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1.
Drug Deliv Transl Res ; 14(5): 1319-1337, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-37930631

RESUMO

The shortage of child friendly formulations constitutes a key part of the major challenges impeding the successful management of tuberculosis disease in the paediatric population. Chewable formulations are an attractive alternative to traditional preparations like tablets and suspensions owing to the possibility for taste masking, administration without water, their unique physical appeal, visually appeasing shapes, and useability in children 2 years old and above. Consequently, we designed a polymeric gummy drug formulation (P-GDF), herein referred to as the FlexiChew formulation, containing a first-line antitubercular agent, isoniazid, using a combined solid-liquid dispersion and temperature dependent sol-gel processing technique. The resulting P-GDF was visually attractive, supple, easy to handle, dimensionally compact (17.738 ± 0.779 mm height, 10.473 ± 0.944 mm width, and 8.603 ± 0.852 mm thickness), light weight (1.425 ± 0.038 g), mechanically robust (hardness = 37.260 ± 4.66 N; resilience = 0.542 ± 0.029), and potentially easy to masticate (chewiness = 30.570 ± 13.090 N; cohesiveness = 0.800 ± 0.283%; adhesiveness = 0.018 ± 0.007 mJ). It was structurally intact, effectively encapsulated isoniazid (101.565 ± 4.181%), and released it (≈100% in 75 min) following zero order and non-Fickian mechanisms in different dissolution media. Besides, it displayed efficient taste masking and palatability relative to its placebo (signal distance = 54). Short-term stability studies revealed optimal storage conditions to be under controlled ambient environments, away from direct light, and without desiccants. Thus, a child friendly isoniazid-loaded edible gummy drug formulation was successfully fabricated with the goal of improving adherence and therapeutic efficacy.


Assuntos
Isoniazida , Paladar , Humanos , Pré-Escolar , Composição de Medicamentos/métodos , Solubilidade , Antituberculosos , Polímeros , Comprimidos , Administração Oral
2.
Eur J Pharm Sci ; 182: 106377, 2023 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-36634740

RESUMO

Non-compliance, dosing inaccuracy, choking risk, flavour, and instability, are some of the issues associated with paediatric, oral dosage forms - tablets, capsules, solutions, and suspensions. Orally disintegrating drug carriers, a dosage form with growing interest, are thought to overcome several of the challenges associated with these conventional formulations by rapidly disintegrating within the buccal cavity without the need for water. This review serves as an up-to-date report on the various types of orodispersible delivery systems, currently being developed or commercialized, by detailing their characteristics, manufacturing processes, and applications in the paediatric population. Mentioned are orodispersible tablets, films, wafers and lyophilisates, mini-tablets, capsules, granules, electrospun fibers and webs. Also highlighted are the choice of excipients, quality control requirements, and expected pharmacokinetics of orally disintegrating drug carriers concerning the paediatric population. Overall, orodispersible formulations, particularly tablets, films, and lyophilisates/wafers, have shown to be a valuable addition to medication administration in minors, thus the execution of more targeted research and development activities is expected to lead to enhanced paediatric care and outcomes.


Assuntos
Portadores de Fármacos , Excipientes , Humanos , Criança , Administração Oral , Comprimidos , Composição de Medicamentos , Solubilidade
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