The aim of this study was the development of three bigel formulations with naproxen sodium as a pharmaceutical ingredient (BG1N, BG2N, BG3N) and the evaluation of their pharmacotechnical properties compared to those of three blank bigels (BG1, BG2, BG3). The proposed bigels were evaluated in terms of appearance, pH, consistency, spreadability, rheology, bioadhesivity and stability while the samples were centrifugated. Two yellow bigels (BG1, BG1N) were obtained while the other four were coloured in white (BG2, BG3, BG2N and BG3N). The pH of the developed bigels ranged in the admitted values mentioned by the in-force Ph. Eur. 11 (ranged between 4.5 and 5.5) decreasing the irritation risk. In comparison with the blank samples, after 5 months from the preparation, in the case of BG2N, the sample consistency decreased significantly (p < 0.05). The evaluation of the spreadability after 5 months indicated that for BG1, the spreadability capacity decreased by 56%, whilst for the other bigels the changes were minor. All the bigels presented a plastic behaviour. In the case of blank bigels, the adhesivity decreased in the following order BG3 < BG2 < BG1, emphasizing that the Carbopol ® 940 bigels present a better adhesivity in comparison with sodium alginate bigels. The bigels BG1 and BG1N maintained a homogenous aspect after centrifugation, on the other hand, for BG2/BG2N and BG3/BG3N a visible separation of the two phases bigels was noticed. In conclusion, naproxen sodium bigels can represent an efficient alternative treatment for patients with inflammatory articular diseases. In addition, compared to the oral route, the cutaneous administration represents a route by which the side effects of the active substance can be avoided, so the developed formulations are proposed for future in vitro/in vivo release studies.
RezumatScopul acestui studiu a constat în dezvoltarea a trei formulări de bigeluri cu naproxen sodic, cu rol de substanță activă (BG1N, BG2N, BG3N) și evaluarea proprietăților farmacotehnice ale acestora în comparație cu cele ale unor bigeluri lipsite de substanță activă (BG1, BG2, BG3). Bigelurile propuse au fost evaluate în termeni de: aspect, pH, consistență, capacitate de etalare, bioadezivitate și stabilitate în timpul centrifugării. S-au obținut două bigeluri de culoare galbenă (BG1, BG1N) și patru de culoare albă (BG2, BG3, BG2N, BG3N). Bigelurile dezvoltate au avut un pH corespunzător prevederilor Ph. Eur. 11, fiind cuprins între 4.5 și 5.5, ceea ce scade riscul unei iritații locale. După 5 luni de la preparare, consistența bigelului BG2N a scăzut semnificativ (p < 0.05) comparativ cu cea a bigelului blanc. Evaluarea capacității de etalare la 5 luni de la prepararea bigelurilor a indicat o scădere cu 56% în cazul BG1, în timp ce, pentru celelalte formulări, modificările au fost minore. Toate formulările au prezentat un comportament plastic. În cazul bigelurilor blanc, adezivitatea a scăzut în ordinea BG3 < BG2 < BG1, subliniind faptul că bigelurile pe bază de Carbopol ® 940 prezintă o adezivitate mai ...