Adv Pharm Bull. 2018;8(3):419-427.
doi: 10.15171/apb.2018.049
PMID: 30276138
PMCID: PMC6156478
Scopus id: 85052572655
  Abstract View: 355
  PDF Download: 439

Research Article

Fabrication and Characterization of Gliclazide Nanocrystals

Nagaraju Ravouru 1 ORCiD, Rajeswari Surya Anusha Venna 1, Subhash Chandra Bose Penjuri 2 * ORCiD, Saritha Damineni 3 ORCiD, Venkata Subbaiah Kotakadi 4, Srikanth Reddy Poreddy 2 ORCiD

1 Institute of Pharmaceutical Technology, Sri Padmavathi Mahila University, Tirupati, Andhra Pradesh, India.
2 Department of Pharmaceutics, MNR College of Pharmacy, Sangareddy, Telangana, India.
3 Department of Pharmaceutics, Sultan-ul-Uloom College of Pharmacy, Hyderabad, Telangana, India.
4 Research Scientist, DST Purse Centre, S.V. University, Tirupati, Andhra Pradesh, India.


Purpose: The main aim of the present investigation was to enhance the solubility of poorly soluble Gliclazide by nanocrystallization. Methods: In present investigation gliclazide nanocrystals were prepared by sonoprecipitation using Pluronic F68, Poly Vinyl Alcohol (PVA), Poly ethylene Glycol 6000 (PEG), Poly Vinyl Pyrrolidine (PVP K30) and Sodium Lauryl Sulphate (SLS) as stabilizers. Fourier Transform Infrared Spectroscopic study (FTIR), Differential Scanning Calorimetry (DSC) and X ray diffraction (XRD) studies were conducted to study the drug interactions. Size and zeta potential of the nanocrystals were evaluated. In vitro and in vivo studies of nanocrystals were conducted in comparison to pure gliclazide. Results: The Gliclazide nanocrystals (GN) showed mean particle size of 131±7.7 nm with a zeta potential of -26.6 mV. Stable nanocrystals were formed with 0.5% of PEG 6000. FTIR, DSC and XRD studies of nanocrystals showed absence of interactions and polymorphism. SEM photographs showed a change in morphology of crystals from rod to irregular shape. There is an increase in the saturation solubility and the percentage drug release from formulation GN5 (Optimized Gliclazide Nanocrystals) was found to be 98.5 in 15 min. In the in vivo study, GN5 nanocrystals have reduced the blood glucose level to 296.4±4.26 mg/dl in 12 hr. The nanocrystals showed lower tmax and higher Cmax values as compared to pure gliclazide. Conclusion: The prepared nanocrystals of gliclazide were stable without any drug polymer interactions. Increase in the dissolution of nanocrystals compared to pure gliclazide and significant reduction in blood glucose level in vivo indicated better bioavailability of the nanocrystals. Therefore, it is concluded that nanocrystal technology can be a promising tool to improve solubility and hence dissolution of a hydrophobic drug.
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Submitted: 21 Mar 2017
Revised: 24 May 2018
Accepted: 15 Aug 2018
First published online: 29 Aug 2018
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