Development of a safe and versatile suspension vehicle for pediatric use: Formulation development

Alarie, Hugo; Roullin, V. Gaëlle; Leclair, Grégoire

doi:10.1016/j.ijpharm.2019.118552

Cited by 6 publications

(4 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…where Vu is the final volume of sediment and V0 is the original volume of suspension [24]. Furthermore, L-HK-BC17 oil suspension was evaluated for re-dispersibility after 1, 14, 30, and 90 days by turning the bottle through a 180-degree cycle.…”

Section: Technological Characterization Of L Vaginalis Bc17 Oil Suspe...mentioning

confidence: 99%

Limosilactobacillus vaginalis Exerts Bifidogenic Effects: A Novel Postbiotic Strategy for Infant Prebiotic Supplementation

Giordani,

Parolin,

Abruzzo

et al. 2023

Nutrients

View full text Add to dashboard Cite

Infant microbiota shaping strictly influences newborns’ well-being and long-term health, and babies born by cesarean-section and formula-fed generally show low microbial gut diversity and are more prone to develop various disorders. The supplementation with beneficial microbes of vaginal origin or derivatives (postbiotics, including heat-inactivated cells) represents a valid strategy to drive the correct gut microbiota shaping. Here, we explored for the first time the bifidogenic activity of a heat-killed vaginal strain (Limosilactobacillus vaginalis BC17), in addition to the assessment of its safety. L. vaginalis BC17 whole genome was sequenced by Nanopore technology and highlighted the absence of antibiotic resistance genes and virulence factors, indicating the strain safety profile for human health. MIC values confirmed that L. vaginalis BC17 is susceptible to widely employed antibiotics. Heat-killed BC17 cells significantly enhanced the planktonic growth of Bifidobacterium spp. For the first time, stimulating effects were observed also toward biofilm formation of bifidobacteria and their pre-formed biofilms. Conversely, heat-killed BC17 cells exerted antibacterial and anti-biofilms activities against Gram-positive and Gram-negative pathogens. Lyophilized heat-killed BC17 cells were formulated in a sunflower oil suspension (1010 heat-killed cell/g) intended for infant oral intake. This possessed optimal technological (i.e., re-dispersibility and stability) and functional properties (i.e., bifidogenic activity) that were maintained even after pre-digestion in acidic conditions.

show abstract

Section: Technological Characterization Of L Vaginalis Bc17 Oil Suspe...mentioning

confidence: 99%

Limosilactobacillus vaginalis Exerts Bifidogenic Effects: A Novel Postbiotic Strategy for Infant Prebiotic Supplementation

Giordani,

Parolin,

Abruzzo

et al. 2023

Nutrients

View full text Add to dashboard Cite

show abstract

“…where V u represents the final volume of sediment as the suspension settles, and V 0 represents the original volume of the suspension [37].…”

Section: Sedimentation Behavior Investigation By Visual Analysismentioning

confidence: 99%

“…In order to achieve the necessary properties of oral liquids, anhydrous vehicles need to be characterized by a certain set of physical characteristics, which must be investigated during the development of the vehicle. The physical properties have a significant impact on quality, stability, organoleptic properties and use (Table S1) [25,36,37]. Liquid vehicles can be formulated to provide the desired osmolarities, viscosities, pH and taste-masking capabilities, which are important factors in matching the intentions of the pharmacist [35].…”

Section: Introductionmentioning

confidence: 99%

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids

Banov,

Liu,

et al. 2023

Pharmaceutics

View full text Add to dashboard Cite

The paucity of suitable drug formulations for pediatric patients generates a need for customized, compounded medications. This research study was set out to comprehensively analyze the physical properties of the new, proprietary anhydrous oral vehicle SuspendIt® Anhydrous, which was designed for compounding pediatric oral liquids. A wide range of tests was used, including sedimentation volume, viscosity, droplet size after dispersion in simulated gastric fluid, microscopic examination and content uniformity measurements to evaluate the properties of the anhydrous vehicle. The results showed that the vehicle exhibited consistent physical properties under varying conditions and maintained stability over time. This can be attributed to the unique blend of excipients in its formulation, which not only maintain its viscosity but also confer thixotropic behavior. The unique combination of viscous, thixotropic and self-emulsifying properties allows for rapid redispersibility, sedimentation stability, accurate dosing, potential drug solubility, dispersion and promotion of enhanced gastrointestinal distribution and absorption. Furthermore, the vehicle demonstrated long-term sedimentation stability and content uniformity for a list of 13 anhydrous suspensions. These results suggest that the anhydrous oral vehicle could serve as a versatile base for pediatric formulation, potentially filling an important gap in pediatric drug delivery. Future studies can further investigate its compatibility, stability and performance with other drugs and in different clinical scenarios.

show abstract

“…Concerning the liquid oral dosage forms formulated as suspensions or syrups, the redispersibility test should be applied as a minimum, if rheological properties and/or particle size distribution cannot be tested, although it has been emphasized in the literature that there is no official methodology describing this test in the guidelines [100]. The property of the active substance to resuspend after shaking will ensure content uniformity and avoid overdosing [101].…”

Section: Stability-indicating Parameters and Guidelinesmentioning

confidence: 99%

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

et al. 2023

View full text Add to dashboard Cite

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.

show abstract

Development of a safe and versatile suspension vehicle for pediatric use: Formulation development

Cited by 6 publications

References 23 publications

Limosilactobacillus vaginalis Exerts Bifidogenic Effects: A Novel Postbiotic Strategy for Infant Prebiotic Supplementation

Limosilactobacillus vaginalis Exerts Bifidogenic Effects: A Novel Postbiotic Strategy for Infant Prebiotic Supplementation

Analysis of the Physical Characteristics of an Anhydrous Vehicle for Compounded Pediatric Oral Liquids

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

Contact Info

Product

Resources

About