Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan

• Published in: Children (Basel) Vol. 9; no. 9; p. 1313
• Main Authors: Saito, Jumpei, Hanawa, Takehisa, Ozawa, Ayuna, Matsumoto, Takahiro, Yoshikawa, Nozomi, Harada, Tsutomu, Iwahashi, Kana, Yamatani, Akimasa
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 29.08.2022; MDPI
• Subjects: Baclofen; Calibration; Cerebral palsy; Childrens health; Chromatography; Dosage and administration; Drug dosages; Drug stores; Lactose; Multiple sclerosis; oral powder; pediatric formulation; Pediatrics; Pharmacy; quality assurance; Quality control; Quality standards; stability; Japan; Germany
• ISSN: 2227-9067; 2227-9067
• DOI: 10.3390/children9091313

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.