Pharmacokinetics and bioequivalence of 20 mg omeprazole capsule in 24 healthy Korean male volunteers.

OBJECTIVE: A randomized, two-way, crossover bioequivalence study in 24 healthy Korean male volunteers was conducted to compare bioequivalence of two brands of 20 mg omeprazole capsules, Hutex omeprazole (Hutex Pharm Co. Korea) as a test and Yuhan Losec (Yuhan Co. Ltd., Korea) as a reference drug. VOLUNTEERS AND METHODS: Subjects were administered single dosage of 1 capsule of 20 mg of each formulation with 240 ml of water after 10 hs overnight fasting on 2 treatment days separated by one-week washout period. After dosing, serial blood sampling was held during 9 hs. Plasma was analyzed for omeprazole by a validated HPLC method with ultraviolet detection in the range of 10 approximately 1,000 ng/ml with the lowest limit of quantification of 10 ng/ml. RESULTS: Several pharmacokinetic (PK) parameters were determined from the plasma samples, and data from reference and test formulations in the plasma were represented such as AUC0-t (1,223.3 vs 1,284.3 ng x h/ml), [formula in text](1,311.1 vs 1,410.0 ng x h/ml), Cmax (598.7 vs 598.1 ng/ml), tmax (1.9 vs 1.9 h), t1/2 (1.3 vs 1.4 h) and Ke (0.67 vs 0.67 h-1), respectively. AUC0-t, [formula in text] and Cmax were tested for bioequivalence after log-transformation of plasma data. PK parameters with 90% confidence interval (CI) of test/reference ratio based on ANOVA analysis were 0.961 approximately 1.135 for AUC0-t, 0.968 approximately 1.144 for [formula in text] and 0.951 approximately 1.117 for Cmax. CONCLUSIONS: PK parameters with 90% CI were within the bioequivalence range of 80 - 125% of FDA statistical limit. Therefore, both omeprazole formulations were bioequivalent during fasting state in these healthy Korean male volunteers.

Original sagittal split osteotomy revisited for mandibular distraction.

INTRODUCTION: A malformed mandible and an abnormally positioned mandibular foramen make it difficult to plan an ideal osteotomy line for mandibular distraction. In addition, there have been reports of such complications as nonunion, damage and stretch injury of the inferior alveolar nerve and tooth germ damage when conventional osteotomy or corticotomy are used for mandibular distraction. The authors utilized the original sagittal split ramus osteotomy for mandibular distraction. PATIENTS AND METHODS: Five patients (three unilateral hemifacial microsomia, one bilateral hemifacial microsomia, and one mandibular retrusion) were included in this study of distraction osteogenesis using the sagittal split ramus osteotomy. Extraoral distraction devices were applied to the first four patients. An intraoral device with mono-cortical screw fixation was used for the fifth patient. RESULT: In all five cases, the results of the distraction were satisfactory. Complications (as listed) of conventional osteotomy when used for distraction were avoided. Satisfactory results were achieved and these were also well maintained postoperatively (mean follow up: 36 months). CONCLUSION: The authors believe that sagittal osteotomy for mandibular distraction osteogenesis makes it possible, to avoid injury to the inferior alveolar nerve during operation and stretching injury during distraction and to prevent tooth germ injury. It is also possible to diversify the osteotomy line for various force vectors to enlarge the bony contact surface area. Therefore, we suggest that sagittal split ramus osteotomy should be used as a preferred modification of osteotomy for mandibular distraction.