Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets
Апстракт
The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investig...ated range.
Кључне речи:
Design space / HPMC / Hydrophilic matrix tablets / Tramadol hydrochlorideИзвор:
Latin American Journal of Pharmacy, 2014, 33, 7, 1131-1138Издавач:
- Colegio Farmaceuticos Provincia De Buenos Aires, La Plata
Финансирање / пројекти:
- Развој производа и технологија које обезбеђују жељено ослобађање лековитих супстанци из чврстих фармацеутских облика (RS-MESTD-Technological Development (TD or TR)-34007)
Институција/група
PharmacyTY - JOUR AU - Nikolić, Nenad D. AU - Ibrić, Svetlana AU - Medarević, Đorđe AU - Đurić, Zorica PY - 2014 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2136 AB - The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investigated range. PB - Colegio Farmaceuticos Provincia De Buenos Aires, La Plata T2 - Latin American Journal of Pharmacy T1 - Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets VL - 33 IS - 7 SP - 1131 EP - 1138 UR - https://hdl.handle.net/21.15107/rcub_farfar_2136 ER -
@article{ author = "Nikolić, Nenad D. and Ibrić, Svetlana and Medarević, Đorđe and Đurić, Zorica", year = "2014", abstract = "The aim of this study was establishing design space for robust formulation of hydrophilic extended release matrix tablets with tramadol hydrochloride as highly soluble, high dose drug. In the first part of the study, linear relationship between slope of Higuchi's model (K-h) and tablet surface/tablet volume (SA/V) ratio was confirmed varying drug loading in the range between 27.78 and 55.56% (w/w). Established relationship was tested in the second part of the study using different tablet shapes and sizes. Compression force was varied between 160 MPa and 300 MPa as critical process parameter, while drug loading and polymer concentration were recognized as critical input material attributes. High correlation was established between experimentally observed drug release profiles and drug release profiles predicted using K-h-SA/V relationship. Design space was established, where drug release could be accurately predicted for any drug loading/polymer content/compression force in the investigated range.", publisher = "Colegio Farmaceuticos Provincia De Buenos Aires, La Plata", journal = "Latin American Journal of Pharmacy", title = "Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets", volume = "33", number = "7", pages = "1131-1138", url = "https://hdl.handle.net/21.15107/rcub_farfar_2136" }
Nikolić, N. D., Ibrić, S., Medarević, Đ.,& Đurić, Z.. (2014). Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets. in Latin American Journal of Pharmacy Colegio Farmaceuticos Provincia De Buenos Aires, La Plata., 33(7), 1131-1138. https://hdl.handle.net/21.15107/rcub_farfar_2136
Nikolić ND, Ibrić S, Medarević Đ, Đurić Z. Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets. in Latin American Journal of Pharmacy. 2014;33(7):1131-1138. https://hdl.handle.net/21.15107/rcub_farfar_2136 .
Nikolić, Nenad D., Ibrić, Svetlana, Medarević, Đorđe, Đurić, Zorica, "Establishing Design Space for Tramadol HCl Release from Hydrophilic Matrix Tablets" in Latin American Journal of Pharmacy, 33, no. 7 (2014):1131-1138, https://hdl.handle.net/21.15107/rcub_farfar_2136 .