Optimization of promethazine theoclate fast dissolving tablet using pore forming technology by 3-factor, 3-level response surface-full factorial design.
The present research work was undertaken to optimize and formulate Promethazine Theoclate as a fast dissolving tablet using pore forming technology that disintegrates or dissolves rapidly and offer a suitable approach for the treatment of nausea and vomiting. Fast dissolving tablets of Promethazine Theoclate was prepared by increasing the solubility i.e. using beta-cyclodextrin, crospovidone, and menthol. A 3(3) full factorial design was employed to investigate the combined influence of these three independent variables, i.e., amount of menthol, crospovidone and beta-cyclodextrin on disintegration time, percentage friability and percentage drug release after 5 min. In the optimization study, multiple regression analysis has revealed that an optimum amount of menthol, crospovidone and beta-cyclodextrin gives a rapidly disintegrating/dissolving tablet. In order to prove the validity of the evolved mathematical model a checkpoint batch was also prepared. Optimized tablets were prepared with an optimum amount of beta-cyclodextrin, menthol and crospovidone which disintegrated in the 30 s, having friability 0.599% and released drug 89% after 5 min.
Sharma
Shailesh
S
Dosage Form Design Lab., Pharmaceutics Research Division, Department of Pharmaceutics, ASBASJSM College of Pharmacy, BELA (Ropar) Punjab, 140111, India. shailesh.bela@gmail.com
Sharma
Neelam
N
Das Gupta
Ghanshyam
G
D000932:Antiemetics / Q000008:administration & dosage* / Q000737:chemistry; D005079:Excipients / Q000737:chemistry*; D008610:Menthol / Q000737:chemistry; D008962:Models, Theoretical; D011205:Povidone / Q000737:chemistry; D011398:Promethazine / Q000008:administration & dosage* / Q000737:chemistry; D012044:Regression Analysis; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical; D047392:beta-Cyclodextrins / Q000737:chemistry
D000932:Antiemetics; D005079:Excipients; D013607:Tablets; D047392:beta-Cyclodextrins; D008610:Menthol; D011398:Promethazine; D011205:Povidone; C031215:betadex