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PubMed1989

The single dose and steady-state pharmacokinetics of a vadocaine tablet in healthy human volunteers.

Vadocaine hydrochloride (2',4'-dimethyl-6'-methoxy-3-(2-methyl-piperidyl)-propionanilide hydrochloride; INN vadocaine) is a novel compound with antitussive and local anesthetic actions. In this study, the single dose and steady-state pharmacokinetics of vadocaine hydrochloride tablet were evaluated in 28 healthy volunteers. In part 1, the pharmacokinetics of a single dose of vadocaine hydrochloride tablet were compared with the pharmacokinetics of a vadocaine hydrochloride solution. The peak concentrations of vadocaine were achieved at 1 h both after the tablet and the solution and there were no statistically significant differences in serum concentrations or in pharmacokinetic parameters. In part 2, the steady-state pharmacokinetics of vadocaine tablet were studied using the dosage of 30 mg vadocaine hydrochloride t.i.d. for four days. The peak concentrations of vadocaine were achieved on the 1st day at 1 h (61.5 +/- 6.1 ng/ml) and on the 4th day at 1.5 h (64.5 +/- 7.9 ng/ml). According to the serum concentrations and pharmacokinetic parameters, no cumulation of vadocaine was observed. Also no side-effects were reported during the study. In conclusion, vadocaine used in the tablet form is suitable for multiple dosing and the pharmacokinetic profile is almost similar to vadocaine administered in aqueous solution.

Adult↗
PubMed1977

[Total frequency of dental caries in the Canton of Vaud after the transition from fluoride tablets to fluoridation of table salt].

This report shows results of a survey on dental caries in the canton of Vaud in the years 1970 and 1974. In this canton fluoridation was carried out by means of fluoride tablets distributed at school until 1969/70 and in subsequent years by adding 250 mg F/kg fluoride to domestic salt. For comparison, results from adjoining and other cantons are also presented. In 1970 the 3 communities in the canton of Vaud (Moudon, Grandson and Vevey) showed a remarkably low overall caries level due to the distribution of fluoride tablets, supplemented in Grandson with regular brushings with fluoride solutions. When the fluoride tablets were discontinued in 1968/70 and fluoridated domestic salt containing 250 mg F/kg NaCl was introduced, caries incidence reached an even lower level. In these 3 communities caries prevalence fell to the lowest level reached, so far, by means preventive measures in Bettlach (canton of Solothurn, toothbrushing with fluoride solutions 6 times per year combined with information, fluoride tablets on every school day, and in addition consumption of table salt fluoridated at a suboptimal level of 90 ppm). The children in the control communities Romont (canton of Fribourg), St-Aubin (canton of Neuchâtel) and Châtel-St-Denis (canton of Fribourg) also showed decreases of caries levels from 1970 to 1974. This decrease is attributed to the distribution of fluoride tablets started at the schools of this community in the late sixties. Caries incidence in the age spans 8 to 12 and 10 to 14 years was estimated. Children from the canton of Vaud where fluoridated table salt was practically the only preventive measure showed a smaller DMF increase than those from the cantons of Fribourg and Neuchâtel. By means of a method combining DMF means of various age groups it was possible to obtain sufficiently large numbers of children for a study of the caries prevalence in each community. All communities showed a decrease of caries levels. In the canton of Vaud this reduction started in 1970 at an already low level and in 1974 reached consistently lower values than those of the control communities of the cantons of Fribourg and Neuchâtel.

Administration, Oral↗
PubMed1989

[A case of remarkable bronchial stenosis due to aspiration of delayed-release iron tablet].

This report describes a rare case of bronchial mucosal injury caused by aspiration of a delayed-iron tablet. A 44-year-old woman had been taking delayed-iron tablets (Feto-Gradumet) regularly because of iron deficiency anemia, and accidentally aspirated a tablet into her bronchus. After this accident, she had complained of wheezing and shortness of breath. On bronchoscopy, the bronchial mucosa of left lower lobe initially showed remarkable swelling and redness, and became corroded and narrowed gradually by iron toxicity over several months, although we tried to remove some fragments of tablet as completely as possible. While we had examined her bronchi repeatedly by bronchoscopy, the bronchial mucosa gradually normalized during 15 months, but moderate stenosis of the left basal bronchus remained. The pathological findings showed infiltration of inflammatory cells, edema and granuloma formation in the submucosal region. This report suggests that the bronchial injury was due to the toxicity of persistent ferrous sulfate eluted from the iron tablet which had adhered firmly to the wet bronchial wall for a long time.

Adult↗
PubMed1985

[A double blind clinical trial of the alpha-adrenergic blocker, Ea-0643 tablet, in the treatment of neurogenic bladder].

The clinical effectiveness, safety and usefullness of the alpha-adrenergic blocker, Ea-0643 tablet, for the treatment of the neurogenic bladder were evaluated by the double blind test method. A total of 61 patients was treated. Five of them were excluded or dropped out. Eighteen patients (group-A) received a 1.0 mg tablet of Ea-0643, 20 patients (group-B) received a 0.5 mg tablet of Ea-0643 and 17 patients (group-C) received a placebo tablet. Each tablet was administered orally three times a day for two weeks. There was no significant difference in the background factors between the three groups. The rate of effectiveness for subjective symptoms was 22.2% in group-A, 30.0% in group-B and 35.3% in group-C. There was no significant difference between the three groups. The rate of effectiveness for residual urine, judged by decrease in value of residual urine rate after treatment of less than 25%, was 55.6% in group-A, 35.0% in group-B and 17.6% in group-C. The rate of effectiveness in group-A was significantly higher than that in group-C. The mean value of net decreased residual urine rate after treatment in group-A was significantly higher than that in group-C. Decrease of maximal urethral pressure by more than 5 cm H2O was seen in 44.4% of group-A, 35.0% of group-B and 41.2% of group-C. There was no significant difference between the three groups. The rate of improvement for flow rate was 66.7% in group-A, 46.2% in group-B and 36.4% in group-C.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1978

Pharmacokinetics and effects on fecal blood loss of a controlled release potassium chloride tablet.

A slow-release tablet containing 12.5 mEq of potassium chloride was compared with a potassium chloride solution in normal human subjects under controlled conditions. Changes in plasma potassium concentration and rates of urinary potassium excretion indicate the tablet is absorbed in a slow, sustained fashion in contrast to the solution. Net potassium excretion after single and multiple doses indicates that the amount of potassium absorbed from the slow-release tablet is comparable to the solution. The slow-release potassium chloride tablets were well tolerated and were effective in correcting experimentally induced potassium depletion of moderate severity. Gastrointestinal tract irritation was not apparent and fecal 51Cr red blood cell loss after the tablet and the solution were of the same order.

Adolescent↗
PubMedDate not supplied

[Effect of Furacillin antiseptic tablets on dental plaque].

According to the modern concepts the ideal oral hygiene is decisive for the prophylaxis of caries and periodontal diseasese. However, its realization is not easy since dental plaque rapidly and ceaslessly cumulates upon all dental surfaces and is difficult to remove by the ordinary means for oral hygiene (tooth brush and tooth paste). Lately hope is centered on the antiseptics, being the base of various preparations as solutions for mouth wash for inhibition of dental plaque. The action of Furacillin tablets on the dental plaque was studied in 10 volunteers with sanated dentition, with on diseases of gingiva and periodontium. The probands sucked one tablet every three hours (6 tablets daily) in the course of 5 days with interrupted oral-hygienic cares. Dentalplaque was controlled by the oral higienic index of the whole dentition daily, after staining with 1 per cent alkaline fuxin. Probands, left on an ahygienic regimen for 5 days served as a control. The results from the study show an essential inhibitory effect of the tablets on trial upon the dental plaque and the possibilities to use the tablets for some patient groups with restrictions as regards the maintenance of oral hygiene via the ordinary means.

Dental Plaque↗
PubMedDate not supplied

Determination of reserpine and hydrochlorothiazide in commercial tablets by liquid chromatography with fluorescence and UV absorption detectors in series.

A procedure is presented for the determination of reserpine and hydrochlorothiazide in commercial tablets by liquid chromatography (LC). Reference and sample solutions are prepared in methanol. For LC, a normal phase column is used, methanol is the eluting solvent, and 2 detectors are arranged in series. A fluorescence detector set at an excitation wavelength of 280 nm and emission wavelength of 360 nm quantitates reserpine, and a UV absorption detector set at 345 nm determines hydrochlorothiazide. Several synthetic mixtures containing the 2 ingredients in the amounts approximately present in commercial tablets were analyzed by the proposed method. Two samples of commercial tablets were also analyzed; for each sample, 5 determinations were made on a ground composite of 20 tablets; 10 individual tablets were also analyzed. For comparison, some of the solutions were analyzed for each ingredient by an alternative procedure.

Chromatography, Liquid↗
PubMedDate not supplied

Liquid chromatographic determination of carbamazepine in tablets.

A simple and rapid liquid chromatographic method is described for the qualitative and quantitative determination of carbamazepine in tablet composites and individual tablets, using the internal standard technique. Analyses were performed on a C-18 reverse-phase column with tetrahydrofuran-methanol-water (8 + 37 + 55) as the mobile phase. A linear relationship was obtained between detector responses at 254 nm and amounts of carbamazepine injected ranging from 0.2 to 1.7 micrograms. The coefficient of variation for 10 consecutive injections of a standard preparation was 0.4%. Recoveries of carbamazepine from 100 and 200 mg tablets averaged 101.4 and 99.7%, respectively. Assay results for commercial tablets analyzed by the proposed method agreed favorably with those obtained by the method of USP XXI. The assay results for individual tablets indicated that deviations from the average value and the range of individual values are much wider with the compendial method than with the proposed method.

Carbamazepine↗
PubMedDate not supplied

Ultraviolet spectrophotometric determination of hydralazine hydrochloride in tablets following derivatization with nitrite.

Routine use of the USP XXI spectrophotometric method for the content uniformity determination of hydralazine hydrochloride tablets has shown that tablet excipients can significantly alter the spectral characteristics of the drug and thus cause inaccurate assay values to be obtained. Because of this problem, a simple and reliable alternative spectrophotometric assay method, based on the conversion of hydralazine to tetrazolo [5,1-alpha]phthalazine with nitrite ions under acidic conditions, was developed. The derivative showed an absorption maximum at about 274 nm and obeyed Beer's law over the concentration range 4-40 micrograms/mL. Mean recoveries of hydralazine hydrochloride added to commercial coated and uncoated tablets were 101.0% (n = 10) and 100.8% (n = 8), respectively. The proposed method was found suitable for the assay not only of individual tablets but also of tablet composites.

Chemical Phenomena↗
PubMedDate not supplied

Liquid chromatographic determination of acetaminophen in tablets: collaborative study.

A reverse phase liquid chromatographic method previously reported for the determination of acetaminophen in tablets was collaboratively studied by 5 laboratories. Each collaborator received duplicate samples of a synthetic tablet formulation and 3 powdered commercial tablet composites. The composites represented single-component and multi-component proprietary products and a single-component generic product. The pooled repeatability (CVDo) and reproducibility (CVDx) values for the proprietary tablets were 0.89 and 1.34%, respectively. For the generic tablets, these values were 0.66 and 0.74%, respectively. The pooled recovery value for acetaminophen added to the synthetic formulation was 98.9 +/- 0.7% (n = 10) with a CV of 0.75%, CVDo of 0.37%, and CVDx of 0.78%. The overall repeatability of the method was 0.64%, and the overall reproducibility was 0.95%. The method has been adopted official first action.

Acetaminophen↗
PubMed1985

The scored tablet--a source of error in drug dosing?

To determine the weight deviation of scored tablets after breaking we took 100 tablets of each of 34 brands of commercially available antihypertensive drugs and broke them into two, using the scored line. We graded the weights of the tablet halves according to their deviation from the expected weight (1 = less than or equal to +/- 5%, 11 = +/- 6-10%, 111 = greater than or equal to +/- 10%). The brands were ranked by the proportion of tablet halves (n = 200) in each category. Only seven brands divided very accurately and 11 brands divided reasonably accurately. Despite the scored line the remainder were either moderately (n = 10) or absolutely (n = 6) unsuitable for breaking, by hand or otherwise. A high proportion of these tablet halves showed weight deviations of 6-10% or more than 10% when compared to the expected weight. These findings show that a great number of antihypertensive drugs do not break evenly despite a scored line. This leads to inaccuracy of dosage.

Antihypertensive Agents↗
PubMed1986

Stability of reserpine injections and tablets submitted by U.S. hospitals.

The stability of reserpine injections and tablets that had been stored in hospital pharmacies across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked to complete a response card indicating information about the reserpine injections and tablets they had in stock. Based on the responses, FDA selected 93 samples of reserpine injections and 51 samples of reserpine tablets. The samples of injections were subjected to tests for identification, pH, presence of other alkaloids, presence of 3,4-dehydroreserpine, and strength. All samples of reserpine injections met USP requirements. Two samples of reserpine tablets representing one lot each from two manufacturers failed to meet USP requirements for content uniformity. Reserpine injections and tablets appear to be stable under actual marketplace conditions.

Chromatography, High Pressure Liquid↗
PubMed1985

Bioavailability and central side effects of different carbamazepine tablets.

The bioavailability and central side effects of five carbamazepine tablets with different rates of absorption were investigated in nine healthy volunteers in a randomized cross-over study using single doses of 400 mg. There were seven-fold differences in the peak times (Tmax), 1.5-fold differences in the peak serum concentrations (Cmax) but no significant differences in the total bioavailability (AUC0-96 h) of these tablets. On the tablets with the slowest absorption the serum concentrations were still, 24 h after the ingestion, more than 90% of the Cmax. Central side effects (dizziness, ataxia) were significantly (p less than 0.01) more common when a brand of tablets with a rapid absorption was used. These tablets were characterized by a rapid dissolution in vitro in 0.1 N HCl. The total bioavailability of carbamazepine does not decrease despite moderate prolongation of the absorption phase. The pure AUC-data alone are inadequate to characterize the clinical equivalency of carbamazepine products. Formulations with a slow absorption may be preferable: central side effects are less common and serum concentrations more constant.

Absorption↗
PubMed1985

Influence of food on the rate and extent of absorption of theophylline after single dose oral administration of a controlled release tablet.

Rate and extent of absorption of theophylline were determined in 7 healthy volunteers on pre- as well as on postprandial administration of commercially available controlled release tablets (Theograd-350 mg). In fasting subjects, maximum serum theophylline concentrations of 3.8 +/- 1.2 mg X 1(-1) (mean +/- SD) were reached at 3.4 +/- 1.2 hours after dosing, whereas under non-fasting conditions maximum serum levels of 5.8 +/- 1.3 mg X 1(-1) were found at 7.4 +/- 1.4 hours after the tablet was given. The bioavailability increased from 65 +/- 8%, observed on preprandial administration to 87 +/- 14%, when Theograd-350 mg tablets were taken after a meal. In conclusion, Theograd-350 mg tablets have a predictable absorption and give relatively high (87%) bioavailability, if the tablets are taken after a meal.

Adult↗
PubMed1985

Adverse effects of iron supplementation: a comparative trial of a wax-matrix iron preparation and conventional ferrous sulfate tablets.

The acceptability of supplemental iron delivered from a wax-matrix tablet of ferrous sulfate was compared with that of a conventional ferrous sulfate tablet in a single-blind, parallel-group study. Both tablets were formulated to deliver 50 mg of elemental iron. The incidence of adverse effects was found to be significantly greater among 272 subjects taking the conventional tablets than among 271 subjects taking the wax-matrix preparation. Eighty-one percent of the subjects taking the wax-matrix preparation experienced no severe or moderate side effects as compared with only 50% of those taking the conventional tablets.

Adolescent↗
PubMed1974

Instability of nitroglycerin tablets.

Nitroglycerin is a volatile substance which evaporates from tablets if strict precautions are not taken. The tablets kept in small, amber, tightly capped glass bottles in a refrigerator maintain their potency for three to five months if bottles are opened once a week. After five months the unused tablets should be discarded. Tablets kept in a pill box and carried with the patient will deteriorate in a week and should be discarded thereafter. Cotton, plastic or paper stuffed in the bottle and frequent opening will reduce the potency of NG tablets considerably. Physicians, pharmacists and drug manufacturers should supply full instructions to patients on how to prevent rapid deterioration of their supply.

Angina Pectoris↗
PubMed1983

Effect of pH on disintegration and dissolution of ketoconazole tablets.

The effect of pH on the in vitro disintegration, dissolution, and solubility of ketoconazole tablets was studied. One 200-mg ketoconazole tablet was added to each of five different buffer solutions having pH values of 2 to 6;900 ml of each solution containing the ketoconazole was placed in a stationary basket dissolution device and stirred at 500 rpm at 37 degrees C for 60 minutes. Single 1-ml samples of each solution were obtained at 1,3, and 5 minutes after addition of the drug, and then every 5 minutes for the duration of the sampling period. This same procedure was repeated using two 200-mg tablets in the buffer solution at pH 3. The effect of pH on ketoconazole solubility was studied by gradually increasing the pH of a ketoconazole solution at pH 3 to pH 10. Samples of this solution were analyzed periodically after allowing a short period for equilibration of pH. All samples were assayed spectrophotometrically against blanks, and concentrations were determined by comparison with a standard curve. Disintegration of ketoconazole tablets occurred within 5 minutes in each buffer solution and was unaffected by pH. At pH 2 and 3, dissolution of ketoconazole was greater than 85% complete after five minutes, and all ketoconazole had dissolved after 30 minutes. As pH increased, the rate and extent of dissolution slowed; only 10% of ketoconazole was dissolved after 60 minutes at pH 6. Ketoconazole precipitated rapidly from solution as the pH of the dissolution medium exceeded 5.5. There was no difference in the rate or extent of dissolution of ketoconazole for the two doses studied at pH 3. In the buffer solutions tested, dissolution but not disintegration of ketoconazole tablets is pH-dependent. Dissolution characteristics of 200- and 400-mg doses of ketoconazole are similar at pH 3.

Hydrogen-Ion Concentration↗
PubMedDate not supplied

Liquid chromatographic determination of prednisolone in tablets and bulk drugs: interlaboratory study.

A normal phase liquid chromatographic (LC) method for the determination of prednisolone in tablets and bulk drugs was studied by 7 analysts. An LC system, consisting of a methanol-water-ethylene dichloride-acetic acid mobile phase and a silica column, was used to analyze bulk drugs, individual tablets, and composite samples. Analysts were supplied with 16 samples, including simulated formulations, composites of commercial tablets, intact tablets, and bulk drug substances. Results agreed with those obtained by the author. The coefficients of variation of the analysts' results ranged from 1.34% for bulk drugs to 2.14% for tablet composites. The LC method is suggested as an alternative to the official AOAC and USP XX blue tetrazolium colorimetric methods.

Chromatography, Liquid↗