Ethylene ($C_2H_4$) is a naturally occurring hormone in some fruit. This study was carried out to manufacture ethylene-producing tablets. The Ethylene-producing tablets were manufactured from ethephon and excipient mixtures, including Prosolv, Hydroxypropylmethylcellulose (HPMC) and Crosscamellose. Ethylene production increased with the increases in temperature. In the aspect of pH condition, ethylene productions at pH 7.0 and pH 9.0 were less than 2 ppm. On the other hand, at pH 13.0, ethylene production from the Prosolv, HPMC, and Crosscamellose tablets was 94.05, 126.28, and 100.11 ppm, respectively. The friability of the Prosolv and HPMC tablets were 0.1 and 0.3%, respectively, while the Crosscamellose tablet was 54.1%. indicating that the Crosscarmellose tablet was not appropriate as an ethylene production tablet. In addition, there were huge variations in disintegration times; the Prosolv, Crosscamelose, and HPMC tablets took 1, 5 min, and 7 min more than respectively. Ethylene production was gradually increased up to 20 hr for the Prosolv tablet and then remained stable.
Journal of the Korean Recycled Construction Resources Institute
/
v.2
no.1
/
pp.40-45
/
2014
Although the accelerators are used at the early stage to control setting-time and strength of concrete when cold-weather concrete is utilized, no security of workability occurs because the early hydration makes them react rapidly. Therefore, the tablet used in previous study is applied in this study. In particular, because a small amount of fly-ash being replaced in cold weather concrete of domestic, fly-ash concrete incorporating the tablet is discussed in workability by elapsed time, early strength to ensure the development of adequate strength, and freezing-thawing resistance. As a result, both 0.5 and 1.0% tablets were found to be superior. Thus, it was verified in cold weather concrete incorporating fly-ash that workability can be secured, as well as the development of early strength to prevent early frost.
Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride $Tablet^{\circledR}$ made by Hanmi Pharm. Co. and the reference product was Allegra $Tablet^{\circledR}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2\;{\time}\;2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were $log\;0.822{\sim}log \;1.142$ and $log\;0.848{\sim}log\;1.172$, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.
A novel polymeric tablet of tinidazole (TD) was formulated to treat Helicobacter pylori and Giardia lambria more efficiently with reduced hepatotoxicity by controlling the release of TD after oral administration. TD tablets containing various concentrations of either xanthan gum (XG, viscosity enhancer) and/or polycarbophil (PC, mucoadhesive) were prepared by the wet granulation method. In vitro release of TD into pH 2.0 and pH 5.0 buffer solutions was observed at 37°C by using an USP dissolution tester and an UV (313 nm) spectrophotometer. In vivo absorption of TD tablets was investigated in rabbits by measuring the blood concentration of TD after oral administration using a HPLC. Compared to a commercial TD tablet, in vitro release of TD in both pH 2.0 and pH 5.0 buffer solutions significantly decreased as the concentration: of XG or PC in the tablet increased up to 30%. However, when XG and PC was added in combination, TD was completely released in a pH 5.0 buffer solution within 8 hours, whereas the release of TD in pH 2.0 buffer solution significantly decreased. TD in a commercial tablet was rapidly absorbed after oral administration in rabbits. After oral administration of the polymeric tablets that contain both XG and PC, plasma concentration of TD dramatically decreased. Since the oral absorption of TD significantly decreased by the addition of XG and PC in the tablets while TD completely released in a pH 5.0 buffer solution, it was speculated that more TD was retained in the gastrointestinal tract. Thus, it was possible to control the release of TD by changing the content of XG and/or PC in the tablet, thereby manipulating the release rate and the gastrointestinal retention of TD after oral administration in rabbits.
This study set out to improve the physical and pharmaceutical characteristics of the present formulation using an appropriate experimental design. The work described here concerns the formulation of the dispersible tablet applying direct compression method containing roxithromycin in the form of coated granules. In this study $2^3$ factorial design was used as screening test model and Central Composite Design (CCC) associated with response surface methodology was used as optimization study model to develop and to optimize the proper formulation of roxithromycin dispersible tablet. The three independent variables investigated were functional excipients like binder (X1), disintegrant (X2) and lubricant (X3). The effects of these variables were investigated on the following responses: hardness (Y1), friability (Y2) and disintegration time (Y3) of tablet. Three replicates at the center levels of the each design were used to independently calculate the experimental error and to detect any curvature in the response surface. This enabled the best formulations to be selected objectively. The effect order of each term to all response variable was X3> X2> Xl> X1*X2> X2*X2> X2*X3> X3*X3> Xl*X3> Xl*Xl and model equations on each response variables were generated. Optimized compositions of formula were accordingly computed using those model equations and confirmed by following demonstration study. As a result, this study has demonstrated the efficiency and effectiveness of using a systematic formulation optimization process to develop the tablet formulation of roxithromycin dispersible tablet with limited experiment.
Objective: The aim of this study was to analyze the status of split tablet prescription in South Korea. Methods: We conducted this analysis using 2016 National Patient Sample data from the Health Insurance Review and Assessment Service. We computed split tablet prescription rates by sex and age and determined which medicine and medical specialties had the highest split tablet prescribing rates. Results: The proportion of prescriptions that included split tablets was 15.6% (n=6,687,35). The proportion of prescriptions that included split tablets was higher for females (56.7%) than for males (43.3%), while that of prescriptions including split tablets versus total prescriptions for each sex was higher for males (16.4%) than for females (14.9%) (p<0.001). In the age group under 19 years, the proportion of prescriptions including split tablets (53.7%) was more than half of the total. The highest tablet splitting rate was found to be 89.9% for formoterol fumarate (40 ㎍), and pseudoephedrine hydrochloride (60 mg) had the highest number of prescriptions. Pediatrics (65.6%) was the medical field with the highest rate of split tablet prescription. Conclusion: Split tablets were most prescribed to pediatric patients. To minimize the use of split tablets, it is necessary to develop lower dose tablets and establish a policy that promotes prescription of these lower-dose tablets.
Park, Jo-Eun;Song, Chan-Woo;Kim, Ki-Suk;Kim, Mee-Eun
Journal of Oral Medicine and Pain
/
v.40
no.1
/
pp.10-16
/
2015
Purpose: Pilocarpine has the effects on improvement of salivary flow and subjective symptoms for xerostomic patients. Because of unwanted side effects following its systemic administration, topical pilocarpine has been paid attention as an alternative. This study aimed to investigate effects of pilocarpine solution as mouthwash on salivary flow and adverse effects compared to systemic administration of 5 mg pilocarpine tablet in healthy subjects. Methods: The study was a double blind, placebo-controlled, crossover clinical trial. Five milligrams pilocarpine tablets, 4 mL of 2% pilocarpine solution and placebo solution were given to 12 healthy volunteers (6 males and 6 females) in a predetermined order with wash-out period of at least two days and unstimulated whole saliva was collected before and after administration of each drug. Blood pressure and pulse rate was also measured and subjective effect and potential side effects were evaluated by a self-administrated questionnaire. Results: Systemic (5 mg tablet) and topical (2% solution) use of pilocarpine significantly increased salivary flow rate in healthy subjects compared to placebo (p<0.001). In both the pilocarpine solution and tablet groups, salivary flow rates at 120 minutes after administration remained increased. Subjective effect on salivation was the largest in the pilocarpine tablet group, followed by the pilocarpine solution group (p<0.05). There was no significant difference in blood pressure and pulse rate after administration of all three drugs. Fewer side effects reported in the pilocarpine solution group than in the tablet group. Conclusions: Two percents pilocarpine solution as mouthwash increases salivary flow rate, definitely superior to placebo solution and comparable to pilocarpine tablet, with fewer side effects in healthy subjects. It indicates a possibility of pilocarpine solution as a useful alternative of pilocarpine tablets for the xerostomic patients with systemic diseases.
Paroxetine, a potent and selective serotonine reuptake inhibitor, has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchully Paroxetine $tablet^{\circledR}$ made by Samchully Pharm. Co. and the reference product was Seroxat $tablet^{\circledR}$ made by GlaxoSmithKline. Twenty healthy male subjects, $22.4{\pm}2.6$ years old and $63.8{\pm}4.2\;kg$, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 20 mg paroxetine was orally administered, blood was taken at predetermined time intervals and the concentration of paroxetine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.84-log 1.16 and log 0.85-log 1.14, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Samchully Paroxetine tablet is bioequivalent to Seroxat tablet.
Kim, Soo-Jin;Sim, Young-Sun;Lim, Dong-Koo;Oh, In-Joon;Shin, Sang-Chul;Suh, Soon-Pal;Lee, Yong-Bok
Journal of Pharmaceutical Investigation
/
v.29
no.3
/
pp.235-240
/
1999
Bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd., Seoul, Korea) and the LG clarithromycin (LG Chemical Co., Ltd., Seoul, Korea), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen normal male volunteers $(20{\sim}26\;years\;old)$ were randomly divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetennined time intervals, and the concentrations of clarithromycin in serum were detennined using HPLC method with electrochemical detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\; T_{max})$ were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t$, $C_{max}$, and $T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were 4.06%,2.67% and -9.70%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 83.53%, 92.34% and 96.64%, respectively. Detectable differences $({\Delta})$ and 90 % confidence intervals $(a=0.05) $were all less than ${\pm}20%$. All the parameters above met the criteria of KGBT 1998, indicating that LG clarithromycin tablet is bioequivalent to $Klaricid^{TM}$ tablet.
Losartan potassium, 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol mono-potassium salt, is a new class of antihypertensive agents, and is an antagonist in angiotensin receptor. The purpose of the present study was to evaluate the bioequivalence of two Losartan potassium tablets, Cozaar tablet (MSD Pharmaceutical Co., Ltd.) and Losata tablet (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of losartan from the two losartan potassium formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty eight healthy male subjects, $23.86{\pm}1.80$ years in age and $67.27{\pm}6.60\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 50 mg as losartan potassium was orally administered, blood samples were taken at predetermined time intervals, and the concentrations of losartan in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and Equiv Test/K-BE Test 2002 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, Cozaar, were -2.70%, 1.45% and 2.31% 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 0.8852~log 1.0655 and log 0.8319~log 1.2342 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Losata tablet was bioequivalent to Cozaar tablet.
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