Research of structure and technological characteristics of pharmaceutical substances of rabeprazole sodium

The purpose of the study is the choice of the pharmaceutical substance rabeprazole sodium with the optimal structure and technological characteristics for the development of Rabeprazole tablets. 

Materials and methods. The study was conducted on samples of pharmaceutical substances rabeprazole sodium of two manufacturers Changzhou Koni Pharmaceutical Co. Ltd., China - RAB 20131102 Series (Sample 1) and Nosh Labs Pvt. Ltd., India - of RS 0280311 (sample 2) and RS 0120914 (sample 3). Microphotographs were obtained on a TM-1000 electron microscope, Hitachi. Powder X-ray diffraction patterns were obtained on a Bruker D8 Advance automatic X-ray diffractometer. To identify the crystalline phases, the PDF-2 Powder Diffractometry Database and the Cambridge Crystal Structural Database were used. The flowability of pharmaceutical substances was determined according to OFS 1.4.2.0016.15, the fractional composition was determined by sieve analysis; to evaluate compressibility, the Carr and Hausner indices were calculated. 

Results. Samples of rabeprazole sodium 1 and 2 are amorphous in nature and are characterized by the presence of two amorphous halo in the range of angles 2θ of 4-7 ° and 18-24 °. Sample 3 is probably a mixed version, in which an amorphous and crystalline component is presented. The studied samples differ in bulk density and fractional composition. Samples 2 and 3 are more uniform compared to sample 1, their bulk density is acceptable for the process. 

Conclusion. Pharmaceutical substance rabeprazole sodium of manufacturer Nosh Labs Pvt. Ltd. (India) has a more uniform fractional composition and acceptable bulk density. However, the processes used by this manufacturer do not exclude the formation in some cases of a crystalline component in a pharmaceutical substance, which can lead to a significant change in the physicochemical and mechanical characteristics of the pharmaceutical substance in different batches.

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