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At least 1,351 records · Page 75Linked to original sources
PubMed1997

[Effect of huoxue tablet on the rheology of erythrocyte in primary hypertension].

OBJECTIVE: To explore the effect of Huoxue Tablet on the rheology of erythrocyte and the therapeutic effect in treating primary hypertension. METHODS: Seventy-five cases of primary hypertension patients were randomly divided into 3 groups. Group I was treated by Huoxue Tablet, group II was treated by composite Danshen tablet, group III was treated by placebo. Erythrocytes deformability and aggregation were determined by laser diffractometry apparatus before and after treatment. RESULTS: After treated by Huoxue Tablet for 5-6 weeks. The authors found that deformability of erythrocyte was increased, the aggregation of erythrocyte, the whole blood viscosity and the blood pressure were reduced. The clinical symptoms were relieved. CONCLUSIONS: Huoxue Tablet can obviously improve the rheology of erythrocyte of the primary hypertension and relieve the clinical symptoms. It can be used as a supplementary medicine in treating primary hypertension.

Adult↗
PubMed1999

The colorimetric analysis of anti-tuberculosis fixed-dose combination tablets and capsules.

SETTING: The perceived need to demonstrate whether or not the actual amounts of rifampicin, isoniazid and pyrazinamide in fixed-dose combination tablets or capsules correspond to their stated drug contents. OBJECTIVE: To adapt specific, robust and simple colorimetric methods that have been previously applied to measuring plasma and urinary rifampicin, isoniazid, pyrazinamide and ethambutol concentrations to estimate tablet and capsule drug contents. DESIGN: The methods were applied to the analysis of 14 commercially manufactured fixed-dose combinations: two capsule and three tablet formulations containing rifampicin and isoniazid; seven tablet formulations containing rifampicin, isoniazid and pyrazinamide; and two tablet formulations containing rifampicin, isoniazid, pyrazinamide and ethambutol. RESULTS: All the combined formulations contained near to their stated drug contents. Replicate analyses confirmed the excellent precision of the drug analyses. CONCLUSION: Such methods are not only rapid to perform but should be practical in many Third World situations with relatively modest laboratory facilities.

Antitubercular Agents↗
PubMed1999

Huperzine-A in capsules and tablets for treating patients with Alzheimer disease.

AIM: To compare the efficacy and safety between huperzine-A (Hup) in capsules and tablets for treating patients with Alzheimer disease (AD). METHODS: Using multicenter, prospective, double-blind, double-mimic, parallel, positive controlled and randomized methods, 60 patients meeting with the NINCDS-ARDRA criteria of AD were divided into 2 equal groups. Patients in the capsule group received 4 capsules of Hup (each contains 50 micrograms) and 4 tablets of placebo (lactose and starch inside); while the tablet group received 4 tablets of Hup (each contains 50 micrograms) and 4 capsules of placebo, p.o., twice a day for 60 d. All the patients were evaluated with a lot of related ranting scales, and physiological and laboratory examination. RESULTS: There were significant differences (P < 0.01) on all the psychological evaluations between 'before' and 'after' the 60-d trial of 2 groups, but there was no significant difference between 2 groups by group t test (P > 0.05). The changes of oxygen free radicals in 2 groups showed marked improvement. No severe side effect besides moderate to mild nausea was found in both groups. CONCLUSION: There is equal efficacy and safety between Hup in capsule and tablet for treating patients with AD, and Hup can reduce the pathological changes of the oxygen free radicals in the plasma and erythrocytes of patients with AD.

Aged↗
PubMed1999

Sandwiched osmotic tablet core for nifedipine controlled delivery.

The sandwiched osmotic tablet core, which is composed of a middle push layer and two attached drug layers, has been prepared and systematically studied with the purpose of delivering water-insoluble nifedipine. The advantage of the sandwiched osmotic tablet system over the commercialized push-pull osmotic tablet system is its simplicity of preparation, as the surface identification was avoided. It was observed that polyethylene oxides (PEO) with molecular weight (MW) of 300,000 and 8,000,000 g/mole were suitable for the thickening agent of drug layer and the expandable hydrogel of push layer, respectively. The weight ratio of 190/190 for drug layer/push layer was also found to be suitable. It has been observed that PEO amount of the push layer and the KCl amount of the drug layer had profoundly positive influence on nifedipine release. A push layer/drug layer co-controlled osmotic delivery mechanism has been proposed and the optimal tablet formulation has been obtained. It was also found that PEO and nifedipine were miscible, which may support the application of PEO in nifedipine dosage forms. Meanwhile, the PEO/nifedipine binary phase diagram has been constructed. The sandwiched osmotic tablet system can deliver nifedipine in an approximate zero-order rate up to 24 hours. It may be potentially used for the delivery of water-insoluble drugs.

Calcium Channel Blockers↗
PubMed2000

Process to manufacture effervescent tablets: air forced oven melt granulation.

In the present study we apply melt granulation in an air forced oven, called "are forced oven melt granulation" to the single-stage manufacture of effervescent granules consisting of anhydrous citric acid (43.2%) and sodium bicarbonate (56.8%) in order to make tablets. This study established that process parameters such as concentration of PEG 6000, residence time in the air forced oven, fineness of PEG 6000, fineness of the initial effervescent mix and efficiency of two lubricants markedly influenced several granule and tablet characteristics. The granules ready to be compressed into tablets were stable for 7 days at 60% RH/18 degrees C. It is a dry, simple, rapid, effective, economical, reproducible process particularly well suited to the manufacture of effervescent granules which are easily compressed into effervescent tablets. Of all the formulations tested, only formulations B2 and E2 melt granulated for 30 minutes gave tablets which had optimum compression characteristics without processing problems during compression.

Chemical Phenomena↗
PubMed2001

Influence of adjuvants on the dissolution profile of tablets containing high doses of spray-dried extract of Maytenus ilicifolia.

A 2(3) factorial design was used in order to evaluate the influence of some adjuvants on the dissolution profile of tablets containing high doses of Maytenus ilicifolia spray-dried extract. Tablets were prepared on a single punch tablet press using 15 mm flat punches by individual direct compression of 650 mg from each formulation containing 375 mg of the spray-dried extract. The factors investigated were disintegrant (croscarmellose sodium or sodium starch glycolate), lubricant (colloidal silicon dioxide or magnesium stearate) and filler/binder (microcrystalline cellulose or lactose). The dissolution profiles were analyzed to determine the dissolution kinetics, the dissolution half-lives (t50%), the similarity factor (f2) and the dissolution efficiency (DE %), which was selected as the response criteria to evaluate the factorial design. The results revealed that in spite of the high content of spray-dried powder in the tablets, the dissolution profiles of the extract did depend on the adjuvant used. The filler/binder had the most important effect on the dissolution efficiency of the tablets.

Adjuvants, Pharmaceutic↗
PubMed1998

[Dental caries, dental fluorosis and use of fluoride tablets. Results of survey by 8, 14, and 20 year old insurance patients].

OBJECTIVE: To assess the prevalence of fluorosis at the age of 8, 14 and 20 years; to evaluate the prevalence of caries and fluorosis at the age of 8 and 14 years in relation tot the use of fluoride tablets during the first 5 years of age. DESIGN: Retrospective study. SETTING: The investigation was carried out in four cities in the Netherlands. METHODS: Caries and fluorosis data were obtained in 8-, 14- and 20-year-old persons by clinical examination. For 8- and 14-year-olds results were compared with data about the use of fluoride tablets during the first 5 years of life. These data were obtained by questionnaires completed by the parents when the child was 5 years old. RESULTS: Prevalence of fluorosis in permanent teeth of 8-, 14 and 20-year-olds was 16%, 31% and 26% respectively. Univariate analysis revealed a statistically significant relation between the frequency of the use of fluoride tablet and caries prevalence in deciduous and permanent teeth on the age of 8. Prevalence of fluorosis and fluoride tablet use did not show such a relation. These findings were confirmed by logistic regression analysis, using frequency of tooth brushing on the age of 5 as possible confounding factor. CONCLUSION: In this group of children the use of fluoride tablets during the first 5 years of life does not seem to increase the prevalence of fluorosis.

Administration, Oral↗
PubMed2002

Effects of xiaoyu tablet on endothelin-1, nitric oxide, and apoptotic cells of atherosclerotic vessel wall in rabbits.

AIM: To investigate the mechanism of xiaoyu tablet on reduction of smooth muscle cells (SMC) in atherosclerotic vessel wall. METHODS: The atherosclerotic model was performed in male New Zealand rabbits that were given high fat diet and abrasion of the abdominal aorta endothelial cells. The rabbits were then administered with xiaoyu tablet 0.16-0.32 g x kg(-1) x d(-1) for 16 weeks. Changes in morphology, endothelin (ET)-1, nitric oxide (NO), and apoptotic cells of atherosclerotic vessel wall were determined by the microscopy, radioimmunoassay, colorimetric method, the techniques of DNA in situ end labeling, and image pattern analysis, respectively. RESULTS: After 16 weeks of xiaoyu tablet treatment, intimal thickness and SMC in atherosclerotic vessel wall were diminished, ET-1 was decreased by 8.2 %-42.6 %, NO was increased by 7.5 %-54.2 %, and labeled apoptotic nuclei were markedly decreased, the area and integral optical density of positive granule were (846+/-308) microm2 and 3425+/-1374 in atherosclerotic group and (225+/-60) microm2 and 1445+/-606 in xiaoyu tablet 0.32 g/kg group, respectively. CONCLUSION: Xiaoyu tablet not only inhibited proliferation of SMC through reducing ET-1 in atherosclerotic vessel wall, but also induced apoptosis of SMC by increasing NO in vessel wall.

Animals↗
PubMed2003

[The dry binders, Vivapur 102, Vivapur 12 and the effect of magnesium stearate on the strength of tablets containing these substances].

Vivapur is microcrystalline cellulose manufactured by the German firm J. Rettenmeier & Söhne GmbH + Co. The types Vivapur 102 and 12 enjoy priority use as dry binders for direct tablet compression. The present paper evaluates tensile strength of tablets made from these substances and the effect of an addition of the lubricant magnesium stearate in connection with its concentration and the conditions of the process of mixing, particularly the period and intensity of mixing. The tested concentrations of stearate were 0.4 and 0.8%, the tested periods of mixing being 2.5, 5, 10, and 20 minutes, intensities of mixing 17 and 34 rot./min. Sensitivity of dry binders to added stearate was evaluated by means of the LSR (lubricant sensitivity ratio) values. The results demonstrated higher sensitivity to an addition of the lubricant in Vivapur 12 than in Vivapur 102. In the first part of the paper focused on the effect of stearate concentration on tensile strength of tablets, Vivapur 102 was also compared with Avicel PH-102. Tablets from Vivapur 102 alone were stronger than those from Avicel PH-102. A concentration of stearate of 0.8% decreased the binding capacity of Vivapur 102 more than that of Avicel PH-102. With a prolonged period of mixing and increased intensity of mixing with stearate, tensile strength of tablets from both Vivapur types was decresed, and a prolonged period of mixing exerted a more marked effect on Vivapur 12 and increased intensity of mixing, on Vivapur 102.

Cellulose↗
PubMed1992

[Treatment of chronic gastritis with traditional Chinese medicine--yingwei tablet].

A prospective controlled study on the treatment of 60 cases chronic gastritis with TCM Yingwei tablet as well as Sucrafati and Doperidone tablets from Oct. 1990 to Sep. 1991 were done. 30 patients in each group. The cases in treated group took Yingwei tablet while that in control group took Sucrafati and Doperidone tablets. Before and after treatment, the patients were examined by gastroscope, pathology and Helicobacter pylori. The results showed that total effective rate, the gastroscopically effective rate, the pathological cure rate, the cure rate of gastric mucosa atrophy and the effective rate of bacteriocidal effect against Helicobacter pylori in treated group and control group was 96.7% and 73.3%; 80% and 70%; 36.7% and 20%; 38% and 9%; 60% and 23.0%, respectively, all of the above-mentioned differences between the two groups was significant (P < 0.05-0.01). Therefore Yingwei tablet is an effective drug for various kind of chronic gastritis.

Adult↗
PubMed2003

Controlled release of nifedipine from mucoadhesive tablets of its inclusion complexes with beta-cyclodextrin.

Mucoadhesive tablets formulated with nifedipine (N) alone and its inclusion complexes with beta-cyclodextrin (betaCD) and the mucoadhesive polymers sodium carboxy methylcellulose and carbopol were investigated with a view to the design of oral controlled release tablets of nifedipine. As nifedipine is practically insoluble in water and aqueous fluids, its complexation with betaCD was investigated to improve its solubility and dissolution rate. Complexation of nifedipine with betaCD has markedly enhanced the solubility and dissolution rate of nifedipine. The phase solubility studies indicated the formation of a N-betaCD inclusion complex with a stability constant of 121.9 M(-1). A 20.6 fold increase in the dissolution rate of nifedipine was observed with N-betaCD (1:2) solid inclusion complex. Mucoadhesive tablets formulated employing nifedipine alone gave very low dissolution, whereas those formulated employing its betaCD inclusion complexes gave slow, controlled and complete release spread over a period of 12 h. Drug release from these tablets followed zero order kinetics up to 85-90% release and the release was diffusion controlled. Good controlled release two layered tablet formulations of nifedipine, satisfying the theoretical sustained release requirements based on its pharmacokinetics, were developed using its inclusion complexes with betaCD.

Adhesives↗
PubMed2003

[Development of sustained release tablet of tamoxifen citrate and its in vitro release profile].

OBJECTIVE: To reduce the frequency of administration of tamoxifen citrate so as to improve its bioavailability and patients' compliance. METHODS: HPMC(K4M) was employed as major retarded-release controller. The wetting granulation and directly compressing method was used to produce the sustained release tablet. Then the in vitro release profile was applied as main criteria to evaluate six formulations according to the variation of HPMC(K4M) amount. The concentration of tamoxifen citrate was measured by UV spectrometry. Finally the releasing characteristics of sustained release and conventional tablets were compared to clarify the sustained effect of the former. RESULT: At 278 nm there was no interaction between tamoxifen citrate and the recipients so that it was adopted as the wavelength of determination. The recovery efficiency of this method ranged from 95%-105%. The final formulation could release 86.40% of its loading amount in 12 h and its releasing profile fitted the Zero-order equation well. The percentages of accumulative release in 1 h were 76.81% and 7.08% for sustained release tablet and conventional tablet respectively. CONCLUSION: The sustained release tablet of tamoxifen citrate could demonstrate a continuous and stable releasing profile and last for over 12 h. It has significant retarded effect in comparison with the conventional one and could be a new choice of regimen in its clinical application.

Delayed-Action Preparations↗
PubMed2003

Development and biopharmaceutical evaluation of osmotic pump tablets for controlled delivery of diclofenac sodium.

Based on the principles of an elementary osmotic pump (OP), OP tablets were designed and evaluated with the aim to deliver diclofenac sodium (DS) in a controlled manner. In vitro evaluation was done in various release media and kinetics was evaluated using the regression coefficient analysis. Effects of orifice size, coating membrane type, coating thickness, static and stirred conditions and pH variation were studied. In vivo evaluation was performed on six healthy human volunteers and various pharmacokinetic parameters (c(max), t(max), AUC(0-24), MRT) and relative bioavailability were calculated. The results were compared with the performance of two commercial tablets of DS. The drug release from OP tablets was dependent on the type and thickness of the coating membrane, but was independent of the orifice size and static and stirred conditions of the release medium. The OP tablets provided a prolonged and controlled DS release compared to commercial sustained-release and conventional tablets of DS.

Administration, Oral↗
PubMed1992

[Absolute bioavailability of beta-acetyldigoxin from tablets and drops in healthy subjects].

In a crossover design in random order 12 healthy male volunteers were given either beta-acetyldigoxin (Novodigal, CAS 5511-98-8) tablets, oral solution or i.v. application at a digoxin equivalent dose of 0.284 mg. To reach steady state each preparation was given for 10 days on a once-daily schedule. On days 8, 9 and 10 of each observation period blood was sampled to determine trough concentrations of digoxin in steady state. In addition, on day 10 blood was collected repeatedly at appropriate time intervals and urine was sampled concomitantly for 24 h. Trough values during steady state and 24 h AUC were used to calculate digoxin bioavailability for tablets and oral solution. From trough values, the mean bioavailability for beta-acetyldigoxin tablets was 91.2% (range 73.1-118.1) and for solution 93.8% (range 65.7-114.8). Using the AUCs 0-24 h at steady state bioavailability was calculated 77.7% for the tablets and 84.5% for the solution. Since trough values in steady state represent the body burden of digoxin which is supposed responsible for the therapeutic effect, trough values should be given priority for the determination of digoxin bioavailability from beta-acetyldigoxin tablets and solution. All formulations were well tolerated. No clinically relevant side effects were observed.

Acetyldigoxins↗
PubMed2003

[Preperation of terbutaline sulphate pulsatile release tablet and mechanism elucidation].

AIM: To prepare terbutaline sulphate (TB) bi-layered pulsatile release tablets, evaluate the effects of the formulation and dissolution medium on drug release behavior, and to elucidate the mechanism of drug release based on obtained results. METHODS: Core tablets containing osmotic active agent were prepared by direct compression and spray coated with swelling layer and semipermeable membrane subsequently. Pharmaceutical properties of TB pulsatile tablets were investigated by dissolution test. The water uptake kinetics and swelling behavior of tablet were studied by the water uptake test and project enlargement method. RESULTS: TB released from bi-layered tablets in pulsatile behaviors. The lag-time was prolonged with the increase of coating level of semipermeable membrane and the steady release rate was increased significantly with the increase of osmotic active agent and swelling layer. It was shown that drug release behaviors were constant irrespective of various pH of dissolution medium and rotation speeds. All results indicated that diffusion, swelling and osmotic pumping were involved in the mechanism of drug release. CONCLUSION: Ideal pulsed release behaviors can be achieved by adjusting the coating level and composition of semipermeable membrane to meet the requirement of chronotherapy.

Administration, Oral↗
PubMed2004

Stability of sulfadiazine oral liquids prepared from tablets and powder.

PURPOSE: To assess the stability of sulfadiazine (SDZ) oral liquids prepared from tablets and powder at two temperatures. METHODS: Solutions of SDZ 200 mg/mL were prepared from commercially available 500 mg tablets and powder in sterile water for irrigation. They were stored in amber glass bottles at 4 degrees C and 23 degrees C. The concentrations of SDZ were determined in duplicate by high-performance liquid chromatography at 0, 1, 3, 7 and 14 days. The initial and final pH of solutions was compared. The recovery of SDZ from tablets was determined. A loss exceeding 10% of the initial concentration of SDZ was considered excessive degradation. RESULTS: The recovery of SDZ from tablets was 100 +/- 3%. The initial pH values were significantly different between solutions prepared from tablets and powder, 6.9 and 9.8 respectively. No significant difference was found between initial and final pH values for the two all formulations. Detectable change in odor was observed for the solutions stored at 23 degrees C. The solution prepared from powder was stable 3 days stored at 4 degrees C. Other formulations lost over 10% of the initial SDZ concentration within 2 days. CONCLUSIONS: SDZ 200 mg/mL oral solution prepared from powder could be used to facilitate drug administration to very young children by nurses but by taking account of its fast degradation.

Administration, Oral↗
PubMed2004

[Pharmacokinetics and bioequivalence of trimebutine dispersive tablet in healthy subjects].

AIM: To develop an HPLC-ESI-MS assay for determination of trimebutine in human plasma and to investigate the pharmacokinetics and bioequivalence of two trimebutine tablets in human. METHODS: After being made alkaline with saturated sodium bicarbonate, plasma was extracted by cyclohexane and separated by HPLC on a reversed-phase C18 column with a mobile phase of 10 mmol x L(-1) ammonium acetate buffer solution (pH 3.5)-methanol (18:82). HPLC-ESI-MS was performed in the selected ion monitoring (SIM) mode using target ions at m/z 388 for trimebutine and m/z 280 for the internal standard (sibutramine, IS). The fragmentor voltage was 50 V. A randomized cross-over 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 0.3 - 150 microg x L(-1). The main pharmacokinetic parameters of T1/2, Tmax and Cmax were (9.2 +/- 2.8) h, (1.0 +/- 0.3) h and (40 +/- 20) microg x L(-1) for the reference tablet; (9.2 +/- 2.3) h, (0.9 +/- 0.4) h and (41 +/- 20) microg x L(-1) for the test tablet. The relative bioavalability of the test tablet was (97 +/- 13)%. The results of variance analysis and two one-sided t-test showed that there was no significant difference between the two formulations in the AUC and Cmax. CONCLUSION: The assay was proved to be sensitive, accurate and convenient. The two formulations were bioequivalent.

Adult↗
PubMed2004

Statistical method for evaluation of dissolution stability in the formulation development of solid dosage forms: tablets of amonafide.

A statistical method for the evaluation of the dissolution stability results and for selecting the most stable formulation within a solid dosage form development is discussed. Three types of tablets of an antineoplastic drug, amonafide, stored at a relative humidities (RH), 45% and 75%, were used. The drug release from tablets was tested before and after storage. The experimental data were statistically fitted to empirical model equations. Furthermore, the best mathematical fit was the statistical comparison of the residuals. From the selected model equation, time-dependent dissolution (Q45 and DE45) and dissolved quantity-dependent parameters (t70, t100 and MDT) were calculated. A useful parameter to present and evaluate the results obtained in comparative stability studies was defined: the Modification Factor (MF). It allowed the selection of the most stable formulation in the easiest and fastest way: the most stable formulation should present the smallest modification of the studied characteristics, in other words, the smallest MF value. In this way, tablets II (manufactured by wet granulation and with Emcompress as main excipient) showed the greater dissolution stability of the three types of tablets studied. Amonafide tablets must be packaged in impermeable containers, since the environmental relative humidity strongly modifies their dissolution characteristics.

Adenine↗