Preparation and scale up of extended-release tablets of bromopride

Author:

Ferreira Guilherme Neves1,Silva Marcos Giovani Rodrigues2,Fraga Aline Guerra Manssour2,Silva Luiz Cláudio Rodrigues Pereira da2,Lira Luiz Marcelo2,Rodrigues Carlos Rangel2,Castro Helena Carla3,Sousa Valéria Pereira de2,Cabral Lucio Mendes2

Affiliation:

1. Federal University of Rio de Janeiro, Brazil; Roche Chemicals and Pharmaceuticals, Brazil

2. Federal University of Rio de Janeiro, Brazil

3. Fluminense Federal University, Brazil

Abstract

Reproducibility of the tablet manufacturing process and control of its pharmaceutics properties depends on the optimization of formulation aspects and process parameters. Computer simulation such as Design of Experiments (DOE) can be used to scale up the production of this formulation, in particular for obtaining sustained-release tablets. Bromopride formulations are marketed in the form of extended-release pellets, which makes the product more expensive and difficult to manufacture. The aim of this study was to formulate new bromopride sustained release formulations as tablets, and to develop mathematical models to standardize the scale up of this formulation, controlling weight and hardness of the tablets during manufacture according to the USP 34th edition. DOE studies were conducted using Minitab(tm) software. Different excipient combinations were evaluated in order to produce bromopride sustained-release matrix tablets. In the scale-up study, data were collected and variations in tableting machine parameters were measured. Data were processed by Minitab(tm) software, generating mathematical equations used for prediction of powder compaction behavior, according to the settings of the tableting machine suitable for scale-up purposes. Bromopride matrix tablets with appropriate characteristics for sustained release were developed. The scale-up of the formulation with the most suitable sustained release profile was established by using mathematical models, indicating that the formulation can be a substitute for the pellets currently marketed.

Publisher

FapUNIFESP (SciELO)

Subject

General Pharmacology, Toxicology and Pharmaceutics

Reference21 articles.

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