New product formulation and multiple dose pharmacokinetics of acetaminophen Public Deposited

http://ir.library.oregonstate.edu/concern/graduate_thesis_or_dissertations/6m311s26z

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  • Four different treatments of acetaminophen were administered to eight healthy volunteers in multiple doses (five doses). Saliva acetaminophen concentration-time profiles were determined. Non-compartmental pharmacokinetic parameters for the first and last dose were calculated and compared to determine whether acetaminophen exhibited linear or dose dependent pharmacokinetics. Dose corrected area under the curve, mean residence time, half-life, and apparent clearance were not significantly different among treatments. Plots of saliva acetaminophen concentration vs time normalized to a 325 mg dose were superimposable, indicating linearity of kinetics. Acetaminophen is a prime candidate for sustained release dosage forms (chapter II) due to its relatively short half-life. Acetaminophen pellets were spray coated with sustained release and/or enteric coats and incorporated into suspension formulations. A non-aqueous semisolid suspension was also investigated using coated pellets. These formulations were aged for a period of one year and in-vitro dissolution studies conducted. Time to 50% drug release after 6 days, 3 months, 9 months, and 12 months aging were similar to each other (about 5 hours) and did not change significantly. Bioavailability studies of some suspension formulations were conducted in two subjects and compared to an immediate release commercial product. Suspension containing 5/10/5 coated acetaminophen pellets produced sustained saliva acetaminophen concentrations over 24 hour period, especially for a formulation with immediate release portion of drug. Non aqueous formulations did not appear promising as the in- vitro dissolution was too rapid following aging. It may be possible to keep the pellets and non aqueous formulations separated in unit dose packages and mix prior to administration of the dose.
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  • File scanned at 300 ppi (Monochrome) using Capture Perfect 3.0.82 on a Canon DR-9080C 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 2013-07-19T20:13:06Z (GMT) No. of bitstreams: 1 SahajwallaChandrahasG1987.pdf: 1095850 bytes, checksum: 3c091181e778db90a5dbd21c87db89af (MD5)
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  • description.provenance : Approved for entry into archive by Patricia Black(patricia.black@oregonstate.edu) on 2013-06-17T17:05:02Z (GMT) No. of bitstreams: 1 SahajwallaChandrahasG1987.pdf: 1095850 bytes, checksum: 3c091181e778db90a5dbd21c87db89af (MD5)
  • description.provenance : Made available in DSpace on 2013-07-19T20:13:06Z (GMT). No. of bitstreams: 1 SahajwallaChandrahasG1987.pdf: 1095850 bytes, checksum: 3c091181e778db90a5dbd21c87db89af (MD5) Previous issue date: 1987-01-15

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