以茶碱为模型药物的剂量‐重量比一致的推拉式渗透泵片的.PDFVIP

Study of Dose-Weight Proportionality in Osmotic Push-Pull Technology using Theophylline as a Model Drug Manish S. Rane and Ali Rajabi-Siahboomi Poster Reprint AAPS 2013 Purpose The purpose of this work was to formulate dose-weight proportional formulation of model drug (theophylline) at 10, 15 and 20 mg doses using standard round concave (SRC) tooling of proportional dimensions to achieve similar drug release profiles. Surface area, volume and shape of the osmotic tablets were analyzed to further explore mechanism of drug release. Experimental Methods Preparation of Core Bilayer Tablets The composition of theophylline push-pull osmotic pump (PPOP) core tablets is given in Table 1. The pull (drug) layer containing theophylline, POLYOX™ WSR N-80 NF LEO and METHOCEL™ E6 Premium LV was prepared by high shear wet granulation (Diosna P/VAC-10) using an ethanol : water mixture (85:15 ratio). Push layer containing POLYOX WSR Coagulant NF LEO, milled sodium chloride and iron oxide red pigment was prepared by dry blending. The bilayer tablets, using pull to push layer ratio of 2 : 1, and dose-weight proportional, were compressed (GlobePharma Manual Press) to 10 mg, 15 mg and 20 mg strength of theophylline using 9.5 mm, 10.3 mm and 11.9 mm standard concave round tooling, at a compression force of 4000 lb (dwell time of 2 sec). Round tooling of different diameters were selected on the basis of linearity to total tablet weight (Figure 1). 10 mg dose tablets were further compressed using pentagon and caplet shapes, with similar surface area to 9.5 mm round tablets. Phy