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 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.
Zoltán-István
ZI
Szabó
Blanka
B
Székely-Szentmiklósi
Boglárka
B
Deák
István
I
Székely-Szentmiklósi
Béla
B
Kovács
Katalin
K
Zöldi
Emese
E
Sipos
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000737:chemistry*; D000959:Antihypertensive Agents / Q000737:chemistry*; D004338:Drug Combinations; D004339:Drug Compounding; D004656:Enalapril / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry; D006244:Hardness; D007190:Indapamide / Q000737:chemistry*; D007700:Kinetics; D016014:Linear Models; D008956:Models, Chemical; D011208:Powders; D049993:Sodium Chloride Symporter Inhibitors / Q000737:chemistry*; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical
D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D004338:Drug Combinations; D005079:Excipients; D011208:Powders; D049993:Sodium Chloride Symporter Inhibitors; D013607:Tablets; D004656:Enalapril; D007190:Indapamide