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At least 163 records · Page 9Linked to original sources
PubMed1985

A comparative study of Neo Sampoon, Ortho Vaginal Tablets and Emko Vaginal Tablets in Accra, Ghana.

Neo Sampoon is an effervescent contraceptive vaginal tablet manufactured in Japan that contains 60 mg of the spermicide menfegol. Ortho Vaginal Tablets (OVT) and Emko Vaginal Tablets (EVT), both containing 100 mg of the spermicide nonoxynol-9, were manufactured in the USA. The three products were compared in a randomized clinical trial conducted at the family planning clinics of the Korle-Bu Teaching Hospital and the Kotobaabi Polyclinic in Accra, Ghana. Three-hundred volunteers participated. At 12 months, the life-table pregnancy rates were 9.6, 11.3 and 12.5 per 100 women in the Neo Sampoon, OVT and EVT groups, respectively (p greater than 0.10). More EVT than Neo Sampoon or OVT users discontinued because of discomfort as well as for other product-related reasons (p less than 0.01). The most common reason for discontinuation was the temporary absence of sexual partner, with more than 40% of the women overall terminating for this reason. The 12-month life-table continuation rates per 100 women were higher for the Neo Sampoon group (62.4) than the OVT group (48.6) or the EVT group (38.5) (p less than 0.01). The effectiveness of the three products seems to be similar, but Neo Sampoon and OVT appear to be more acceptable than EVT in this Ghanaian population.

Adult↗
PubMed2005

Raman spectroscopic measurement of tablet-to-tablet coating variability.

We report new results suggesting the feasibility of Raman spectrometry as a tool by which to examine the variability of tablet coatings. Our experiments feature a probe that can operate with a revolving laser focus to average content and coating non-uniformity. Raman spectral changes are correlated with tablet exposure times in a pan coater by means of partial least squares (PLS) multivariate analysis. Statistical models are found to be improved by pre-processing schemes that emphasize spectral changes while minimizing the effects of background light scattering and fluorescence. These pre-processing techniques include multiplicative scatter correction (MSC) and standard normal variate (SNV) transformation, used in concert with Savitzky-Golay second derivative smoothing (SGSD). The two approaches give comparable results yielding R2 values for PLS calibration and cross-calibrated prediction variance regression of 0.999 and 0.997, respectively. Correlation results and model residual values demonstrate that Raman spectroscopy serves sensitively to reflect the coating thickness of the tablets studied.

Algorithms↗
PubMed1999

Efficacy of an ondansetron orally disintegrating tablet: a novel oral formulation of this 5-HT(3) receptor antagonist in the treatment of fractionated radiotherapy-induced nausea and emesis. Emesis Study Group for the Ondansetron Orally Disintegrating Tablet in Radiotherapy Treatment.

A significant number of patients who are receiving radiotherapy experience the distressing side effects of emesis and nausea. Although prophylactic antiemetics are often given to patients who are receiving single-fraction, high-dose radiotherapy to the abdomen, a survey has revealed that antiemetic prophylaxis is not routinely offered to those receiving fractionated radiotherapy. Hence there is a need for an effective treatment of emesis for use in this group of patients. Ondansetron is an effective and well-tolerated antiemetic, which is used for the prevention of both chemotherapy and radiotherapy-induced emesis and nausea. This agent has been developed as a novel freeze-dried oral formulation. Ondansetron orally disintegrating tablets (ondODT) disperse rapidly when placed on the tongue. As the tablet does not need to be swallowed with water, it is a particularly useful formulation for patients who have difficulty with swallowing or who do not feel able to drink. This study was undertaken to investigate the efficacy of ondODT in the treatment of established emesis and nausea induced by radiotherapy. Two doses of ondODT, 8 mg and 16 mg, were compared with placebo in patients who developed emesis and/or moderate/severe nausea after receiving fractionated radiotherapy to sites located between the thorax and the pelvis. The study showed that ondODT was clinically superior to placebo in treating emesis and nausea successfully over a 12-hour period after taking the medication. There were no statistically significant differences between the two doses of ondODT. In the 2 hours after taking the study medication, patients who received ondODT (8 mg and 16 mg) had significantly fewer emetic episodes compared with those who received placebo. They also experienced significantly less nausea. In conclusion, ondODT 8 mg is effective in the treatment of radiotherapy-induced emesis and nausea and provides an effective alternative to the conventional ondansetron tablet.

Administration, Oral↗
PubMed2002

Roller compaction and tabletting of St. John's wort plant dry extract using a gap width and force controlled roller compactor. II. Study of roller compaction variables on granule and tablet properties by a 3(3) factorial design.

The purpose of this study was to investigate the influence of roller compaction parameters and the amount of magnesium stearate used in dry granulation on granule and tablet properties of a dry herbal extract from St. John's wort (Hypericum perforatum L.). Two different extract batches were blended with magnesium stearate and compacted using a gap width and force controlled roller compactor. A 3(3) factorial design was used to evaluate the influence of the three independent variables, the amount of magnesium stearate, the roller compaction force, and the granulating sieve size on the mean particle size of granulated extracts and on the disintegration time of tablets containing these granulated extracts. The evaluation was done by multilinear stepwise regression analysis. The mean particle size d50 (R2 > 0.9) of both compacted extracts increased with increasing compaction force and with granulating sieve size. The disintegration time of the tablets was mostly in the range 5-15 min and increased slightly with increasing magnesium stearate concentration in the compacted extract and with decreasing compaction force of the roller compaction. The incorporation of magnesium stearate into the granulated extract reduced its potential negative influence on the disintegration time, while maintaining its functionality as a lubricant.

Compressive Strength↗
PubMed1973

Therapeutic non-equivalence of digoxin tablets in the United Kingdom: correlation with tablet dissolution rate.

Seven types of digoxin 0.25 mg tablet in common use in the United Kingdom were administered to a total of 38 patients. Significant differences were found in the mean plasma digoxin levels and in the control of atrial fibrillation achieved with these brands. There was a close correlation between the dissolution rate of the tablets and the plasma digoxin levels. Measurement of in-vitro dissolution rate appears to be a valid method of ensuring that different tablets of digoxin are of equal efficacy. However, in some patients absorption of the drug is markedly sensitive to changes in dissolution rate and new pharmacopoeal standards should not be defined until very rapidly-dissolving formulations have been studied.

Administration, Oral↗
PubMed2003

Formulation study for lansoprazole fast-disintegrating tablet. III. Design of rapidly disintegrating tablets.

Lansoprazole fast-disintegrating tablets (LFDT) are a patient-friendly formulation that rapidly disintegrates in the mouth. LFDT consist of enteric-coated microgranules (mean particle size, approximately 300 microm) and inactive granules. In the design of the inactive granules, mannitol was used as a basic excipient. Microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), and crospovidone were used as binders and disintegrants. A new grade of L-HPC (L-HPC-33), with a hydroxypropoxy group content of 5.0-6.9%, was developed and it has no rough texture due to a decrease in water absorption. It was clarified that L-HPC-33 could be useful as a binder and disintegrant in rapidly disintegrating tablets. LFDT contain enteric-coated microgranules in tablet form. The enteric-coated microgranule content in LFDT affect qualities such as tensile strength, disintegration time in the mouth, and dissolution behavior in the acid stage and in the buffer stage of LFDT. The 47.4% content of the enteric-coated microgranules was selected to give sufficient tensile strength (not less than 30 N/cm(2)), rapid disintegration time in the mouth (not more than 30 s), and dissolution behavior in the acid stage and buffer stage similar to current lansoprazole capsules. Compression force affected the tensile strength and the disintegration time in the mouth, but did not affect the dissolution behavior in the acid and buffer stages.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Esomeprazole MUPS 40 mg tablets and esomeprazole MUPS 40 mg tablets encapsulated in hard gelatine are bioequivalent.

OBJECTIVE: To investigate the bioequivalence of esomeprazole MUPS 40 mg tablets administered with and without a hard gelatine capsule. MATERIAL AND METHODS: Bioequivalence of the esomeprazole MUPS 40 mg tablet administered without (Reference) and with a hard gelatine capsule (Test) was evaluated using a randomized, two-period crossover study. In each study period 49 healthy male Caucasian subjects received a single oral dose of 40 mg esomeprazole. Blood samples were collected at specified time intervals, and serum was separated and analyzed for esomeprazole concentrations using a validated HPLC-MS method. The primary parameters were AUC (extent of absorption) and Cmax (rate of absorption). The time-to-peak plasma concentration, tmax, and the elimination half-life, t1/2, were determined as secondary characteristics. Point estimates and 90%-confidence intervals were obtained for the ratio of the population medians of Test and Reference, using a multiplicative model and a parametric analysis except in the case of tmax, where an additive model and a non-parametric analysis was used. Bioequivalence of Test and Reference was concluded if the 90%-confidence intervals were entirely within the predefined equivalence ranges. RESULTS: The AUC(0-infinity) and Cmax-ratios (Test/Reference) were 1.00 and 1.01, respectively. The 90%-confidence intervals for AUC(0-infinity) (0.94-1.06) and Cmax (0.93-1.09) of these ratios were within the predefined equivalence range of 0.80-1.25 and 0.75-1.33, respectively. The ratios and 90%-confidence intervals of the secondary characteristics t1/2 and tmax were also within the respective predefined equivalence ranges. Both esomeprazole formulations were well tolerated and safe. CONCLUSION: The encapsulation of esomeprazole MUPS 40 mg tablets does not influence the extent and rate of absorption assessed by using AUC(0-infinity) and Cmax. Thus, bioequivalence could be demonstrated.

Absorption↗
PubMed2004

The effect of xylitol on the stability and morphological parameters of tablets with sorbitol made by direct tabletting of formulation components.

Model tablets of polyols (sorbitol and xylitol) comprised 88% by mass, were produced using a direct compression method. Morphological and mechanical parameters of the model tablets were investigated ex tempore as well as after 12 and 24 months' storage. The effect of xylitol on selected morphological parameters of practical relevance during storage was estimated. The results obtained are a basis for further work on the use of polyols (sorbitol, xylitol and other sugar alcohols) in the production of oral forms of drugs, particularly buccal tablets.

Chemistry, Pharmaceutical↗
PubMedDate not supplied

[The evaluation of the teratogenesis and embryotoxicity of the pharmaceutical product Boicil tablets. I. The effect of the pharmaceutical product Boicil tablets on fertilization and implantation in rats and mice].

The teratogen action of Boicil tablets was studied in two animal species, rats and mice, the prefertilization and implantation stages being the main interest. Three generations of animals were followed up. The active powder suspended in distilled water (0.1 ml/10 g for mice and 1 ml/100 g for rats) was administered per os in a single dose, prepared on spot and in two doses, 2 mg/kg body weight and 20 mg kg body weight, respectively. The administered doses were equivalent to the daily maximum therapeutic dose prescribed in humans (110 mg active principle). The first gestational day was determined differently in the two species. For estimating the effect on prefertilization, Boicil tablets was administered for 5 days before making and for its effects on the number of implantations during the first 3 gestational days. The two parameters under investigation were within normal limits and all newborn animals followed up for three generations did not present pathological microscopic and gross alterations or somatic malformations. It was concluded that Boicil tablets is not teratogenic.

Abnormalities, Drug-Induced↗
PubMed1989

[Formulation of effervescent tablets containing acetylsalicylic acid. III. Investigation of the stability of the active principles of tablets].

Parameters influencing the stability of active principles of effervescent tablets containing acetylsalicylic acid were investigated. On the basis of factorial experiment project the effects of contents of citric acid: sodium hydrogen carbonate, polyvinylpyrrolidone and those of storing temperature of tablets and humidity of atmosphere on decomposition of active principle were studied. High performance liquid chromatographic method has been developed for simultaneous determination of acetylsalicylic acid and salicylic acid. It has been established that first of all storing circumstances effect the stability of preparation and composition of tablets also significantly influences the decomposition of acetylsalicylic acid.

Aspirin↗
PubMed1984

A comparative trial of ordinary metoprolol tablets and metoprolol sustained-release tablets in hypertensive patients at rest and on exercise.

An open, randomized crossover trial was carried out in 10 patients with hypertension to compare the degree and duration of antihypertensive effect of metoprolol given as 100 mg ordinary tablets twice daily and as single daily doses of a 200 mg sustained-release tablet. Blood pressures and heart rate were measured, at rest and during maximum exercise effort, before treatment, at the second hour after the start of each treatment sequence, and at the end of both 14-day treatment periods: after 12 hours in the case of ordinary metoprolol and after 24 hours with sustained-release metoprolol. The results showed that heart rate was greatly reduced (less than 0.001) both at rest and on exercise at all times studied with both treatments. At rest, blood pressure was significantly reduced except by sustained-release metoprolol at 2 hours. On exercise, blood pressure was also significantly reduced except for the 12-hour value for diastolic pressure with ordinary metoprolol. It is concluded that, for similar reductions in heart rate reflecting satisfactory beta-receptor blockade, the antihypertensive effect of metoprolol given at a dosage of 200 mg per day was more rapid in onset after the ordinary tablet formulation but less marked at 12 hours than at 24 hours after the sustained-release formulation.

Adult↗
PubMed1982

The bioavailability of diazepam from uncoated tablets in humans--Part I: correlation with the dissolution rates of the tablets.

Dissolution studies of 15 preparations of commercial uncoated tablets of diazepam (5 mg) were performed by six methods (beaker, rotating basket, oscillating basket, solubility simulator, rotating flask, and single basket). Diazepam dissolved rapidly at pH 1.2; the T50 (the time of 50% dissolution) values were less than 5 min. But at pH 4.6, T50 estimated by rotating basket method lasted 3-120 min. Four different tablets of diazepam were chosen for the bioavailability tests in humans. The bioavailabilities of the four tablet preparations were estimated by serum level measurements after a single dose to 12 adult male volunteers. Statistical analysis of the data showed significant differences in the rate of bioavailability (peak concentrations and serum concentrations at 1, 2, and 3 h after administration), but not in the amount of available (AUC). The mean peak concentration and serum concentration at 1 h showed significant correlation with T50 and T70 determined by the rotating flask method at pH 4.6 in log-log regression. The peak concentration and serum concentration at 1 h were also correlated with T70 determined by the rotating flask method at pH 4.6 and T70 determined by the rotating basket method at pH 4.6 on normal-normal regression. In contrast, the dissolution rates determined at pH 1.2 did not show a good correlation with in vitro parameters.

Adult↗
PubMedDate not supplied

Steady-state pharmacokinetics of enteric-coated naproxen tablets compared with standard naproxen tablets.

In this open-label, randomized, cross-over study, 24 healthy volunteers (12 men and 12 women) received either enteric-coated (EC) naproxen tablets 500 mg twice daily or standard naproxen tablets 500 mg twice daily for 7 days. In each of the two study periods, blood sampling began on day 8, after one last dose of the study drug was administered, to determine and compare steady-state pharmacokinetics for each of the two naproxen formulations. The plasma half-life of naproxen averaged 16.3 and 16.9 hours following EC naproxen and standard naproxen treatments, respectively. Mean time to maximum plasma concentration (Tmax) was greater for EC naproxen than for standard naproxen (4.0 vs 1.9 hours), while the maximum observed plasma concentration (Cmax) was slightly, but not significantly, smaller (94.9 vs 97.4 micrograms/mL, respectively). The mean values for average plasma concentration (Cave) and minimum plasma concentration for EC naproxen were 70.4 and 60.6 micrograms/mL, respectively, compared with 63.9 and 44.1 micrograms/mL for standard naproxen. The mean plasma fluctuation about the mean was greater for standard naproxen than for EC naproxen (85.3% vs 49.3%), while the mean area under the plasma concentration-time curve (AUC) was smaller for standard naproxen (766.8 vs 845.0 micrograms x h/mL). At steady state, EC naproxen was similar to standard naproxen tablets with respect to Cmax, Cave, Cmax:Cave, 0- to 12-hour AUC, and half-life but differed in Tmax. In addition, fluctuations about Cave in plasma levels were considerably lower with EC naproxen than with standard naproxen.

Administration, Oral↗
PubMedDate not supplied

Compact quadruple therapy with the lamivudine/zidovudine combination tablet plus abacavir and efavirenz, followed by the lamivudine/zidovudine/abacavir triple nucleoside tablet plus efavirenz in treatment-naïve HIV-infected adults.

PURPOSE: To assess efficacy, safety, and adherence with compact quadruple therapy comprising one lamivudine 150-mg/zidovudine 300-mg tablet (COM) twice daily + one abacavir (ABC) 300-mg tablet twice daily + three efavirenz (EFV) 200-mg capsules at bedtime for 24 weeks, followed by one lamivudine 150-mg/zidovudine 300-mg/ABC 300-mg triple nucleoside tablet (TZV) twice daily + three EFV 200-mg capsules at bedtime for 24 weeks. METHOD: A pilot 48-week, prospective, open-label trial in which 38 antiretroviral-naïve HIV-infected adults (baseline median HIV-1 RNA 5.1 log(10) copies/mL, CD4+ cell count 285/microL) received the above treatment and were monitored regularly with respect to plasma HIV-1 RNA levels, CD4+ cell counts, T-cell receptor excision circles (TRECs), adherence, and adverse events. RESULTS: At Week 48, intent-to-treat, switch-included analysis showed plasma HIV-1 RNA levels <400 copies/mL in 100% (29/29) of patients and <50 copies/mL in 93% (27/29); 59% of patients who achieved <50 copies/mL had <3 copies/mL (16/27). Similar virologic suppression was observed in patients with baseline HIV-1 RNA above or below 100000 copies/mL. HIV-1 RNA and CD4+ cell counts changed from baseline by a median of -3.4 log(10) copies/mL and +172 cells/microL, respectively. One virologic failure occurred at Week 16. Median TRECs/100000 peripheral blood lymphocytes increased 6-fold between baseline and Week 48. Median adherence rates were consistently 100% by self-report and 94% by pill count. Grade 2-4 treatment-related adverse events included dreams (16%), nausea (13%), decreased white cells (8%), dizziness (8%), sleep disorders (8%), and malaise and fatigue (8%). A suspected ABC hypersensitivity reaction occurred in 8% (3/38) of patients. CONCLUSION: COM/ABC/EFV or TZV/EFV produced potent, durable virologic suppression and immunologic benefits, was associated with high adherence rates, and was generally well tolerated.

Adult↗
PubMed1999

A double-blind placebo-controlled study assessing the efficacy and tolerability of 50 mg sumatriptan tablets in the acute treatment of migraine. Sumatriptan Tablets S2CM07 Study Group.

BACKGROUND: Oral sumatriptan 50 mg has been found to have good efficacy and tolerability in the acute treatment of migraine but has been less well studied than the 100 mg dose. METHODS: This was a double-blind, parallel-group study (Glaxo Wellcome protocol number S2CM07) comparing the efficacy and safety of sumatriptan 50 mg tablets with placebo in the acute treatment of migraine. Patients treated three migraine attacks with study medication; a second, optional dose was available for treating recurrent headache. Of the 560 patients randomized, 485 treated at least one attack, 411 at least two attacks, and 362 three attacks. The primary efficacy measure was the proportion of patients who had obtained complete or almost complete headache relief at 4 h after dosing. RESULTS: For all attacks, a significantly greater proportion of patients experienced headache relief at 4 h with sumatriptan 50 mg tablets than with placebo (59% to 62% versus 32% to 42%; P = 0.005). The same was true at 3 h across all attacks, and at 2 h for attacks 1 and 2 (49% versus 23% and 45% versus 29%, respectively). Although sumatriptan and placebo were associated with similar incidences of recurrence, sumatriptan was associated with a longer time to recurrence. The incidence of adverse events with sumatriptan was similar to that with placebo, and there was no increase in adverse events associated with use of a second dose to treat recurrence. CONCLUSIONS: Sumatriptan 50 mg tablets are well tolerated and efficacious in relieving migraine headache.

Acute Disease↗
PubMed1981

Tri-potassium di citrato bismuthate chewing tablets and cimetidine tablets in the treatment of duodenal ulcers. A double-blind double-dummy comparative study.

A randomized, double-blind, double-dummy comparative 6-week study of tri-potassium di-citrato bismuthate (TDB) (Ulcerone; De-Nol) chewing tables and cimetidine was carried out in 60 patients suffering from duodenal ulceration. The data on 51 patients (27 on TDB and 24 on cimetidine) were analysed (9 patients absconded). Both treatments appeared to be highly effective in ulcer healing at the 6-week endoscopic assessment. The healing rate for TDB chewing tablets was 89% and that for cimetidine tablets 92%. Both forms of therapy were comparable in respect of improvement of pain and effect on all other observed symptoms. Neither drug had a statistically significant effect on any of the haematological or clinical chemical parameters tested during the trial, except that the cimetidine-treated group showed a significant linear reduction in white blood cell count. No side-effects were reported. It is suggested that TDB chewing tablets are a safe, effective and cheaper alternative to cimetidine in the treatment of patients with duodenal ulceration.

Adult↗
PubMedDate not supplied

Gravimetric and spectrophotometric determination of some phenothiazine and imidazole derivatives in coated tablets and tablets.

Two drugs in the form of coated tablets: Promazin (promazine hydrochloride) (1) and Thioridazin (thioridazine hydrochloride) (2), and tablets Clotrimazolum (clotrimazole) (3) were assayed gravimetrically and spectrophotometrically in the same process using complexes with ammonium molybdate. Stoichiometry of these complexes was established by elemental analysis and analysis of the incineration residue (MoO3). The complexes were subsequently characterized using their IR and UV spectra and melting points. The active substances of the complexes were also determined spectrophotometrically. Using this method Beers Law was found to hold for the concentration ranges of 5-40 microg/ml (complex of 1), 5-60 (microg/ml (complex of 2) and 2-10 microg/ml (complex of 3). The method was validated in terms of precision, linearity, detection limit and quantification limit. The two methods of drug determination, used in a single analytical process verify each other.

Anti-Bacterial Agents↗
PubMed1989

[Therapeutic effect of pyronaridine in plain tablets and enteric-coated tablets in falciparum malaria patients].

A new oral dosage regimen and formulation of pyronaridine basing on the pharmacokinetic studies and a theoretical dosage regimen reported previously, was clinically evaluated for its therapeutic and undesirable effects on falciparum malaria patients in west Hainan Province, where chloroquine-resistant falciparum malaria was prevalent. 32 cases were treated with pyronaridine by the new dosage regimen of 0.5 g in d1, and 0.3g in d2 in plain tablets (group A), while additional 32 patients received enteric-coated tablets of pyronaridine by the current dosage regimen as a control (group B), which was 0.4 g x 2 on d1, and 0.4g on d2. The average fever clearance time for A and B groups was 27.0 +/- 14.1 and 30.2 +/- 13.8h respectively (P greater than 0.05), and the clearance time for asexual parasites was 57.2 +/- 10.2 and 57.9 +/- 8.7h. Upon 28d following-up examination the cure rates were found to be 100% in group A and 93.8% in group B. The undesirable responses were recorded in 18.8% of group A patients (6/32), and 28.1% of group B (9/32) respectively, and they were light and tolerable and short in time duration. It was shown that the new dosage regimen of pyronaridine could retain the same therapeutic effect as that currently used, although the total dose was reduced by one third. Hence, an important basis was provided for more rational use and further study of pyronaridine in malaria therapy.

Adolescent↗