Formulation and Evaluation of Bi-Layer Tablets of Ketorolac Tromethamine

  • Dhaval M. Patel Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India
  • Riddhi Trivedi Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India
  • Hardik Patel Shri Sarswati Institute of Pharmaceutical Sciences, Gandhinagar, Gujarat, India

Abstract

The objective of the present study was to develop and evaluate bi-layer tablets of Ketorolac tromethamine, a nonsteroidal antiinflammatory drug with short half-life, that are characterized by initial burst drug release in the stomach and comply with the release requirements of sustained-release products. Each of the proposed bi-layer tablets is composed of an immediate-release layer and a sustained-release layer, anticipating rapid drug release that starts in the stomach to rapidly alleviate the symptoms and continues in the intestine to maintain protracted analgesic effect. Gastro retentive Bi-Layer tablets of Ketorolac Tromethamine were prepared by using hydrophilic polymers with direct compression on floating – matrix technology and evaluated. Ketorolac tromethamine is freely soluble in water, so it is suitable to develop it as gastro retentive bi-layer tablets using hydrophilic polymers. The developed formulation is equivalent to calculated theoretical drug profile in view of its in vitro release. Immediate release layer was prepared by using dry granulation method in which ac-di sol used as a disintigrant for immediate release of drug. Sustained release layer formulated by using HPMC as release retardant, two grades of HPMC that are HPMC K4M and HPMC K100M used to get sustained release profile for 24 hr. Various trial batches are taken to get desired release profile. Ketorolac tromethamine release from the developed floating formulation followed Higuchi model and nonFickian diffusion is found to be the main mechanism of drug release. The manufacturing procedure was found to be reproducible and formulations were stable after one month of stability studies.


Keywords: FTIR; Gastro retentive bilayer; ketorolac tromethamine; in vitro release; stability; higuchi.

Keywords: FTIR, Gastro retentive bilayer, ketorolac tromethamine, in vitro release, stability, higuchi

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Author Biographies

Dhaval M. Patel, Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Riddhi Trivedi, Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Professor, SAL Institute of Pharmacy, Ahmedabad, Gujarat, India

Hardik Patel, Shri Sarswati Institute of Pharmaceutical Sciences, Gandhinagar, Gujarat, India

Shri Sarswati Institute of Pharmaceutical Sciences, Gandhinagar, Gujarat, India

References

1. Buckley, M.T., Brogden, R.N. Ketorolac: A review of its pharmacodynamics and pharmacokinetics properties and therapeutic potential. Drugs. 1990; 39:86-109.
2. Lieberman, H., Lachman, L., Schwetz, J.B. Pharmaceutical dosage forms. 2nd edition. 2: 179-181.
3. The merck index, 12th edition: 5324.
4. Drug Today, 2006; 1: 210.
5. Patel, D.M., Patel, A.B., Trivedi, R.D., Parmar, V.J., Bangoriya, U.V. Evaluation of the effect of hydroalcoholic extract of Cassia occidentalis leaves in neutrophil adhesion test in rats. JDDT. 2019; 9 (4s):1218-1221.
6. Metkar, V., Kumar, A., Pant, P., Pal, D., Sahu, S., Shurngarpure, M., Madhusudan, D. Formulation development and evaluation of Bilayer tablets of Lornoxicam. IJDDR. 2012; 4 (2):173-179.
7. Wells, J. Pharmaceutical preformulation: The physiochemical properties of drug substances. In: Aulton ME, editor. Pharmaceutics the science of dosage form design. London: Churchill Livingstone; 2002; 247.
8. Girish, S.S. , Devendra, K.J., Dhananjay, M.M. Preparation and in vitro evaluation of bilayer and floating-bioadhesive tablets of rosiglitazone maleate. Asian Journal of Pharmaqceutical Sciences. 2007; 2(4):161-169.
9. Singh, S.K., Srinivasan, K.K., Gowthamarajan, K., Narayan, G.B. Development and validation of discriminatory dissolution procedure for poorly soluble glyburide. Asian Journal of Pharmaceutics. 2010; 4:205-212.
10. Patel, A., Patel, D., Patel, D., Sheth, A., Shah, U.J. Method Development and Validation for Simultaneous Estimation of Benidipine Hydrochloride and Metoprolol Succinate in Tablet. JDDT. 2019; 9 (6s):28-33.
11. Trivedi, R.D., Shah, S.K. “Formulation and Evaluation of Mucoadhesive Nasal Microspheres of Hydralazine Hydrochloride” The Journal of medical research, 2018,
12. Costa, P., Manuel, S.L. Modeling and comparison of dissolution profiles. Eur. J. of Pharma.Sci. 2001; 12:123-133.
13. Ravindran, V.K., Vasa, S., Banji, D. Comparative Study of Mucoadhesive Polymers Carbopol 974P and Sodium Carboxy Methyl Cellulose for single unit dosage of Imatinib Mesylate. Malay J.Pharm. Sci. 2012; 10:61-77.
14. Colombo, P., Bettini, R., Peppas, N.A. Observation of swelling process and diffusion front position during swelling in Hydroxypropylmethylcellulose (HPMC) matrices containing a soluble drug. J. Control. Release. 1999; 61:83-91.
15. Momin, M.M., Kane, S., Abhang, P. Formulation and evaluation of bilayer tablet for bimodal release of venlafaxine hydrochloride. Front. Pharmacol. 2015; 6(144):1-10. doi: 10.3389/fphar.2015.00144
16. Dave, R., Patel, R. “Preparation and characterization of doxorubicin HCl loaded chitosan nanoparticles by w/o emulsion method” International Journal Of Pharmacy & Life Sciences, 2013; 4(2).
17. Dave, R.M., Patel, R., Chauhan, H. “Effect of cryoprotectant on lyophlisation of doxorubicin -HCl loaded chitosan nanoparticles” International Journal Of Pharmacy & Life Sciences, 2012; 3(6).
18. Patel, A.B., Patel, D.R., Patel, D.M., Patel, K.S., Patel, P. Stability indicating HPLC method development and validation of Enrofloxacin and Bromhexine HCl in combined dosage form. Aegaeum Journal. 2020; 8 (5):443-457.
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Patel DM, Trivedi R, Patel H. Formulation and Evaluation of Bi-Layer Tablets of Ketorolac Tromethamine. JDDT [Internet]. 15Jan.2021 [cited 28Sep.2021];11(1):36-1. Available from: https://jddtonline.info/index.php/jddt/article/view/4487