Development and evaluation of diltiazem hydrochloride controlled-release pellets by fluid bed coating process

Abstract

The aim of the present study was to develop controlled-release pellets of diltiazem HCl with ethyl cellulose and hydroxylpropyl methylcellulose phthalate as the release rate retarding polymers by fluid bed coating technique. The prepared pellets were evaluated for drug content, particle size, subjected to Scanning Electron Microscopy (SEM) and Differential Scanning Calori metry (DSC), and evaluated for in vitro release. Stability studies were carried out on the optimized formulations for a period of 3 months. The drug content was in the range of 97%-101%. The mean particle size of the drug-loaded pellets was in the range 700-785 μm. The drug release rate decreased as the concentration of ethyl cellulose increased in the pellet formulations. Among the prepared formulations, FDL10 and FDL11 showed 80% drug release in 16 h, matching with USP dissolution test 6 for diltiazem HCl extended-release capsules. SEM photographs confirmed that the prepared formulations were spherical in nature with a smooth surface. The compatibility between drug and polymers in the drug-loaded pellets was confirmed by DSC studies. Stability studies indicated that the pellets were stable.

Modified extrusion-spheronization as a technique of microencapsulation for stabilization of choline bitartrate using hydrogenated soya bean oil

“…MCC has better spheronizing capacity than lactose. [ 23 24 ] But, the extrudate prepared with MCC PH 102 showed cracks with a granular surface which did not observed in case of MCC PH 101. Hence, MCC PH 101 was selected as spheronizing aid for further study.…”

“…The results revealed that there was no major interaction or complexation between the drug and the wax throughout the process of pelletization. [ 24 ]…”

In Vitro and In Vivo Evaluation of Oral Controlled Release Formulation of BCS Class I Drug Using Polymer Matrix System

“…The countless number of existing and novel drugs, however, has led to continuous efforts to establish new formulas, technologies, and devices to regulate their release profiles [ 10 ]. The majority of studies have been focused on enhancing drug bioavailability and reducing dosing frequencies [ 11 , 12 ]. This can be achieved by several pharmaceutical approaches, including, for example, coating systems [ 13 ], osmotic pressure systems [ 14 ], and matrices systems [ 15 ].…”

Development of a Surface Coating Technique with Predictive Value for Bead Coating in the Manufacturing of Amorphous Solid Dispersions

“…The fluidization aspect of this process enables an in-device drying step to reduce the residual solvent level, thereby circumventing a transfer to a post-drying device, and thus further minimizing potential stability issues. The versatility of the device also allows for the subsequent application of an additional coating layer, either to serve as a drug release rate controlling membrane or as a protection barrier against surface crystallization [ 12 ]. In addition to process-related advantages, bead coating also offers interesting opportunities concerning clinical aspects.…”