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Experimental design for novel in-vitro dissolution method validation for lamivudine-150mg and zidovudine-300mg film-coated tablets
Corresponding Author(s) : K. Aishwarya
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 11 No. 4 (2023): 2023 Volume -11 - Issue 4
Abstract
The present study objective is Experimental Design for novel in- vitro Dissolution method validation for Lamivudine150 and Zidovudine 300 mg film-coated tablets and its provide the direction to design and conduct performance test for the same and established documentary evidence through the test method defined in the study , its helps to demonstrate that the chromatographic analytical methods for determination of dissolution in Lamivudine/Zidovudine 150 mg/300 mg film-coated tablets Films coating tablet will yield consistent, reliable and reproducible results within in the pre-determined acceptance criteria The active ingredient Lamivudine and Zidovudine and Inactive ingredients include microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, povidone, magnesium stearate, and opadry white (composed of Hydroxy Propyl methylcellulose 2910/Hypromellose 5cP, Titanium dioxide, and Polyethylene glycol 400).
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- Chein YW. Novel Drug Delivery Systems Chein YW, editor. New York: Marcel Dekker, Inc 1992; 139-96.
- Sahoo CK, Rao SRM, Sudhakar M, Sahoo NK. Advances in osmotic drug delivery system. J Chemicaland Pharm Res. 2015;7:252-73.
- Zentner GM, Rork GS, Himmelstein KJ. The controlled porosity osmotic pump. J Control Release. 1985;1(4):269-82. doi: 10.1016/0168-3659(85)90003-3.
- Verma RK, Krishna DM, Garg S. Formulation aspects in the development of osmotically controlled oral drug delivery systems. J Control Release. 2002;79(1-3):7-27. doi: 10.1016/s0168-3659(01)00550-8, PMID 11853915.
- Sahoo CK, Sahoo NK, Rao SRM, Sudhakar M. A review on prevention and treatment of Aids. Pharm Pharmacol Int J. 2017;5(1):00108.
- Mugavero MJ, Hicks CB. HIV resistance and the effectiveness of combination antiretroviral treatment. Drug Discov Today Ther Strateg. 2004;1(4):529-35. doi: 10.1016/j.ddstr.2004.11.006.
- Jilakara VS, Chowdary YA. Formulation and evaluation of sustained release matrix tablets of zidovudine. Int J Pharm Sci Rev Res. 2013;18(1):143-9.
- Kumaravelrajan R, Narayanan N, Suba V. Development and evaluation of controlled porosity osmotic pump for nifedipine and metoprolol combination. Lipids Health Dis. 2011;10:51. doi: 10.1186/1476-511X-10-51, PMID 21477386.
- Sahoo CK, Sahoo NK, Rao SRM, Sudhakar M, Satyanarayana K. A review on controlled porosity osmotic pump tablets and its evaluation. Bull Fac Pharm Cairo Univ. 2015;53(2):195-205. doi: 10.1016/j.bfopcu.2015.10.004.
- Sahoo CK, Rao SRM, Sudhakar M. Evaluation of controlled porosity osmotic pump tablets a review. Res J Pharm Technol. 2015;8(12):119-25. doi: 10.5958/0974-360X.2015.00312.1.
- Sirisha VNL, Rao YKK, Eswaraiah MC. Formulation and evaluation of Lamivudine and Zidovudine extended release tablets. Int J Res Pharm Biomed Sci. 2012;3(4):1759-63.
- Costa P, Sousa Lobo JMS. Modelling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123-33. doi: 10.1016/s0928-0987(01)00095-1, PMID 11297896.
- Sahoo CK, Rao SRM, Sudhakar M, Kokkula S. The kinetic modeling of drug dissolution for drug delivery systems: an overview. Pharm Lett. 2015;7(9):186-94.
- Sharma F, Jain H, Kanzariya V, Upadhyay U. Formulation and evaluation of controlled release osmotic tablet of metoprolol succinate. Asian J Pharm Clin Res. 2014;7(3):38-43.
- Banerjee A, Verma PRP, Gore S. Controlled porosity solubility modulated osmotic pump tablets of gliclazide. AAPS PharmSciTech. 2015;16(3):554-68. doi: 10.1208/s12249-014-0246-0, PMID 25378281.
- Kuksal A, Tiwary AK, Jain NK, Jain S. Formulation and in vitro, in vivo evaluation of extended release matrix tablet of zidovudine: influence combination of hydrophilic and hydrophobic matrix formers. AAPS PharmSciTech 86 of 86. 2006;7(1):E1. doi: 10.1208/pt070101, PMID 16584139.
- Khan ZA, Tripathi R, Mishra B. Design and evaluation of enteric coated microporous osmotic pump tablet (ECMOPT) of quetiapine fumarate for the treatment of psychosis. Acta Pol Pharm. 2012;69(6):1125-36. PMID 23285674.
- Kanagale P, Lohray BB, Misra A, Davadra P, Kini R. Formulation and optimization of porous osmotic Pumpbased controlled release system of oxybutynin. AAPS PharmSciTech. 2007;8(3):E1-7. Pore former. doi: 10.1208/pt0803053, PMID 17915803.
- Rao BP, Geetha M, Purushothama N, Sanki U. Optimization and development of swellable controlled porosity osmotic pump tablet for theophylline. Trop J Pharm Res. 2009;8(3):247-55. doi: 10.4314/tjpr.v8i3.44541. Cartensen JT. Drug stability: principle and practices, Marcel Dakker, New York. 2nd ed; 1995. p. 538-50.
References
Chein YW. Novel Drug Delivery Systems Chein YW, editor. New York: Marcel Dekker, Inc 1992; 139-96.
Sahoo CK, Rao SRM, Sudhakar M, Sahoo NK. Advances in osmotic drug delivery system. J Chemicaland Pharm Res. 2015;7:252-73.
Zentner GM, Rork GS, Himmelstein KJ. The controlled porosity osmotic pump. J Control Release. 1985;1(4):269-82. doi: 10.1016/0168-3659(85)90003-3.
Verma RK, Krishna DM, Garg S. Formulation aspects in the development of osmotically controlled oral drug delivery systems. J Control Release. 2002;79(1-3):7-27. doi: 10.1016/s0168-3659(01)00550-8, PMID 11853915.
Sahoo CK, Sahoo NK, Rao SRM, Sudhakar M. A review on prevention and treatment of Aids. Pharm Pharmacol Int J. 2017;5(1):00108.
Mugavero MJ, Hicks CB. HIV resistance and the effectiveness of combination antiretroviral treatment. Drug Discov Today Ther Strateg. 2004;1(4):529-35. doi: 10.1016/j.ddstr.2004.11.006.
Jilakara VS, Chowdary YA. Formulation and evaluation of sustained release matrix tablets of zidovudine. Int J Pharm Sci Rev Res. 2013;18(1):143-9.
Kumaravelrajan R, Narayanan N, Suba V. Development and evaluation of controlled porosity osmotic pump for nifedipine and metoprolol combination. Lipids Health Dis. 2011;10:51. doi: 10.1186/1476-511X-10-51, PMID 21477386.
Sahoo CK, Sahoo NK, Rao SRM, Sudhakar M, Satyanarayana K. A review on controlled porosity osmotic pump tablets and its evaluation. Bull Fac Pharm Cairo Univ. 2015;53(2):195-205. doi: 10.1016/j.bfopcu.2015.10.004.
Sahoo CK, Rao SRM, Sudhakar M. Evaluation of controlled porosity osmotic pump tablets a review. Res J Pharm Technol. 2015;8(12):119-25. doi: 10.5958/0974-360X.2015.00312.1.
Sirisha VNL, Rao YKK, Eswaraiah MC. Formulation and evaluation of Lamivudine and Zidovudine extended release tablets. Int J Res Pharm Biomed Sci. 2012;3(4):1759-63.
Costa P, Sousa Lobo JMS. Modelling and comparison of dissolution profiles. Eur J Pharm Sci. 2001;13(2):123-33. doi: 10.1016/s0928-0987(01)00095-1, PMID 11297896.
Sahoo CK, Rao SRM, Sudhakar M, Kokkula S. The kinetic modeling of drug dissolution for drug delivery systems: an overview. Pharm Lett. 2015;7(9):186-94.
Sharma F, Jain H, Kanzariya V, Upadhyay U. Formulation and evaluation of controlled release osmotic tablet of metoprolol succinate. Asian J Pharm Clin Res. 2014;7(3):38-43.
Banerjee A, Verma PRP, Gore S. Controlled porosity solubility modulated osmotic pump tablets of gliclazide. AAPS PharmSciTech. 2015;16(3):554-68. doi: 10.1208/s12249-014-0246-0, PMID 25378281.
Kuksal A, Tiwary AK, Jain NK, Jain S. Formulation and in vitro, in vivo evaluation of extended release matrix tablet of zidovudine: influence combination of hydrophilic and hydrophobic matrix formers. AAPS PharmSciTech 86 of 86. 2006;7(1):E1. doi: 10.1208/pt070101, PMID 16584139.
Khan ZA, Tripathi R, Mishra B. Design and evaluation of enteric coated microporous osmotic pump tablet (ECMOPT) of quetiapine fumarate for the treatment of psychosis. Acta Pol Pharm. 2012;69(6):1125-36. PMID 23285674.
Kanagale P, Lohray BB, Misra A, Davadra P, Kini R. Formulation and optimization of porous osmotic Pumpbased controlled release system of oxybutynin. AAPS PharmSciTech. 2007;8(3):E1-7. Pore former. doi: 10.1208/pt0803053, PMID 17915803.
Rao BP, Geetha M, Purushothama N, Sanki U. Optimization and development of swellable controlled porosity osmotic pump tablet for theophylline. Trop J Pharm Res. 2009;8(3):247-55. doi: 10.4314/tjpr.v8i3.44541. Cartensen JT. Drug stability: principle and practices, Marcel Dakker, New York. 2nd ed; 1995. p. 538-50.