1. Scintigraphy is the gold standard for measuring gastric emptying, but the use of radioactive isotopes can produce substantial irradiation. The [(13)C]-acetate/octanoic acid breath test is widely used as a non-radioactive alternative. 2. The half [(13)CO(2)] excretion time (T1/2b) is closely correlated with the scintigraphic half-emptying time (T1/2s). However T1/2b, is consistently remote from T1/2s, because the distribution of [(13)CO(2)] into the bicarbonate pool delays the respiratory excretion of the [(13)C] marker, which has already been emptied from the stomach. The time for the distribution process should be adjusted to diminish the discrepancy between the results of the scintigraphic and breath tests. 3. The Wagner-Nelson method provides an accurate profile of drug absorption. We have recently applied the Wagner-Nelson method to breath testing to adjust the time for [(13)CO(2)] distribution. In the present study, the [(13)C]-breath test with Wagner-Nelson analysis was compared with scintigraphy. 4. Six female volunteers simultaneously underwent scintigraphy and the breath test on two occasions, either to measure gastric emptying of the liquid phase (16 kcal) or for that of the solid phase (214 kcal). Time-percentage gastric retention curves were generated by scintigraphy and the breath test with Wagner-Nelson analysis. The half-emptying times were determined by interpolation from the scintigraphic curve (T1/2s) and the Wagner-Nelson curve (T1/2WN). T1/2b was calculated by conventional curve-fitting techniques. 5. For liquid and solid emptying, the gastric retention curves generated by the Wagner-Nelson method were comparable to the scintigraphic retention curves. For the liquid, T1/2b was significantly longer than T1/2s (93.8 +/- 7.3 vs 14.2 +/- 9.3 min, respectively; P < 0.0001), as was also observed for the solid phase (147.8 +/- 34.4 vs 35.3 +/- 11.2 min, respectively; P < 0.0001). In contrast, no significant differences were found between T1/2WN and T1/2s for the liquid (13.5 +/- 5.0 vs 14.2 +/- 9.3 min, respectively; P = 0.734) and the solid (45.8 +/- 10.2 vs 35.3 +/- 11.2 min, respectively; P = 0.051) phase. 6. In conclusion, Wagner-Nelson analysis makes the [(13)C]-breath test comparable to scintigraphy.
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http://dx.doi.org/10.1111/j.1440-1681.2007.04624.x | DOI Listing |
AAPS PharmSciTech
October 2024
Industrial Pharmacy Laboratory, Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Institute, National Research Centre (Affiliation ID: 10014618), 33 EL Bohouth St. (Former EL Tahrir St.), Dokki, P.O. 12622, Giza, Egypt.
This study explored, for the first time the role of different designs of the Flow-Through-Cell (FTC, USP IV) dissolution Tester in predicting the in-vivo performance of Pentoxifylline (PTX) sustained-release (SR) market product, under fed & fasting conditions. Release studies of Trental SR 400 mg (Sanofi, Egypt), were carried-out in the FTC under different conditions, including: different volumes / compositions of release media, variable FTC flow patterns as well as applying open / closed loop configuration setups. Pharmacokinetic (PK) data, obtained from literature, were converted to in-vivo fraction-absorbed [F] using Wagner-Nelson (WN) method.
View Article and Find Full Text PDFACS Omega
October 2024
Department of Pharmacy, Birla Institute of Technology and Science (BITS) Pilani, Hyderabad Campus, Hyderabad, Telangana State 500078, India.
Eur J Pharm Sci
November 2024
Departament of Biopharmaceutics and Pharmaceutical Technology, Johannes Gutenberg University Mainz, 55099, Mainz, Germany; Departament of Pharmaceutical Sciences, University of Michigan, 428 Church Street, Ann Arbor, MI, 48109, USA.
Deconvolution and convolution are powerful tools that allow decomposition and reconstruction, respectively, of plasma versus time profiles from input and impulse functions. While deconvolution have commonly used compartmental approaches (e.g.
View Article and Find Full Text PDFCurr Pharm Des
October 2024
School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang 110016, China.
Background: Essential hypertension is a common clinical disease and a risk factor for cardiovascular and cerebrovascular diseases. Olmesartan medoxomil, amlodipine, and hydrochlorothiazide are commonly used antihypertensive drugs. The aim of this study was to establish a robust UPLC-MS/MS method for the simultaneous determination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide in dog plasma.
View Article and Find Full Text PDFCurr Pharm Des
January 2024
Laboratory of Pharmaceutical Industrial Technology (LabTIF), Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
Background: Oral suspensions are heterogeneous disperse systems, and the particle size distribution, crystalline form of the dispersed solid, and composition of the formulation can be listed as parameters that control the drug dissolution rate and its bioavailability.
Objective: The aim of this work was to develop a discriminative dissolution test, which, in association with in silico methodologies, can make it possible to safely anticipate bioavailability problems.
Methods: Nimesulide and ibuprofen (BCS class II) and cephalexin (BCS class I) oral suspensions were studied.
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