New acetaminophen products : formulation development and bioavailability Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/j9602420f

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  • Development of a novel, useful, orally administered dosage form providing controlled, sustained release of an active ingredient was desired. Film layers of Aquacoat and Eudragit L-30D (commercially available coating materials) were applied to acetaminophen cores. Amount of coating material, number of polymer layers, and order of application were varied. In vitro dissolution results indicate amount/thickness of film layer and sequence in which polymeric materials were applied are important factors in formulating multiple layer drug beads. A unique sustained release suspension was formulated by incorporating multilaminar polymer-coated acetaminophen beads into a suspending vehicle. Choice of suspending media, length of aging, and application of heat alter acetaminophen release from these polymer-coated beads and are likely to influence in vivo performance. Relative bioavailability and pharmacokinetic parameters for two different three-layer polymer-coated bead types were evaluated in two suspending vehicles of differing viscosity containing an immediate release dose of acetaminophen powder. These four test products were administered to 26 human subjects in a modified 4-way cross-over study and compared to two commercially available control products (immediate release acetaminophen tablets and prolonged release multi-symptom cold tablets containing acetaminophen). Saliva acetaminophen concentration were determined for a 24 hour period following administration of each dosage form and correlated to plasma concentrations. Concentration-time profiles and model-independent pharmacokinetic parameters have been determined. Computer simulations were made to determine the effect of alternative dosing regimens using a unique sustained release suspension. Results indicate achievement of sustained therapeutic plasma concentrations is possible using multiple polymer film-coated drug products.
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  • File scanned at 300 ppi (Monochrome, 8-bit Grayscale) using ScandAll PRO 1.8.1 on a Fi-6670 in PDF format. CVista PdfCompressor 4.0 was used for pdf compression and textual OCR.
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  • description.provenance : Approved for entry into archive by Patricia Black(patricia.black@oregonstate.edu) on 2013-04-23T18:42:04Z (GMT) No. of bitstreams: 1 MansellLibbieJ1990.pdf: 6038534 bytes, checksum: 8ad0f6bf9481a02901821a6365fa439c (MD5)
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