Study on functional performance of anhydrous dibasic calcium phosphate文献综述

 2022-12-28 11:12

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Anhydrous dibasic calcium phosphate occurs as a white, odorless, tasteless powder that is stable in air. It is practically insoluble in water, insoluble in alcohol and soluble in 3 N hydrochloric acid and 2 N nitric acid.

The objective of this study is to study the general performance of excipient , so to cover this study we are going to do the pharmaceutical preformulation study of anhydrous dibasic calcium phosphate

To ensure this study of functional performance of anhydrous dibasic calcium phosphate there are several aspects of the study of excipient we have to check them as follows

Usage of anhydrous dibasic calcium phosphate excipient in pharmaceutics, whereby it is widely used as binder and filler or diluents I oral dosage forms which include compressed tablets and hard gelatin capsule.

The purpose of the performance anhydrous dibasic calcium phosphate is to know the physical and chemical properties of the excipient so as to ensure it performance, . The excipient performance characteristics might then be correlated with its physical properties such as particle size, particle shape, particle size distribution, specific gravity, viscosity, the hygroscopic nature of the excipient, etc. It is also possible that these characteristics might be correlated with chemical composition such as the level of concomitant and other components. The excipient manufacturer would be able to evaluate the impact of a process change by comparing these excipient properties before and after the change to ensure the excipient performance. The performance we are going to study considering our excipient anhydrous dibasic calcium phosphate, Stability, Dibasic calcium phosphate anhydrous is a nonhygroscopic , relatively stable material . Under condition of high humidity it does not hydrate to form dehydrate.

Incompatibilities, dibasic calcium phosphate should not be used to formulate tetracycline antibiotics and has been reported to be incompatible with indomethacin , aspirin , aspartame, ampicillin , cephalexin and erythromycin. The coarse grade material has good flow properties, but is abrasive and requires a lubricant when used for tableting. The surface milled of anhydrous dibasic calcium phosphate is Alkaline and consequently should not be used with drugs that are sensitive to alkaline PH.

Validation study and manufacturing process , Calcium phosphate are usually prepared by reacting very pure phosphoric acid with calcium hydroxide , obtained from limestone , in stoichiometric ratio in aqueous suspension followed by drying at a temperature that will allow the correct hydration state to be achieved . After drying , the coarse grade material is obtained by means of classification unit , the fine particle size material obtained by milling. Dibasic calcium phosphate, anhydrous may also be prepared by spray drying.

References

1 Fischer E . Calcium phosphate as a pharmaceutical excipient.Manuf Chem 1992 649(6):25-27

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