• Korean Journal of Clinical Pharmacy
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• v.10 no.2
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• pp.68-73
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• 2000

The bioequivalence of two omeprazole preparations was evaluated following their oral administration to 16 normal volunteers. The test product was 'Ulpro tablet' made by Boryung Pharmaceutical Co. and the reference was 'Losec capsule' made by Yuhan Corp. After one capsule or tablet containing 20 mg omeprazole was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was determined with an HPLC method. AUC and $C_{max}$ were determined and analyzed statistically for the evaluation of bioequivalence of the two products. The differences in AUC and $C_max$ between two products were $0.45\%\;and\;2.83\%$, respectively. The powers for AUC and $C_{max}\;were\;89.2\%\;and\;>90\%$, respectively. Confidence intervals were within $20\%$ for AVC and $C_{max}$All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Ulpro tablet' is bioequivalent to 'Losee capsule.'

• Maxillofacial Plastic and Reconstructive Surgery
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• v.30 no.3
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• pp.292-295
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• 2008

Temporomandibular joint cysts usually occur between the second and fourth decade of life. There is a female predominance to male of approximately 3 to 1. The patients complain of swelling, pain and sometimes decreased mouth opening. Synovial cysts of the temporomandibular joint seem to develop by an increase of intraarticular pressure due to trauma or inflammation which causes capsular herniation. However, if inflammatory synovial cysts develop by an increase of synovial fluid into inflammation tissue in the capsule without capsular herniation, a differential diagnosis should include synovial chondromatosis and synovitis. This is a case report of a synovial cyst developed in a capsule of the temporomandibular joint.

• Korean Journal of Head & Neck Oncology
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• v.16 no.1
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• pp.80-82
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• 2000

Lipoma is a benign neoplasm composed of mature fat cells and usually circumscribed by a fibrous capsule. The fat cells are arranged in irregular lobules, partitioned by fibrous septa with supportive vascular channels. Lipoma of the oral cavity is uncommon, and has been reported to be infrequent in the literature in the world so far. An oral lipoma mainly occurs in the cheek and tongue. Surgical excision is the only treatment recommended, and prognosis is uniformly excellent. Recently we experienced two cases of lipoma of the oral cavity and removed the tumor completely by surgical excision.

• Imaging Science in Dentistry
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• v.36 no.1
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• pp.41-48
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• 2006

Purpose : To evaluate the reliability and clinical usefulness of ultrasonography in the temporomandibular joint (TMJ). Materials and Methods : Parasagittal and paracoronal 1.5 T MR images and 7.5 MHz ultrasonographs of 40 TMJs in 20 asymptomatic volunteers were obtained. Disc position using MR imaging was evaluated and the distance between the lateral surface of mandibular condyle and the articular capsule using MR image and ultrasonograph of 27 TMJs with normal disc position was measured and compared. Intraobserver and interobserver measurements reliability was evaluated by using interclass correlation coefficients (ICC) and measurement error. Also, the distance measured on ultrasonographs was compared, according to mouth position and disc postion. Results : The normal disc position was found in 27 of 40 asymptomatic joints. At the intraobserver reliability of measurement, ICC at the closed and open mouth position were 0.89 and 0.91. The measurement error was 0.4% and 0.5%. At the interobserver reliability, ICC at the closed and open mouth position were 0.92 and 0.81. The measurement error was 0.4% and 0.7%. At the TMJ with normal disc position, the distances between the lateral surface of mandibular condyle and the articular capsule measured on MR images and ultrasonographs were $2.0{\pm}0.7mm,\;1.8{\pm}0.5mm$, respectively (p<0.05). On the ultrasonographs, the distances at open mouth position were $1.2{\pm}0.5mm$ (p<0.05). At the TMJ with medially displaced disc, the distances at the closed and open mouth position were $1.3{\pm}0.3\;mm\;and\;0.9{\pm}0.2\;mm$ (p<0.05). Conclusion : The results suggest ultrasonography of TMJ is a reliable imaging technique for assessment of normal disc position.

• The Journal of the Korean dental association
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• v.17 no.9 s.124
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• pp.695-700
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• 1979

An experimental study was performed to study the tissue reactions to tissue conditioners in rabbits. Thirty rabbits were divided into three groups, 10, Hydro-cast group, 10, Coe-comfort group, and 10, heat-cured resin group. Tissue conditioners and heat-cured resin were embedded in the oral mucosa of rabbits. The tissue specimens were removed on 3rd, 7th, 14h, 21st and 28th day after embedding and examined under microscope after staining them with H-E stain, Van Gieson's stain, Masson's trichrome stain and PAS reaction. The results were as follows : 1. Tissue reactions to tissue conditioners were somewhat different from each other in the early stage, but, with the increase of the embedding period, the fibrous capsule was thickened in both. These tissue reactions were similar to those to heat-cured resin. 2. Newly formd fibrous components were stained deep-red with Van Gieson's stain and dark-green with Masson's trichrome stain. But their stainability was decreased as collagenous fibers became matured. 3. Newly formed fibrous components showed intense PAS reactivity, but PAS reactivity was reduced as the connective tissue capsule became completed.

• Journal of Pharmaceutical Investigation
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• v.41 no.4
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• pp.255-262
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• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.38 no.5
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• pp.305-309
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• 2012

Temporomandibular joint (TMJ) subluxation and dislocation are uncommon but very unpleasant and distressing conditions to patients. Subluxation of the TMJ is an excessively abnormal condylar excursion secondary to flaccidity and laxity of the capsule. When the condyle head excurses anterior to the eminence upon wide opening, it can return to the fossa by self-manipulation or non-surgical conservative reduction. Surgery is recommended if a complete dislocation, so-called open lock, occurs as a chronic or recurrent protracted condition that cannot be reduced voluntarily. A range of surgical procedures can be performed to limit condylar hypermobility inclusing soft tissue tethering, creation of articular obstacles, removal of mechanical blockade and augmentation of articular eminence using different kinds of grafts. In the present case, a 74-year-old woman was diagnosed with a chronic TMJ dislocation that had lasted for 6 months. Bilateral condylectomy was performed and the post-operative results were good without functional limitations or recurrence.

• Journal of Pharmaceutical Investigation
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• v.40 no.2
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• pp.109-115
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• 2010

The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

• Journal of Pharmaceutical Investigation
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• v.37 no.2
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• pp.119-126
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• 2007

Tablet splitting is used in pharmacy practice to adjust the dose to be administered. However, it also causes several problems such as undesirable effect for sustained release or enteric-coated dosage form, inaccuracy of dose, and pharmacist's safety by splitting hazardous drugs. This study investigated the current status of oral dosage form splitting for patients older than 19 years by analyzing Korea National Health Insurance Claims Database. Out of oral solid drugs prescribed (N=1,486,584) 9.8% of them included tablets (or capsules) split. There were some splitting cases even in sustained release (4.9%), enteric-coated forms (1.3%) and hazardous drugs (2.7%) that were selected by NIOSH (The National Institute for Occupational Safety and Health). The most frequently split drugs were antihistamines, neuropsychotics and steroids. In case of digoxin and warfarin, unit doses in a domestic market were not diverse compared to foreign markets. Guidelines for splitting oral solid dosage forms, approval of diverse doses and conducting dose-response studies for the commonly splitting ingredients on Korean people are needed for the saff and effective use of oral solid drugs.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.49 no.6
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• pp.354-359
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• 2023

The temporomandibular joint is a unique structure composed of the joint capsule, articular disc, mandibular condyles, glenoid fossa of the temporal bone, surrounding ligaments, and associated muscles. The condyle is one of the major components of a functional temporomandibular joint. Reconstruction of large mandibular defects involving the condyle is a surgical challenge for oral and maxillofacial surgeons. To restore large mandibular defects, there are different options for free flap method such as fibula, scapula, and iliac crest. Currently, the vascularized fibula free flap is the gold standard for reconstruction of complex mandibular defects involving the condyle. In the present report, neocondyle regeneration after mandible reconstruction including the condyle head with fibula free flap was evaluated. In this report, two patients were evaluated periodically, and remodeling of the distal end of the free fibula was observed in both cases after condylectomy or mandibulectomy. With preservation of the articular disc, trapezoidal shaping of the neocondyle, and elastic guidance of occlusion, neocondyle bone regeneration occured without ankylosis. Preservation of the articular disc and maintenance of proper occlusion are critical factors in regeneration of the neocondyle after mandible reconstruction.