| Relative bioavailability of new formulation of paracetamol effervescent powder containing sodium bicarbonate versus paracetamol tablets: a comparative pharmacokinetic study in fed subjects. | |
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MedLine Citation:
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PMID: 17931082 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: the aim of this relative bioavailability study was to determine the rate and extent of absorption of Alikal Dolor (effervescent powder containing paracetamol 500 mg/sodium bicarbonate 2318 mg)--test formulation (T) in relation to Parageniol (paracetamol 500 mg coated tablets)--reference formulation (R). METHODS: 18 healthy volunteers (10 male and 8 female aged between 21 and 46 years) received, after 2 h of standardized breakfast, a single oral dose with 220 ml of water, in an open, randomized, crossover study, with a 7-day wash-out period. Paracetamol concentrations were established at 0, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 75, 90 min and at 2, 4, 6, 8 and 10 h postdose by HPLC with an ultraviolet detector. RESULTS: the regression coefficient determined for paracetamol calibration curves was 0.9983 +/- 0.0034 and the working range was from 0.2 to 50 microg/ml. The quantification limit was 0.2 microg/ml. The rate of absorption was significantly greater (p < 0.03) for T (T(max) = 20.4 min) compared with R (T(max) = 38.4 min). Extent of absorption over the first 30 min postdose AUC((0-30 min)) was 4.21-fold greater (p < 0.03) for T compared with R, without differences between C(max.) The 90% CI on the geometric mean for C(max), AUC((0-10 h)) and AUC((0-)) ratios (T/R) were within the limits of 0.80-1.25, indicating both formulations were bioequivalent with respect to these parameters. CONCLUSION: paracetamol was absorbed at least twice as fast from T-containing sodium bicarbonate compared with R. This pharmacokinetic feature could prove crucial from the therapeutic point of view as it would allow a lower latency in the action time of paracetamol in producing its analgesic and antithermal effect. |
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Authors:
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Guillermo Di Girolamo; Javier A W Opezzo; Marcela I Lopez; Daniel Schere; Guillermo Keller; Claudio D Gonzalez; Javier Martinelli Massa; María Cecilia de los Santos |
Publication Detail:
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Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Expert opinion on pharmacotherapy Volume: 8 ISSN: 1744-7666 ISO Abbreviation: Expert Opin Pharmacother Publication Date: 2007 Oct |
Date Detail:
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Created Date: 2007-10-12 Completed Date: 2007-12-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100897346 Medline TA: Expert Opin Pharmacother Country: England |
Other Details:
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Languages: eng Pagination: 2449-57 Citation Subset: IM |
Affiliation:
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Second Chair of Pharmacology, Universidad de Buenos Aires, Department of Pharmacology, School of Medicine, Ciudad Autónoma de Buenos Aires, Argentina. gdigirolamo@arnet.com.ar |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Acetaminophen
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chemistry*,
pharmacokinetics* Adult Biological Availability Chemistry, Pharmaceutical / methods Cross-Over Studies Female Food* Humans Intestinal Absorption / drug effects, physiology Male Middle Aged Powders Sodium Bicarbonate / chemistry*, pharmacokinetics* Tablets |
| Chemical | |
Reg. No./Substance:
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0/Powders; 0/Tablets; 103-90-2/Acetaminophen; 144-55-8/Sodium Bicarbonate |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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