Abstract

This study evaluates pharmaceutical stability under diverse environmental conditions as defined by ICH climatic zones. The research examines degradation pathways, packaging considerations, and storage recommendations to ensure product quality in different geographical regions.

---

References

1. Rowe RC, Sheskey PJ, Quinn ME, editors. Handbook of Pharmaceutical Excipients. 8th ed. London: Pharmaceutical Press; 2017.

2. Katdare A, Chaubal MV. Excipient functionality and innovation in pharmaceutical formulation. J Pharm Sci. 2006;95(4):821–832.

3. Thoorens G, Krier F, Leclercq B, Carlin B, Evrard B. Microcrystalline cellulose, a direct compression binder in pharmaceutical formulations—A review. Int J Pharm. 2014;473(1–2):64–72.

4. Williams RO, Watts AB, Miller DA. Formulating Poorly Water Soluble Drugs. 2nd ed. New York: Springer; 2016.

5. Goole J, Amighi K. New trends in pharmaceutical excipients for oral drug delivery. Int J Pharm. 2014;466(1–2):45–52.

6. Pifferi G, Restani P. The safety of pharmaceutical excipients. Farmaco. 2003;58(8):541–550.

7. Van der Merwe SM, Grobler AF, Steenekamp JH. Functional excipients in solid dosage forms: Applications and future perspectives. Drug Dev Ind Pharm. 2020;46(5):689–701.