Formulation, development and evaluation of an osmotic drug delivery system for lornoxicam

Abstract

Background and Aims: The current study aimed to develop an osmotic drug delivery system for Lornoxicam to prolong its release. Methods: Two different approaches were used for development of the osmotic drug delivery system; the first one was to for- mulate a controlled porosity osmotic tablet and the other was to design an elementary osmotic tablet. The controlled porosity osmotic tablets were coated with different concentrations of osmogents, a pore former, and varying coating thicknesses, and the effects were observed on the release. In the elementary osmotic pump, the tablets were drilled to make an orifice that creates pressure to release the drug by osmosis, and drug release was studied. Results: The formulations were evaluated for different parameters namely appearance, uniformity of weight, drug content, hardness, and drug release. Also, the effect of different osmotic agents responsible for developing the osmotic pressure such as sodium chloride and mannitol along with the different concentrations of pore-forming sorbitol were studied. A compari- son was made between the controlled porosity osmotic tablet in which the membrane coating contains water-soluble pore- forming polymers that leach when the membrane comes in contact with water thereby permitting water inside the wall and creating the osmotic pressure to release the drug, and the elementary osmotic tablet containing the osmotic agent sodium chloride coated with the rate-controlling semipermeable membrane, cellulose acetate, which contains an orifice of a critical size through which the drug is delivered. Conclusion: From the results, it was found that the developed formulation of the controlled porosity osmotic tablet was able to release Lornoxicam (CPOP) over 12 hours at zero-order kinetics and, the concentration of the osmotic agent, level of pore former, and thickness of the membrane coating are responsible for controlling the release of lornoxicam. The membrane coating was subjected to SEM analysis, which showed the formation of pores in the membrane. The developed controlled porosity osmotic pump tablet of lornoxicam was found to control the drug release for 12 hours.

Keywords

• Lornoxicam
• Controlled porosity osmotic tablet
• Elementary osmotic tablet
• Drug Release
• Osmotic agents
• Pore former & Scanning Electron Microscopy

References

1. Chai, H. F., Xu, J., & Liu, G. C. (2008). Sodium salicylate micro-po- rous osmotic pump controlled release tablet. Journal of Guang- dong College of Pharmacy, 3, 22–25.
2. Edavalath, S., Shivanand, K., Kalyani, P. M., Prakash, R., & Goli, D. (2011). Formulation development and optimization of controlled porosity pump tablet of diclofenac sodium. International Journal of Pharmacy & Pharmaceutical Sciences, 3, 80–87.
3. Government of India Ministry of health and family welfare. (1996). Indian pharmacopeia, 2, 735–736).
4. Herbig, S. M., Cardinal, J. R., Korsmeyer, R. W., & Smith, K. L. (1995). Asymmetric-membrane tablet coatings for osmotic drug deliv- ery. Journal of Controlled Release, 35(2–3), 127–136. https://doi. org/10.1016/0168-3659(95)00028-7
5. Kumar, P., Singh, S., & Mishra, B. (2009). Development and evalu- ation of elementary osmotic pump of the highly water-soluble drug: Tramadol hydrochloride. Current Drug Delivery, 6(1), 130– 139. https://doi.org/10.2174/156720109787048249
6. Liu, H., Yang, X. G., Nie, S. F., Wei, L. L., Zhou, L. L., Liu, H., Tang, R., & Pan, W. S. (2007). Chitosan-based controlled porosity osmotic pump for the colon-specific delivery system: Screening of formu- lation variables and in vitro investigation. International Journal of Pharmaceutics,332(1–2),115–124. https://doi.org/10.1016/j. ijpharm.2006.09.038
7. Patel, R.B., Patela, H.R., Patel, G.N., Patel, R.P., & Patel, M.M. (2010). Development of an osmotically controlled drug delivery system by inclusion complex with HP-β-CD of glipizide: Optimization of formulation using response surface methodology. Asian Journal of Pharmaceutical Sciences,5(2), 74–86.
8. Pritam, K., Braj, B.L., Ambikanandan, M., Prakash, D., & Rajesh, K. (2007). Formulation and Optimization of porous Osmotic Pump- based Controlled Release System of oxybutynin. AAPS PharmSci- Tech, 8(3), 44–48.

9. Santus, G., & Baker, R. W. (1995). Osmotic drug delivery: A review of patent literature. Journal of Controlled Release, 35(1), 1–21. https://doi.org/10.1016/0168-3659(95)00013-X
10. Syed, S.M., Farooqui, Z., Mohammed, M., Dureshawar, K., & Farooqui, M. (2015). Osmotic drug delivery system: An overview. Internation- al Journal of Pharmaceutical Research& Allied Sciences, 4(3), 10–20.
11. Syed, S., & Mohammad, M. (2014). Validation of UV spectrophoto- metric method for determination of atenolol. International Jour- nal of Pharmaceutical Research, 6(1), 25–27.
12. Syed, S.M., Lahoti, S., & Syed, A.A. (2016). Controlled porosity os- motic tablet of atenolol: In vitro and in vivo evaluation. Marmara Pharmaceutical Journal, 20(3), 325–332. https://doi.org/10.12991/ mpj.20162040694
13. Syed, S.M., Marathe, R.P., & Mahaparale, P.R.(2019). Analytical Method Development and validation of RP-HPLC Method for De- termination of eletriptan HBr. Journal of Current Pharma Research, 10(1), 3535–3542.
14. Syed, S.M., Marathe, R.P., &Mahaparale, P.R. (2019). Development and validation of UV spectrophotometric and RP-HPLC method for metoprolol succinate. International Research Journal of Phar- macy, 10(11), 24–28, https://doi.org/10.7897/2230-8407.1011315
15. Syed, S.M., & More, R.I. (2019). Quality by design: An approach for formulation development. Inventi Rapid: Pharm Analysis & Quality Assurance, 2020 (1), 1–6.
16. Theeuwes, F. (1975). Elementary osmotic pump. Journal of Phar- maceutical Sciences, 64(12), 1987–1991. https://doi.org/10.1002/ jps.2600641218
17. Zentner, G. M., McClelland, G. A., & Sutton, S. C. (1991). Controlled porosity solubility and resin-modulated osmotic drug delivery systems for the release of diltiazem hydrochloride. Journal of Con- trolled Release, 16(1–2), 237–243. https://doi.org/10.1016/0168- 3659(91)90047-H