دورية أكاديمية
Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles
| العنوان: | Development of in vitro-in vivo correlation for nimesulide loaded ethylcellulose microparticles |
|---|---|
| المؤلفون: | Khan, Shujaat A., Ahmad, Mahmood, Shoaib, Harris M., Murtaza, Ghulam, Aamir, Muhammad N., Kousar, Rozina, Rasool, Fatima, Madni, Asadullah |
| سنة النشر: | 2010 |
| المجموعة: | Universidad Nacional de La Plata (UNLP): SeDiCI (Servicio de Difusión de la Creación Intelectual) |
| مصطلحات موضوعية: | Farmacia, dissolution studies, bioavailability, internal prediction error, IVIVC, nimesulide, Farmacología, Disolución, Biodisponibilidad, Medicamentos, Agentes antiinflamatorios |
| الوصف: | A predictive in vitro-invivo correlation (IVIVC) can empower in vitro dissolution as a surrogate for in vivo bioavailability / bioequivalence. IVIVCs can decrease regulatory burden by decreasing the number of biostudies required in support of a drug product. The present study concerns the establishment of in vitro-in vivo correlation for three different sustained release nimesulide loaded ethylcellulose microparticulate formulations (M1, M2 and M3) and conventional tablet (100 mg Nimaran®-Novartis, Pakistan). In vitro dissolution study was conducted in phosphate buffer pH 6.8 stirred at 50 rpm and 37 ± 0.5ºC. A validated HPLC method was adopted to conduct bioavailability studies in young healthy human volunteers. Ultimately IVIVC of prepared microparticles and conventional tablet was established using Wagner-Nelson method. M1 and M2 formulations and Nimaran® exhibited good linear IVIVC (R 2 = 0.9220, 0.9124, 0.8728, respectively) as compared to M3 (R 2 = 0.9449). The results substantiate the success of this mathematical simulation study encourage researchers to conduct biowaiver studies for other BCS class II drugs. ; Colegio de Farmacéuticos de la Provincia de Buenos Aires |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf; 1029-1034 |
| اللغة: | English |
| العلاقة: | http://sedici.unlp.edu.ar/handle/10915/8022Test; http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_2_7.pdfTest |
| الإتاحة: | http://sedici.unlp.edu.ar/handle/10915/8022Test http://www.latamjpharm.org/resumenes/29/6/LAJOP_29_6_2_7.pdfTest |
| رقم الانضمام: | edsbas.D3A39FCA |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |