• Korean Journal of Clinical Pharmacy
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• v.9 no.1
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• pp.44-48
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• 1999

The bioequivalence of two aceclofenac tablets was evaluated in 14 normal volunteers (age $21\sim29$ yrs) following oral administration. The test product was 'Apental tablet' made by Asia Pharmaceutical Co. and the reference was 'Airtal tablet' made by Daewoong Pharmaceutical Co. After one tablet containing 100 mg aceclofenac was administered, blood was taken at predetermined time intervals and the concentration of the drug in plasma was quantitated with an HPLC method. AUC, $C_{max}\;and\;T_{max}$ were calculated and statistically analyzed for the bioequivalence of the two products. The results showed that the differences in AUC, $C_{max}\;and\;T_{max}$ between two products were $4.23\%,\;2.15\%\;and\;0\%$, respectively. The powers for AUC,$\;C_{max}\;and\;T_{max}\;were\;>90\%,\;>90\%\;and\;85.8\%$, respectively. Confidence intervals were within $\pm20\%$ for three parameters. All of these parameters met the criteria of KFDA for bioequivalence, indicating that 'Apental tablet' is bioequivalent to "Airtal tablet".(Kor. J. Clin. Pharm. 1999; 9(1): 44-48)

• Journal of Pharmaceutical Investigation
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• v.28 no.4
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• pp.289-294
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• 1998

Bioequivalence of two aceclofenac tablets, the $Airtal^{TM}$ (Daewoong Pharmaceutical Co., Ltd.) and the $Senital^{TM}$ (Hana Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{\sim}29$ years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 100 mg of aceclofenac was orally administered, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters ($C_{max}$, $T_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max}$, $T_{max}$ and $AUC_t$ between two tablets were 3.69%, 2.44% and 0.51%, respectively. The powers $(1-{\beta})$ for $C_{max}$, $T_{max}$ and $AUC_t$ were 87.85%, 98.70% and more than 99%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Senital^{TM}$ tablet is bioequivalent to $Airtal^{TM}$ tablet.

• Polymer(Korea)
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• v.39 no.1
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• pp.6-12
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• 2015

In order to improve the poor water solubility of aceclofenac, it was loaded into solid Kollidon VA 64 dispersion prepared by spray drying and rotary evaporation methods using different drug and polymer ratios. Morphology and physicochemical behavior of the aceclofenac loaded solid dispersions was analyzed by scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR), X-ray diffractometry (XRD), and differential scanning calorimetry (DSC). Encapsulation efficiency and dissolution behavior in a simulated intestinal juice of aceclofenac in the solid dispersions was measured using HPLC and the latter was compared with that of the active pharmaceutical ingredient (API) and Airtal$^{(R)}$. It was demonstrated that two methods could significantly improve the dissolution behavior of aceclofenac.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.50-53
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• 2003

Aceclofenac (AFC) as a model has poor solubility in water, resulting in lower dissolution rate and bioavailability. A solid dispersion (SD) is one of effective methods to enhance the solubility or dissolution rate of various poorly water-soluble drugs. Polyvinylpyrrolidone (PVP) that is a nontoxic, water-soluble and generally applicable pharmaceutical excipient has been widely used as a carrier in the preparation of solid dispersions. (omitted)

• Journal of Pharmaceutical Investigation
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• v.34 no.1
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• pp.49-55
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• 2004

To develop a aceclofenac soft capsule, four preparations with various solubilizers were prepared and their dissolution test was carried out. Among four preparations tested, a preparation with ethanolamine was selected as a formula of aceclofenac soft capsule (Clanza $S^{TM}$), since it showed the fastεst dissolution rate. Bioequivalence of aceclofenac tablet, $Airtal^{TM}$ (Dae-Woong Pharmaceutical Co., Ltd.) and aceclofenac soft capsule, Clanza $S^{TM}$ (Korea United Pharmaceutical Co., Ltd.) was evaluated according to the guideline of KA Fourteen normal male volunteers (age 20 - 25 years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After oral administration of one tablet or capsule containing 100 mg of aceclofenac, blood was taken at predetermined time intervals and the concentration of aceclofenac in plasma was determined with an HPLC method under UV detector The pharmacokinetic parameters ($C_{max}$ and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters using logarithmetically transformed $AUC_t$, $C_{max}$ and $T_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between Aral tablet and Clanza soft capsule were 2.89%, 0.18% and 43.0%, 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(15) (e.g. log(0.81) -log(1.23) ad log(0.89) -log(1.4)) fo $AUC_t$ and $C_{max}$, respectively. Thus, the criteria of the KFDA guidelines for the equivalence was satisfied, indicating that Clanza $S^{TM}$ soft capsule is bioequivalent to$Airtal^{TM}$ tablet.

• YAKHAK HOEJI
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• v.44 no.4
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• pp.308-314
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• 2000

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).

• Proceedings of the PSK Conference
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• 2000.10a
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• pp.261.1-261.1
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• 2000

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.310.2-310.2
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• 2001

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.412.2-413
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• 2002

Purpose. To prepare polymer based physical mixtures or solid dispersions containing solubilizing compositions using a spray-dryer. Methods. Lovastatin.simvastatin.aceclofenac and cisapride were selected as poorly water-soluble drugs. Dextrin. poly(vinylalcohol). poly(vinylpyrrolidone)and polyethylene glycol were chosen as solubilizing carriers for solid dispersions. The solid dispersions containing solubilizing compositions without drug were prepared without using organic solvents or tedious changes of formulation compositions. (omitted)

• Proceedings of the PSK Conference
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• 2001.10a
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• pp.304.2-305
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• 2001