scholarly journals Clinical utility of topiramate extended-release capsules (USL255): Bioequivalence of USL255 sprinkled and intact capsule in healthy adults and an in vitro evaluation of sprinkle delivery via enteral feeding tubes

2016 ◽  
Vol 57 ◽  
pp. 105-110 ◽  
Author(s):  
Annie M. Clark ◽  
John M. Pellock ◽  
Mary Holmay ◽  
Bob Anders ◽  
James Cloyd
2017 ◽  
Vol 52 (11) ◽  
pp. 752-760 ◽  
Author(s):  
Kristin Reindel ◽  
Fang Zhao ◽  
Susan Hughes ◽  
Vivek S. Dave

Purpose: The feasibility of preparing an eslicarbazepine acetate suspension using Aptiom tablets for administration via enteral feeding tubes was evaluated. Methods: Eslicarbazepine acetate suspension (40 mg/mL) was prepared using Aptiom tablets after optimizing the tablet crushing methods and the vehicle composition. A stability-indicating high-performance liquid chromatography (HPLC) method was developed to monitor the eslicarbazepine stability in the prepared suspension. Three enteric feeding tubes of various composition and dimensions were evaluated for the delivery of the suspensions. The suspension was evaluated for the physical and chemical stability for 48 hours. Results: The reproducibility and consistency of particle size reduction was found to be best with standard mortar/pestle. The viscosity analysis and physical stability studies showed that ORA-Plus:water (50:50 v/v) was optimal for suspending ability and flowability of suspension through the tubes. The developed HPLC method was found to be stability indicating and suitable for the assay of eslicarbazepine acetate in the prepared suspension. The eslicarbazepine concentrations in separately prepared suspensions were within acceptable range (±3%), indicating accuracy and reproducibility of the procedure. The eslicarbazepine concentrations in suspensions before and after delivery through the enteric feeding tubes were within acceptable range (±4%), indicating absence of any physical/chemical interactions of eslicarbazepine with the tubes and a successful delivery of eslicarbazepine dosage via enteric feeding tubes. The stability study results showed that eslicarbazepine concentration in the suspension remained unchanged when stored at room temperature for 48 hours. Conclusion: The study presents a convenient procedure for the preparation of a stable suspension of eslicarbazepine acetate (40 mg/mL) using Aptiom tablets, for administration via enteral feeding tubes.


1974 ◽  
Vol 25 (1) ◽  
pp. 269-278 ◽  
Author(s):  
P L Greenberg ◽  
S L Schrier

2020 ◽  
Vol 587 ◽  
pp. 119624 ◽  
Author(s):  
Arun Butreddy ◽  
Sandeep Sarabu ◽  
Nagireddy Dumpa ◽  
Suresh Bandari ◽  
Michael A. Repka

2009 ◽  
Vol 62 (1) ◽  
Author(s):  
Paul Stewart ◽  
Natalie Dayneka ◽  
Sylvain Grenier ◽  
Carolyn Stewart ◽  
Lise Beadow ◽  
...  

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