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      Co-stabilization of pioglitazone HCL nanoparticles prepared by planetary ball milling: in-vitro and in-vivo evaluation.

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          Abstract

          Pioglitazone (PGZ) is an oral antidiabetic agent that increases cell resistance to insulin, thereby decreasing blood glucose levels. PGZ is a class II drug. Because of its pH-dependent solubility, it precipitates at the intestinal pH, resulting in an erratic and incomplete absorption following oral administration, which causes fluctuations in its plasma concentration. A nanoparticle drug delivery system offers a solution to enhance the dissolution rate of this poorly water-soluble drug. PGZ nanoparticles were formulated by the wet milling technique using a planetary ball mill. The effects of the steric stabilizer (Pluronic F-127, PL F-127), electrostatic stabilizer (sodium deoxycholate, SDC), and number of milling cycles were optimized using a Box-Behnken factorial design. The results showed that the ratio of PL F-127: SDC significantly affected the zeta potential and the dissolution efficiency (DE%) of PGZ. The optimized PGZ nanoparticle formulation enhanced the dissolution to reach 100% after 5 min. The in-vivo results showed significant enhancement in Cmax (1.3-fold) compared to that of the raw powder, and both AUC0-24 and AUC0-∞ were significantly (p < 0.05) enhanced. In conclusion, PGZ nanoparticle formulation had enhanced dissolution rate in the alkaline media, which improved its drug bioavailability relative to that of the untreated drug.

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          Author and article information

          Journal
          Pharm Dev Technol
          Pharmaceutical development and technology
          Informa UK Limited
          1097-9867
          1083-7450
          Sep 2020
          : 25
          : 7
          Affiliations
          [1 ] Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
          [2 ] Department of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Al-Azhar University, Assiut, Egypt.
          [3 ] Department of Pharmaceutical Chemistry and Drug Bioavailability Laboratory, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
          [4 ] Drug Bioavailability Center, National Organization for Drug Control and Research, (NODCAR), Cairo, Egypt.
          [5 ] Department of Pharmaceutics, College of Pharmacy, Assiut University, Assiut, Egypt.
          Article
          10.1080/10837450.2020.1744163
          32174213

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