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Design of Experiment for Fluphenazine Hydrochloride 2.5 Mg Table Using Extra Granular Material - Magnesium Stearate with Novel Technology
Corresponding Author(s) : S. Sandeep Goud
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
The scope of this study is to Design of experiment (DOE) for Fluphenazine Hydrochloride 2.5 mg mg table using extra granular material- Magnesium Stearate with novel technology, Fluphenazine HCl is poorly soluble in water and other common vehicles used for the parenteral adm inistration of drugs. Certain organic solvents may at least partially dissolve fluphenazine HCl. However, when a water-miscible organic solvent containing fluphenazine HCl at near its saturation solubility is diluted with aqueous infusion fluid, the drug tends to precipitate or adsorb to internal surfaces of the infusion set. Oral dosage is easy for intake and unit dose form.
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- Xu F, Xia Y, Feng Z, Lin W, Xue Q, Jiang J et al. Repositioning antipsychotic fluphenazine hydrochloride for treating triple negative breast cancer with brain metastases and lung metastases. Am J Cancer Res. 2019;9(3):459-78. (PMC Free article). PMID 30949404.
- Drugs and lactation database (LactMed®) [internet]. Bethesda: National Institute of Child Health and Human Development; Nov 30, 2022. Fluphenazine. PMID PubMed.
- Chen JJ. Treatment of psychotic symptoms in patients with Parkinson disease. Ment Health Clin. 2017 Nov;7(6):262-70. (PMC Free article). doi: 10.9740/mhc.2017.11.262, PMID 29955532.
- Tardy M, Huhn M, Engel RR, Leucht S. Fluphenazine versus low-potency first-generation antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2014 Aug 03;8(8):CD009230. doi: 10.1002/14651858.CD009230.pub2, PMID 25087165.
- Matar HE, Almerie MQ, Sampson SJ. Fluphenazine (oral) versus placebo for schizophrenia. Cochrane Database Syst Rev. 2018 Jun 12;6(6). (PMC Free article):CD006352. doi: 10.1002/14651858.CD006352.pub3, PMID 29893410.
- Mogwitz S, Buse J, Wolff N, Roessner V. Update on the pharmacological treatment of tics with dopamine-modulating agents. ACS Chem Neurosci. 2018 Apr 18;9(4):651-72. doi: 10.1021/acschemneuro.7b00460, PMID 29498507.
- Ostuzzi G, Bighelli I, So R, Furukawa TA, Barbui C. Does formulation matter? A systematic review and meta-analysis of oral versus long-acting antipsychotic studies. Schizophr Res. 2017 May;183:10-21. doi: 10.1016/j.schres.2016.11.010, PMID 27866695.
- Brodeur S, Vanasse A, Courteau J, Stip E, Lesage A, Fleury MJ et al. Comparative effectiveness and safety of antipsychotic drugs in patients with schizophrenia initiating or reinitiating treatment: A Real-World Observational Study. Acta Psychiatr Scand. 2022 May;145(5):456-68. doi: 10.1111/acps.13413, PMID 35158404.
- Correll CU, Kim E, Sliwa JK, Hamm W, Gopal S, Mathews M et al. Pharmacokinetic characteristics of long-acting injectable antipsychotics for schizophrenia: an overview. CNS Drugs. 2021 Jan;35(1):39-59. (PMC Free article). doi: 10.1007/s40263-020-00779-5, PMID 33507525.
- Lytle S, McVoy M, Sajatovic M. Long-acting injectable antipsychotics in children and adolescents. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):2-9. doi: 10.1089/cap.2016.0055, PMID 28112539.
- Sampford JR, Sampson S, Li BG, Zhao S, Xia J, Furtado VA. Fluphenazine (oral) versus atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2016 Jul 02;7(7). (PMC Free article):CD010832. doi: 10.1002/14651858.CD010832.pub2, PMID 27370402.
- Maayan N, Quraishi SN, David A, Jayaswal A, Eisenbruch M, Rathbone J et al. Fluphenazine decanoate (depot) and enanthate for schizophrenia. Cochrane Database Syst Rev. 2015 Feb 05;2015(2):CD000307. doi: 10.1002/14651858.CD000307.pub2, PMID 25654768.
- Einarson A, Boskovic R. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 2009 May;15(3):183-92. doi: 10.1097/01.pra.0000351878.45260.94, PMID 19461391.
References
Xu F, Xia Y, Feng Z, Lin W, Xue Q, Jiang J et al. Repositioning antipsychotic fluphenazine hydrochloride for treating triple negative breast cancer with brain metastases and lung metastases. Am J Cancer Res. 2019;9(3):459-78. (PMC Free article). PMID 30949404.
Drugs and lactation database (LactMed®) [internet]. Bethesda: National Institute of Child Health and Human Development; Nov 30, 2022. Fluphenazine. PMID PubMed.
Chen JJ. Treatment of psychotic symptoms in patients with Parkinson disease. Ment Health Clin. 2017 Nov;7(6):262-70. (PMC Free article). doi: 10.9740/mhc.2017.11.262, PMID 29955532.
Tardy M, Huhn M, Engel RR, Leucht S. Fluphenazine versus low-potency first-generation antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2014 Aug 03;8(8):CD009230. doi: 10.1002/14651858.CD009230.pub2, PMID 25087165.
Matar HE, Almerie MQ, Sampson SJ. Fluphenazine (oral) versus placebo for schizophrenia. Cochrane Database Syst Rev. 2018 Jun 12;6(6). (PMC Free article):CD006352. doi: 10.1002/14651858.CD006352.pub3, PMID 29893410.
Mogwitz S, Buse J, Wolff N, Roessner V. Update on the pharmacological treatment of tics with dopamine-modulating agents. ACS Chem Neurosci. 2018 Apr 18;9(4):651-72. doi: 10.1021/acschemneuro.7b00460, PMID 29498507.
Ostuzzi G, Bighelli I, So R, Furukawa TA, Barbui C. Does formulation matter? A systematic review and meta-analysis of oral versus long-acting antipsychotic studies. Schizophr Res. 2017 May;183:10-21. doi: 10.1016/j.schres.2016.11.010, PMID 27866695.
Brodeur S, Vanasse A, Courteau J, Stip E, Lesage A, Fleury MJ et al. Comparative effectiveness and safety of antipsychotic drugs in patients with schizophrenia initiating or reinitiating treatment: A Real-World Observational Study. Acta Psychiatr Scand. 2022 May;145(5):456-68. doi: 10.1111/acps.13413, PMID 35158404.
Correll CU, Kim E, Sliwa JK, Hamm W, Gopal S, Mathews M et al. Pharmacokinetic characteristics of long-acting injectable antipsychotics for schizophrenia: an overview. CNS Drugs. 2021 Jan;35(1):39-59. (PMC Free article). doi: 10.1007/s40263-020-00779-5, PMID 33507525.
Lytle S, McVoy M, Sajatovic M. Long-acting injectable antipsychotics in children and adolescents. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):2-9. doi: 10.1089/cap.2016.0055, PMID 28112539.
Sampford JR, Sampson S, Li BG, Zhao S, Xia J, Furtado VA. Fluphenazine (oral) versus atypical antipsychotics for schizophrenia. Cochrane Database Syst Rev. 2016 Jul 02;7(7). (PMC Free article):CD010832. doi: 10.1002/14651858.CD010832.pub2, PMID 27370402.
Maayan N, Quraishi SN, David A, Jayaswal A, Eisenbruch M, Rathbone J et al. Fluphenazine decanoate (depot) and enanthate for schizophrenia. Cochrane Database Syst Rev. 2015 Feb 05;2015(2):CD000307. doi: 10.1002/14651858.CD000307.pub2, PMID 25654768.
Einarson A, Boskovic R. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 2009 May;15(3):183-92. doi: 10.1097/01.pra.0000351878.45260.94, PMID 19461391.