Invitro Designing of Fluvastatin Chrono Formulation
Article Sidebar
-
Chrono therapeutics, fluvastatin, ludiflash, lycoat, HPMC K200M and Ethylcellulose
Abstract
The objective was to improve fluvastatin prescribed pulsatile release formulation to get the disintegrative and ruptured lag-time mechanism with a fixed time delay which matches the chronotherapeutics (hypercholesteroidal disorder). Pre formulation studies UV, FTIR (Drug excipient compatibility), solubility studies and flow properties were evaluated for blend and drug. All the values were within the limit. 12 core tablets were prepared with two novel disintegrants, i.e. ludiflash, lycoat in different concentrations after doing the post-compression parameters & drug release F8 was optimized & then coated with PH sensitive polymers HPMC K200M & Ethylcellulose in different concentrations. An evaluation was carried out for all six formulations, and all the values were within the limit. Based on In-vitro dissolution studies, swelling index and rupture test C5F8 is optimized and compared with the marketed product for 10 hours. As per the ICH guidelines optimized formulation (C5F8), stability tests were conducted for three months and was found to be stable. Optimized formulation (C5F8) contains 3:2 polymers (HPM K200M: Ethylcellulose) demonstrates an outstanding pulsatile drug delivery relative to the branded version (Lexcol XL) compared to all other formulations.
Full text article
References
Amit, K., Sonam, R. 2012. Pulsatile Drug Delivery System: Method and Technology Review. International Journal of Drug Development and Research, 4:95–107.
Anand, D. S., NeelofarSultana, S., Sultana, S. S., Ramana, B. V., Nagarajan, G. 2014. Formulation and evaluation of bilayer floating tablets of simvastatin and lovastatin. Journal of Chemical and Pharmaceutical Research, 6(12):186–197.
Chaudhari, S. P., Chaudhari, P. D., Mistry, C. J., Patil, M. J., Barhate, N. S. 2007. The effect of core and coating composition on drug release from directly compressed time-controlled release tablets. Pharm Tech, 31:132–144.
De Geest, B. G., Mehuys, E., Laekeman, G., Demeester, J., De Smedt, S. C. 2006. Pulsed drug delivery. Expert Opinion on Drug Delivery, 3(4):459–462.
Garg, B. K., Gnanarajan, P., Kothiyal 2012. Formulation and evaluation of pulsatile drug delivery system of rosuvastatin calcium using different swelling polymers. The pharma innovation, 1(7):61–67.
Gothoskar, A. V., Joshi, A. M., Joshi, N. H. 2004. Pulsatile drug delivery systems: a review. Drug Delivery Technology, 4(5):1–11.
Karavas, E., Georgarakis, E., Bikiaris, D. 2006. Felodipine nanodispersions as active core for predictable pulsatile chronotherapeutics using PVP/HPMC blends as coating layer. International Journal of Pharmaceutics, 313(1-2):189–197.
Keerthi, S., Reddy, V. B., Muralidharan, L. V. G., Nargund 2014. Formulation and evaluation of pulsatile drug delivery system of the anti-asthmatic drug. Am. J. Pharmtech res, 4(1):797–809.
Krishnaveni, G., Muthukumaran, M., Krishnamoorthy, B. 2013. Development and evaluation of the pulsatile drug delivery system containing montelukast sodium by press coated tablet using natural polysaccharides. Int j adv pharm genres, 1(2):41–51.
Mukhopadhyay, S., Pant, R., Goswami, L. 2014. Formulation and evaluation of pulsatile drug delivery system for sequential release of atorvastatin. International journal of pharmaceutical and chemical sciences, 3(2):123–136.
Mutalik, S., Anju, P., Manoj, K., Usha, A. N. 2008. Enhancement of dissolution rate and bioavailability of aceclofenac: A chitosan-based solvent change approach. International Journal of Pharmaceutics, 350(1-2):279–290.
Parag, A., Kulkarni, M., Jaaiswal, Santosh, B., Jawale, Satish, V., Shirolkar, Pramod, V., Kasture 2010. Development and evaluation of press coated tablets for Chrono pharmaceutical drug delivery using gellable and permeable polymers. Scholars research library, 2(4):482–497.
Patil, B., Abhishek, M., Motegi, U., Kulkarni, Hariprasanna, R. C., Shivanand, A. 2012. Development and evaluation of time-controlled pulsatile release lisinopril tablets. Journal of Pharmaceutical Science and Bio scientific Research, 2(1):30–35.
Patil, V., Chandrasekhara, S., Nagesh, C., Praveen, K., Rekha, S. 2013. Pulsatile Drug Delivery System of Terbutaline Sulphate, Using pH-Sensitive polymer. American Journal of Advanced Drug Delivery, 1(4):635–650.
RavikumarReedy, J., VeeraJyotsna, M., Mohamed- Saleem, T. S., Praveen, K., Rekha, S. 2009. Pulsatile drug delivery systems. American Journal of Advanced Drug Delivery, 1(4):109–111.
Schachter, M. 2005. Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundamental & Clinical Pharmacology, 19(1):117–125.
Smolensky, M. H., D’Alonzo, G. E. 1988. Biologic rhythms and medicine. The American Journal of Medicine, 85(1):34–46.
Sungthongjeen, S., Puttipipatkhachorn, S., Paeratakul, O., Dashevsky, A., Bodmeier, R. 2004. Development of pulsatile release tablets with swelling and rupturable layers. Journal of Controlled Release, 95(2):147–159.
Tejaskumar, P., Ananthapur, M., Sabitha, J. S., Trivedi, S. 2013. Rinku Mathappan, Prasanth V.V. Formulation and evaluation of erodible pulsatile drug delivery system of salbutamol sulphate for nocturnal asthma. International Journal of Pharmaceutical Innovations. (IJPI), 3(3):24–35.
Yang, W., Donald, E. O., Robert, O. W. 2012. Pharmaceutical Cryogenic Technologies, in Formulating Poorly Water-Soluble Drugs. Springer, 3:443– 500.
Authors
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.