Back to Search
Start Over
Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan.
- Source :
- Children; Sep2022, Vol. 9 Issue 9, pN.PAG-N.PAG, 15p
- Publication Year :
- 2022
-
Abstract
- Baclofen is used as a skeletal muscle relaxant for multiple sclerosis patients and pediatric patients with cerebral palsy and is prescribed to pediatric patients at 0.3 to 1.0 mg/kg/dose. Baclofen tablets, an oral drug, are usually administered as a powder in pediatric wards after a formulation change by the pharmacist. However, there is no information about stability and assurance of quality for compounded products. The purpose of this study was to design a 10 mg/g oral powder of baclofen and to investigate the stability and changes in the physical properties of this compounded product. A 10 mg/g baclofen powder was prepared by adding extra-fine crystal lactose hydrate to crushed and filtrated baclofen tablets and was stored in a polycarbonate amber bottle with desiccant or in a coated paper laminated with cellophane and polyethylene. The stability of baclofen at 25 ± 2 °C/60 ± 5%RH was tested for 120 days in 'bottle (closed)', 'bottle (in use)', and 'laminated' storage conditions. Baclofen concentrations ranged from 90.0% to 110.0% of the initial concentration under all storage conditions. No crystallographic or dissolution changes were observed after storage. This information can help with the management of baclofen compounded powder in pharmacies. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 22279067
- Volume :
- 9
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Children
- Publication Type :
- Academic Journal
- Accession number :
- 159336124
- Full Text :
- https://doi.org/10.3390/children9091313