LG Chem Life Sciences

Korea - Seoul

Biotechnology

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Focus: Small Molecules, Vaccines, Biologics, Aesthetic Medicine

LG Chem Life Sciences is a life sciences company focused on Small Molecules, Vaccines, Biologics, Aesthetic Medicine.

Infectious DiseasesVaccines

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gemifloxacin mesylate

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CLINICAL PHARMACOLOGY Pharmacokinetics The pharmacokinetics of gemifloxacin are approximately linear over the dose range from 40 mg to 640 mg. There was minimal accumulation of gemifloxacin following multiple oral doses up to 640 mg a day for 7 days (mean accumulation <20%). Following repeat oral administration of 320 mg gemifloxacin once daily, steady-state is achieved by the third day of dosing. Absorption and Bioavailability Gemifloxacin, given as an oral tablet, is rapidly absorbed from the gastrointestinal tract. Peak plasma concentrations of gemifloxacin were observed between 0.5 and 2 hours following oral tablet administration and the absolute bioavailability of the 320 mg tablet averaged approximately 71% (95% CI 60%-84%). Following repeat oral doses of 320 mg to healthy subjects, the mean ± SD maximal gemifloxacin plasma concentrations (Cmax) and systemic drug exposure (AUC (0-24)) were 1.61 ± 0.51 μg/mL (range 0.70-2.62 μg/mL) and 9.93 ± 3.07 μg•hr/mL (range 4.71-20.1 μg•hr/mL), respectively. In patients with respiratory and urinary tract infections (n=1423), similar estimates of systemic drug exposure were determined using a population pharmacokinetics analysis (geometric mean AUC (0-24), 8.36 μg•hr/mL; range 3.2 – 47.7 μg•hr/mL). The pharmacokinetics of gemifloxacin were not significantly altered when a 320 mg dose was administered with a high-fat meal. Therefore FACTIVE tablets may be administered without regard to meals. Distribution In vitro binding of gemifloxacin to plasma proteins in healthy subjects is approximately 60 to 70% and is concentration independent. After repeated doses, the in vivo plasma protein binding in healthy elderly and young subjects ranged from 55% to 73% and was unaffected by age. Renal impairment does not significantly affect the protein binding of gemifloxacin. The blood-to-plasma concentration ratio of gemifloxacin was 1.2:1. The geometric mean for Vdss/F is 4.18 L/kg (range, 1.66 – 12.12 L/kg). Gemifloxacin is widely distributed throughout the body after oral administration. Concentrations of gemifloxacin in bronchoalveolar lavage fluid exceed those in the plasma. Gemifloxacin penetrates well into lung tissue and fluids. After five daily doses of 320 mg gemifloxacin, concentrations in plasma, bronchoalveolar macrophages, epithelial lining fluid and bronchial mucosa at approximately 2 hours were as in Table 1. Table 1. Gemifloxacin Concentrations in Plasma and Tissues (320 mg Oral Dosing) Tissue Concentration (mean ± SD) Ratio compared with plasma (mean ± SD) Plasma 1.40 (0.442) μg/mL — Bronchoalveolar Macrophages 107 (77) μg/g 90.5 (106.3) Epithelial Lining Fluid 2.69 (1.96) μg/mL 1.99 (1.32) Bronchial Mucosa 9.52 (5.15) μg/g 7.21 (4.03) Metabolism Gemifloxacin is metabolized to a limited extent by the liver. The unchanged compound is the predominant drug-related component detected in plasma (approximately 65%) up to 4 hours after dosing. All metabolites formed are minor (<10% of the administered oral d

infections caused by susceptible strains of the designated microorganisms in the conditions listed belowdevelopment of drug-resistant bacteriamaintain the effectiveness of FACTIVE+3 more

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LOE Approaching1 (100%)

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