Assessment Of Olanzapine Orodispersible Tablets Bioequivalence In Healthy Volunteers

Dispersible tablet form (ODD of drugs is convenient for patients to take; the effectiveness of its use increases significantly with non-compliance treatment of mental disorders. Upon the expiration of the patent for the original drug, the production of generics with the same pharmacologically active ingredient often starts. Due to differences in fillers and manufacturing techniques, even high-quality copies of the original product may not be equivalent to it. Therefore, the aim of this study was to evaluate the bioequivalence of the ODT form of the original drug and generic with 10 mg olanzapine. After taking the original drug and generic in two stages, on an empty stomach from healthy volunteers, from the vein were sampled bloods into vacuum heparin tubes. The washout period between doses of the drugs was 21 days. The extraction (LLE) of olanzapine was carried with a mixture of n-hexane:isopropanol (3:1) at pH 8.0, and analyzed by liquid chromatography-tandem mass spectrometry (quadrupole-linear ion trap). The degree of extraction olanzapine from bloods (model samples, 20 ng/ml) was 75.2% (CV 4.6%). The quantitative limit for olanzapine by HPLC-MS/MS (LLOQ) was 0.50 ng/ml (CV 2.0%, accuracy 17.6%). Conducted on an open randomized cross scheme studies showed a satisfactory bioavailability and bioequivalence profile of the original drug and generic containing olanzapine. The calculated pharmacokinetic parameters for the logarithmically converted mean values verified with a 90% confidence interval were: C-max-95.93-99.80% (average value 97.64%); AUC(0-t)- 95.43-100.35% (average value 97.75%); C-max/AUC(0-t)- 94.44-101.73% (average value 97.87%).