Material-Sparing and Expedited Development of a Tablet Formulation of Carbamazepine Glutaric Acid Cocrystal– a QbD Approach

• Published in: Pharmaceutical Research Vol. 37; no. 8; p. 153
• Main Authors: Yamashita, Hiroyuki, Sun, Changquan Calvin
• Format: Journal Article
• Language: English
• Published: New York Springer Science and Business Media LLC 01.08.2020; Springer US; Springer; Springer Nature B.V
• Subjects: Biochemistry; Biomedical and Life Sciences; Biomedical Engineering and Bioengineering; Biomedicine; Carbamazepine; Carbamazepine - chemistry; Carbamazepine - pharmacology; Cellulose; Cellulose - chemistry; Crystallization; Dissolution; Drug Compounding; Excipients; Excipients - chemistry; Glutarates; Glutarates - chemistry; Glutarates - pharmacology; Medical Law; Pharmacology/Toxicology; Pharmacy; Phase Transition; Powders; Research Paper; Silicon Dioxide; Silicon Dioxide - chemistry; Solubility; Tablets; Tablets - chemistry; quality by design; tablet; material-sparing; cocrystal; formulation development; manufacturability

Purpose To efficiently develop a tablet formulation of carbamazepine using a soluble cocrystal with excess coformer to maintain phase stability during dissolution. Methods The carbamazepine – glutaric acid cocrystal (CBZ-GLA, 1:1) and excess glutaric acid (GLA) were mixed with suitable tablet excipi...