Preformulation Study of Carbamazepine Orally Disintegrating Tablets for Pediatric Patients Using Direct Compression and the SeDeM Diagram Tool: A Quality by Design Approach.

ABSTRACT: Background/Objectives: Carbamazepine is widely used as a first-line treatment for pediatric patients with benign epilepsy. However, most commercial formulations have doses of 100 mg or higher, limiting their suitability for pediatric use. The aim of this study was to develop mini orally disintegrating tablets (ODTs) containing 50 mg of carbamazepine, utilizing direct compression technology, specifically tailored to meet the unique needs of pediatric patients. Methods: The development was carried out following a Quality by Design (QbD) approach, beginning with preformulation studies using the SeDeM expert system. Various co-processed excipients (PROSOLV^® ODT and PARTECK^® ODT) and non-co-processed excipients (L-HPC LH11 and L-HPC NBD-022) were evaluated. A

SUBMITTER: Canadell-Heredia R 

PROVIDER: S-EPMC12115275 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature