An update of systemic analgesics in children

Wright, Jennifer A.; Anderson, Brian J.

doi:10.1016/j.mpaic.2022.02.014

Cited by 1 publication

(1 citation statement)

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“…Tuning the area (1 cm 2 and 2 cm 2 or 6 cm 2 ) of the optimized formulation (Formulation F13, Table 3), it would be possible to make available personalize dosage forms to manage acute migraines [27] and pain [28,29] in pediatric patients. This aspect could be of interest for children, since to the best of our knowledge, there is no commercially available pediatric dosage form (e.g., syrup or suspension) of DNa due to its stability issues.…”

Section: Accelerated Stability Studymentioning

confidence: 99%

Extemporaneous printing of diclofenac orodispersible films for pediatrics

Khalid

Musazzi

Selmin

et al. 2021

Drug Development and Industrial Pharmacy

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Objective: The possible application of a hot-melt ram extrusion printing to the preparation of diclofenac orodispersible films (ODF) made of maltodextrin was studied focusing the attention on the effects of taste-masking agents (i.e., namely mint, licorice-mint, and sucralose) and an opacifier (TiO 2 ).Significance: This is a proof-of-concept of the feasibility to print ODF loaded with a thermosensitive drug substance by hot-melt technologies.Methods: DNa ODF made of maltodextrin (DE=6) plasticized with glycerol were prepared by hot-melt extrusion printing. ODF were characterized for disintegration time, drug content and solid state, in vitro dissolution in deionized water and simulated salivary fluid pH 5.7, tensile, and adhesive properties. Moreover, the stability of ODF was assessed in accelerated conditions over six months.Results: After the preparation, no variation in drug solid state was evident and the formation of impurity A of DNa was detected even if it remains below the Ph. Eur. limits (< 0.2%). Only the addition of DNa significantly improved the ODF tensile properties: the tensile strength increased from 0.17±0.03 MPa (placebo ODF) to 2.21±0.54 MPa (p≤0.03). All ODF disintegrated in about 1 min, and the t 80% was lower than 3 min. TiO 2 reduced the static and dynamic peel forces (p≤0.006) favoring the detachment the ODF from the primary packaging material. During the accelerated stability study, ODF were easy to handle without fracture; the drug content, impurity A, and dissolution profiles remained superimposable. Conclusion:Hot-melt printing can be suitable to prepare palatable ODF loaded with bitter thermosensitive drugs.

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Section: Accelerated Stability Studymentioning

confidence: 99%