Validation and Cultural Adaptation of an Arabic Version of Pediatric Eating Assessment Tool (Pedi-EAT-10Arabic).

Pediatric eating assessment tool (Pedi-EAT-10Arabic) is a validated and reliable caregiver administered outcome instrument designed for detection of children at high risk of penetration/aspiration. The objective of this study is to translate and validate the Arabic version of Pedi-EAT-10 and to correlate its results with pharyngeal residue and aspiration on fiber optic endoscopic examination of swallowing (FEES). A cross-sectional study including 202 children selected randomly from those attending the swallowing clinic in phoniatrics unit, Otorhinolaryngology department (ORL) at main university hospital between February 2019 and October 2020 complaining of dysphagia. For test-retest reliability, one hundred caregivers refilled the Pedi-EAT-10Arabic after a 2-week period following their first visit. Validity was established by comparing the scores of dysphagia patients to healthy controls. Internal consistency of Pedi-EAT-10Arabic was high (Cronbach's alpha 0.986). Intra class correlation showed excellent test-retest reliability (r = 0.968). The median Pedi-EAT 10Arabic score was significantly higher in dysphagia group compared to healthy controls. (Median 27 IQR 21-34 for cases compared to median zero IQR 0-2 points for healthy controls, P less than 0.001). A strong correlation was found between Pedi-EAT 10Arabic scores and PAS scores with Spearman's correlation coefficient r = 0.803 and P < 0.001. The ROC for evaluating the discriminatory capacity of Pedi-EAT 10 for aspiration showed an AUC of 0.92 (95% CI of 0.89 to 0.96). Conclusion: Pedi-EAT 10Arabic was found to be a valid and reliable screening tool for further instrumental assessment of risk of dysphagia in pediatric population.

Design of innovated lipid-based floating beads loaded with an antispasmodic drug: in-vitro and in-vivo evaluation.

CONTEXT: Drotaverine hydrochloride (DRT) is used to treat gastrointestinal spasms accompanied with diarrhoea. Hence, the drug suffers from brief residence in the highly moving intestine during diarrhoea which leads to poor bioavailability and frequent dosing. OBJECTIVE: This study aimed to extend DRT residence in the stomach. METHODS: Calcium alginate floating beads were prepared using sodium alginate, isopropylmyristate (oil), and Gelucire® 43/01 (lipid) adopting emulsion gelation technique. The beads were evaluated for their floating ability, DRT entrapment efficiency and in-vitro release. Gelucire® 43/01 /oil-based beads of the selected formula were coated using ethylcellulose and different plasticizers as polyethylene glycol 400 and triethyl citrate to retard the drug release. The coated beads were re-characterized. Finally, the best formulae were investigated for their in-vivo floating ability in dogs besides their delivery to the systemic circulation compared to drug powder in human volunteers. RESULTS: Incorporation of Gelucire® 43/01 to oil-based beads enhanced the in-vitro performance of the beads. Coated beads prepared using drug:sodium alginate ratio of 1:3 (w/w), 20% (w/v) isopropylmyristate, 20% (w/v) Gelucire® 43/01 showed promising in-vitro performance. The beads floated for 12 h in the dogs' stomach and produced three-fold increase of the total amount of DRT absorbed within 24 h compared to that of DRT powder. CONCLUSIONS: Gelucire® 43/01 /isopropylmyristate-based calcium alginate floating beads coated with ethylcellulose using either PEG 400 or TEC as plasticizers proved to be a successful dosage form in extending DRT release.