relevant to parenteral administration.
- Analysis of how pH affects drug behavior in various intravenous admixture scenarios.
Main Results:
- Solutions deviating from the pH of maximum solubility can lead to drug precipitation.
- Solutions deviating from the pH of maximum stability result in accelerated drug degradation and reduced beyond-use dates.
- pH is a critical determinant of drug performance and safety in parenteral products.
Conclusions:
- Maintaining optimal pH is essential for ensuring the solubility and stability of parenteral drugs.
- Understanding pH effects is critical for safe and effective preparation of intravenous admixtures and parenteral nutrition.
- This article series provides foundational knowledge on pH considerations for pharmaceutical practitioners.
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