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At least 1,369 records · Page 76Linked to original sources
PubMed2004

[Pharmacokinetics and bioequivalence of eperisone hydrochloride tablet in healthy subjects].

AIM: To develop a HPLC-ESI-MS assay for determination of eperisone hydrochloride in human plasma and investigate the pharmacokinetics and bioequivalence of two eperisone hydrochloride tablets in human. METHODS: Buflomedil hydrochloride was used as the internal standard. After alkalized with saturated sodium bicarbonate solution, plasma was extracted with diethylether-cyclohexane (1:1) and separated using HPLC on a reversed-phase C18 column with a mobile phase of 10 mmol x L(-1) ammonium acetate buffer solution (adjusted to pH 3.88 with acetic acid)-methanol (20:80). HPLC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 260 for eperisone and m/z 308 for the internal standard. A randomized crossover design was performed in 20 healthy volunteers. In the two study periods, a single 100 mg dose of each tablet was administered to each volunteer. RESULTS: Calibration curve was linear over the range of 0.02-20 microg x L(-1). The limit of quantification for eperisone hydrochloride in plasma was 0.02 microg x L(-1). The main pharmacokinetics parameters T1/2, Tmax and Cmax were (2.7 +/- 0.4) h, (1.1 +/- 0.5) h and (2.8 +/- 2.8) microg x L(-1) for the reference tablet; (2.8 +/- 0.5) h, (1.1 +/- 0.4) h and (3 +/- 4) microg x L(-1) for the test tablet, respectively. The relative bioavalability of the test tablet was (101 +/- 13)%. CONCLUSION: The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.

Adult↗
PubMed2004

[Development of effervescent tablet of Chinese traditional medicine and its technology study].

Effervescent tablets which contain an effervescent mixture of a suitable organic acid and an alkali metal bicarbonate and/or carbonate can give out carbon dioxide when they meet water. The effervescent tablets for oral solution can be dissolved in cool water about 17-20 degrees C, therefore it is convenient to carry and use. It also has a good taste for patient with deodorizing agent added. The foam produced by external effervescent tablets is usually helpful in killing the local bacteria. The review displayed the main supplementary material, preparative technique and the study development of effervescent tablets of Chinese traditional medicine. Effervescent tablets that have been used to clinic were enumerated.

Citric Acid↗
PubMed2005

Effects of conversion from sirolimus oral solution to tablets in stable Taiwanese renal transplant recipients.

BACKGROUND AND PURPOSE: Sirolimus (SRL) has a considerable inter- and intra- individual variability in clearance. Steady-state trough concentration (C(0)) is a reliable index of SRL exposure. This study assessed the effect of conversion of SRL oral solution to tablet form on C(0) in stable renal transplant recipients. METHODS: Twenty two stable renal transplant recipients who had received calcineurin inhibitor (CNI)/SRL solution/ steroid for more than 3 months before conversion from SRL solution to tablets were included. C(0) values of SRL were compared for the periods of use of each dosage form. The relation between liver function and SRL levels was also assessed. RESULTS: With a dose of 0.03 mg/kg/day, SRL solution and tablets achieved a similar dose-adjusted C(0) (mean +/- SEM, 2.9 +/- 0.3 ng/mL/mg) upon conversion. Similar results were found when multiple SRL C(0) values from different dosage form periods were compared. Four patients with persistent liver enzyme elevation had significantly higher dose-adjusted SRL C(0) values with both the solution (mean +/- SEM, 4.5 +/- 0.7 vs 2.3 +/- 0.1 ng/mL/mg; p < 0.01) and the tablet formulation (4.0 +/- 0.5 vs 2.6 +/- 0.2 ng/mL/mg; p < 0.05). CONCLUSIONS: Conversion from SRL solution to SRL tablets did not significantly affect the dose-adjusted SRL C(0). The dose-adjusted C(0) of SRL in patients with persistent liver enzyme elevation was significantly higher than in those with normal liver function.

Administration, Oral↗
PubMed2005

Optimization of "Askoeziuofito" tablets.

OBJECTIVE: To determine experimentally the optimal limits of excipients (silica colloidal anhydrous, magnesium stearate, potato starch, saccharose), which would determine the following technological properties of the tablets: sticking of the mass to the puansons, crushing strength, resistance to abrasion-off and the speed at which medicinal substances are released from the tablets. MATERIAL AND METHODS: The following technological parameters were assessed according to the requirements of European Pharmacopoeia 04/2002:0479: mean mass, crushing strength, resistance to abrasion, duration of decomposition, speed of release of ascorbic and chicoric acids. Ferments and ascorbic acid were identified by color and precipitation reactions. Flavonoids (quercetin, quercitrin, kempferol, hyperoside, vitexin, luteolin) were identified by method of high-pressure liquid chromatography; caffeic and ascorbic acids were identified by method of thin layer chromatography; and hydroxycinnamonic acids -- by method of spectrophotometry. In tablets, ascorbic acid was quantitatively determined using the method of oxidimetry, and chicoric acid -- using the method of spectrophotometry. It has been established that the use of techniques of mathematical planning (2(4-1) fraction replica plan, maximum gradient direction and orthogonal compositional plan) made it possible to select optimal amounts of excipients which determine optimal quality requirements for production of tablets: crushing strength, resistance to abrasion, pressing, disintegration time and release rate of medicinal substances. By applying chemical and physico-chemical methods of analysis in determining active substances in tablets, technology for analyzing such preparations has been developed and stability tests have been performed.

Ascorbic Acid↗
PubMed1992

Pharmacokinetics and relative bioavailability of ofloxacin tablets in 12 healthy volunteers.

Single oral dose of tablet A (Daiichi Pharmaceutical Co Ltd, Japan) and B (Jining Pharmaceutical Factory, Shandong, China) of 300 mg ofloxacin (Ofl) were given to 12 Chinese healthy male volunteers in an open, randomized crossover study. Drug concentrations in serum and urine were assayed by HPLC and partial least squares spectrophotometric method, respectively. The serum concentration-time course after medication conformed to a 2-compartment open model with a first order absorption. Pharmacokinetic parameters after tablet B did not differ significantly from the corresponding values after tablet A. The bioavailability of tablet B was comparable to that of tablet A.

Adult↗
PubMed2005

[A correlate analysis of UV absorption spectra of compound danshen tablets from different manufactures].

OBJECTIVE: To evaluate the value of UV absorption spectrum for identification and quality control of compound Danshen tablets and pills. METHOD: UV absorption spectra of compound Danshen tablets and pills, and other drugs were scanned using ultraviolet spectrophotometer (water as the solvent). Pearson's correlation coefficients (Pearson's R) were displayed in the correlations table obtained from SPSS correlate, and deltaR defined as the absolute value of the difference between Pearson's R and its mirror image in the table were used for measuring the spectral similarity between two drugs from different manufacturers. RESULT: Regarding compound Danshen tablets and pills, the spectral similarity between different batch drugs from same manufacturer was very high with Pearson's R = 0.995-0.9999, and the similarity between two manufactures was high with Pearson's R = 0.92-0.997 and deltaR < 0.02. Compared with the spectra of compound Danshen tablets and pills, the spectral similarity of the other drugs was low with Pearson's R = 0.25-0.98 and deltaR > 0.02. CONCLUSION: The results showed that UV absorption spectrum could be suitable for identification and quality control of compound Danshen tablets and pills.

Drug Combinations↗
PubMed2005

[Effects of baisong tablets on the behavior and levels of norepinephrine and dopamine in the brain of stress rats].

OBJECTIVE: To explore the effects of baisong tablets on the behavior and contents of norepinephrine and dopamine in the brain of stress rats. METHODS: Forty adult Sprague-Dawley male rats were randomly divided into 4 groups: the control group, the depression model group, the baisong tablet group and the fluoxetine group. The depression model was replicated by chronic unpredictable mild stress and single house in 21 days. Ten rats as a group were treated with baisong tablets or fluoxetine hydrochloride. Changes of behaviors were observed by open-field test and the volume of sugar-solution the rat drank in 24 hours. The weight increase was also observed. The levels of norepinephrine and dopamine in the brain in each group were detected with high-pergomance liquid chromatography. RESULTS: Compared with the model group, baisong tablets could improve the depressive behaviors significantly, and increase the levels of norepinephrine and dopamine in the rat brain. CONCLUSION: Baisong tablets can improve the depressive behaviors and increase the levels of 5-hydroxytryptaimne and dopamine in the brain of stress rats.

Animals↗
PubMedDate not supplied

Development and validation of a method for determination of caffeine in diuretic tablets and capsules by high-performance thin-layer chromatography on silica gel plates with a concentration zone using manual spotting and ultraviolet absorption densitometry.

A new quantitative method using silica gel high-performance thin-layer chromatography plates with channels and a concentration zone, manual application of standards and samples, development with methanol-ethyl acetate (15 + 85) mobile phase, and ultraviolet absorption densitometry is reported for the determination of caffeine in diuretic pharmaceutical preparations. Tablet and capsule products containing potassium salicylate, acetaminophen, and salicylamide as active ingredients were analyzed to test the applicability of the new method, and precision, accuracy, linearity, limits of detection and quantitation, and selectivity were validated. The milligrams of caffeine in each tablet ranged from 48.0 to 51.0, and the milligrams in each capsule from 37.9 to 40.3. Within-day precision was 1.48 and 1.78% (n=6), and interday precision 0.723 and 1.26% (n=5) for analysis of 2 tablets and 2 capsules, respectively. Accuracy validation of the tablet and capsule results produced errors of 1.0 and 1.9% for spiked blank analyses and 2.6 and 3.5% for standard addition analyses, respectively. A comparative study using a caffeine standard solution and a multicomponent analgesic tablet solution containing caffeine, acetaminophen, and acetylsalicylic acid showed that manual application on the concentration zone, instrumental application on the concentration zone, and instrumental application on the silica gel gave quite similar results in terms of number of theoretical plates, resolution, limit of detection, and linearity.

Acetaminophen↗
PubMed2005

[Investigation on the formula of Fuyankang dispersed tablets].

OBJECTIVE: To investigate the preparation technique and optimal formulation of Fuyankang dispersed tablets. METHOD: The formula of Fuyankang dispersed tablets were optimized in terms of disintegrating time by studying single factor and orthogonal design test. RESULT: The products formulated with the optimum techniques met the quality specification of dispersed tablets. The dissolubility of the optimized dispersed tables was obviously faster than that of common tablets. CONCLUSION: This prescription and technology of Fuyankang dispersed tablets are reasonable and effective.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2006

[Optimization of formulation of Fufang Danshen immediate release tablet by colligation score].

OBJECTIVE: To optimize the formulation of immediate release tablet. METHOD: The immediate release tablet was prepared by using dry granules. The preparation was optimized by using orthogonal design which took the flow property of granules, the hardness, the disintegrating time and the dissolution rate of the tablet as indices. RESULT: The optimized formulation contained 40% microcrystalline cellulose, 10% sodium carboxymethyl starch and 15% dextrin. The hardness disintegrating time and T50 of the tablet were 4.5 kg, 3 min, 5 min respectively. CONCLUSION: It is successful to prepare on immediate release tablet using the optimized formula above.

Cellulose↗
PubMed2006

Colon-specific delivery tablets of sodium 4-aminosalicylic acid.

AIM: To prepare a new oral colon-specific delivery formulation and to investigate the release profile in vitro and the colon-specific delivery property in vivo in dogs. METHODS: Sodium 4-aminosalicylic acid was selected as the model drug. The combination of Eudragit RL30D and RS30D were used as sustained-release film, and Eudragit FS30D used as enteric film, which was expected to release drug depending on pH and time. The release profile of tablets was studied in three phosphate buffers with the pH 6.5, 7.0 or 7.4 for 12 h after a simulated gastric presoak for 2 h in 0.1 mol x L(-1) HCl. The tablets were radiolabelled with 99mTc to make their release times and positions in the gastrointestinal tract be followed using a gamma camera. RESULTS: For the in vitro study, there was no drug released in 0.1 mol x L(-1) HCl for 2 h, and release occurred slowly when pH was above 6.5. Drug was released faster while pH was higher. For the in vivo study, the coated tablets remained intact in the upper gastrointestinal tract, and drug release began after the colonic arrival. The uncoated tablets, however, disintegrated in the stomach of the dogs rapidly. CONCLUSION: The coating could protect the drug until the tablets reached the ascending colon, where drug was released slowly for over 10 h.

Acrylic Resins↗
PubMed2006

Comparative determination of halofantrine tablets by titrimetry, spectrophotometry and liquid chromatography.

Comparative determination of halofantrine tablets by titrimetry, ultraviolet spectrophotometry and liquid chromatography (LC) is described. Non-aqueous titrimetry on halofantrine hydrochloride tablets was carried out using glacial acetic acid as solvent, perchloric acid as titrant and crystal violet as indicator. Simultaneous potentiometric monitoring of end point delineated an exact color shade of indicator at the end point. Direct measurement of methanol solution, at 254 nm, was adopted for UV spectrophotometric method while reversed-phase liquid chromatographic (LC) method employed a C8 column (4.6 mm x 25 cm) with mobile phase consisting of methanol / 0.05 M NaH2PO4 (76:24, v/v) containing 55 mmol/L perchloric acid (pH 3.4) at a flow rate of 1 ml / min. The three methods gave precise and accurate results. Mean percentage recovery were obtained respectively as 100.73 +/- 0.41, 100.36 +/- 0.79 and 99.93 +/- 3.74% while coefficient of variation were 0.41, 1.36 and 3.74% for non-aqueous. UV spectrophotometry and LC. The three methods were successfully applied to analysis of halofantrine tablets (Halfan) and showed no statistically significant difference in accuracy (P > 0.05, ANOVA). Validated assay methods for halofantrine tablets have been developed. The titrimetric and spectrophotometric methods are of equivalent accuracy with the liquid chromatographic method and could be used for routine quality control of halofantrine tablets where LC method is not readily available.

Antimalarials↗
PubMed1991

[Assessment of the use of oxybutynin hydrochloride (Pollakisu tablets) in the elderly].

Oxybutynin hydrochloride (Pollakisu tablets) was administered at a daily dose of 6 or 9 mg to 75 elderly patients with urinary tract disorders, including neurogenic bladder and unstable bladder, with chief complaints of pollakisuria, urgency on urination and urinary incontinence. A post-marketing follow-up survey (phase IV study) was then performed to evaluate the efficacy safety and usefulness of Pollakisu tablets in these patients. The administration of Pollakisu tablets produced good results in the comprehensive assessment of overall improvement, being rated as "improved" or better in 57.5% of the patients and "slightly improved" or better in 89.0%. The assessment of general safety revealed that the drug caused almost no problems, with "no problem in safety" accounting for 97.3% of the responses. The assessment of the usefulness indicated that Pollakisu tablets are highly useful, being rated as "useful" or better in 58.9% and as "slightly useful" or better in 82.2%. Evaluation of the results according to daily dose indicated that a dose of 6 mg per day was appropriate for elderly patients from the viewpoint of drug efficacy and safety. With respect to adverse reactions, thirst was found in 5 and dysuria in 3 of the 73 patients. The overall incidence of adverse reactions was 11.0%. The above results indicate the efficacy, safety and usefulness of Pollakisu tablets in treating elderly patients with pollakisuria, urgency on urination and urinary incontinence.

Aged↗
PubMed1991

Deposition and gastrointestinal transit of conventional sucralfate tablets.

Sucralfate was labelled with 99mTc by the stannous reduction method. Tablets were compressed using 1 g of radioactive sucralfate and suitable additives. On the first test day, five fully informed healthy volunteers were given one radioactive tablet of sucralfate each, following 10 h fasting. On the second test day, the sucralfate tablet was given after a standard meal. The gastrointestinal transit of the 99mTc-labelled sucralfate was evaluated using gamma camera technique. The labelling of sucralfate with 99mTc by the stannous reduction method enables the deposition and the transition of sucralfate in the gastrointestinal tract to be monitored. The tablets disintegrated almost immediately after administration and the released sucralfate distributed homogenously over the entire stomach area, in both fasted and fed subjects. Transit from the stomach into the intestine was noted already 10 min after administration in fasted subjects, whereas the gastric emptying of sucralfate was markedly delayed in fed subjects. To achieve a wider and more homogenous distribution in the GI-tract, sucralfate tablets should be taken before eating.

Adult↗
PubMed1991

[Treatment of peptic ulcer with jian-wei yu-wang tablets].

This article reports the results of second stage clinical trial on the treatment of peptic ulcer with jian-wei yu-yang (JWYY) tablets in comparison with a control group treated with ranitidine. The results showed that the cure rate for JWYY tablet group was 62.4% and its effective rate was 93. 8% in 354 cases, whereas the cure rate of the control group was 50.7% and its effective rate was 86. 4% in 140 cases. The differences between these two groups were highly significant (P less than 0.01). Based on syndrome differentiation, optimal effect was reached in treating liver stagnation and spleen deficiency syndrome and disharmony of liver and stomach syndrome. After one year follow up studies of the therapeutic effect, the recurrence rate of the JWYY tablet group was 17.7%, while that of the ranitidine group was 54.1%. In addition, JWYY tablet had no side-effects. These data indicated that JWYY tablets were a more effective therapeutic remedy for peptic ulcer.

Adult↗
PubMed1977

PH-dependent drug release from certain commercial tablets.

A dissolution-dialysis profile for each of several brands of nitrofurantoin, hydrochlorothiazide and sulfisoxazole tablets was developed at three pH levels. The study used a two-compartment diffusion cell with a semipermeable cellophane membrane. Nitrofuratoin tablets were tested at pH values of 7.2, 4.7 and 1.2; sulfisoxazole tablets at 7.2, 5.5 and less than 1. Studies with hydrochlorothiazide tablets were terminated because the pH of the dissolution medium had no effect of practical significance on dissolution or dialysis rates. The dissolution rates of the nitrofurantoin and sulfisoxazole tablets were highly brand-individualized and complex. The effects of pH upon a particular formulation were unpredictable. The results suggest that dissolution testing at one fixed pH, as commonly practiced, may be insufficient for some products. This pH-dependent release characteristic may not correspond to a change in bioavailability in all cases, but it represents a potential problem which should be considered by the formulator.

Biological Availability↗
PubMed1985

[Therapeutic effect of Robaveron tablet (KN-7) on urinary disturbance by benign prostatic hypertrophy].

Therapeutic effect of Robaveron tablet (KN-7) was studied on 101 patients with urinary disturbance accompanied by benign prostatic hypertrophy. Robaveron tablet, which contains 20 mg of a swine prostatic extract per tablet, was administered 6 tablets daily for 3 weeks in principle. Evaluation of drug efficacy was based on residual urine, cystometric findings, urethral pressure profile, uroflowmetry and subjective symptoms. Remarkable decrease of residual urine was observed at all stages of Guyon classification, in parallel with increases of cystometric pressure amplitude and average flow rate. Rate of residual urine reduction rose in proportion to the higher stage or bulkier volume of residual urine. Improvements of subjective symptoms were also obtained. The overall effectiveness, rated slightly improved or better was 76.8%. Side effects were seen at a low rate of 3.9%, and there were no abnormal changes directly due to the drug in clinical laboratory tests. These results indicate that Robaveron tablets act on the detrusor muscle and contribute to improve the depressed voiding efficiency and incidental symptoms of the subjects.

Aged↗
PubMedDate not supplied

Liquid chromatographic determination of coumarin anticoagulants in tablets: collaborative study.

A liquid chromatographic method for the determination of coumarin anticoagulants in tablets was collaboratively studied by 7 laboratories. The method uses an octadecylsilane-bonded microparticulate column, tetrahydrofuran-methanol-water-acetic acid mobile phase, and photometric detection at 311 nm. Each collaborator received samples of warfarin sodium, phenprocoumon, and dicumarol as a synthetic composite and as commercial individual and composited tablets. Pooled average assay values for synthetic and commercial tablet samples of warfarin sodium were 101.6 and 99.5%, respectively, with a combined reproducibility SD of 2.38% (CV = 2.37%) and combined repeatability SD of 1.49% (CV = 1.49%). Pooled average (SD) assay values for dicumarol and phenprocoumon commercial samples were 98.0 (2.27) and 101.3% (4.00), respectively. The content uniformity determinations of 2 mg warfarin sodium and 25 mg dicumarol tablets indicated average tablet contents (range) of 99.5% (91.0-116.0) and 98.0% (89.8-108.8), respectively. The method has been approved interim official first action.

Chromatography, Liquid↗