FORMULATION AND CHARACTERIZATION OF SUSTAINED RELEASE MATRIX TABLETS OF IVABRADINE USING 32 FULL FACTORIAL DESIGN


Olvishkumar M. Kothiya, Bhavana A. Patel, Kunal N. Patel, Madhubhai M. Patel

Abstract


Objective: Ivabradine (IB) is anti-Ischemic drug and used for the symptomatic management of stable angina pectoris. IB acts by reducing the heart rate in a mechanism different from beta blockers and calcium channel blockers, two commonly prescribed anti-anginal drugs. IB has a short biological half-life and the dose of 5/7.5 mg twice a day. In this present study, an attempt has been made to prepare sustained release tablet of IB to achieve the desired drug release.

Methods: The sustained release polymers, hydroxypropyl methylcellulose K100M (HPMC K100M), guar gum (GG) and xanthan gum (XG) were taken for the preliminary trail from which guar gum and xanthan gum had shown better drug release. Initially, drug-excipients compatibility studies were carried out by using Fourier transformed infrared spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) which showed no interaction between drug and excipients. Tablets were prepared by wet granulation technique and evaluated for pre-compression and post-compression parameters.

Results: 32 full factorial design was applied to achieve controlled drug release up to 24 h. The concentration of GG (X1) and XG (X2) were selected as independent variables and the % CDR at 2 h. (Y1) and 18 h. (Y2) were taken as dependent variables. In vitro drug release study revealed that as the amount of polymers increased, % CDR decreased.

Conclusion: Contour as well as response surface plots were constructed to show the effect of X1 and X2 on % CDR and predicted at the concentration of independent variables X1 (10 mg) and X2 (10 mg) for a maximized response. The optimized batch (O1) was kept for stability study at 40±2 °C/75±5 %RH for a period of 6mo according to ICH guidelines and found to be stable.


Keywords


Sustained release matrix tablet, IB, Guar gum, Xanthan gum, 32 full factorial design

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References


Ratnaparkhi MP, Gupta JP. Sustained release oral drug delivery system. Int J Pharm Res Rev 2013;2:11-21.

Lodhi M, Dubey A, Narayan R, Prabhu P, Priya S. Formulation and evaluation of buccal film of IB hydrochloride for the treatment of stable angina pectoris. Int J Pharma Invent 2013; 3:47-53.

Jadav MM, Teraiya SR. Formulation and evaluation of oral controlled porosity osmotic pump tablet of zaltoprofen. Int J Pharm Res Scholars 2012;1:254-67.

The Indian Pharmacopoeia. 4th Edition. Vol. II. Ministry of Health and Family Welfare; Government of India; Controller of Publications, New Delhi; 1996.

The Japanese Pharmacopoeia. 15th Edition. The Ministry of health, Labour and welfare ministerial; Japan; 2006.

Patel KN, Mehta TA. Design and optimization of nicardipine hydrochloride push-pull osmotic pump tablet using 32 full factorial design. Int J Pharm Biomed Res 2013;4:155-63.

Shah TJ, Amin AF. Process optimization and characterization of poloxamer solid dispersions of a poorly water-soluble drug. AAPS PharmSciTech 2007;8:E1–E7.

Ariani L, Surini S, Hayun. Formulation of diclofenac sodium sustained release tablet using co-processed excipients of crosslinked amylose–xanthan gum as a matrix. Int J Pharm Pharm Sci 2016;8:151-5.

Swain RP, Kumari TR, Panda S. Formulation development and evaluation of sustained release ibuprofen tablets with acrylic polymers (eudragit) and HPMC. Int J Pharm Pharm Sci 2016;8:131-5.

Patel NA, Makwana ST, Patel ZP, Solanki SM, Patel MB. Formulation and evaluation of once daily sustained release matrix tablet of pramipexole dihydrochloride. Int J Pharm Res Scholars 2012;1:370-6.

Ain S, Kumar B, Pathak K. Development and characterization of controlled release famotidine matrix tablets containing complexes. Int J Appl Pharm 2017;9:38-46.

Chatap VK, Marathe GM. Formulation and evaluation of zaltoprofen fast disintegrating tablet. J Pharma Sci Technol 2013;3:20-6.

Mahajan P, Mahajan SC, Mishra DK. Valsartan release from sustained release matrix tablet and effect of cellulose derivatives. Int J Pharm Life Sci 2011;2:521-30.

Mahjan PD, Sarode M. Formulation and evaluation of colon-specific drug delivery system of zaltoprofen. World J Pharm Pharm Sci 2014;3:933-52.

Sharma S, Singh G, Gupta GD. Formulation design and optimization of mouth dissolving tablets of domperidone using sublimation technique. Int J Pharm Sci 2010;1:12-21.

Chudiwal PD, Pawar PL, Nagaras MA. Statistical evaluation and optimization of the influence of viscosity and content of polymer on floating microspheres of clarithromycin. Int J PharmTech Res 2009;1:1366-72.

Agnivesh SR, Bhalchandra U, Chhanda KJ. Design, optimization, preparation and evaluation of dispersion granules of valsartan and formulation into tablets. Curr Drug Delivery 2009;6:28-37.

Patel JV, Patel KN, Patel KD, Nayak BS. Development and evaluation of fast dissolving tablets of quetiapine fumarate using 32 full factorial design. Int J Pharm Res Scholars 2014;3:281-97.




About this article

Title

FORMULATION AND CHARACTERIZATION OF SUSTAINED RELEASE MATRIX TABLETS OF IVABRADINE USING 32 FULL FACTORIAL DESIGN

Keywords

Sustained release matrix tablet, IB, Guar gum, Xanthan gum, 32 full factorial design

DOI

10.22159/ijap.2018v10i1.21584

Date

06-01-2018

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 10, Issue 1 (Jan-Feb), 2018 Page: 59-66

Online ISSN

0975-7058

Statistics

284 Views | 79 Downloads

Authors & Affiliations

Olvishkumar M. Kothiya
PG Student, Department of Pharmaceutics, Shree Swaminarayan Sanskar Pharmacy College, Zundal, Gandhinagar, Gujarat, India-382421.
India

Bhavana A. Patel
Assistant Professor, Department of Pharmaceutics, Shree Swaminarayan Sanskar Pharmacy College, Zundal, Gandhinagar, Gujarat, India-382421.
India

Kunal N. Patel
Associate Professor, Department of Pharmaceutics, Shree Swaminarayan Sanskar Pharmacy College, Zundal, Gandhinagar, Gujarat, India-382421.
India

Madhubhai M. Patel
Director, Shree Swaminarayan Sanskar Pharmacy College, Zundal, Gandhinagar, Gujarat, India-382421.
India


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