Stability of an Extemporaneously Compounded Baclofen Oral Liquid

Johnson, Cary E.; Hart, Susan M.

doi:10.1093/ajhp/50.11.2353

Cited by 3 publications

(2 citation statements)

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“…All three formulations studied in this study are frequently crushed and administered to the pediatric population. Since there are no appropriate pediatric formulations in the world, many studies have been conducted on compounding these three drugs [14,[16][17][18][19][20][21][22][23][24][25], and there have been reports of errors in preparation and incidents involving patients during the compounding process [26][27][28][29][30]. Therefore, in addition to assuring quality, there is an urgent need to ensure safety through the standardization of formulation preparation.…”

Section: Discussionmentioning

confidence: 99%

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

Saito,

Suzuki,

Nakamura

et al. 2023

Children

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The quality-assured preparation of crushed and diluted preparations for children is a challenge. In this study, a multicenter study was conducted to validate the preparation method for the quality assurance of baclofen powder, clonidine powder, and hydrocortisone powder prepared from tablets according to a previously established method. In-hospital preparations were prepared at five medical facilities under different crushing and mixing conditions. After storage in closed bottles, in-use bottles, and laminated paper for 120 days, ingredients stability, drug elution, and content uniformity after packaging were evaluated. All three ingredients were maintained at between 90% and 110% of their initial content for 120 days under packaging conditions of 25 ± 2 °C and 60 ± 5% relative humidity, with no change in dissolution in all formulations made at all five facilities. The content uniformity was also acceptable. The established method may contribute to quality-assured pediatric dosage form modification.

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Section: Discussionmentioning

confidence: 99%

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

Saito,

Suzuki,

Nakamura

et al. 2023

Children

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“…Concerning the stability of baclofen liquid formulation, Polonini and their colleagues demonstrated 90 days of stability of a 2.0 mg/mL extemporaneous aqueous baclofen solution compounded with SyrSpend SF PH4 at room temperature [ 35 ]. Johnson and their colleagues also demonstrated 35 days’ stability of baclofen in tablet-dissolved solutions in simple syrup NF, which were kept at 4 °C in amber glass [ 36 ]. A 10 mg/mL baclofen suspension by crushing baclofen tablets prepared in a 1:1 mixture of Ora-Sweet and Ora-Plus (Paddock Laboratories), a 1:1 mixture of Ora-Sweet SF and Ora-Plus (Paddock Laboratories), and cherry syrup stored at 25 °C in amber, clear polyethylene terephthalate bottles also maintained stability for up to 60 days [ 37 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2022

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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.

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Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use

et al. 2022

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Stability of an Extemporaneously Compounded Baclofen Oral Liquid

Cited by 3 publications

References 0 publications

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

Study on the Preparation Method of Quality-Assured In-Hospital Drug Formulation for Children—A Multi-Institutional Collaborative Study

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

Development, Quality by Design-Based Optimization, and Stability Assessment of Oral Liquid Formulations Containing Baclofen for Hospital Use

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