FORMULATION AND EVALUATION OF GLICLAZIDE NANOSPONGES
DOI:
https://doi.org/10.22159/ijap.2019v11i6.35006Keywords:
Nanosponge, Gliclazide, Controlled release, Emulsion solvent diffusion methodAbstract
Objective: The objective of the present study was to develop and characterize an optimal stable nanosponges of Gliclazide (GLZ) by using the emulsion solvent diffusion method and aimed to increase its bioavailability and release the drug in sustained and controlled manner.
Methods: The GLZ nanosponge was prepared by emulsion solvent diffusion method using different drug-polymer ratios (1:1 to 1:5) Eudragit S100 is used as a polymer. Differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) estimated the compatibility of GLZ with polymer. All formulations evaluated for production yield, entrapment efficiency, in vitro drug release, scanning electron microscopy (SEM) and stability studies.
Results: The DSC and FTIR Studies revealed that no interaction between drug and polymer. The Production yield of all batches in the range of 73.8±0.30 to 85.6±0.32. Batch F3 showed the highest production yield, the entrapment efficiency of batch F3 70.6±0.77. The average particle size ranges from 303±2.36 to 680±2.50 nm. By the end of 10th hour F3 formulation shown highest drug release was found to be 94.40±1.12%. The release kinetics of the optimized formulation shows zero-order drug release. The stability study indicates no significant change in the in vitro dissolution profile of optimized formulation.
Conclusion: The results of various evaluation parameters, revealed that GLZ nanosponges would be possible alternative delivery systems to conventional formulation to improve its bioavailability, the emulsion solvent diffusion method is best method for preparation of nanosponges and release the drug in sustained and controlled manner.
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References
Bhowmik H, Venkatesh ND, Kuila A, Kumar HK. Nanosponge: a review. Int J Appl Pharm 2018;10:1-5.
Subramanian S, Singireddy S, Krishnamoorthy K, Rajappan M. Nanosponges: a novel class of drug delivery system review. J Pharm Sci 2012;15:103-11.
Cavalli R, Trotta F, Tumiatti W. Cyclodextrin-based nanosponges drug delivery. J Inclusion Phenom Macrocyclic Chem 2006;56:209-13.
Sharma R, Roderick B Walker, Kamla P. Evaluation of kinetics and mechanism of drug release from econazole nitrate nanosponge loaded carbopol hydrogel. Ind J Pharm Edu Res 2011;45:25-31.
Kilicarslan M, Baykara T. The effect of drug-polymer ratio on the properties of verapamil loaded microspheres. Int J Pharm 2003;252:99-109.
Pentewar RS, Kaji S, Bharati R, MDS technology: an approach for topical, oral controlled and cosmetic formulations. Res J Pharm Biol Chem Sci 2014;5:1170.
Sehgal N, Gupta V, Kanna S. A review on nanosponges: a boon to targeted drug delivery for an anticancer drug. Asian J Pharm Clin Res 2019;12:1-7.
Salunkhe A, Kadam S, Magar S, Dangare K. Nanosponges: a modern formulation approach in drug delivery system. World J Pharm Pharm Sci 2018;7:575-92.
Swetha A, Gopal Rao M, Venkata Ramana K, Niyaz Basha B, Koti Reddy V. Formulation and in vitro evaluation of etodolac entrapped in microsponge based drug delivery system. Int J Pharma 2011;1:73-90.
Swaminathan S, Vavia PR, Trotta F, Torne S. Formulation of Β-cyclodextrin based nanosponges of itraconazole. J Incl Phenom Macrocycl Chem 2007;57:89–94.
Arvapally S, Harini M, Harshitha G, Arun Kumar A. Formulation and in vitro evaluation of glipizide nanosponges. Am J Pharmtech Res 2017;7:341-61.
Kumar AN. Enhancement of the dissolution rate of glibenclamide using liquisolid technique. Int J Res Pharm Nano Sci 2015;4:206-16.
Singh R, Bharati N, Madan J, Hiremath SN. Characterization of cyclodextrin inclusion complexes–a review. J Pharm Sci Tech 2010;2:171-83.
Swaminathan S, Pastero L, Serpe L, Trotta F, Vavia P, Aquilano D, et al. cyclodextrin-based nanosponges encapsulating camptothecin: physicochemical characterization, stability and cytotoxicity. Eur J Pharm Biopharma 2010;74:193-201.
Dubey P, Sharma HK, Shah S, Tyagi CK, Chandekar A. Jadon SR. Formulation and evaluation of cyclodextrin complexed ceadroxil loaded nanosponges. Int J Drug Delivery 2017;9:84-100.
ICH, Q1A, (R2) Stability testing guidelines: stability of new drug substances and product: methodology in processing of ICH Geneva; 2003.
Paulo Costa, Jose Manuel Sousa Lobo. Modelling and comparison of dissolution profiles. Eur J Pharm Sci 2001;13:123-33.
Varma Mohan M, Kumar Satish P. Formulation and evaluation of gliclazide tablet containing PVP-K30 hydroxypropyl-β-cyclodextrin solid dispersion. Int J Pharm Sci Nanotechnol 2012;5:1706-19.
Biswal S, Sahoo J, Murthy PN. Characterization of gliclazide-PEG 8000 solid dispersions. Tropical J Pharm Res 2009;8:417-24.
Keerthi Priya Darshaini M, Jyothshna Devi K, Shilpaja C, Usmankar K. Atorvastatin loaded nanosponges-a novel strategic approach for enhanced bioavailability. World J Pharm Pharm Sci 2017;6:1223-36.
Asad M, Bashir S, Mahmood T, Nazir I, Imran M, karim S, et al. Fabrication and characterization of gliclazide loaded microcapsules. Braz Arch Biol Technol 2014;57:874-81.