Development and Stability Control of Pediatric Oral Tizanidine Hydrochloride Formulations for Hospital Use

Gobetti, Caren; Balsan, Maria Eduarda; Ayres, Márcio Vinícius; Almeida, Sílvia Helena Oliveira de; Simon, Elisa; Wingert, Nathalie Ribeiro; Oppe, Tércio Paschke; Garcia, Cássia Virgínia

doi:10.1208/s12249-020-01751-8

Cited by 3 publications

(2 citation statements)

References 21 publications

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“…One potential explanation for its limited use in the pediatric population is that tizanidine is only commercially available in tablet form. A liquid formulation of the drug, which would be more suitable for children, is currently under development and investigation [20,21].…”

Section: Discussionmentioning

confidence: 99%

Effect of Tizanidine on Spasticity in Pediatric Patients with Cerebral Palsy: A Systematic Review

Castro

Valencia

2023

Ann Child Neurol

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Purpose: Cerebral palsy (CP) is a permanent, non-progressive disorder of the developing brain. Tizanidine is an effective treatment for spastic CP; however, insufficient evidence exists regarding its effect on motor function and side-effect profile. This review explored the effects and safety of tizanidine in treating spasticity among pediatric patients with CP.Methods: Two reviewers conducted a literature search. The Cochrane risk of bias tool and the 14-item National Institutes of Health Quality Assessment Tool were used to evaluate the risk of bias. A systematic review was performed for relevant studies.Results: Five studies were included: three randomized controlled trials (RCTs) and two observational studies. The control group received a placebo in two RCTs, while baclofen was used in the remaining studies. Tizanidine dosage and duration varied across reports, except for the two observational studies. Excepting one observational study, tizanidine was associated with a greater improvement on the modified Ashworth scale. Pain reduction was also greater with tizanidine treatment compared to the placebo, as evidenced by one RCT. Three studies evaluating gross motor function reported superior results with tizanidine compared to baclofen. Two RCTs indicated similar safety profiles between tizanidine and the placebo. The remaining studies reported a more favorable safety profile for tizanidine than baclofen.Conclusion: The studies examined in this review reported beneficial effects of tizanidine on spasticity, pain, and gross motor function. Tizanidine usage was associated with no serious adverse events, reflecting a better safety profile than baclofen. Nevertheless, high-quality RCTs are recommended to support tizanidine administration in pediatric patients.

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Section: Discussionmentioning

confidence: 99%

Effect of Tizanidine on Spasticity in Pediatric Patients with Cerebral Palsy: A Systematic Review

Castro

Valencia

2023

Ann Child Neurol

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“…These results conrm the stability of the drugs across diverse conditions, aligning with existing literature on their stability attributes. 40,62 Notably, while prior research demonstrated TZ's stability over extended periods (70 days) with consistently high purity results, this 30 days study timeframe is deemed sufficient for sample collection and quantication.…”

Section: Stability Studiesmentioning

confidence: 92%

An isocratic RP-HPLC-UV method for simultaneous quantification of tizanidine and lidocaine: application to in vitro release studies of a subcutaneous implant

Picco,

Anjani,

Donnelly

et al. 2024

Anal. Methods

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Excipients in the Paediatric Population: A Review

et al. 2021

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This theoretical study seeks to critically review the use of excipients in the paediatric population. This study is based on the rules and recommendations of European and American drug regulatory agencies. On the one hand, this review describes the most frequent excipients used in paediatric medicine formulations, identifying the compounds that scientific literature has marked as potentially harmful regarding the side effects generated after exposure. On the other hand, this review also highlights the importance of carrying out safety -checks on the excipients, which, in most cases, are linked to toxicity studies. An excipient in the compilation of paediatric population databases is expected to target safety and toxicity, as in the STEP database. Finally, a promising pharmaceutical form for child population, ODT (Orally Disintegrating Tablets), will be studied.

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Development and Stability Control of Pediatric Oral Tizanidine Hydrochloride Formulations for Hospital Use

Cited by 3 publications

References 21 publications

Effect of Tizanidine on Spasticity in Pediatric Patients with Cerebral Palsy: A Systematic Review

Effect of Tizanidine on Spasticity in Pediatric Patients with Cerebral Palsy: A Systematic Review

An isocratic RP-HPLC-UV method for simultaneous quantification of tizanidine and lidocaine: application to in vitro release studies of a subcutaneous implant

Excipients in the Paediatric Population: A Review

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