Author(s): S. Nandhakumar, G. Sugreevudu, N. Harikrishnan

Email(s): nandha.pharm@gmail.com

DOI: 10.52711/0974-360X.2021.01135   

Address: S. Nandhakumar1*, G. Sugreevudu2, N. Harikrishnan1
1Faculty of Pharmacy, Dr. M.G.R. Educational and Research Institute, Chennai-600077, Tamilnadu, India.
2Research Scientist, Alembic Pharmaceutical Ltd., Vadodara-390003, Gujarat, India.
*Corresponding Author

Published In:   Volume - 14,      Issue - 12,     Year - 2021


ABSTRACT:
Overactive bladder syndrome (OAB) is a chronic condition with a composite of symptoms and has a significant negative impact on the physiological and psychological well-being of the patients. The present study is aimed at developing extended-release formulations of oxybutynin that is effective in reducing the side effects associated with the drug by maintaining a steady state concentration with minimal fluctuations in plasma drug concentration and thereby achieves improved patient compliance. The extended-release drug delivery of tablets can be achieved by preparing the matrix tablet of oxybutynin chloride with klucel HF in core tablet by wet granulation technique and functional coating with a combination of aquacoat ECD-30 and hypromellose E5 followed by film coating with opadry. For confirmation of compatibility, the pure drug and its physical mixtures were subjected to FTIR studies. All the formulations have shown acceptable limits in all precompression and post compression parameters. The in vitro release studies in 0.1N HCl and 6.8 phosphate buffer revealed that the optimized formulation F10 extend the release of the drug to 91% at 24 hours and the release profile was similar to the innovator’s product as revealed by the similarity factor study. The release kinetics study revealed that the release of the drug followed diffusion mechanism. Stability studies of the selected formulation tablets were carried out at 25°C ±2°C/60% RH±5% and 40°C ±2°C /75%±5% RH for different time period and all the parameter was within the limits after storage period. Thus the extended release matrix tablets of oxybutynin chloride developed in this study have immense potential to develop into a marketed product following the testing in animals and human volunteers.


Cite this article:
S. Nandhakumar, G. Sugreevudu, N. Harikrishnan. Formulation design and Evaluation of Extended-Release Tablets of Oxybutynin for Effective Management of Overactive Bladder Syndrome. Research Journal of Pharmacy and Technology. 2021; 14(12):6558-4. doi: 10.52711/0974-360X.2021.01135

Cite(Electronic):
S. Nandhakumar, G. Sugreevudu, N. Harikrishnan. Formulation design and Evaluation of Extended-Release Tablets of Oxybutynin for Effective Management of Overactive Bladder Syndrome. Research Journal of Pharmacy and Technology. 2021; 14(12):6558-4. doi: 10.52711/0974-360X.2021.01135   Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-12-65


REFERENCES:
1.    Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011; 108:1132–8.
2.    Irwin DE et al. The economic impact of overactive bladder syndrome in six Western countries. BJU Int. 2009; 103:202–9.
3.    Allahdin S and Oo N. An overview of treatment of overactive bladder syndrome in women. Journal of Obstetrics and Gynaecology, 2012; 32: 217–21
4.    Bartley JM, Blum ES, Sirls LT, Peters KM. Understanding clinical options for overactive bladder. Curr Urol Rep 2013; 14:541-48.
5.    Shafik A, Shafik IA. Overactive bladder inhibition in response to pelvic floor muscle exercises. World Journal of Urology. 2003; 20:374 –7.
6.    Andersson KE, Yoshida M. Antimuscarinics and the overactive detrusor–which is the main mechanism of action? Eur Urol. 2003; 43:1–5.
7.    Vaseeha Banu TS, Sukhen Som. Preparation and Evaluation of Transdermal Films of Oxybutynin. Research Journal of Pharmaceutical Dosage Forms and Technology. 2009; 1(2): 130-4
8.    Waldeck K, Larsson B, Andersson KE. Comparison of oxybutynin and its active metabolite, N-desethyl-oxybutynin, in the human detrusor and parotid gland. J Urol. 1997; 157:1093–7.
9.    Madhuvrata P, Cody JD, Ellis G, Herbison GP, Hay-Smith EJC. Which anticholinergic drug for overactive bladder symptoms in adults. Cochrane Database Syst Rev 2012; 18(1):CD005429.
10.    Jirschele K, Sand PK. Oxybutynin: past, present and future. Int Urogynecol J. 2013; 24: 595–604
11.    White N, Iglesia CB. Overactive bladder. Obstet Gynecol Clin N Am. 2016; 43: 59–68.
12.    Goldenberg MM. An Extended-Release Formulation of Oxybutynin Chloride for the Treatment of Overactive Urinary Bladder. Cinical Therapeutics. 1999; 21(4): 634-42.
13.    Gupta SK, Sathyan G. Pharmacokinetics of an oral once-a-day controlled-release oxybutynin formulation compared with immediate-release oxybutynin. J Clin Pharmacol. 1999; 39: 289–296
14.    Rahul SS, Ravindra AD, Kore KJ, Madhuri TD, Rutuja RF, Rajkumar VS. Formulation and Development of Enteric Coated Tablet for Parkinson’s Disease. Research J. Pharm and Tech. 2020; 13(2):639-44
15.    Patel V. Design, Development, Evaluation and Optimization of Antiulcer Delayed Release Tablets. Research J. Pharm. and Tech. 2013; 6(6): 669-84.
16.    Fliszar KA, Foster N. Examination of Metformin hydrochloride in a continuous dissolution/HDM system, Int. J. Pharm. 2008; 351(3): 127-132
17.    Surkha Y, Venugopalaiah P, Gnan Prakash K, Gobinath M. Design and Characterization of Enteric Coated Delayed Release Pellets of Rabeprazole Sodium. Research J. Pharm. and Tech. 2013; 6(12): 1380-6.
18.    Hadi MA, Babu VL, Pal N. Formulation and Evaluation of Sustained Release Matrix Tablets of Glimepiride Based on Combination of Hydrophilic and Hydrophobic Polymers. J. App. Pharm. Sci. 2012; 2(6): 101-7.
19.    Shah RS, Shah RR, Nitalikar MM, Magdum CS. Design, Development and Evaluation of Enteric Coated Tablets of Glimepiride. Asian J. Pharm. Res. 2017; 7(3): 155-64.
20.    Suvakanta D, Narasimhamurthy P, Lilakanthnath, Chaudhary P. Kinetic modeling on drug release from controlled drug delivery systems. Acta Pol Pharm. 2010;67(3):217-233.
21.    Hashmat D, Shoaib MH, Mehmood ZA, Bushra R, Yousuf RI, Lakhani F. Development of Enteric Coated Flurbiprofen Tablets using Opadry/acryl-eze System—A Technical Note. AAPS PharmSciTech. 2008; 9(1): 116- 21.
22.    Kadam S, Yadav P, Langde D. Formulation and Evaluation of Colon Trageted Enteric coated Tablets of loperamide. Research. J. Pharm and Tech. 2020; 13(3): 1447-52.
23.    Kanagagiri D, Omprakash H, Kishorekumar M, Vishwanadham Y. Formulation and evaluation of Pantaprazole delayed release tablets using Eudragit l30D55. Research J. Pharm and Tech.  2017;10(2): 421-5.
24.    Akhter A, Kibria G. Effect of acrylic polymers on physical parameters of spheronized pellets using an aqueous coating system.  Asian Journal of Pharmaceutics 2009;3(4):292-8.
25.    Paruti MP, Alange VV, Mutalik S, Naikawadi AA, Kulkarni RV. Formulation and evaluation of compression coated tablets for controlled release of cefadroxil monohydrate. Research J.Pharm and Tech. 2013; 6(4):356-9
26.    Grassi M, Grassi G. Mathematical modelling and controlled drug delivery: matrix systems. Curr Drug Deliv. 2005; 2(1):97-116.
27.    Kumar P, Tiwari R, Chaurasia B, Sahu RR, Tripathi FM, Bhardhwaj A. Multiparticulate extended-release formulation for propranolol hydrochloride. Research J.Pharm and Tech. 2010; 3(3): 835-9.
28.    Naddour RF, Kaddar NA. In vitro bioequivalence for three products of warfarin sodium in Syrian market. Research J.Pharm and Tech. 2018; 11(2):532-6.

Recomonded Articles:

Author(s): R. Narayana Charyulu, P. Parvathy Devi, Jobin Jose, A. Veena Shetty

DOI: Not Available         Access: Open Access Read More

Author(s): Divakar Kanakagiri, Hari Omprakash, Kishore Kumar M, Vishwanadham Y

DOI: 10.5958/0974-360X.2017.00084.1         Access: Open Access Read More

Author(s): Rekha Kallam, Padma Sree K, Srinivas Arutla, MA Bari

DOI: Not Available         Access: Open Access Read More

Author(s): Samip Shah, T. Y. Pasha, Dipti Desai, Anil Bhandari

DOI: Not Available         Access: Open Access Read More

Author(s): Pratiksha V. Shrikhande

DOI: Not Available         Access: Open Access Read More

Author(s): Deependra Jain, Nishiprakash Jain, SK Jain, Nitin Jonwal, Shashank Mishra, Deepak Bhatt, Soham Shukla

DOI: Not Available         Access: Open Access Read More

Author(s): RS Kamble, BV Bakde, MA Channawar, RL Bakal, SR Gawande, AV Chandewar

DOI: Not Available         Access: Open Access Read More

Author(s): Sanjeev Gubbi, Ravindra Jarag

DOI:         Access: Open Access Read More

Author(s): Gupta Khemchand, Singhvi I., Ashawat M.S., Gupta Santosh Kumar

DOI: Not Available         Access: Open Access Read More

Author(s): M.A. Saleem, Raghavendra V. Kulkurni, Patil Noornadim G

DOI: Not Available         Access: Open Access Read More

Author(s): Suresh V Kulkarni, Ranjit Kumar P, Nikunj Patel, Ramesh B, Someshwara Rao B, Ashok Kumar P

DOI: Not Available         Access: Open Access Read More

Author(s): Rajendra Jangde, S. J. Daharwal

DOI: Not Available         Access: Open Access Read More

Author(s): Kothawade PI, Zate SU, Gajbe JW, Rathi MN, Yewale CP, Baheti DR

DOI: Not Available         Access: Open Access Read More

Author(s): Mahesh S Nemade, Supriya S Thorat, Rajesh Y Chaudhari, Vijay R. Patil

DOI: Not Available         Access: Open Access Read More

Author(s): Ramadevi Bhimavarapu, Ramesetti RamaDevi, Srinath Nissankararao, Chaitanya Devarapalli, Sowjanya Paparaju

DOI: Not Available         Access: Open Access Read More

Author(s): Ashish Jayant Saraf, Sudhir Pange, Satyajit Deshmukh, Rahul Hajgude

DOI: Not Available         Access: Open Access Read More

Author(s): P Kumar, R Tiwari, B Chaurasia, RR Sahu, FM Tripathi, Anjana Bhardhwaj

DOI: Not Available         Access: Open Access Read More

Author(s): Abdul Hasan Sathali. A, Jeya Chandra Prakash. S.K.

DOI: 10.5958/0974-360X.2015.00235.8         Access: Open Access Read More

Author(s): Jitendra Kumar Putikam, Y. Narasimha Rao, V. Anjaneyulu, Vivek Kumar Undralla

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags