Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design
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 pharmace...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2016-06-01
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| Series: | Acta Pharmaceutica |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/acph-2016-0019 |
| _version_ | 1826843512478367744 |
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| author | Szabó Zoltán-István Székely-Szentmiklósi Blanka Deák Boglárka Székely-Szentmiklósi István Kovács Béla Zöldi Katalin Sipos Emese |
| author_facet | Szabó Zoltán-István Székely-Szentmiklósi Blanka Deák Boglárka Székely-Szentmiklósi István Kovács Béla Zöldi Katalin Sipos Emese |
| author_sort | Szabó Zoltán-István |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T20:24:45Z |
| format | Article |
| id | doaj.art-e32f58d03c1945ce96af29c030c84159 |
| institution | Directory Open Access Journal |
| issn | 1846-9558 |
| language | English |
| last_indexed | 2025-02-16T13:43:57Z |
| publishDate | 2016-06-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Acta Pharmaceutica |
| spelling | doaj.art-e32f58d03c1945ce96af29c030c841592025-02-02T09:44:15ZengSciendoActa Pharmaceutica1846-95582016-06-0166219120610.1515/acph-2016-0019acph-2016-0019Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental designSzabó Zoltán-István0Székely-Szentmiklósi BlankaDeák Boglárka1Székely-Szentmiklósi István2Kovács BélaZöldi Katalin3Sipos Emese4 Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mureș, Romania Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mureș, Romania Gedeon Richter Romania S.A. Technological Development Department, RO-540306, Tîrgu Mureș, Romania Gedeon Richter Romania S.A. Technological Development Department, RO-540306, Tîrgu Mureș, Romania Faculty of Pharmacy, University of Medicine and Pharmacy, RO-540139, Tîrgu Mureș, RomaniaTo 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.https://doi.org/10.1515/acph-2016-0019design of experimentsoptimizationfactorial designplacebo formulation |
| spellingShingle | Szabó Zoltán-István Székely-Szentmiklósi Blanka Deák Boglárka Székely-Szentmiklósi István Kovács Béla Zöldi Katalin Sipos Emese Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design Acta Pharmaceutica design of experiments optimization factorial design placebo formulation |
| title | Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| title_full | Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| title_fullStr | Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| title_full_unstemmed | Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| title_short | Study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| title_sort | study of the effect of formulation variables on the characteristics of combination tablets containing enalapril maleate and indapamide as active substances using experimental design |
| topic | design of experiments optimization factorial design placebo formulation |
| url | https://doi.org/10.1515/acph-2016-0019 |
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