Bioadhesive polymers in drug product formulations Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/ms35td88z

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  • Gastric retention time of single unit dosage forms in swine was found to be much longer than in humans. It was concluded that swine are not a good animal model to study GI transit time of nonerodable or slowly eroded dosage forms. Noneradable and slowly eroded dosage forms used to study GI transit were magnesium hydroxide and Motrin SR caplets. Radiodense bismuth was incorporated into caplet formulations in amounts which showed no interference with dissolution of Motrin SR. In vitro erosion studies showed that even though ibuprofen does not dissolve (less than 6% dissolved over 24 h) in gastric fluids, the caplet eroded in simulated gastric fluid. In order to prolong GI transit time of nonerodable or slowly eroded dosage forms, polymers which are extensively used in the pharmaceutical industry were studied for their hydration and bioadhesion properties. A strong relationship between hydration and bioadhesion was found. Excessive amounts of moisture present on tissue surfaces reduces bioadhesive strength greatly. Hydration and bioadhesion were measured at three different pH's (1.4, 5.5 and 7.2) which represent the pH of stomach, saliva and duodenum, and small intestine. An in vitro bioadhesive test was developed which measures surface "sticking" of polymer tablets to swine gastric and intestinal tissue. Bioadhesive strength of polymers of interest was compared with bioadhesive strength of commercially available buccal tablets. Polymers which hydrated most quickly and adhered most strongly to swine gastrointestinal tissue were identified.
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