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Tablet shapes and in vitro evaluation of coated hydrophilic matrix tablets novel mupirocin formulations non-acidic enteric coating of omeprazole and novel hot-melt coating process

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dc.contributor.advisor Ayres, James W.
dc.creator Leung, Manshiu
dc.date.accessioned 2012-07-16T17:59:43Z
dc.date.available 2012-07-16T17:59:43Z
dc.date.copyright 2002-05-14
dc.date.issued 2002-05-14
dc.identifier.uri http://hdl.handle.net/1957/31105
dc.description Graduation date: 2003 en_US
dc.description.abstract This dissertation is comprised of four distinct formulation sections, which are described below: A novel solid dosage formulation was investigated for achieving zero-order drug release profile by combining tablet shape design and tablet membrane film coating. Verapmail (model drug) was compressed into hydrophilic matrix tablet cores of flat-faced and bi-convex shape, which were encapsulated with membrane controlling film. The hydrophilic tablet core contained hydroxypropyl methylcellulose (HPMC) 15 LV, pectin, and Avecil®. The membrane film coating solution was comprised of deionized water, Opadry®, Surelease® and talc. The combination of membrane film coating and tablet shape design was found to influence in vitro verapamil release profile towards the zero-order release demonstrated by the commercial Covera HS® (Pharmacia). An alternative formulation for the commercial Bactroban® (Smithkline Beacham) ointment 2% was developed. Both the texture and consistency of the new ointment were comparable to the Bactroban® ointment. The new and the commercial formulations were found to be equivalent in drug release by the Bauer-Kirby test. Mupirocin remained unstable in the new formulation. Mg²⁺ was added to help stabilize mupirocin and was shown to complex with mupirocin by nuclear magnetic resonance (NMR). The modified formulation including Mg²⁺ however failed to stabilize mupirocin. The stability assay results showed an average of 67.2% mupirocin recovery along with 25.2% degradation products. A generic omeprazole formulation was developed, which was comprised of nonpareil core, omeprazole matrix layer, and an enteric locating layer of ammoniated hydroxypropyl methylcellulose phthalate (HPMCP) 55S. The new formulation was gastro-resistant in protecting against omeprazole degradation for up to 2 h, but failed to dissolve as rapidly as the commercial Prilosec® (Astra Merk) in simulated intestinal fluid. The addition of expotab® to the enteric coating layer failed to improve omeprazole dissolution rate. A novel hot-melt coating methodology utilizing direct blending technique has been developed. The processing steps for the direct blending hot-melt coating are: (a) Hot-melt system preparation; (b) Dispersion/dissolution of the active ingredient(s) in the hot-melt system; (c) Pre-heating of the coating substrate; and (d) Cooling and congealing of the hot-melt on substrate surface. Immunogenic effect was observed in mice administered with enteric-coated ragweed pollen extract (RPE) alpha fraction by the hot-melt coating encapsulation with direct blending method. The effect was not shown to be statistically significant. en_US
dc.language.iso en_US en_US
dc.subject.lcsh Tablets (Medicine) -- Technological innovations en_US
dc.subject.lcsh Tableting en_US
dc.subject.lcsh Pharmaceutical technology en_US
dc.subject.lcsh Mupirocin en_US
dc.subject.lcsh Drugs -- Coatings en_US
dc.title Tablet shapes and in vitro evaluation of coated hydrophilic matrix tablets novel mupirocin formulations non-acidic enteric coating of omeprazole and novel hot-melt coating process en_US
dc.type Thesis/Dissertation en_US
dc.degree.name Doctor of Philosophy (Ph. D.) in Pharmacy en_US
dc.degree.level Doctoral en_US
dc.degree.discipline Pharmacy en_US
dc.degree.grantor Oregon State University en_US
dc.description.digitization File scanned at 300 ppi (Monochrome, 256 Grayscale) using Capture Perfect 3.0 on a Canon DR-9050C in PDF format. CVista PdfCompressor 4.0 was used for pdf compression and textual OCR. en_US
dc.description.peerreview no en_us

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