Bethanechol chloride oral solutions: stability and use in infants.
OBJECTIVE
To assess the stability of a bethanechol chloride oral solution prepared from tablets.


METHODS
The initial concentrations were determined. These solutions were stored at 4 degrees C for 90 days. During this period, the concentrations of the bethanechol chloride solutions were determined by spectrophotometry. The clinical efficacy of the oral solution was tested in five infants with gastroesophageal reflux disease by comparison of gastric pH before and after treatment.


RESULTS
Significant decomposition of bethanechol chloride occurred in the two formulations. Bethanechol oral solution in sterile water for irrigation was well tolerated by five pediatric patients, and the clinical efficacy was equivalent to that of the tablet formulation.


CONCLUSIONS
The bethanechol chloride oral solution 1 mg/mL in sterile water for irrigation was stable at least 30 days when stored at 4 degrees C and at an initial pH of 6.5. This formulation appears to be clinically acceptable and provides a convenient dosage form for use in pediatric patients.
Schlatter
J L
JL
Department of Pharmacy, Hospital of Gonesse, France.
Saulnier
J L
JL
D018723:Bethanechol / Q000008:administration & dosage / Q000737:chemistry*; D004355:Drug Stability; D005744:Gastric Acid / Q000378:metabolism; D005764:Gastroesophageal Reflux / Q000188:drug therapy / Q000503:physiopathology; D006801:Humans; D007223:Infant; D018721:Muscarinic Agonists / Q000008:administration & dosage / Q000737:chemistry*; D010277:Parasympathomimetics / Q000008:administration & dosage / Q000737:chemistry*; D012996:Solutions; D013607:Tablets; D014867:Water
D018721:Muscarinic Agonists; D010277:Parasympathomimetics; D012996:Solutions; D013607:Tablets; D018723:Bethanechol; D014867:Water