Significance of Formulation and Process Variables on Development of Drug Loaded Micro-Granules

Authors : Vijay Kumar Sharma, Shailesh Sharma

Volume/Issue : Volume 2 - 2017, Issue 9 - September

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Present study evaluated three independent factors amalgam of two process variable such as atomization, and product temperature; and one formulation variable such as binder concentration of the drug dispersion. Central Composite Design (CCD) with three factors, two levels with5 centre points was used to generate experimental plan for optimization of these three independent factors with target constraints of three dependent factors such as % Efficiency (R1), % agglomeration (R2),and % drug release(R3). Target constraints used for the optimization was; 80% ≤ R1 ≥ 100%; 0% ≤ R2 ≥ 10%; 85% ≤ R3 ≥ 100%.Study indicated the responses were significant for the functional of the change in the level of the independent variables. Analysis of the design generates overlay plot to obtain design space.Binder concentration found significant for all the responses with its main impact and other factors like atomization and product temperature found significant with their main and two way interaction effect on drug loaded micro-granules. Prepared drug loaded micro-granules can be used for the further enteric coating.


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