ارزيابي فيزيكوشيمياييي و باليني قرص كلسيم استات

Physicochemical and Clinical Evaluation of Calcium Acetate Tablets

Phosphorous binders such as calcium carbonate (CC) and aluminum hydroxide have been used in Chronic Renal Failure (CRF) patients to decrease hyperphosphatemia. The aim of this study was to prepare calcium acetate (CA) tablets and evaluate their effects in CRF patients. CA tablets were prepared by wet granulation method and their physicochemical properties such as weight variation, hardness, friability, disintegration time and dissolution rate were studied. Calcium was determined by atomic absorption method. The in vitro phosphorus binding capacity of CA was evaluated and compared with CC tablets marketed in Iran. The stability of prepared tablets was studied as well. Clinical usefulness of CA as phosphorus binder was assessed in 24 adult patients. Mean weight, hardness and disintegration time of CA tablets were 1161.5 mg, 49.5 N and 34.5 min, respectively. Percent of the drug released after 30 and 60 minutes were 76.2% and 97.6%, respectively. The tablets released 50% of their content up to 18.4 min. Percent of phosphorus insolublized as calcium phosphate by CC and CA were 30.7% and 16.2% respectively. CA tablets disintegration time in acidic, neutral and basic media were 39.5, 34.4 and 42.2 min. Physicochemical properties of tablets during the stability test condition were acceptable based on FDA standards. CA decreased serum phosphorus concentration more effectively than CC. Our data confirm that a given dose of calcium administrated orally as CA, binds more phosphorus in the intestine than the same dose of CC. This may be due to the better solubility of CA.