Chemical stability of acetylsalicylic acid in tablets prepared with different particle size fractions of a commercial brand of dicalcium phosphate dihydrate

Unusual Effect of Water Vapor Pressure on Dehydration of Dibasic Calcium Phosphate Dihydrate

“…Dibasic calcium phosphate dihydrate has a stoichiometric water content of 20.9% (w/w). As a diluent, it can constitute a substantial fraction (over 50%, w/w) of the dosage form 9,10. The dehydration of DCPD to yield DCPA has been documented in numerous studies 11–14.…”

“…The released water can cause chemical or physical changes in the dosage form components. Aspirin degradation during accelerated stability testing [35°C and 82.9% relative humidity (RH)] has been attributed to the water released by DCPD dehydration 10,15. In addition, the functionality of excipients can be affected by the released water.…”

Physical Characterization of Dibasic Calcium Phosphate Dihydrate and Anhydrate

“…On the other hand, in tablets containing DCPD, dehydration to DCPA during storage is a possibility and has been documented in the literature 13–16. The dehydration process is complicated since it occurs in multiple steps17 and is initiated by water 18.…”

“…The moisture‐induced phase transformation is the principal cause of changes in the physical attributes and dissolution characteristics of stored tablets formulated with DCPD 21–23. If the API in the formulation is susceptible to hydrolysis, as in the case of acetylsalicylic acid, the water from DCPD can lead to its chemical degradation 1, 16. Thus, the use of DCPD in tablet formulations can have implications on both physical and chemical stability.…”

Modulating the Dehydration Conditions of Adefovir Dipivoxil Dihydrate to Obtain Different Physical Forms of Anhydrate

“…(i) The release of water due to dehydration of AD dihydrate. This released water can interact with the other formulation components causing chemical decomposition . It can also alter the functionality of the excipients in the formulation .…”