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

Simon, Elisa; Wingert, Nathalie Ribeiro; Gobetti, Caren; Primieri, Gabriele Bordignon; Ayres, Márcio Vinícius; Almeida, Sílvia Helena Oliveira de; Volpato, Nádia Maria; Steppe, Martin

doi:10.1208/s12249-022-02447-x

Cited by 2 publications

(2 citation statements)

References 34 publications

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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

View full text Add to dashboard Cite

show abstract

“…Another interesting approach in the stability study design of oral liquid dosage forms is to apply the principles of Quality by Design (QbD) in order to determine the most suitable formulation from a stability perspective [117]. Such cases have demonstrated, by extrapolation, chemical stability for at least 850 days.…”

Section: Stability Study Designmentioning

confidence: 99%

Stability of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review

et al. 2023

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The development of safe and effective pediatric formulations is essential, especially in therapeutic areas such as pediatric cardiology, where the treatment requires multiple dosing or outpatient care. Although liquid oral dosage forms are considered the formulation of choice given the dose flexibility and acceptability, the compounding practices are not endorsed by the health authorities, and achieving stability can be problematic. The purpose of this study is to provide a comprehensive overview of the stability of liquid oral dosage forms used in pediatric cardiology. An extensive review of the literature has been performed, with a particular focus on cardiovascular pharmacotherapy, by consulting the current studies indexed in PubMed, ScienceDirect, PLoS One, and Google Scholar databases. Regulations and guidelines have been considered against the studies found in the literature. Overall, the stability study is well-designed, and the critical quality attributes (CQAs) have been selected for testing. Several approaches have been identified as innovative in order to optimize stability, but opportunities to improve have been also identified, such as in-use studies and achieving dose standardization. Consequently, the information gathering and the results of the studies can be translated into clinical practice in order to achieve the desired stability of liquid oral dosage forms.

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

Cited by 2 publications

References 34 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 of Oral Liquid Dosage Forms in Pediatric Cardiology: A Prerequisite for Patient’s Safety—A Narrative Review

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