Author(s):
Ghanshyam M. Umaretiya, Jayant R. Chavda, Jayvadan. K. Patel
Email(s):
shyam.umaretiya@gmail.com
DOI:
10.5958/0974-360X.2020.00676.9 
Address:
Ghanshyam M. Umaretiya1, Dr. Jayant R. Chavda2, Dr. Jayvadan. K. Patel3
1Research Scholar, School of Pharmacy, RK University, Rajkot, Gujarat, India.
2B.K. Mody Government Pharmacy College, Gujarat, India.
3Nootan Pharmacy College, Gujarat, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 8,
Year - 2020
ABSTRACT:
Fluvoxamine maleate (FLV) is a sparingly water-soluble drug which is prescribed for compulsive disorder (OCD) and social anxiety disorder. Pharmacokinetics parameters of FLV urge it to be formulated into controlled release design which provides constant release. So, in the present study an attempt has been made to develop single core osmotic pump (SCOP) along with solubility modulation of FLV. Different tools of QbD were employed for risk free formulation of SCOP. Central composite design (CCD) was used defining, amount of osmogene (X1) and amount of leachable component in coating (X2) as independent variables (IVs). The quantification of FLV was done by UV method with a linearity range of 5-25µg/mL. Citric acid was found as best solubility modulator which had shown 43.12% increment in solubility of FLV. The stand error of applied CCD was less than 1. The ANOVA results of CCD proved significant effect of selected IVs on critical quality attributes of FLV osmotic pump (FLVOP). Initial drug release from SCOP was greatly affected by the amount of leachable component in coating. %Error was found to be less than 5% in check point batches confirming suitability of developed multiple linear regression (MLR) equations. Risk free control space was outlined from overlay region. The optimized batch was composed of 13.04% osmogen (Xylitab) and 12.79% leachable component in coating (HPMC E5). The SEM study helped to understand the mechanism of drug release from SCOP. The drug release data were best suited to zero order with RSQ is 0.998. The drug release profile of optimized batch was unaffected by change in pH, agitation and ionic strength. Short term stability data proved stable characteristics of developed SCOP of FLV.
Cite this article:
Ghanshyam M. Umaretiya, Jayant R. Chavda, Jayvadan. K. Patel. Fabrication and Characterization of Single Layer Osmotic Pump (SCOP) by Solubility Modulation Approach for Fluvoxamine Maleate. Research J. Pharm. and Tech. 2020; 13(8):3817-3824. doi: 10.5958/0974-360X.2020.00676.9
Cite(Electronic):
Ghanshyam M. Umaretiya, Jayant R. Chavda, Jayvadan. K. Patel. Fabrication and Characterization of Single Layer Osmotic Pump (SCOP) by Solubility Modulation Approach for Fluvoxamine Maleate. Research J. Pharm. and Tech. 2020; 13(8):3817-3824. doi: 10.5958/0974-360X.2020.00676.9 Available on: https://rjptonline.org/AbstractView.aspx?PID=2020-13-8-49
REFERENCES:
1. Wen H, Park K. Oral controlled release formulation design and drug delivery: theory to practice: John Wiley & Sons; 2011.
2. Siegel RA, Rathbone MJ. Overview of controlled release mechanisms. Fundamentals and Applications of Controlled Release Drug Delivery: Springer; 2012. p. 19-43.
3. Fix JA. Oral controlled release technology for peptides: status and future prospects. Pharmaceutical research. 1996;13(12):1760-4.
4. Sahoo CK, Rao SRM, Sudhakar M. Evaluation of controlled porosity osmotic pump tablets: A Review. Research Journal of Pharmacy and Technology. 2015;8(12):1340.
5. Gupta BP, Thakur N, Jain NP, Banweer J, Jain S. Osmotically controlled drug delivery system with associated drugs. Journal of Pharmacy & Pharmaceutical Sciences. 2010;13(4):571-88.
6. Verma RK, Krishna DM, Garg S. Formulation aspects in the development of osmotically controlled oral drug delivery systems. Journal of Controlled Release. 2002;79(1-3):7-27.
7. Thombre AG, Appel L, Chidlaw M, Daugherity P, Dumont F, Evans L, et al. Osmotic drug delivery using swellable-core technology. Journal of Controlled Release. 2004;94(1):75-89.
8. Jagtap P, Awargaonkar A, Kuchekar S, Bhise K. Formulation and Evaluation of Controlled Porosity Osmotic Pump Tablet of Ranitidine Hydrochloride. Research Journal of Pharmacy and Technology. 2010;3(4):1205-8.
9. Wankhade V, Sridhar E, Ingole S, Sheaikh S, Kawtikwar P. To Evaluate the Effect of Food and other GI Factors on Osmotic Tablet of Aceclofenac. Research Journal of Pharmacy and Technology. 2010;3(4):1053-7.
10. B Parejiya P, S Barot B, K Patel H, K Shelat P, K Shukla A. Development of platform technology for oral controlled delivery of highly water soluble drugs using milnacipran HCl as a model drug. Drug Delivery Letters. 2012;2(1):35-45.
11. Prabakaran D, Singh P, Kanaujia P, Vyas SP. Effect of hydrophilic polymers on the release of diltiazem hydrochloride from elementary osmotic pumps. International Journal of Pharmaceutics. 2003;259(1-2):173-9.
12. Qin C, He W, Zhu C, Wu M, Jin Z, Zhang Q, et al. Controlled release of metformin hydrochloride and repaglinide from sandwiched osmotic pump tablet. International Journal of Pharmaceutics. 2014;466(1-2):276-85.
13. Salve P. Development and Evaluation of Oral Osmotic Tablets for Metoprolol Succinate. Research Journal of Pharmacy and Technology. 2011;4(12):1797-804.
14. Sri KT, Rani MS, Rao DN, Raju MN, Narasayah K, Rao GS. Formulation and In vitro Evaluation of Osmotic Drug Delivery System of Metoprolol Succinate. Research Journal of Pharmacy and Technology. 2013;6(11):1225-30.
15. Sahoo CK, Rao SRM, Sudhakar M, Satyanarayana K. Development and evaluation of controlled release formulation of zidovudine based on microporous osmotic tablet technology using fructose as osmogen. Research Journal of Pharmacy and Technology. 2017;10(5):1459.
16. Reddy MS, Varalakshmi K, Prasad CS, Swetha S, Shruthi B. Drug Delivery Through Osmotic Micropump-A Review. Research Journal of Pharmacy and Technology. 2013;6(1):3.
17. Kidane A, Ray SK, Bhatt PP, Bryan Jr JW. Osmotic delivery of therapeutic compounds by solubility enhancement. Google Patents; 2009.
18. Banerjee A, Verma P, Gore S. Controlled porosity solubility modulated osmotic pump tablets of Gliclazide. AAPS PharmSciTech. 2015;16(3):554-68.
19. Foda NH, Radwan MA, Al Deeb OA. Fluvoxamine maleate. Analytical Profiles of Drug Substances and Excipients. 24: Elsevier; 1996. p. 165-208.
20. Starczewska B. Spectrophotometric determination of fluvoxamine maleate and fluoxetine hydrochloride. Journal of Trace and Microprobe Techniques. 2001;19(1):19-24.
21. Potter C. the State of Quality by Design for Generics. Pharmaceutical Engineering. 2012.
22. Desai N, Purohit R. Design and development of clopidogrel bisulfate gastroretentive osmotic formulation using quality by design tools. AAPS PharmSciTech. 2017;18(7):2626-38.
23. Wu X-j, Liu W-n, Wang J, Shi X-l, Yao H-m, LI S-m. Preparation of nefopam hydrochloride controlled porosity osmotic pump by central composite design [J]. Journal of Shenyang Pharmaceutical University. 2009;11.
24. Farheen F, Elango K, Devi DR, Santhanalakshmi G. Formulation and Evaluation of Controlled Porosity Prednisolone Osmotic tablets for Colon Targeting. Research Journal of Pharmacy and Technology. 2011;4(7):1106-10.
25. Thapa H, Alexander A, Banjare T, Agrawal P, Bhandarkar A, Bhatt A, et al. Formulation and evaluation of Self-Poring osmotic tablet of diltiazem HCl for the treatment of hypertension. Research Journal of Pharmacy and Technology. 2018;11(5):1768-73.
26. Shivhare U. Formulation Development and Evaluation of Osmotic Controlled Drug Delivery System. Research Journal of Pharmacy and Technology. 2011;4(10):1551-6.
27. Patel GM, Patel JD. Single core osmotic pump (SCOP): development of single layer osmotic controlled release tablet for poorly soluble drug. journal of Pharmaceutical Technology and Drug Research. 2012;1(1):1.
28. Philip AK, Pathak K. Osmotic flow through asymmetric membrane: a means for controlled delivery of drugs with varying solubility. AAPS Pharmscitech. 2006;7(3): E1-E11.
29. Bajaj S, Singla D, Sakhuja N. Stability Testing of Pharmaceutical Products. Journal of Applied Pharmaceutical Science. 2012;2(3):129-38.
30. Parejiya PB, Barot BS, Patel HK, Shelat PK, Shukla A. Innovation of novel ‘Tab in Tab’system for release modulation of milnacipran HCl: optimization, formulation and in vitro investigations. Drug Development and Industrial Pharmacy. 2013;39(11):1851-63.