| Title |
Investigation of the bioequivalence of montelukast chewable tablets after a single oral administration using a validated LC-MS/MS method
|
|---|---|
| Published in |
Drug Design, Development and Therapy, September 2015
|
| DOI | 10.2147/dddt.s87938 |
| Pubmed ID | |
| Authors |
Abdel Naser Zaid, Murad N Abualhasan, David G Watson, Ayman Mousa, Nadia Ghazal, Rana Bustami |
| Abstract |
Montelukast (MT) is a leukotriene D4 antagonist. It is an effective and safe medicine for the prophylaxis and treatment of chronic asthma. It is also used to prevent acute exercise-induced bronchoconstriction and as a symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis. The aim of this study was to evaluate the bioequivalence (BE) of two drug products: generic MT 5 mg chewable tablets versus the branded drug Singulair(®) pediatric 5 mg chewable tablets among Mediterranean volunteers. An open-label, randomized two-period crossover BE design was conducted in 32 healthy male volunteers with a 9-day washout period between doses and under fasting conditions. The drug concentrations in plasma were quantified by using a newly developed and fully validated liquid chromatography tandem mass spectrometry method, and the pharmacokinetic parameters were calculated using a non-compartmental model. The ratio for generic/branded tablets using geometric least squares means was calculated for both the MT products. The relationship between concentration and peak area ratio was found to be linear within the range 6.098-365.855 ng/mL. The correlation coefficient (R (2)) was always greater than 0.99 during the course of the validation. Statistical comparison of the main pharmacokinetic parameters showed no significant difference between the generic and branded products. The point estimates (ratios of geometric means) were 101.2%, 101.6%, and 98.11% for area under the curve (AUC)0→last, AUC0→inf, and C max, respectively. The 90% confidence intervals were within the predefined limits of 80.00%-125.00% as specified by the US Food and Drug Administration and European Medicines Agency for BE studies. Broncast(®) pediatric chewable tablets (5 mg/tablet) are bioequivalent to Singulair(®) pediatric chewable tablets (5 mg/tablet), with a similar safety profile. This suggests that these two formulations can be considered interchangeable in clinical practice. |
X Demographics
The data shown below were collected from the profiles of 3 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Germany | 1 | 33% |
| India | 1 | 33% |
| United Kingdom | 1 | 33% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 33% |
| Scientists | 1 | 33% |
| Practitioners (doctors, other healthcare professionals) | 1 | 33% |
Mendeley readers
The data shown below were compiled from readership statistics for 68 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 1% |
| Unknown | 67 | 99% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 11 | 16% |
| Researcher | 7 | 10% |
| Student > Ph. D. Student | 7 | 10% |
| Student > Doctoral Student | 6 | 9% |
| Student > Bachelor | 5 | 7% |
| Other | 11 | 16% |
| Unknown | 21 | 31% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 20 | 29% |
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 10% |
| Sports and Recreations | 4 | 6% |
| Biochemistry, Genetics and Molecular Biology | 3 | 4% |
| Agricultural and Biological Sciences | 2 | 3% |
| Other | 9 | 13% |
| Unknown | 23 | 34% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 29 September 2015.
All research outputs
#16,048,009
of 25,374,917 outputs
Outputs from Drug Design, Development and Therapy
#925
of 2,268 outputs
Outputs of similar age
#147,242
of 276,789 outputs
Outputs of similar age from Drug Design, Development and Therapy
#52
of 133 outputs
Altmetric has tracked 25,374,917 research outputs across all sources so far. This one is in the 34th percentile – i.e., 34% of other outputs scored the same or lower than it.
So far Altmetric has tracked 2,268 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 7.1. This one has gotten more attention than average, scoring higher than 55% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 276,789 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 44th percentile – i.e., 44% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 133 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 56% of its contemporaries.