PHARMACEUTICAL DOSAGE FORM INTEGRITY UNDER SPACEFLIGHT-INDUCED MECHANICAL STRESS: A REVIEW OF THE EFFECTS OF ACOUSTIC VIBRATIONS AND MECHANICAL SHOCK ON FORMULATION STABILITY

The structural and functional stability of pharmaceutical dosage forms under spaceflightinduced mechanical stress remains a critically underexamined frontier in extraterrestrial medicine. As human missions extend beyond low Earth orbit, formulations are subjected to high-frequency vibrations, mechanical shocks, and microgravity-altered fluid dynamicsstressors capable of inducing tablet lamination, emulsion destabilization, protein denaturation, and container–closure compromise. Current regulatory guidelines (ICH, USP, WHO) inadequately address such mechanical degradation pathways, creating a significant methodological gap. Dosage formsranging from solid orals to biopharmaceuticals exhibit distinct mechanical susceptibilities, requiring formulation-specific strategies, protective packaging, and mechanical stress modeling. This review consolidates existing insights into mechanistically driven degradation phenomena, evaluates mitigation tactics, and advocates for integration of aerospace-derived mechanical testing within pharmaceutical quality-by-design (QbD) protocols. Formal incorporation of these parameters into space pharmacopoeial standards is essential for safeguarding drug efficacy in autonomous, resource-constrained space settings. Addressing these challenges advances the foundation for space-certified, mission-critical therapeutics within the evolving field of space pharmacology.

Keywords: Spaceflight pharmaceuticals, Mechanical stress degradation, Vibroacoustic stability, Microgravity formulation integrity, Aerospace drug delivery