Studies on the influence of formulation and processing factors on the drug release from multiparticulate systems

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KVRNS Ramesh

RAK Medical & Health Sciences University,UAE

: J Pharm Drug Deliv Res

Abstract

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New technologies and processes are being developed for existing and new drug molecules to prepare sustained release (SR) and controlled release (CR) dosage forms. Multi-unit forms such as pellets offer significant advantages such as better control over drug release and less chances of dose dumping. In the present work, pellets of furosemide (as a model drug) are prepared by extrusion and spheronization. It belongs to BCS class IV drugs having poor solubility. Since furosemide exhibits low solubility in gastric fluids, to initiate a prompt release from the pellets, a novel approach of incorporating the inclusion complex of furosemide in sulfobutyl ether cyclodextrin in the pellets was employed. Inclusion complex is prepared by kneading method. The utility of almond gum as a binding agent in extrusion and spheronization was investigated. Compared to pellets prepared by employing microcrystalline cellulose, the pellets made by using almond gum were found to be more uniform in size and exhibited a more controlled release spread over 12 hours. The influence of various processing parameters such as speed of extrusion, rpm of spheronizer and time of operation was studied. The characteristics of pellets such as size, size distribution, and shape and drug release are influenced by formulation and processing variations. The drug release data showed a good fit into both Higuchi and Korsmeyer - Peppas equations. The differential scanning calorimetry and infrared spectroscopy (IR) studies revealed that there are no interactions between furosemide and almond gum. The x-ray diffraction studies indicated that the drug furosemide existed in amorphous state in the inclusion complex. The scanning electron microscope (SEM) images of pellets showed that the pellets have spherical shape and their size depended on amount of almond gum employed. The details of experiments performed and results of the investigations will be presented.

Biography

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KVRNS Ramesh has completed his Post-graduation in Pharmaceutical Sciences and obtained his Doctoral degree in Pharmaceutics specialization from Andhra University, India. His broad area of interest is in the development of controlled release dosage forms and investigations on the stabilization of fast dissolving dosage forms. He has 30 years of teaching and research experience. He has published about 35 research papers in national and international journals. He has delivered lectures in different seminars and conferences organized in the area of Pharmaceutics and Drug Product Development. He has worked in Addis Ababa University under the United Nations Development Project. He is presently Associate Dean and Professor at RAK College of Pharmaceutical Sciences, RAK Medical & Health Sciences University, United Arab Emirates.

E-mail: venkatramesh@rakmhsu.ac.ae