When developing liquid oral dosage forms, one critical consideration is pH sensitivity—the impact of pH on the stability, solubility, and bioavailability of active pharmaceutical ingredients (APIs). This factor can make or break the formulation process and ultimately determine the drug’s efficacy and safety for patients.
During preformulation, it’s essential to:
- Assess the pH range where the API is stable and soluble.
- Optimize excipient selection to buffer or adjust pH, ensuring that the final product maintains desired stability throughout its shelf life.
- Evaluate the impact of gastric pH on drug dissolution and absorption in vivo.
- Conduct rigorous testing to ensure consistency in product performance under various conditions.
By understanding and controlling pH sensitivity, formulators can create more effective, patient-friendly oral medications that perform reliably.
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Resource Person: Janki Parmar