• Journal of Korean Traditional Oncology
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• v.28 no.1
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• pp.33-44
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• 2023

목적: 항암유발말초신경병증은 암 환자가 겪는 흔한 항암 부작용이나 현재까지 효과적으로 알려진 치료법은 없다. 본 연구의 목적은 항암유발말초신경병증에 대한 침 치료와 가바펜틴의 병용 요법의 효과와 안전성을 평가하는 것이다. 방법: 항암유발말초신경병증을 겪고 있는 24명의 암 환자를 침 치료 단독군 (AG, acupuncture group)과 침과 가바펜틴의 병용요법군 (CG, combined acupuncture and gabapentin group)으로 무작위 배정하였다. 두 그룹 모두 침 치료는 주 3회, 4주간 수행하였다. 병용 요법군은 침 치료와 더불어 1일 900mg의 가바펜틴을 복용하도록 하였다. 치료 효과는 Neuropathic Pain Symptom Inventory (NPSI), visual analogue scale (VAS), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 items (EORTC-CIPN20)를 이용하여 측정하였다. 치료로 인한 부작용은 대상자가 방문할 때마다 조사하였다. 결과: 총 23명의 대상자(AG, n=12; CG, n=11)의 평가지표를 분석한 결과, 치료 4 주 후 침 치료 단독군은 NPSI 점수가 44.33±25.04에서 30.58±21.55으로 감소하였고, 병용 요법군은 30.55±25.59에서 18.64±19.42로 감소하였으며, 두 군 모두 통계적으로 유의미하게 감소하였다(p<0.001). VAS점수는 침 치료 단독군에서는 4.79±2.17 에서 3.42±2.49으로 감소하였고, 병용 요법군에서는 3.55±2.07에서 2.73±2.49 로 감소하였다(p<0.05). 치료 효과는 치료 완료 2주후까지 지속되었으며, 두 군간의 유의미한 차이는 없었다. EORTC-CIPN20은 침 치료 단독군은 30.27±18.87에서 20.84±16.35으로 감소하여(p<0.01), 두 군 모두에서 삶의 질이 향상되었다. 결론: 본 연구로 침 치료와 가바펜틴의 병용 요법이 항암유발말초신경병증 환자의 증상 및 삶의 질 개선에 효과적이며 안전한 치료법임을 확인하였다. 그러나 침 치료와 가바펜틴의 시너지 효과에 대해서는 확인 할 수 없었으며, 이를 확인하기 위해 추가적인 연구가 필요할 것으로 사료된다.

• Journal of Oral Medicine and Pain
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• v.36 no.3
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• pp.199-205
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• 2011

During root canal treatment, overinstrumentation with hand or mechanically driven files can perforate the mandibular canal, allowing the extrusion of endodontic sealers, dressing agents, and irrigant solutions out of the tooth and into the canal. The patient may report symptoms such as pain, hyperesthesia, hypoesthesia, anesthesia, dysesthesia and paresthesia. Such problems must be resolved as quickly as possible to avoid irreversible sequelae caused by certain neurotoxic materials that form part of endodontic sealants. Although there have been no controlled trials of treatment protocols involving endodontically related injuries to the inferior alveolar nerve, the normal therapeutic sequence for this complication is the control of pain and inflammation and, whenever possible, the surgical elimination of the cause. However, total resolution of pain and reduction in or disappearance of paraesthesia after a non-surgical management have been reported. Antiepileptic drugs such as gabapentin or pregabalin have been used for the treatment of neuropathic pain. This article describes a case of inferior alveolar nerve(IAN) damage after endodontic treatment of a mandibular right second molar and the treatment with non-surgical approach using prednisone and gabapentin medication, monitoring the patient's condition with clinical neurosensory examination and current perception threshold test(Neurometer).

• Journal of Pharmaceutical Investigation
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• v.39 no.4
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• pp.269-273
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• 2009

The objective of this investigation was to develop a gastro-retentive(GR) dosage form of gabapentin and was to evaluate of its dissolution characteristics. GR tablet consists of expandable core tablet matrix and semi-permeable membrane coating. Poloxamer 407 and sodium bicarbonate were used to prepare the core matrix. Polyvinly acetate dispersion (Kollicoat $SR30D^{(R)}$) and polyvinyl alcohol-polyethylene glycol copolymer ((Kollicoat $IR^{(R)}$)) were employed to form the semi-permeable membrane. The GR tablets significantly expanded up to fivefold in simulated gastrointestinal fluids with no apparent damage of the coating membrane over 12 hours. Also, the swelling rate was controllable with the amount of sodium bicarbonate. The drug release was observed to be substantially sustained based on coating level. The release rate of gabapentin from the GR tablet was gradually slowed down as the coasting amount was increased. The gabapentin GR tablet with 8% coating level showed a pseudo-zero order release kinetics over 12 hours. These results suggest that this swellable GR tablet system having semi-permeable membrane coating can be applicable for hydrophilic drug substances like gabapentin.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.63-68
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• 2006

Gabapentin, 1-(aminomethyl-1-cyclohexyl)acetic acid, is anew antiepileptic drug related to ${\gamma}-aminobutyric$ acid(GABA) currently being introduced in therapy worldwide. The bioavailability and pharmacokinetics of gabapentin capsules were examined in 22 volunteers who received a single oral dose in the fasting state by randomized balanced $2{\times}2$ crossover design. After dosing, blood samples were collected for a period of 24 hours and analyzed by liquid chromatography-tandem mass spectrometry (LC/MS/MS). Time course of plasma gabapentin concentration was analyzed with non-compartmental and compartmental approaches. $WinNonlin^{(R)}$, the kinetic computer program, was used for compartmental analysis. One compartment model with first-order input, first-order output with no lag time and weighting by $1/(predieted\;y)^2$ was chosen as the most appropriate pharmacokinetic model for the volunteers. The major pharmacokinetic parameters $(AUC_{0-24hr},\;AUC_{inf},\;C_{max}\;and\;T_{max})$ and other parameters $(K_a,\;K_{el},\;V_d/F\;and\;Cl/F)$ of $Gapentin^{TM}$ (test drug) and $Neurontin^{TM}$ (reference drug) were estimated by non-compartmental analysis and compartmental analysis. The 90% confidence intervals of mean difference of logarithmic transformed $AUC_{0-24hr}\;and\;C_{max}$ were $log(0.9106){\sim}log(1.l254)\;and\;log(0.8521){\sim}log(1.0505)$, respectively. It shows that the bioavailability of the test drug is equivalent with that of the reference drug. There was no statistically significant difference between the two drugs in all pharmacokinetic parameters.

• Journal of Pharmaceutical Investigation
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• v.38 no.4
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• pp.261-267
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• 2008

The aim of the present study was to evaluate the bioequivalence of two gabapentin preparations. We used Neurontin tablet 800 mg (Pfizer Korea Inc.) as a reference drug for bioequivalence of Gabalep tablet 800 mg (Chong Kun Dang Pharmaceutical Co., Korea), and performed this whole study according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty five healthy male volunteers were administered with each drug in a randomized $2{\times}2$ cross-over study with one week washout interval. After drug administration, blood was taken at predetermined time intervals ($0{\sim}24$ hours) and the concentrations of gabapentin in serum were determined using an high performance liquid chromatography-tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction mornitoring (MRM). The analytical method was validated in specificity, accuracy, precision and linearity. The phar-macokinetic parameters such as AUCt and Cmax were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUCt and Cmax. $Mean{\pm}SD$. of AUCt and Cmax value for reference drug and test drug were $29.94{\pm}9.23\;({\mu}g/mL{\cdot}hr)$ and $3.12{\pm}1.11\;({\mu}g/mL{\cdot}hr)$, and $31.48{\pm}9.77\;({\mu}g/mL{\cdot}hr)$ and $3.15{\pm}1.03\;({\mu}g/mL)$, respectively. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) for AUCt and Cmax, respectively. These results indicate that Gabalep tablet 800 mg is bioequivalent to Neurontin tablet 800 mg.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.193-199
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• 2005

Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

• YAKHAK HOEJI
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• v.52 no.4
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• pp.299-305
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• 2008

Gabapentin, 1-(aminomethyl) cyclohexaneacetic acid, is a amino acid derivative, and is clinically effective in the treatment of neuropathic pain and partial seizures of epilepsy as a complementary therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin tablets, $Neurontin^{R}$ tablet 800 mg (Pfizer Pharmaceuticals Co., Ltd.) and Gabapenin tablet 800 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with 0.06 M HCI dissolution media. Twenty six healthy male subjects, $23.85{\pm}2.24$ years in age and $69.40{\pm}11.11$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 800 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution media. The pharmacokinetic parameters such as $AUC_{t}$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_{t}$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{R}$, were 1.28%, 0.63% and 0.62% for $AUC_{t}$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.9097{\sim}log1.1598$ and $log0.8919{\sim}log1.1262$ for $AUC_{t}$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabapenin tablet 800 mg was bioequivalent to $Neurontin^{R}$ tablet 800 mg.

• Journal of Oral Medicine and Pain
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• v.34 no.4
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• pp.429-433
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• 2009

Burning mouth syndrome (BMS) is defined as burning pain in the tongue or other oral mucous membrane associated with normal sign and laboratory findings at least 4 to 6 months. There are many factors that affect this condition and the pain characters are various among the sufferers, so it is difficult to diagnose exactly and treat properly. The cause of BMS is currently unknown. The etiology is presumed to be that it is related with local, systemic and psychogenic factor. The BMS is related with local factor such as allergic reaction, oral fungal infection(candidiasis), parafunctional oral habits and systemic factors such as diabetes mellitus, hypothyroidism, nutritional deficiencies(vitamin $B_{12}$, folic acid), hyposalivation and psychogenic factor such as depression, anxiety, cancerphobia. So clinicians must be aware of these factors and can give proper treatment options to patients. The management of BMS are pharmacologic management, cognitive behavioral therapy and psychotherapy treatment. Clonazepam, gabapentin, amitriptyline, alpha-lipoic acid and capsaicin are used to manage the BMS. Among these, topical clonazepam is reported that the effect is higher than systemic medication and the complications are rare. This case report is about some cases of the effect of topical clonazepam on BMS.

• YAKHAK HOEJI
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• v.52 no.3
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• pp.195-200
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• 2008

Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.