Graduate Thesis Or Dissertation
 

Evaluation of solid dispersed particles for formulation of oral ibuprofen tablets

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https://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/dz010s474

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  • Dissolution profiles of two commercial products (Motrine and Rufen®) were analyzed and compared at 8 pH levels, ranging from pH 2.0 to pH 8.0. It was demonstrated, as expected, that the rate and extent of ibuprofen dissolution dissolution was pH dependent. In vitro dissolution characteristics of the ibuprofen solid dispersion formulations prepared by freeze-drying method with various proportions of excipients (theobroma oil, lecithin and PEG 20,000) were investigated at 3 pH levels - pH 2.0, 5.4, and 7.2. As the amount of theobroma oil increased from zero to 31%, the dissolution rate and the percent ibuprofen dissolved was decreased. Freeze-dried systems with a combination of lecithin and PEG 20,000 showed a slower dissolution rate and less amount of drug dissolved than the formulation with only PEG 20,000. The optimal ratio of drug to PEG 20,000 was 1:1. Solid dispersions of ibuprofen prepared by the freezedrying method provided the highest dissolution rate and percentage of drug dissolved when compared with the direct melting method, the solvent method or the physical-mixing method. Dissolution characteristics of the ibuprofen freeze-dried formulation (ratio of drug to PEG 20,000 1:1) were unaffected after storage in 98% relative humidity, but commercial formulation dissolution was drastically reduced. Relative bioavailability of ibuprofen solid dispersed tablets were studied in rabbits after a single oral administration of 50 mg ibuprofen preparations. The freeze-dried solid dispersion formulation with ratio of drug to PEG 1:1 exhibited the greatest relative extent of absorption (129.50 +̲ 27.99% over control). Preparations with PEG 20,000 enhanced the extent of absorption when compared to the formulation of ibuprofen drug powder. There appeared no advantage in formulating ibuprofen in PEG by freeze-drying over the direct melting method. A slower rate of absorption of ibuprofen was obtained when the amount of theobroma oil was increased in the formulation.
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