Romanian Society of Pharmaceutical Sciences
 

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THE INFLUENCE OF SOME CHARACTERISTICS OF RANITIDINE HYDROCHLORIDE ON THE FORMING AND PREPARATION OF THE TABLETS

POSTOLACHE LILIANA*1,2, ONUŢĂ ALEXANDRU-EVLAMPIE2,3

1Faculty of Pharmacy, University of Medicine and Pharmacy “Gr. T. Popa”, Str. Universităţii nr. 16, 700115 Iasi, Romania
2 Antibiotice S.A., Str. Valea Lupului nr. 1, 707410, Iassy, Romania
3 Faculty of Automation and Computer Science, Technical University “Gheorghe Asachi”of Iasi, Str. Prof, Dr. Doc. Demetrius Mangeron, nr. 27, 70005, Iasi, Romania

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The physical behavior of pharmaceutical solid forms is determined by the raw materials characteristics used in their manufacture. These must come only from authorized sources. When the raw materials are coming from different sources they may not have identical properties in the formula. It is important to know the properties of the active pharmaceutical ingredient (API), individually and in combination with the excipients, within the formula. The aim of this study was to evaluate the influence of API’s characteristics, from different producers, on the behavior of some ranitidine tablets, obtained by dry granulation. The statistical method for data processing consisted in the multivariate linear regression analysis (Partial Least Squares – PLS). Its implementation was performed using Modde 9.0 Umetrics Suedia software. The results have shown that in order to avoid the additional costs of technology re-optimization and technological flow sheet revalidation in the case of changing the API supplier, we should re-evaluate it, in the context of formula and of the authorized production process.