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https://doi.org/10.1515/acph-2016-0019

Study of the effect of formulation variables on combination tablet characteristics containing enalapril maleate and indapamide as active substances using experimental design

ZOLTÁN-ISTVÁN SZABÓ ; Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mures, Romania
BLANKA SZÉKELY-SZENTMIKLÓSI ; Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mures, Romania; Gedeon Richter Romania S.A., Technological Development Department, RO-540306, Tîrgu Mures, Romania;
BOGLÁRKA DEÁK ; Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mures, Romania
ISTVÁN SZÉKELY-SZENTMIKLÓSI ; Gedeon Richter Romania S.A., Technological Development Department, RO-540306, Tîrgu Mures, Romania
BÉLA KOVÁCS ; Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mures, Romania; Gedeon Richter Romania S.A., Technological Development Department, RO-540306, Tîrgu Mures, Romania
KATALIN ZÖLDI ; Gedeon Richter Romania S.A., Technological Development Department, RO-540306, Tîrgu Mureș, Romania
EMESE SIPOS ; Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mures, Romania

Sažetak

To evaluate the influence of different variables on tablet formulations containing enalapril maleate and indapamide as active substances, two separate experimental designs were employed: one for evaluating powder properties and the other for tablet characteristics. Because of the low active pharmaceutical ingredient content, it was hypothesized that both powder and tablet properties could be determined only by the characteristics of excipients. In order to test this assumption, both experimental designs were done with placebo mixtures. The optimized formulation was then evaluated both with and without APIs. Results indicated that filler and lubricant percentage, along with compression force, were the most important variables during the formulation study. The optimized formulation showed similar characteristics in both cases for all responses, except for angle of repose and friability where only minor differences were observed. The combination of the applied approaches (using placebo composition and fractional experimental design) proved to be efficient, cost effective and time saving.

Ključne riječi

design of experiments; optimization; factorial design; placebo formulation

Hrčak ID:

153869

URI

https://hrcak.srce.hr/153869

Datum izdavanja:

30.6.2016.

Posjeta: 1.354 *