Formulation development and evaluation of duloxetine extended-release tablets
Abstract
Duloxetine is an anti-depressant drug which is used in depression. The aim of present investigation was to prepare an ER tablet of duloxetine with similar dissolution profile matching to Effexor ER. An immediate release core tablet of 100mg was prepared and it was compression coated using HPMC matrix system. HPMC of three viscosity grades i.e., K4M, K15M, K100M and different concentrations of 15% polymer, 25% polymer, 35% polymer & 45% polymer were taken. With the above polymers by using wet granulation and direct compression process 11 formulations were prepared. The data obtained from in vitro drug release was used to determine the similarity factor between marketed and optimized product. Out of all F11 formulation (K15M 35% polymer) is optimized and is matching with the marketed product.
Downloads
References
2. Remington. The Science and Practice of Pharmacy. 21st ed, Vol. 1; 2005: 889-905.
3. Ansel H, Nicholas G. Ansels Pharmaceutical dosage forms and drug delivery system.9th edn. Lippincott Williams and Wilkins: 225-256.
4. Gartlehner G, Gaynes BN, Hansen RA et al. Comparative benefits and harms of second-generation antidepressants: background paper for the American College of Physicians. Ann Int. Med Nov 18, 2008; 149(10): 734-50.
5. Hamilton M. A rating scale for depression, Journal Neural Neurosurgery Psychiatry. 1960; 23: 56 63.
6. American Psychiatric Association. Arlington (VA): Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Part B: Background Information and Review of Available Evidence: c2010.
7. Keith S (2006). Advances in psychotropic formulations. Prog Neuro psychopharmacol Biol Psych; 30:996-1008.
8. Ric AM, Moyer A, Haskins JT, Andree TH, Husbands GE (1991). Biochemical, Neurophysiological and behavioral Effects of Wy- 45,233 and other identified Metabolites of the Antidepressant Duloxetine . Drug Dev Res; 23: 191-199.
9. Simona JS, Aguair Lm (2004). Extended Release Duloxetine in relapse prevention for patients with major Depressive disorders, J Psychiatr Res; 38: 249-257
10. Troy S.M, Parker VD, Fruncillo RJ, Chiang ST (1995). The Pharmacokinetics of Duloxetine when given in a twice –daily regimen, J Clin Pharmacol; 35:404-409.
11. Shinde Anilkumar. J (2008). Gastro retentive drug delivery system-An overview, Pharmainfo.net; 6(1).
12. R. Colombo, P.S. Bettini, N.A. Peppas, Swellable matrixes for Controlled drug delivery; gel-layer behavior, mechanism and optical performance Pharm. Sci. Technol. Today.3(2000) 198-204
13. Marabathuni VJ, Dinesh P, Ravikumar R, Yamini P, Kiran PS, Hussain SP, Rao CM. Chitosan based sustained release mucoadhesive buccal patches containing amlodipine besylate (AMB). Asian J Res Pharm Sci. 2017 Jun 28;7:97-104.
14. Marabathuni VJ, Bhavani M, Lavanya M, Padmaja K, Madhavi N, Babu P, Rao CM. Formulation and evaluation of mouth dissolving Tablets of carbamazepine. Asian Journal of Pharmacy and Technology. 2017;7(3):137-43.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.