• Proceedings of the PSK Conference
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• 2003.10b
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• pp.228.1-228.1
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• 2003

Purpose. The purpose of this study is to compare in vitro dissolution characteristics and bioavailability in beagle dog of a hard gelatine capsule containing erdosteine (Yuhan Erdosteine capsule$\^$TM/) with those of commercial product (Erdos capsule$\^$TM/). Methods. Yuhan Erdosteine capsule$\^$TM/ was prepared using erdosteine 300 mg, lactose, magnesium stearate, and others by powder filling method. The dissolution characteristics of Yuhan Erdosteine capsule$\^$TM/ and Erdos capsule$\^$TM/ were determined by USP dissolution apparatus 2. (omitted)

• Tuberculosis and Respiratory Diseases
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• v.44 no.6
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• pp.1296-1307
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• 1997

Background : Erdosteine is a thiol derivative developed for the treatement of chronic obstructive bronchitis, including acute infective exacerbation of chronic bronchitis. Erdosteine has mucomodulating and antioxidant properties and especially exhibits excellent gastrointestinal tolerability. Methods : The study was conducted as a prospective evaluation, with 2 comparative groups orally treated with erdosteine 300mg (bid.) or ambroxol 30mg (b.i.d.) for 7 days and the design of trial was double-blind. The treatments have been assigned randomly to patients (n=80) with acute or chronic bronchitis. The primary end-point used to determine efficacy in this study was subjective symptoms including expectorating frequence, expectoration volume, expectorating difficulty, expectoration viscosity, cough intensity and dyspnea. The secondary end-points of efficacy was the result of arterial blood gas analysis and pulmonary function test. Safety was evaluated with adverse drug reactions and laboratory tests monitoring. 61 patients was included in the efficacy analysis, due to the fact that 19 patients drop-out for different reasons. The obtained values have been analyzed with paired Hest., ANOVA test., multivariate $t^2$-test, repeated measures analysis of covariance, two sample t-test, loglinear-logit model analysis, Fisher's exact test. Results : 1) There was no significant difference on demographic data and vital signs between erdosteine and ambroxol treated groups. 2) The comparison between erdosteine and ambroxol treated groups showed no significant difference in improvement of each symptom in spite of the more favorable efficacy obtained with erdosteine. No difference on the contrary was observed for arterial blood gas analysis and pulmonary function test. 3) As safety is concerned, no clinical significant changes in laboratory test and symptom were induced in erdosteine and ambroxol treated group and two patients in ambroxol treated group drop-out for adverse reactions in symptom. 4) In the evaluation of final clinical efficacy, erdosteine improved more effectively patient's overall symptoms {very good effect (11/31), good effect (12/31), moderate effect (6/31), no effect (2/31), aggravation (0/31)} than ambroxol {very good effect (6/30), good effect (14/30), moderate effect (5/30), no effect (4/30), aggravation (2/30)}. And the probability of symptomatic improvement by erdosteine compared to ambroxol was 2.5 times. (p<0.05). Conclusion : This study showed that erdosteine was clinically effective and safe drug for treatment of acute and chronic bronchitis.

• Journal of Pharmaceutical Investigation
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• v.33 no.3
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• pp.237-243
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• 2003

Erdosteine, the thiol derivatives chemically related to cysteine, is a mucolytic and mucoregulator agent which modulates mucus production and viscosity and increases mucociliary transport. The purpose of the present study was to evaluate the bioequivalence of two erdosteine capsules, Erdos (Dae Woong Pharmaceutical Co., Korea) and Erblon (Kuhn Il Pharmaceutical Co., Korea), according to the guidelines of Korea Food and Drug Administration (KFDA). The erdosteine release from the two erdosteine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33{\pm}2.06$ years in age and $66.18{\pm}8.19\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 300 mg as erdosteine were orally administered, blood was taken at predetermined time intervals and the concentations of erdosteine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, 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 $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Erdos were 0.20%, 1.10% and -9.44% 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) $(e.g.,\;log(0.94){\sim}log(1.22)\;and\;log(0.92){\sim}log(1.20)\;for\;AUC_t\;and\;C_{max},\;respectively$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Erblon capsule and Erdos capsule are bioequivalent.

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.242.2-242.1
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• 2003

The purpose of the present study was to evaluate the bioequivalence of two Erdosteine capsules, $Erdos^{TM}$(Dae Woong Pharmaceutical Co., Ltd.) and $Ersteine^{TM}$(Dae Won Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers,23.88 ${\pm}$2.89 year in age and 68.50 ${\pm}$ 7.71 kg in body weight, were divided into two groups and radkomied 2${\times}$2 cross-over study was empolyed. Ater three capsules containing 300 mg of erdosteine per capsule were orally administered, blood was taken at predetermined time intervals and concentrations of erdostene I in plasma were determined using HPLC. (omitted)

• Proceedings of the PSK Conference
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• 2003.10b
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• pp.230.2-230.2
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• 2003

Erdosteine, an expectorant, has been known to show a very poor flowability. Furthermore, high dosing amount (300mg/cap) and bulk density make it more difficult to fill in a capsule less than No. 0 size as bulk state. We have studied the possibility of dry granulation process in purpose of getting a better flowability and manufacturing efficiency. A roller compactor was introduced for this purpose and the applicability of laboratory result into commercial scale instrument was also experimented.Roller compacting process was very favorable to obtain the granules with good flowability and improved density profiles. (omitted)

• Proceedings of the Korean Society of Veterinary Clinics Conference
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• 2007.10a
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• pp.564-564
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• 2007