• Journal of Pharmaceutical Investigation
• /
• v.36 no.6
• /
• pp.405-411
• /
• 2006

Epinastine is an antiallergic drug effective for bronchial asthma, allergic rhinitis, urticaria and dermatitis. Epinastine is topically active, direct H1-receptor antagonist and an inhibitor of the release of histamine from the mast cell. The purpose of the present study was to evaluate the bioequivalence of two epinastine hydrochloride tablets, Alesion Tablet (Boehringer Ingelheim Korea Ltd.) and S-napine tablet 10 mg(Sam Chun Dang Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration(KFDA). The release of epinastine from the two epinastine 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, $23.35{\pm}1.57$ years in age and $66.29{\pm}10.61kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 20 mg as epinastine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of epinastine in serum were determined using HPLC with UV 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, Alesion tablet, were 1.50, 1.46 and -13.48% 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 0.95$\sim$log 1.12 and log 0.93$\sim$log 1.10 for $AUC_t\;and\;C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating S-napine tablet 10 mg was bioequivalent to Alesion tablet.

• YAKHAK HOEJI
• /
• v.52 no.3
• /
• pp.188-194
• /
• 2008

Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic 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, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% 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 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

• Pediatric Gastroenterology, Hepatology & Nutrition
• /
• v.4 no.1
• /
• pp.47-53
• /
• 2001

Purpose: Following up the cases of cow's milk-sensitive enteropathy (CMSE), We observed the development of clinical tolerance with cow's milk and other foods. We investigated the clinical outcome of CMSE. Methods: We reviewed the clinical records of patients who had been admitted and diagnosed as CMSE by responses to cow's milk challenge and elimination test and the findings of small intestinal biopsy at Department of Pediatrics, Taegu Catholic University Hospital from March 1992 to March 1997. All of them were being fed with protein hydrolysate before 6 months old, and tried cow's milk and other foods challenge test at following each two month. Twenty-one cases of them returned to be followed. The age at admission was $30.7{\pm}8.8$ (18~47) days old and at survey was $43.4{\pm}23.7$ (16~84) months old. Results: 1) Although the body weight at birth of the patients was 25~75 percentile, all on admission was below 3 percentile. The body weight on interview was 25~75 percentile. 2) The development of clinical tolerance in cow's milk was observed at 16~24 months of age and the tolerance rate was 61% at 12 months of age, 90% at 16 months of age. The development of clinical tolerance in other foods was observed at 10~24 months of age and the tolerance rate was 33% at 12 months of age, 80% at 18 months of age. 3) Adverse reactions after challenge test with cow's milk were observed at 19 cases, manifestated as vomiting (31%), diarrhea (31%), irritability or lethargy (21%), skin rash (10%), and abdominal distention (5%). 4) Comparing serum IgE and milk RAST positive group on admission (5 cases) and negative group on admission (16 cases), there was no significant difference at the age of tolerance in cow's milk (p>0.05), the age of tolerance in other foods (p>0.05), allergy history in family, and the incidence of other allergic diseases. 5) The history of family allergy was observed in 3 cases (14%) in 21 patients and 3 cases (14%) showed rhinitis, urticaria or asthma through a follow-up interview. Conclusion: The development of clinical tolerance in cow's and other foods was sharply increased at 12 months of age and most of all tolerated within 24 months of age. CMSE is a temporary disorder of infancy.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.33 no.4
• /
• pp.16-31
• /
• 2020

Objectives : This study is designed to analyze outpatients who received medical treatment for skin diseases in ophthalmology & otolaryngology & dermatology clinic of Korean Medical Hospital from March 1st, 2016 to February 28th, 2019. To discover the tendencies of dermatology outpatients and provide the base data for future researches in dermatology patients' characteristics, korean medical treatments on dermatology field, more statistical analysis and establishment of korean medical health care policy. Methods : We classified dermatology outpatients who received treatments in ophthalmology & otolaryngology & dermatology clinic of Korean Medical Hospital from March 1st, 2016 to February 28th, 2019 according to gender, year, age, seasonal, main diagnosis, visit days. The statistical analysis was performed using IBM SPSS 23.0 Results : The results of the analysis on 651 dermatology patients treated in ophthalmology & otolaryngology & dermatology clinic of Dunsan Korean Medical Hospital for the past 3 years are as follows. 1. The number of outpatients who visited ophthalmology & otolaryngology & dermatology clinic of Dunsan Korean Medical Hospital for skin diseases were 651; 286 male(43.9%) and 365 female(56.1%). The number of female patients were approximately 1.27 times higher. 2. The average age of the dermatology outpatients were 37.6. The most frequent visitors turned out to be 20s, and the number of 20s, 30s patients were 267, consisting 41.0% of the whole patients. 3. By examining the change on yearly basis, we noticed that the number of outpatients treated with skin diseases steadily increased with the years. 1) In the analysis of the number of patients classified by gender and year, the number of male and female patients both increased with the years. 2) In the analysis of the number of patients classified by age and year, there were statistically significant difference between two groups. 3) In the analysis of the number of patients classified by season and year, there were statistically significant difference between two groups. 4) In the analysis of the number of patients classified by main diagnosis and year, there were statistically significant difference between two groups. 4. In the analysis of the number of outpatients by seasonal basis, the number of the outpatients visited in summer was the largest by 185(28.4%), followed by winter 181(27.8%), spring 148(22.7%), and the autumn 137(21.0%). 1) In the analysis of the number of patients classified by age and season, there were no statistically significant difference. 2) In the analysis of the number of patients classified by age and season, there were no statistically significant difference. 5. By classifying the outpatients according to main diagnosis, it turned out that there were 40 diagnosis, with eczema the largest followed by urticaria, allergic contact dermatitis, seborrheic dermatitis, and folliculitis. 6. The average number of visit days of dermatology outpatients were 10.24 days, and the number declined steadily with the years. 1) In the analysis of the number of patients classified by gender and visit days, there were no statistically significant difference. 2) In the analysis of the number of patients classified by age and visit days, the visit days of 70s were the shortest and the patients below 20s were longer than the other age groups. Conclusions : By analyzing the outpatients who received medical treatment for skin diseases in ophthalmology & otolaryngology & dermatology clinic of Korean Medical Hospital from March 1st, 2016 to February 28th, 2019 according to gender, year, age, seasonal, main diagnosis, visit days, We drew various meaningful results. The outpatients with skin diseases increased steadily by the years, and patients visited in winter especially shown the outstanding increase. And though the number of female patients were larger than male, the increase was bigger in male patients. We hope that this results would provide useful resources for future researches in dermatology patients'characteristics, korean medical treatment and establishment of korean medical health care policy.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
• /
• v.18 no.3
• /
• pp.84-94
• /
• 2005

Objective: In order to help clinical approach on OME patient in progress observation and decision on improvement by clinical research results using tympanometry. Methods: Data was collected from 163 ears of 96 patients who were treated in Dept. of Oriental Medical Ophthalmology & Otolaryngology & Dermatology, Kyung-Hee Medical Center from 2001-2-12 to 2005-4-29 for Otitis Media with Effusion(OME). Tympanometry was applied to all patients and the test result was used to evaluate progress and improvement. F/U cases below 3 times were excluded. Results & conclusion: 1. Age and sex distribution was as follows: Mean Age 5.5years old(Standard deviation: 2.1), age distribution 2-61years old, below 10years old 151cases(92.6%) and above 10years old 12cases(7.4%). Male and female ratio was 1.81:1. 2. There were 67people(69.8%) with bilateral affected ear. Unilateral was 29people(30.2%). Affected ear distribution according to sex came out similarly. 3. Affected period distribution was as follows: over 12weeks 71cases(43.6%), under 12weeks 92cases(56.4%). Out of under 12weeks cases, 2-4weeks was 34cases(20.9%), 0-1weeks and 5-8weeks 20cases(12.3%), 9-12weeks 18cases(11.0%). There was evident difference about affected period between male and female. 4. All patients who served previous Tx in medical clinic(118 cases) took antibiotics. Only 6cases took tube insertion. The period of Taking antibiotics was as fellows: over 6weeks 42cases(35.6%), under 5weeks 37cases(31.4%). unknown 25cases(21.2%), jntermittent 14cases(11.9%). 5. In Period of Tx distribution, 5-6weeks showed 40cases(24.5%) which was highest number. In Improved cases(85cases), 3-4weeks and 5-6weeks each 22cases(25.9%) which was highest number. 1-2weeks 3cases(3.5%), 7-8weeks 12cases(14.1%), 9-10weeks 9cases(10.6%), 11-12weeks 10cases(11.8%), over 12weeks 7cases(8.2%). 6. The cases which have gastrointestinal Sx were 71cases(43.6%), the others 92cases(56.4%). Details of gastrointestinal Sx were as follows: Sx associated with appetite 47cases(47.5%), constipation 15cases(15.2%), abdominal pain and diarrhea 14cases(14.1%), frequent vomitting Teases(7.1%), etc 4cases(4.0%). 7. The cases which have accompanying disease were 116case(71.2%), the other 47cases(28.8%). Details a accompanying disease were as follows: sinusitis 57cases(35%), rhinitis 55cases(3.7%), allergic rhinitis 20cases(12.3%), atopic dermatitis 19cases(1.7%), urticaria 4cases(2.5%), asthma 3cases(1.8%), nasal polyp and conjunctivitis 2cases(1.2%) each, laryngitis 1case(0.6%).