e-journal

Development and validation of an in vitroein vivo correlation (IVIVC) model for propranolol hydrochloride extended-release matrix formulations

---

The objective of this study was to develop an in vitroein vivo correlation (IVIVC) model for
hydrophilic matrix extended-release (ER) propranolol dosage formulations. The in vitro
release characteristics of the drug were determined using USP apparatus I at 100 rpm, in a
medium of varying pH (from pH 1.2 to pH 6.8). In vivo plasma concentrations and pharmacokinetic
parameters in male beagle dogs were obtained after administering oral, ER
formulations and immediate-release (IR) commercial products. The similarity factor f2 was
used to compare the dissolution data. The IVIVC model was developed using pooled
fraction dissolved and fraction absorbed of propranolol ER formulations, ER-F and ER-S,
with different release rates. An additional formulation ER-V, with a different release rate
of propranolol, was prepared for evaluating the external predictability. The results showed
that the percentage prediction error (%PE) values of Cmax and AUC0-oo were 0.86% and
5.95%, respectively, for the external validation study. The observed low prediction errors
for Cmax and AUC0-oo demonstrated that the propranolol IVIVC model was valid.

Keywords:
IVIVC
Extended-release dosage
Propranolol

---

Ketersediaan

Tidak ada salinan data

Informasi Detail

Judul Seri

Journal of food and drug analysis

No. Panggil

-

Penerbit

Taiwan : Elsevier Taiwan., 2014

Deskripsi Fisik

Journal of food and drug analysis 22 (2014) 257 - 263

Bahasa

English

ISBN/ISSN

http://dx.doi.org/10

Klasifikasi

-

Tipe Isi

-

Tipe Media

-

Tipe Pembawa

-

Edisi

22 (2014)

Subjek

MAKANAN DAN OBAT

Info Detail Spesifik

-

Pernyataan Tanggungjawab

agus

Versi lain/terkait

Lampiran Berkas

Komentar

---

Anda harus masuk sebelum memberikan komentar