The effect of food vehicles on in vitro performance of pantoprazole sodium delayed release sprinkle formulation

Wu, Kai-Wei; Zheng, Kai; Li, Tian; Li, Xia; Hwang, Sung-Yong; Nwakama, Patrick E.; Sun, Wei-Jhe; Kim, Myong‐Jin; Tampal, Nilufer; Xu, Xiaoming; Boyce, Heather; Feng, Xinliang

doi:10.1016/j.ijpharm.2023.122737

Cited by 2 publications

(1 citation statement)

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“…In any case, the lack of information in SmPC or patient information leaflets or incomplete advice from their pharmacy often leads the parents, caregivers, or nurses to improvise, possibly using incompatible vehicles [ 24 ]. The impact of mixing capsules, crushed tablets, and other oral compounded formulations with foods and beverages has been evaluated in some studies [ 25 , 26 , 27 , 28 ]. It was highlighted that the physicochemical properties of food vehicles are an important consideration for drug exposure [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

Dispensing Oral Temozolomide in Children: Precision and Stability of a Novel and Ready to Use Liquid Formulation in Comparison with Capsule Derived Mixtures

Lemarchand,

Bienaymé,

Rieutord

et al. 2023

Pharmaceutics

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Temozolomide (TMZ) is part of the therapeutic armamentarium used in managing pediatric cancers; however, available oral forms (capsules) are not adapted for use in children. Our aim was to assess the dose accuracy and stability of TMZ using capsule contents mixed with food compared with a novel, ready-to-use liquid formulation specifically developed for children (Ped-TMZ, brand name KIZFIZO). Dose accuracy and TMZ stability testing were performed with TMZ capsule contents (90 mg) mixed with food vehicles (apple juice, apple sauce, cream, milk, and mashed potatoes) and compared to an equivalent dose of Ped-TMZ. Acceptance criteria were predefined for TMZ (95.0–105.0%) and its degradation product amino-imidazole-carboxamide (AIC; <1%) content. The delivered dose was significantly higher using Ped-TMZ (96.6 ± 1.2%) and within the predefined criteria for TMZ content, whereas it was systematically under the lower specifications of 95% using capsule-derived preparations with apple juice (91.0 ± 1.5%) and apple sauce (91.6 ± 1.4%), respectively (p < 0.0001). In chemical stability tests, the four food vehicles (apple sauce, cream, milk, mashed potatoes) had a significant effect on TMZ stability (p = 0.0042), and the AIC significantly increased with time in three of the four vehicles (p < 0.0001). Only 1/72 of preparations from capsules met the predefined acceptance criteria, whereas Ped-TMZ showed no TMZ loss, and the AIC remained within specifications. In conclusion, mixing TMZ capsule content with food may result in significant underexposure, possibly even greater in routine practice, as complete food intake by the child is unlikely.

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