DESIGN AND OPTIMIZATION OF SUSTAINED RELEASE MATRIX TABLET OF OPIPRAMOL HCL BY USING QUALITY BY DESIGN APPROACH
Quality by Design (QbD) refers to an advance approach towards drug development. Quality by design is a vital part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) for formulation development with a case study of sustained release tablet of Opipramol. The QbD means designing and developing formulations to ensure predefined product quality. The study describe elements of the QbD for Opipramol sustained release tablet, include: Defining Quality target product profile, Identifying critical quality attributes, establishing design space, control strategy. Sustained release tablet of Opipramolwere prepared by dry granulation using HPMC K4M and level of polymer was optimized, factorial design was used as part of risk analysis to optimize level of other excipients. Invivo study of optimizes formulation was done in animals and it was correlated with in vitro drug release study (IVIVC).
The optimized formulation could able to release the drug for 24 hrs making once a daily tablet, Design space for polymer was determined to be (10 to 15%), level of flow property enhancer () and hardness of 4-5 which ensure extended drug release. The IVIVC shown level A correlation (R2 = 0.996).Thus work facilitates the adoption and implementation of QbD for formulation development using QbD and could increase efficiencies, provide regulatory support, flexibility and pharmaceutical quality is assured by understanding and controlling formulation variables.
Keywords: QbD, Sustain Release, Opipramol HCl, Risk assessment
Food and Drug Administration. Final Report on Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach. Available from: http://www.fda.gov/cder/gmp/gmp 2004/GMP_ final report 2004.htm. [Last accessed on 2013 Jan 12]
Patil AS, Pethe AM. Quality by design (QbD): A new concept for development of quality pharmaceuticals. Int J Pharm Qual Assur 2013;4(2):13-9.
Charoo NA, Shamsher AA, Zidan AS, Rahman Z. Quality by design approach for formulation development: A case study of dispersible tablets. Int J Pharm 2012;423(2):167-78.
GÃ¶nÃ¼llÃ¼ U, Uner M, Yener G, AltÄ±nkurt T. Introduction of sustained release opipramol dihydrochloride matrix tablets as a new approach in the treatment of depressive disorders. Int J Biomed Sci 2006;2(4):337 43.
Validation of analytical procedures text and methodology Q2(R1): November, 2005. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf. [Last accessed on 2014 Feb 23].
Sweetman SC, editor. Matrindale: The Complete Drug Reference. 34th ed. London: The Pharmaceutical Press Publication; 1999. p. 859.1.
Patel H, Parmar S, Patel B. A comprehensive review on quality by design (QbD) in pharmaceuticals. Int J Pharm Sci Rev Res 2013;21(1):223-36.
Shewale BD, Rautr NA, Gaikwadl NJ, Fursule RA. Drug excipient compatibility of gliclazide using thermal and nonthermal methods. Int J Pharm Excip 2007;2007:140-6.
Sharma S, Pratap R. A case study of risks prioritization using FMEA method. Int J Sci Res Publ 2013;3(10):1-5.
Chandana B, Debnath S. Formulation and evaluation of extended release tablets. J Chronotherapy Drug Deliv 2011;2(1):43-8.
Gollapudi R, Javvaji H, Tadikonda RR, Arpineni V. Formulation and in vitro evaluation of sustained release matrix tablets of losartan potassium. Int J Adv Pharm Sci 2011;2(1):30-5.
Pawan P, Nitin K. Formulation, evaluation and comparison of sustained release matrix tablet of diclofenac sodium using natural polymer. Int J Res Pharm Biomed Sci 2013;4(1):367-79.
Dash TR, Verma P. Matrix tablets: An approach towards oral extended release drug delivery. Int J Pharm Res Rev 2013;2(2):12-24.
Kuksal A, Tiwary AK, Jain NK, Jain S. Formulation and in vitro, in vivo evaluation of extended- release matrix tablet of zidovudine: Influence of combination of hydrophilic and hydrophobic matrix formers. AAPS PharmSciTech 2006;7(1):E1.
Kees F, Bucher M, Mair G, Grobecker H. Determination of opipramol in human plasma by high-performance liquid chromatography with photometric detection using acyanopropyl column. J Chromatogr B 2001;753:337-42.
Sakore S, Chakraborty B. In vitro-in vivo correlation (IVIVC): A strategic tool in drug development. J Bioequiv Availab 2011;S3:1-12.
Rabindranath PA, Chakraborty M, Debnath R, Gupta BK. In vitro-in vivo correlation (IVIVC) study of leflunomide loaded Microspheresint. J Pharm Pharm Sci 2009;1 Suppl 1:165-70.
Huang Y, Khanvilkar KH, Moore AD, Hilliard-Lott M. Effects of manufacturing process variables on in vitro dissolution characteristics of extended-release tablets formulated with hydroxypropyl methylcellulose. Drug Dev Ind Pharm 2003;29(1):79-88
How to Cite
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.