• Journal of Pharmaceutical Investigation
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• 제41권4호
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• pp.211-215
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• 2011

The aim of this study was to develop a stable enteric coated diclofenac sodium (DFS) tablets using Aqua-Polish E without using a subcoat. DFS uncoated tablets were manufactured through the non direct compression process. AquaPolish E white aqueous coating dispersion was used as enteric coating material. This film forming polymer is a mixture of selected polymethacrylic/ethylacrylate copolymers. The stability of the obtained enteric coated tablets was evaluated according to ICH guidelines. No signs of disintegration or cracking was observed when they placed in 0.1N HCl solution (pH1.2), but they were completely disintegrated within 10 minutes when they placed in buffered solution at pH6.8. Dissolution test was also conducted by placing tablets in 0.1 N HCl for 2 hours and then 1 hour in phosphate buffer at pH 6.8. Less than 0.9 % of drug was released in the acidic phase and up to 97% in the basic medium. These findings suggest that aqueous enteric coating with AquaPolish E system is an easy and economical approach for preparing stable DFS enteric coat without the use of a subcoating layer.

• Journal of Pharmaceutical Investigation
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• 제41권4호
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• pp.217-225
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• 2011

The aim of this work was to prepare porous osmotic pump tablets for controlled delivery of Aceclofenac. Aceclofenac solid dispersion was prepared to improve the solubility by using the drug - carrier (Mannitol) ratio of 1:1. The osmotic pump tablets were prepared using the solid dispersed product of Aceclofenac. The formulation contains potassium chloride as osmotic agent, cellulose acetate as semipermeable membrane, poly ethylene glycol (PEG 4000) as pore former and sodium lauryl sulphate (SLS) as solubility enhancer. The formulations were designed by the general factors such as osmotic agent and pore former. All formulations were evaluated for various physical parameters and, the in vitro release studies were conducted as per USP. The drug release kinetic studies such as zero order, first order, and Higuchi and Korsmeyer peppas were determined and compared. All the formulations gave more controlled release compared to the marketed tablet studied. Numerical optimization techniques were applied to found out the best formulation by considering the parameter of in vitro drug release kinetics and dissolution profile standards. It was concluded that the porous osmotic pump tablets (F7) composed of Aceclofenac solid dispersion/Potassium chloride/Lactose/Sodium lauryl sulphate/Magnesium Stearate (400/40/95/10/5, mg/tab) and coating composition with Cellulose acetate/ PEG 4000 (60/40 %w/w) is the most satisfactory formulation. The porous osmotic pump tablets provide prolonged, controlled, and gastrointestinal environment-independent drug release.

• Journal of Pharmaceutical Investigation
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• 제39권1호
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• pp.43-49
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• 2009

Aspirin or acetylsalicylic acid, a member of the salicylate family, is frequently used as an analgesic, antipyretic, anti-inflammatory and antiplatelet drug. Because aspirin is chemically unstable in water and heat for tablet formulation, additives including lubricants are used in preparing aspirin tablets, using a dry-granulation process. Aspirin tablets are produced by a number of manufacturers which usually use their own unique combination of additives during the manufacturing process. In this study, we employed an NMR based metabolomics technique to identify the manufacturers of various aspirin tablets. Aspirin tablets from six different companies were analyzed by 1H 400 MHz NMR. The acquired data was then integrated and processed by principal component analysis (PCA). Based on the NMR data, we were able to identify peaks corresponding to acetylsalicylic acid in all of the six samples, whereas different NMR patterns were found in the aromatic and aliphatic regions depending on the unique additive used. These observations led to the conclusion that the differences in the NMR patterns among the different aspirin tablets were due to the presence of additives.

• Asian Pacific Journal of Cancer Prevention
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• 제15권23호
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• pp.10241-10244
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• 2015

Objective: To investigate the efficacy and side effects of Bifidobacterium tetragenous viable bacteria tablets in treating cancer patients with functional constipation during chemotherapy. Methods: A consecutive cohort of 100 cancer patients with functional constipation were divided into two equal groups: patients in the experimental group were given Bifidobacterium tetragenous viable bacteria tablets combined with chemotherapy, while patients in the control group received chemotherapy alone. After 4 weeks, the efficacy and side effects in treating functional constipation were evaluated. Results: Constipation in 48 patients in experimental group was controlled (9 returned to normal), with a total response rate of 96%, and 1 patient reported diarrhea (2%). In contrast only 16 patients in the control group demonstrated improvement and 34 were still constipated after chemotherapy, with a response rate of 32%. The difference in response rate was statistically significant (P<0.05). Conclusion: This study suggested that Bifidobacterium tetragenous viable bacteria tablets are effective and safe in treating cancer patients with functional constipation during chemotherapy.

• Journal of Pharmaceutical Investigation
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• 제39권6호
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• pp.451-456
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• 2009

The purpose of the present study was to evaluate the bioequivalence of two ciprofloxacin tablets, Ciprobay (Bayer Korea Ltd.) and Rofcin (Binex Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The release of ciprofloxacin from the two ciprofloxacin tablets in vitro was tested using KP XIII Apparatus I method with dissolution media (0.01 M HCl). The dissolution profiles of two ciprofloxacin tablets were very similar at dissolution media. Twenty four healthy male volunteers were divided into two groups and a randomized 2$2{\times}2$2 cross-over study was employed. After one tablet (250 mg ciprofloxacin) was orally administrated, blood was taken and the concentrations of ciprofloxacin in serum were determined using HPLC with UV detector. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two ciprofloxacin tablets based on the Ciprobay were -0.63%, 3.98% and -9.23%, respectively. There were no sequence effects between two tablets in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25)(e.g., log(0.9520)~log(1.0523) and log(0.9689)~log(1.1663) for $AUC_1\;and\;C_{max}$, respectively). Thus, Rofcin tablet was bioequivalent to Ciprobay tablet.

• Journal of Pharmaceutical Investigation
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• 제17권3호
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• pp.135-139
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• 1987

This study was attempted to investigate the dissolution rate and the bioavailability of commercially available sulfamethoxazole and trimethoprim (SMX-TM) tablets in rabbits. The dissolution test was conducted in artificial gastric juice by basket method with eight SMX-TM tablets which were chemically equivalent. According to the dissolution rate, SMX-TM tablets were divided into four groups, such as rapid, intermediate, slow and very slow groups for the bioavailability test in rabbits. The results were as follows: 1) The dissolution rate of brand A was most rapid but brand H was most slow in artificial gastric juice. 2) Area under the blood concentration curve was larger in the order of brand A > C > E > H in rabbits. 3) There was a little difference in pharmacokinetic parameters such as biological half life, absorption rate constant and $t_{max}$. 4) The relationship between the dissolution rate and relative bioavailability was significant in brand A, C, E and H. From the results of this experiment, the bioavailability of SMX-TM tablets in rabbits may be predicted from the results of dissolution rate studies.

• Journal of Pharmaceutical Investigation
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• 제19권3호
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• pp.131-136
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• 1989

This study was attempted to investigate the dissolution rate and the bioavailability after oral administration of commercially available aspirin tablets in normal volunteers. The dissolution test was conducted in artificial gastric juice using basket method with three aspirin preparations (A, B and C) which were chemically equivalent. The results were as follows; The dissolution rate was higher in the order of three different brand B>A >C. Area under the blood concentration and peak blood concentration were larger in the order of brand A>B>C. Absorption rate constant and peak time were larger in the order of brand B>A>C, and there was a little difference in elimination rate constant and biological half-life. The correlation of the dissolution rate and absorption rate constant, as well as correlation of the dissolution rate and peak time showed significant linear relationship respectively. From the results of this experiment, it can be concluded that the bioavailability of aspirin tablets showed much difference according to commercial preparations, and that the bioavailability of aspirin tablets in human may be predicted from the results of dissolution rate studies.

• Journal of Pharmaceutical Investigation
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• 제9권1호
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• pp.20-27
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• 1979

Furazolidone tablets were made of lactose and corn'starch as adjuvants by compression method. Six formulations were used with variation of lactose and starch contents. Dissolution, disintegration, content unifomity, hardness, and weight variation were examined for furazolidone tablets. Furazolidone tablets showed good results by the ratio of 4 : 1 or 3: 2 (lactose:starch), and the pressure of $2500kg/cm^2$.

• 대한약학회:학술대회논문집
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• 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-2
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• pp.246.1-246.1
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• 2003

Bioequivalence of two enalapril maleate tablets, formulation A and B, was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 2001). Twenty healthy male volunteers (19∼27 years old) were randomly divided into two groups and a randomized 2x2 cross-over study was performed. Following oral administration of enalapril maleate tablets (20 mg dose), blood sample was taken at pre-determined time intervals and the concentrations of enalapril in plasma were determined using LC-MS. (omitted)

• Journal of Pharmaceutical Investigation
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• 제14권3호
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• pp.122-130
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• 1984

The dissolution profiles of the seven branded prednisolone tablets were determined by means of available compendium. Those tablets were stored at $40^{\circ}C,\;50^{\circ}C\;and\;60^{\circ}C$ for 15, 30 and 60 days respectively. Under the stress conditions, the dissolution efficiency showed significant changes. It is considered that the determination of shelf life of drug from these aging effects is possible because the dissolution data followed a logarithmic distribution. There were no substantial differences of dissolution between two prednisolone formulations with different particle size not larger than $100\;{\mu}m$. The effect of two starches (corn and potato) on the rate of dissolution of prednisolone from dosage form was also investigated. All marketed tablets met the requirement of the established compendium.