scholarly journals Fiber-Reinforced-Phospholipid Vehicle-Based Delivery of l-Ascorbic Acid: Development, Characterization, ADMET Profiling, and Efficacy by a Randomized, Single-Dose, Crossover Oral Bioavailability Study

ACS Omega ◽  
2021 ◽  
Author(s):  
Joby Jacob ◽  
Nimisha Pulikkal Sukumaran ◽  
Shintu Jude
Keyword(s):  
Ascorbic Acid ◽  
Single Dose ◽  
Oral Bioavailability ◽  
Fiber Reinforced ◽  
Bioavailability Study

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF MICRONIZED GLICLAZIDE IN HUMAN PLASMA BY LC-MS/MS AND ITS PHARMACOKINETIC STUDIES

INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (09) ◽  
pp. 24-33
Author(s):  
R. Bose ◽  
◽  
S Dan ◽  
P. Mandal ◽  
P. Sarkar ◽  
...  
Keyword(s):  
Single Dose ◽  
Oral Bioavailability ◽  
Method Development ◽  
Test Preparation ◽  
Pharmacokinetic Parameters ◽  
Pharmacokinetic Studies ◽  
Particle Size Reduction ◽  
Male Adult ◽  
Minimum Effective Concentration ◽  
Reference Preparation

Drugs having poor oral bioavailability, fail to reach the minimum effective concentration required to achieve pharmacological action. Improvement of the oral bioavailability of the drug is the most realistic approach, as it is the most preferred and convenient route of administration. Besides numerous techniques to improve oral bioavailability of the drugs, particle size reduction leads to increase in the effective surface area, resulting in enhancement of solubility and dissolution velocity of the drug. In the present study a sustained release tablet formulation containing 60mg micronized gliclazide was attempted to develop and a randomized, two period, two treatment crossover, single dose, pilot study of test preparation along with a marketed sample of Gliclazide 60mg was carried out on 6 healthy male, adult, human volunteers under fasting condition to establish the bioequivalence of the new formulation with a washout period of one week. The developed method was found to be simple, reproducible, sensitive, and specific for the determination of gliclazide from plasma and was also applied to study the pharmacokinetic parameters of gliclazide. The mean peak plasma levels of gliclazide with the reference preparation on the study day ranged between 2562.27–2823.61ng/mL, while the test preparation ranged between 3091.24–3467.66ng/mL. On the basis of comparison of the AUC0-t for gliclazide after single dose administration, the relative bioavailability of the test preparation was 109.96% of that of the reference preparation.

Influence of food on the oral bioavailability of rupatadine tablets in healthy volunteers: A single-dose, randomized, open-label, two-way crossover study

2007 ◽  
Vol 29 (5) ◽  
pp. 900-908 ◽  
Author(s):  
Anna Solans ◽  
Marcel·lí Carbó ◽  
Juana Peña ◽  
Teresa Nadal ◽  
Iñaki Izquierdo ◽  
...  
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Healthy Volunteers ◽  
Oral Bioavailability ◽  
Open Label ◽  
Influence Of Food

Stabilization of a non-aqueous self-double-emulsifying delivery system of rutin by fat crystals and nonionic surfactants: preparation and bioavailability study

2017 ◽  
Vol 8 (7) ◽  
pp. 2512-2522 ◽  
Author(s):  
Qiang Wang ◽  
Juan Huang ◽  
Caibiao Hu ◽  
Nan Xia ◽  
Tong Li ◽  
...  
Keyword(s):  
Delivery System ◽  
Oral Bioavailability ◽  
Nonionic Surfactants ◽  
Emulsion Stability ◽  
Fat Crystals ◽  
Emulsifier System ◽  
Bioavailability Study

The use of a dual emulsifier system enhances emulsion stability and the non-aqueous SDEDS improves the oral bioavailability of rutin.

scholarly journals The Influence of Chitosan on the Oral Bioavailability of Acyclovir—a Comparative Bioavailability Study in Humans

2015 ◽  
Vol 32 (7) ◽  
pp. 2241-2249 ◽  
Author(s):  
Marlies Kubbinga ◽  
Mai Anh Nguyen ◽  
Petra Staubach ◽  
Steven Teerenstra ◽  
Peter Langguth
Keyword(s):  
Oral Bioavailability ◽  
Bioavailability Study ◽  
Comparative Bioavailability ◽  
Comparative Bioavailability Study

scholarly journals Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants

2021 ◽  
Author(s):  
Aline Barth ◽  
Mohammad Hossain ◽  
Darin B. Brimhall ◽  
Caroline R. Perry ◽  
Courtney A. Tiffany ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Adult ◽  
Relative Bioavailability ◽  
Wet Granulation ◽  
Free Base ◽  
Formulation Development ◽  
Confidence Bounds ◽  
Time Curve ◽  
Bioavailability Study ◽  
New Treatment

Gepotidacin is a novel, first-in-class triazaacenaphthylene antibiotic that may provide a new treatment option for antibiotic-resistant pathogens. Two pharmacokinetic evaluations of oral gepotidacin are presented; a relative bioavailability study that guided formulation development, followed by an adult and adolescent study of the final formulation. In the relative bioavailability study, after gepotidacin administration to 26 healthy adults as free base roller compacted (RC) tablets, free base high shear wet granulation (HSWG) tablets, and mesylate salt reference capsules, the RC tablet exposure ratios and 90% confidence intervals (CIs) were within the 0.80 to 1.25 confidence bounds; however, the HSWG tablet maximum observed concentration (C max ) was higher compared to the reference (ratio: 1.15; 90% CIs: 1.0113, 1.3047). In the healthy adult (n=16) and adolescent (n=17) study, a gepotidacin mesylate salt tablet was evaluated as a 1,500-mg single dose, 2 doses administered 6 or 12 h apart (6,000 mg total), or placebo. Single-dose mean C max was ∼27% higher in adolescents versus adults and area under the concentration-time curve (AUC) was comparable in both populations. After 2 doses were administered, mean C max was similar for both ages and mean AUC was ∼35% higher in adolescents versus adults. Concentrations increased proportionally with dose. Safety-risk profiles were similar in both ages. Across studies, the most common adverse events were gastrointestinal. Overall, the pharmacokinetics of the final gepotidacin mesylate salt tablet have been well-characterized, enrollment of adolescents into the pivotal trials is supported, and dosing intervals were determined that should provide adequate exposures for microbiological efficacy.

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