Formulation, Development and Evaluation of Bilayer Floating Tablet of Gemfibrozil

  • Mohammad Faizan Mohammad Gufran
  • Sailesh Kumar Ghatuary
  • Reena Shende
  • Prabhat Kumar Jain
  • Geeta Parkhe

Abstract

Formulation development is an important part of drug design and development. Bioavailability and bioequivalence are totally dependent on formulation development. Now-a-days formulation development is done by following QbD (Quality by Design).The aim of present study is to formulate Gemfibrozil (Gem) sustained release (SR) and immediate release (IR) bilayer tablet by different concentration of Hydroxypropyl methylcellulose (HPMC) and HPMC K 100 M to control the release pattern. The sustained release layer of Gem was prepared by using different grades of HPMC like, HPMC K-15, HPMC K-4 along with other excipients by direct compression technique. The immediate release layer of Gem was prepared by Cross carmellose sodium, Crospovidone and Sodium starch glycolate by direct compression technique. The powders were evaluated for their flow properties and the finished tablets were evaluated for their physical parameters. The both immediate release and sustained release layers of Gem were characterized by FT-IR and in vitro dissolution studies. The drug release study of Gem was evaluated using USP-II paddle type dissolution apparatus. The release rate of Gem in immediate release layer was studied for 15 min in 0.1 N HCL media and that of Gem in sustained release layer was studied for 12 h in 0.1 N HCL. From the nine batches F6 batch showed good release behaviour 99.85% of drug is released over 12 hours. Gem belongs to BCS Class II (log P 3.6) with poor solubility and high permeability resulting in limited and variable bioavailability. Total four trial batches of each drug have been manufactured to optimize and develop a robust and stable formulation, the stability studies of the products also comply with ICH guideline.


Keywords: Bilayer floating tablets, Gemfibrozil, Biphasic drug release, HPMC K 15.

Downloads

Download data is not yet available.

Author Biographies

Mohammad Faizan Mohammad Gufran

RKDF School of Pharmaceutical Science, Bhopal (M.P.), India

Sailesh Kumar Ghatuary

RKDF School of Pharmaceutical Science, Bhopal (M.P.), India

Reena Shende

RKDF School of Pharmaceutical Science, Bhopal (M.P.), India

Prabhat Kumar Jain

Scan Research Laboratories, Bhopal (M.P.), India

Geeta Parkhe

Scan Research Laboratories, Bhopal (M.P.), India

References

1. Shaikh TK, Gadhave MV, Jadhav SL, Gaikwad DD. Different techniques of bilayer tablet: a review. Int J Univ Pharm Life Sci 2012; 2(2): 450-460.
2. Mayavanshi AV, Gajjar SS. Floating drug delivery systems to increase gastric retention of drugs: A review. J Pharm Tech 2008; 1(14): 345-348.
3. Patra CN, Kumar AB, Pandit HK, Singh SP, Devi MV. Design and evaluation of sustained release bilayer tablets of propranolol hydrochloride, Acta Pharm 2007; 57: 479-489.
4. Deshpande RD, Gowda DV, Mahammed M, Maramwar DN, Bi-Layer tablets-an emerging trend: a review, Int J Pharm Sci Res2011; 2(10); 2534-2544.
5. Yadav BV, Yadav VA. Enhancement of solubility and dissolution rate of BCS class II pharmaceuticals by nonaquious granulation technique. Int J Pharma Res Devel 2010; 1: 1‐12.
6. Taneja S, Shilpi S, Khatri K. Formulation and optimization of efavirenz nanosuspensions using the precipitation-ultrasonication technique for solubility enhancement. Artif Cells Nanomed Biotechnol 2016; 44:978 84.
7. Patel R, Baviskar T, Rajput A. Development and in-vivo characterization of SMEDDs (self-microemulsifying drug delivery system) for gemfibrozil. Int J Pharm Pharm Sci 2013; 5:793-800.
8. Talib H, Watersa L, Gareth M, Parkes G. Microwave processed solid dispersions for enhanced dissolution ofgemfibrozil using non-ordered mesoporous silica. Colloids Surf A Physicochem Eng Asp 2017;520:428-35
9. Huang QP, Wang JX, Chen GZ, Shen ZG, Chen JF, Yun J. Micronization of gemfibrozil by reactive precipitation process. Int J Pharm 2008; 360:58-64.
10. Liberman HA, Lachman L, Schwartz JB. Pharmaceutical dosage forms: Tablets, 3rd edition, Marcel Dekker, New York, 1990.
11. Lordi GN. Sustained release dosage forms. In: Lachman L, Liberman HA, Kanig JL, 3rd edition. The Theory and Practice of Industrial Pharmacy. Mumbai, India: Varghese Publishing House; 1987:430-456;
12. Aulton ME; Wells TI; Pharmaceutics: The Science of Dosage Form Design, Churchill Livingstone, London, England, 1988.
Statistics
38 Views | 52 Downloads
How to Cite
Mohammad Gufran, M. F., Ghatuary, S. K., Shende, R., Jain, P. K., & Parkhe, G. (2019). Formulation, Development and Evaluation of Bilayer Floating Tablet of Gemfibrozil. Journal of Drug Delivery and Therapeutics, 9(4), 574-578. https://doi.org/10.22270/jddt.v9i4-s.3401

Most read articles by the same author(s)