PMID- 31349864
OWN - NLM
STAT- MEDLINE
DCOM- 20200106
LR  - 20231013
IS  - 1756-0500 (Electronic)
IS  - 1756-0500 (Linking)
VI  - 12
IP  - 1
DP  - 2019 Jul 26
TI  - Prevalence of ethanol and other potentially harmful excipients in pediatric oral 
      medicines: survey of community pharmacies in a Nigerian City.
PG  - 460
LID - 10.1186/s13104-019-4486-7 [doi]
LID - 460
AB  - OBJECTIVE: Excipients are needed in the formulation of oral liquid medicines 
      intended for children; they have however been reported to trigger safety issues. 
      This study evaluated the concentrations and prevalence of ethanol and other 
      potentially harmful excipients in pediatric formulations marketed in South 
      Eastern Nigeria in line with international labeling guidelines and allowable 
      daily limits (ADL). The study sampled oral pediatric formulations offered for 
      sale in registered pharmacies. Those with accessible information leaflets were 
      assessed for the presence and quantity of previously flagged excipients with 
      potential to harm the pediatric population. RESULT: Of the 380 oral pediatric 
      medicines, 140 provided access to list/quantity of ingredients. 47.9% (67) of the 
      formulations contain at least one of the flagged excipients while the remaining 
      only listed the active ingredients. Ethanol had the highest occurrence (62.7%) 
      and was more in cough/cold medicines. A homeopathic cough and cold remedy had 
      concentration of 90% v/v. Ethanol and sucrose in some formulations exhibited 
      concentrations with a potential of crossing their approved daily intake (ADI) 
      (1-90% v/v and 1.7 g-3.7 g/5 ml respectively). Ethanol use in studied pediatric 
      formulations was quite high, with ethanol-containing formulations being 
      prescribed for children 0-6 years and older. Only 26 (38.8%) completely satisfied 
      the labelling requirements for ethanol containing formulations.
FAU - Soremekun, Rebecca
AU  - Soremekun R
AUID- ORCID: 0000-0002-2997-666X
AD  - Department of Clinical Pharmacy, Faculty of Pharmacy, University of Lagos, Lagos, 
      Nigeria. rsoremekun@unilag.edu.ng.
AD  - Faculty of Public Health, West African Postgraduate College of Pharmacists, 
      Lagos, Nigeria. rsoremekun@unilag.edu.ng.
FAU - Ogbuefi, Irene
AU  - Ogbuefi I
AD  - Faculty of Public Health, West African Postgraduate College of Pharmacists, 
      Lagos, Nigeria.
FAU - Aderemi-Williams, Roseline
AU  - Aderemi-Williams R
AD  - Department of Clinical Pharmacy, Faculty of Pharmacy, University of Lagos, Lagos, 
      Nigeria.
AD  - Faculty of Public Health, West African Postgraduate College of Pharmacists, 
      Lagos, Nigeria.
LA  - eng
PT  - Journal Article
DEP - 20190726
PL  - England
TA  - BMC Res Notes
JT  - BMC research notes
JID - 101462768
RN  - 0 (Azo Compounds)
RN  - 0 (Dosage Forms)
RN  - 0 (Excipients)
RN  - 0 (Parabens)
RN  - 0 (Polysorbates)
RN  - 3K9958V90M (Ethanol)
RN  - 506T60A25R (Sorbitol)
RN  - 57-50-1 (Sucrose)
RN  - 6DC9Q167V3 (Propylene Glycol)
RN  - FST467XS7D (Saccharin)
RN  - OJ245FE5EU (Sodium Benzoate)
RN  - Z0H242BBR1 (Aspartame)
SB  - IM
MH  - Administration, Oral
MH  - Aspartame/analysis
MH  - Azo Compounds/analysis
MH  - Child
MH  - *Dosage Forms
MH  - Ethanol/*analysis
MH  - Excipients/*analysis
MH  - Humans
MH  - Nigeria
MH  - Parabens/analysis
MH  - Pharmacies/*ethics
MH  - Polysorbates/analysis
MH  - Propylene Glycol/analysis
MH  - Saccharin/analysis
MH  - Sodium Benzoate/analysis
MH  - Sorbitol/analysis
MH  - Sucrose/analysis
MH  - Surveys and Questionnaires
PMC - PMC6660694
OTO - NOTNLM
OT  - Community pharmacy
OT  - Ethanol
OT  - Excipients
OT  - Oral liquid medicines
OT  - Pediatrics
COIS- The authors declare that they have no competing interests.
EDAT- 2019/07/28 06:00
MHDA- 2020/01/07 06:00
PMCR- 2019/07/26
CRDT- 2019/07/28 06:00
PHST- 2019/06/04 00:00 [received]
PHST- 2019/07/15 00:00 [accepted]
PHST- 2019/07/28 06:00 [entrez]
PHST- 2019/07/28 06:00 [pubmed]
PHST- 2020/01/07 06:00 [medline]
PHST- 2019/07/26 00:00 [pmc-release]
AID - 10.1186/s13104-019-4486-7 [pii]
AID - 4486 [pii]
AID - 10.1186/s13104-019-4486-7 [doi]
PST - epublish
SO  - BMC Res Notes. 2019 Jul 26;12(1):460. doi: 10.1186/s13104-019-4486-7.