MOISTURE AND MOISTURE SCAVENGING ON DRUG STABILITY IN TABLETS

Abstract

Moisture plays a critical role in product stability. While there are various methods to control moisture, there is limited study on the use of excipients to mitigate moisture induced stability issues. This research work attempted to critically understand moisture-excipients interaction and how the interaction can impact excipients selection in formulations containing moisture sensitive components. Ability of excipients to interact with moisture was shown to be related to moisture retention of excipients. Additionally, distribution of moisture into bulk structure of the excipients as internally absorbed moisture reduced moisture availability for reactions, leading to better drug stability. Moisture properties of formulations was affected by the formulations components and it was necessary to consider tablet mechanical properties alongside stability. Findings from this study could aid formulators in making judicious choice of excipients in moisture sensitive formulations. Also, characterisation of moisture properties of excipients could be instrumental during the formulation development stage.