Stability study of a clonidine oral solution in a novel vehicle designed for pediatric patients

Background Imatinib is a protein-tyrosine kinase inhibitor which is currently only commercially available as a tablet dosage form in the strength of 100mg and 400mg. The elaboration of new oral liquid formulations is suitable in pediatrics and for patients who have difficulties to swallow, notably in the absence of commercial forms. This enables the adaptation of dosage and secure the administration. Objectives The formulation of an oral pediatric solution of imatinib at a concentration of 30 mg/mL and the evaluation of its stability for the treatment of pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia. Methods The physicochemical stability parameters: appearance, pH, osmolality, and drug content of formulation were evaluated for 30 days when stored at 2–8°C. Concentration of solution was measured with a validated method using high performance liquid chromatography (HPLC) coupled with an absorbance UV detector. Equally, microbiological stability was performed. Results The remaining imatinib concentration was at least 95% of the initial concentration after 30 days stored in fridge temperature. No changes were observed regarding the physical properties of the formulation during the study period. Conclusions The stability study showed that the imatinib oral solution at a concentration of 30 mg/mL provides an alternative option at the commercial tablet dosage forms for pediatric patients and patients who have difficulties to swallow.

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Design and stability study of an oral solution of amlodipine besylate for pediatric patients

European Journal of Pharmaceutical Sciences ◽

10.1016/j.ejps.2016.05.019 ◽

2016 ◽

Vol 92 ◽

pp. 220-223 ◽

Cited By ~ 5

Author(s):

A.C. van der Vossen ◽

I. van der Velde ◽

O.S.N.M. Smeets ◽

D.J. Postma ◽

A. Vermes ◽

...

Keyword(s):

Pediatric Patients ◽

Oral Solution ◽

Stability Study ◽

Amlodipine Besylate

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Availability of Morphine Oral Solution for Childhood Cancer Patients in Low-Income Countries: Compounding and Stability Study in a Cote d'Ivoire University Teaching Hospital

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2019.10.005 ◽

2020 ◽

Vol 59 (1) ◽

pp. e10-e13

Author(s):

Bertrand Pourroy ◽

Christophe Curti ◽

Edouard Lamy ◽

Jauhel N'Gbesso ◽

Innocent Krasse ◽

...

Keyword(s):

Childhood Cancer ◽

Cancer Patients ◽

Teaching Hospital ◽

Cote D'ivoire ◽

Low Income ◽

Côte D’Ivoire ◽

Oral Solution ◽

Stability Study ◽

University Teaching ◽

Low Income Countries

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3PC-005 Stability study of a 10% sodium benzoate oral solution

10.1136/ejhpharm-2019-eahpconf.86 ◽

2019 ◽

Author(s):

A Castro Balado ◽

A Bayón Fernández ◽

I Adán Barrientos ◽

JM Giráldez Montero ◽

I Varela Rey ◽

...

Keyword(s):

Sodium Benzoate ◽

Oral Solution ◽

Stability Study

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Larotrectinib (Vitrakvi)

Canadian Journal of Health Technologies ◽

10.51731/cjht.2021.199 ◽

2021 ◽

Vol 1 (11) ◽

Author(s):

Reimbursement Team

Keyword(s):

Gene Fusion ◽

Pediatric Patients ◽

Drug Class ◽

Treatment Options ◽

Acquired Resistance ◽

Resistance Mutation ◽

Clinical Effectiveness ◽

Oral Solution ◽

Severe Morbidity ◽

Clinician Perspectives

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses larotrectinib (Vitrakvi); 25 mg and 100 mg capsules (as larotrectinib sulphate) and 20 mg/mL oral solution (as larotrectinib sulphate). Indication: For the treatment of adult and pediatric patients with solid tumours that: have an NTRK gene fusion without a known acquired resistance mutation are metastatic or where surgical resection is likely to result in severe morbidity have no satisfactory treatment options

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Pediatrics: Bethanechol Chloride Oral Solutions: Stability and Use in Infants

Annals of Pharmacotherapy ◽

10.1177/106002809703100304 ◽

1997 ◽

Vol 31 (3) ◽

pp. 294-296 ◽

Cited By ~ 2

Author(s):

Joël L Schlatter ◽

Jean-Louis Saulnier

Keyword(s):

Clinical Efficacy ◽

Dosage Form ◽

Pediatric Patients ◽

Oral Solution ◽

Gastric Ph ◽

Sterile Water ◽

Before And After ◽

Initial Ph ◽

The Stability ◽

Bethanechol Chloride

Objective To assess the stability of a bethanechol chloride oral solution prepared from tablets. Method The initial concentrations were determined. These solutions were stored at 4 °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 °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.

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Pharmacokinetics, safety, and efficacy of tapentadol oral solution for treating moderate to severe pain in pediatric patients

Journal of Pain Research ◽

10.2147/jpr.s197039 ◽

2019 ◽

Vol Volume 12 ◽

pp. 1777-1790 ◽

Cited By ~ 3

Author(s):

Derek Muse ◽

Eva Tarau ◽

Claudia Lefeber ◽

Melanie Sohns ◽

Martin Brett ◽

...

Keyword(s):

Severe Pain ◽

Pediatric Patients ◽

Oral Solution ◽

Safety And Efficacy

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Genetic and Non-genetic Factors Contributing to the Significant Variation in the Plasma Trough Concentration-to-Dose Ratio of Valproic Acid in Children With Epilepsy

Frontiers in Pediatrics ◽

10.3389/fped.2020.599044 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ze-Yue Xu ◽

Hong-Li Guo ◽

Ling Li ◽

Min Zhang ◽

Xia Jing ◽

...

Keyword(s):

Valproic Acid ◽

Trough Concentration ◽

Genetic Factors ◽

Pediatric Patients ◽

Oral Solution ◽

Total Daily Dose ◽

Nucleotide Polymorphisms ◽

Dose Ratio ◽

Control Effect ◽

Patients With Epilepsy

Objective: This study was conducted to evaluate the potential genetic and non-genetic factors contributing to plasma trough concentration-to-dose (C0/D) ratio of valproic acid (VPA) in pediatric patients with epilepsy.Study Design: A single-center, retrospective cohort study was performed by collecting data from 194 children aged 1–14 years between May 2018 and November 2018. The oral solution (n = 135) group and the sustained-release (SR) tablet group (n = 59) were defined, and the plasma VPA C0 was measured. Twenty-six single-nucleotide polymorphisms (SNPs) were chosen for genotyping with the MassARRAY system. A multiple logistic regression model was used for data analysis.Results: Body weight (BW) and age were positively correlated with the C0/D ratio in 194 patients, but the positive correlation disappeared after the patients were divided into oral solution and SR tablet subgroups. The average C0/D ratio was significantly increased by 2.11-fold (P = 0.000) in children who took VPA SR tablets compared with children who were administered VPA oral solutions. No significant association between genetic variants and the C0/D ratio was found, even for the five well-studied SNPs, namely UGT2B7 G211T, C802T, C161T, T125C, and CYP2C9*3 A1075C. However, a significant association between the C0/D ratio and UGT1A6/9 Del>A (rs144486213) was observed in the VPA oral solution group, but not in the VPA SR tablet group.Conclusions: The dosage forms of sodium valproate, rather than BW, age, or genetic polymorphisms, significantly affected the VPA C0/D ratios in pediatric patients with epilepsy. Based on our findings, switching the dosage form between solution and SR tablet should be performed cautiously. Total daily dose adjustment should be considered, and the plasma concentration, seizure-control effect, and adverse drug reaction should also be monitored very closely.

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