Preparation and Evaluation of Micro particulate Drug Delivery Systems of Gliclazide Employing Starch Acetate
Journal Title: Drug Designing & Intellectual Properties International Journal - Year 2018, Vol 1, Issue 1
Abstract
Recently much emphasis is being laid on the development of micro particulate DDS in preference to single unit systems because of their potential benefits such as increased bioavailability, reduced risk of systemic toxicity, reduced risk of local irritation and predictable gastric emptying. The objective of the present study is to prepare and evaluate micro particulate drug delivery systems of Gliclazide using starch acetate, a new modified starch for oral controlled release. The starch acetate (DS 2.75) was freely soluble in chloroform and insoluble in several aqueous fluids and organic solvents. Chloroform could be used as solvent for starch acetate in the preparation of micro particles, microcapsules and in film coating Spherical starch acetate- Gliclazide micro particles could be prepared by the emulsification-solvent evaporation method. The method is industrially feasible as it involves emulsification and removal of the solvent, which can be controlled precisely. The emulsification solvent evaporation method was reproducible with regard to size and size distribution of the micro particles. About 65-70% of micro particles in each batch were in the size range 35/50 mesh (398.5μm) Encapsulation efficiency was in the range 96.0-99.3 % in the preparation of micro particles. Gliclazide release from the starch acetate micro particles was slow and spread over longer periods of time. The drug release depended on the proportion of core: coat in the micro particles. A good linear relationship (R2=0.826) between percent coat and release rate (ko) was observed. The relationship could be expressed by the linear equation, y=12.18-0.173x where x is percent coat and y is release rate (ko). Gliclazide release from the starch acetate micro particles was by non fickian (anomalous) diffusion. Formulation F2 prepared using a Core: coat ratio of 8:2 gave slow, controlled and complete release (100%) of Gliclazide over 12 hours. As such formulation F2 is considered as a promising micro particulate DDS for oral control release of Gliclazide over 12 hours for b.i.d administration. The design of micro particulate drug delivery systems is an efficient technique to provide the sustained & controlled delivery of drugs over long periods of time. Micro particulate drug delivery systems [1] consist of small particles of solids or small droplets of liquids surrounded by walls of natural & synthetic polymer films of varying thickness & degree of permeability acting as a release rate controlling substance & have a diameter up to the range of 0.1μm- 200μm. Micro particulate dosage forms [2] are pharmaceutical formulations in which the active substance is present as a number of small independent subunits. To deliver the recommended total dose, these subunits are filled into capsules, encapsulated or compressed into a tablet. Micro particulate drug delivery systems contain discrete particles that make up a multiple-unit system. They provide many advantages over single-unit systems because of their small size. Multi particulates are less dependent on gastric empty time, resulting in less inter and intra-subject variability in gastrointestinal transit time. They are also better distributed and less likely to cause local irritation [3]. Recently much emphasis is being laid on the development of micro particulate dosage forms in preference to single unit systems because of their potential benefits such as increased bioavailability, reduced risk of systemic toxicity, reduced risk of local irritation and predictable gastric emptying.
Authors and Affiliations
P Veera Lakshmi, KPR Chowdary, A Prameela Rani, VUM Prasad
Keywords
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- EP ID EP585666
- DOI 10.32474/DDIPIJ.2018.01.000103
- Views 221
- Downloads 0
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