Methodologies for Assessing the Acceptability of Oral Formulations among children and older adults: A Systematic Review

This is an open access article distributed under the terms and conditions of the Creative Commons Attribution NonCommercial-NoDerivatives 4.0 International CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/Acceptability of medicinal products in children and older populations is pivotal in ensuring adherence and therapeutic outcomes. This review systematically identifies studies reporting on formulation aspects of oral medications that affect their acceptability in these patient groups. Particular emphasis is placed on the evaluation of the methodologies employed in the studies. Sixty-eight studies were included for analysis, with 51 (75%) in children and 17 (25%) in older populations. The studies evaluated a range of oral formulations; however, the methodologies used differ considerably in participants’ characteristics, study settings, tools, acceptability definitions and criteria. It is evident that there is a lack of standardisation in study design as well as the assessment methods used in assessing acceptability of medicines in children and older populations. This review presents a systematic analysis on methods employed for assessing acceptability of oral medicines in children and older adults, to provide insights and recommendations regarding the design of reliable instruments in future studies.Peer reviewe

The Acceptability, Efficacy and Safety of a New Paediatric Oral Suspension of Roxithromycin in Respiratory Tract Infections

A new paediatric formulation of roxithromycin was tested for acceptability, efficacy and safety in a multicentre, prospective, non-comparative trial in 210 children, aged between 2 and 8 years, with a variety of respiratory tract infections. Most children were diagnosed as having rhinobronchitis, acute pharyngitis or acute tonsillitis. A dose of 5–8 mg/kg/day (mean ± SD, 5.92 ± 1.12) roxithromycin was given orally for 5–10 days (mean ± SDL 6.86 ± 1.80). The formulation consists of a tablet for suspension in a small volume of water, administered using a spoon, twice daily. Acceptability was good, with only eight children refusing their medication because of the taste or because of vomiting. The method of administration was found to be convenient by 76% of parents. The clinical success rate was 89.1% in the intent-to-treat analysis. There were only 18 adverse events reported by 14 patients; of these, only 10 events (all gastrointestinal) in eight patients were classified as drug related. A total of eight patients discontinued treatment because of an adverse event, but in only four were the events drug related. </jats:p

Detection of Mycoplasma pneumoniae in clinical samples from pediatric patients by polymerase chain reaction

The polymerase chain reaction (PCR) technique was used to detect Mycoplasma pneumoniae DNA in clinical samples (nasopharyngeal aspirations or bronchoalveolar lavages) obtained from 100 children, 1 month to 16 years old. PCR allowed the detection of M. pneumoniae DNA from 20 out of the 100 patients studied. In 16 cases, PCR positivity was associated with acute respiratory symptomatology. For five PCR-positive patients, a positive culture or a serological response evidenced acute M. pneumoniae infections. A lack of antibody response was observed particularly with immunocompromised children and infants less than 12 months old. The amount of M. pneumoniae DNA in the PCR was estimated in a semiquantitative way by comparison of its hybridization signal with those obtained for 100, 10, and 1 color-changing unit (CCU) of the M. pneumoniae FH strain. Small amounts (less than or equal to 10(2) CCU/ml) of M. pneumoniae were found in samples from asymptomatic patients, while larger amounts (greater than or equal to 10(2) to greater than or equal to 10(4) CCU/ml) were found for 8 out of 10 patients with acute pneumonia.</jats:p

Susceptibility of Enterobacteriaceae to β-lactam agents and fluoroquinolones: a 3-year survey in France

ObjectiveTo assess trends in the susceptibility to β-lactam agents and to fluoroquinolones of clinically relevant Enterobacteriaceae isolated over a 3-year period in 14 French hospital laboratories.MethodsDuring the second quarter of 1996, 1997 and 1998, 180 consecutive non-duplicate isolates of Enterobacteriaceae were collected in each center. Sixteen β-lactams and four quinolones were tested by the disk diffusion method. In addition, the double-disk synergy test was used to screen for the production of extended-spectrum β-lactamase (ESBL).ResultsTotals of 2507, 2312 and 2506 clinical isolates were obtained in each period, respectively. The distribution of Enterobacteriaceae species according to clinical specimens and wards was similar in each study period. No significant variation in the susceptibility rates to β-lactams and fluoroquinolones was observed, except in Klebsiella pneumoniae and Enterobacter aerogenes. The prevalence of ESBL-producing isolates decreased from 18% to 9% in the former, while it increased from 32% to 54% in the latter. At the same time, the susceptibility to ofloxacin and pefloxacin increased for K. pneumoniae (P < 0.003) and cephalosporinase-producing species (P < 0.05), except Enterobacter spp.ConclusionOver the 3-year study period β-lactams and fluoroquinolones remained highly active against Enterobacteriaceae clinical isolates, with the exception of E. aerogenes, probably as a result of the dissemination of multiresistant clones in French hospitals