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At least 145 records · Page 8Linked to original sources
PubMed2003

Quantitation of film coating on Zantac 75 mg tablets and Epivir HBV 100 mg tablets by ICP-AES.

PURPOSE: To present a selective analytical Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES) method developed and validated for the quantitation of tablet film coatings containing titanium. METHODS: Tablet samples were decomposed by either digestion or dry ashing. The amount of film tablet coating was calculated based on titanium content of the sample. RESULTS: The reported ICP-AES method was accurate, precise, sensitive and linear for determination of titanium concentrations from 2.9 to 8.6 ppm. CONCLUSION: This method provides an accurate determination of the amount of coating on a tablet and has general applicability for a variety of coating formulations containing different elements.

Anti-HIV Agents↗
PubMed1999

The tabletting machine as an analytical instrument: qualification of the tabletting machine and the instrumentation with respect to the determination of punch separation and validation of the calibration procedures.

The quality of the determination of punch separation in an eccentric tabletting machine equipped with two inductive displacement transducers was carefully investigated, since this tabletting machine is used as an 'analytical instrument' for the evaluation of the compression behaviour of pharmaceutical materials. For a quasistatic calibration procedure using gauge blocks, the repeatability under standard conditions and the robustness against variations in machine settings, installation conditions, equipment and methods were examined. The readings during calibration can be easily influenced by machine parameters as a result of deficiencies in the construction of the machine and in the mode of instrumentation. The poor plane-parallelism of the punch faces has a further negative effect on the accuracy of punch separation. In addition, the response at loading to lower and higher forces as during calibration was investigated. While at loading up to 100 N, the response of the system to the gauge blocks is systematically influenced by punch separation, for slow manually applied punch-to-punch loading up to 16.5 kN at a broad range of penetration depths, no significant effects were observed in the region of interest for tabletting. To get an indication of the transferability of the calibration and the determination of punch deformation to normal operating conditions, the lateral tilting of the punches during dynamic idle runs, punch-to-punch loading, and compression of microcrystalline cellulose was analyzed. A transfer of the response derived from punch-to-punch compression to tabletting conditions seems to be possible, although this must be questioned on grounds of theoretical considerations. From all the experiments performed, a total error of about +/- 30 microns must be assessed for the determination of punch separation.

Calibration↗
PubMed1999

The tabletting machine as an analytical instrument: consequences of uncertainties in punch force and punch separation data on some parameters describing the course of the tabletting process.

The influence of the uncertainties involved in the measurement of punch forces and punch separation in an eccentric tableting machine on the validity of the analytical results was evaluated using six direct compression excipients. The analytical parameters considered were the maximum upper punch pressure, the minimum punch separation, the maximum relative density, the contact time, the area quotient according to Emschermann and Müller, the Weibull and Heckel parameters, as well as the total, expansion and apparent net work. The measuring uncertainties were divided into between-run deviations (BD) and within-run deviations (WD), which are constant and variable, respectively, during a tableting event. Both types of uncertainties were expressed as simple error limits. The effects of the measuring BD's were calculated by adding them to the force and displacement data and then computing the analytical parameters in the conventional way. The estimation of the effects of the measuring WD's needs special methods for each parameter. Their validation showed that they were in most cases able to include the true effects of some exemplary selected errors but tend to overestimate them. From the sum of the confidence interval (CI) of a mean parameter value from repeated tableting experiments, the confidence interval with respect to curve fitting, the BD and the WD of the analytical results, the total deviation (TD) of the results was obtained, which provides a worst case measure of the uncertainties. The TD makes a differentiation between materials with similar tableting behaviour impossible in many cases, thus providing too low a selectivity. The best case uncertainties account for the difference in the response of the data to be compared to the measuring errors. The uncertainty decreases considerably under best case conditions. However, the best case intervals predicted from the worst case limits are not generally valid. Thus, besides the TD, only the CI's remain for the assessment of the analytical results. However, in the presence of systematic errors the statistical analysis cannot assure the correctness of the conclusions drawn with the degree of certainty supposed, even if the systematic measuring errors are the same for the data to be compared.

Chemistry, Pharmaceutical↗
PubMed1996

Determination of tablet coating distribution by deconvolution of uncoated and coated tablet weight distributions.

PURPOSE: The purpose of this research is to obtain the tablet coating distribution from weight distributions of uncoated and coated tablets. METHODS: The method of deconvolution with digital smoothing was used to calculate the distribution of coating applied to a tablet population from separate random measurements of individual uncoated and coated tablets. RESULTS: It was demonstrated that the calculated coating weight distribution agrees well with the measured distribution. The effect of the smoothing factor on the solution is illustrated. CONCLUSIONS: This method can be used during development to facilitate process scale-up/optimization. In routine production, the method can assess the reproducibility and consistency of a coating process.

Chemistry, Pharmaceutical↗
PubMed2001

The influence of excipients on the stability of the moisture sensitive drugs aspirin and niacinamide: comparison of tablets containing lactose monohydrate with tablets containing anhydrous lactose.

The purpose of this study is to test the hypothesis that in tablet formulations, moisture-sensitive drugs formulated with lactose monohydrate have the same stability as formulations containing anhydrous lactose, and to characterize the kinetics of niacinamide degradation in the solid state. Aspirin and niacinamide decomposition were used as indicators of stability. Aspirin and niacinamide tablets containing either lactose monohydrate or anhydrous lactose were separately investigated at different temperatures and relative humidities; the stability tests were done at 25 degrees C--60% RH, 40 degrees C--80% RH, 60 degrees C--60% RH, 60 degrees C--80% RH, and 80 degrees C--80% RH. Official U.S. Pharmacopeia methods were used for the aspirin and niacinamide assays. Statistical analysis showed that tablets containing lactose monohydrate have the same stability as tablets containing anhydrous lactose, which means that even though water is present in the crystal structure, the bound water does not influence the reaction rate. In addition, niacinamide degradation in the solid-state can be described by a third order rate equation.

Aspirin↗
PubMed1976

Oxytetracycline tablet formulations: the effect of wet mixing time, particle size and batch variation on granule and tablet properties.

The wet mixing time has been shown to influence the properties of an oxytetracycline dihydrate tablet formulation, wet granulated with PVP solution. Increased time of wet mixing produced larger, stronger and more dense granules, which compressed into tablets with longer disintegration and dissolution times. Decreased drug particle size aggravated these trends. A decrease in drug particle size also produced larger, stronger and more dense granules. Above an oxytetracycline mean particle diameter of about 6 mum, the tablet dissolution was satisfactory. As the oxytetracycline particle size was decreased further, however, the distintegration and dissolution of the corresponding tablets was markedly slower.

Drug Compounding↗
PubMed1990

Studies on internal structure of tablets. III. Manufacturing of tablets containing microcapsules.

The aim of this study was to establish the best manufacturing conditions for preparation by the direct compression method of tablets which contain microcapsules having a minimal destruction rate of the coating wall, show the same dissolution pattern as microcapsules, and have enough mechanical strength for practical use, and to elucidate the internal structure of the tablets under the best manufacturing conditions. Degree of destruction of the microcapsule wall was evaluated by the dissolution rate of the medicine in the microcapsules. To learn the mechanical strength of tablets, the crushing strength and friability were measured; their internal structure was analyzed by the porosity and pore size distribution. The best manufacturing conditions for the tablets were thus determined, and it was clarified by analysis of the internal structure that these conditions are markedly affected by the flowability of prescribed powders and the packing state at compression.

Capsules↗
PubMed1996

Studies on internal structure of tablets. VI. stress dispersion in tablets by excipients.

The aim of this study was to reduce the stress concentration of a medicine by dispersing the stress in tablets at tableting by addition of excipients. The mechanism of the stress dispersion was elucidated. Phenacetin (PHE) was used as a model of crystalline medicine with a high brittleness, and the degree of stress dispersion was evaluated by the change in the exposed surface area of PHE. To learn the mechanical strength of tablets, the crushing strength and friability were measured, their internal structure was analyzed by the porosity and pore size distribution, and stress relaxation experiments were performed. The results were as follows. Calcium silicate (Florite RE, FLR) showed a high stress dispersion effect, adding a high formability and mechanical strength to tablets. It was thought that the high stress dispersion resulted from the rapid stress relaxation caused by the plastic deformation and brittleness fracture of pores in FLR under a low compression pressure. Thus the stress caused locally on PHE particles may disperse.

Drug Compounding↗
PubMed2006

Medicinal carbon tablets for treatment of acetaminophen intoxication: adsorption characteristics of medicinal carbon powder and its tablets.

Adsorption characteristics of medicinal carbon powder (JP 14) for acetaminophen were examined at 37 degrees C using conventional incubation in an attempt to obtain an effective oral dosage form. Hydroxypropyl cellulose (HPC) and maltitol (MT), being able to act as a binding agent, were tested as additives. Tablets of medicinal carbon were produced by the wet granulation method. The rate and extent of adsorption of the medicinal carbon powder were roughly similar in water, JP 14 1st fluid (pH 1.2) and JP 14 2nd fluid (pH 6.8). The relationship between concentrations of free and adsorbed acetaminophen indicated that the adsorption followed the Langmuir mode. The maximal adsorption of acetaminophen in water was 0.219 g per gram medicinal carbon powder, little influenced by the addition of MT, but slightly reduced by the addition of HPC. The tablet prepared using MT as a binding agent displayed a favorable hardness and adequate disintegration time. The tablet showed good adsorption potential for acetaminophen, though the adsorption rate and extent of the tablet were reduced to some extent as compared with powder.

Acetaminophen↗
PubMed2001

Bioequivalence between omeprazole MUPS 20 mg as tablet and omeprazole MUPS 20 mg as tablet encapsulated in a hard gelatine capsule.

AIMS: To investigate pharmacokinetic characteristics of omeprazole MUPS 20 mg tablets and its encapsulated form. MATERIAL AND METHODS: Bioequivalence of omeprazole MUPS 20 mg tablet (Reference) and omeprazole MUPS 20 mg tablet in a hard gelatine capsule (Test) was evaluated in a randomized, 2-period crossover study in 38 healthy male Caucasian subjects who received a single oral dose of 20 mg omeprazole in each study period. Serum concentrations of omeprazole MUPS 20 mg were measured using an HPLC assay. In addition, in vitro dissolution profiles were studied. RESULTS: Both formulations were bioequivalent as assessed by the primary pharmacokinetic characteristics AUC(0-infinity) and Cmax, the corresponding ratios (Test/Reference) being 0.97 and 0.98, respectively. Thus, the 90% CI of these ratios were within the equivalence range of 0.8 to 1.25 for AUC(0-infinity) (CI 0.90-1.04) and 0.67 to 1.50 for Cmax (Cl 0.86-1.10). The ratios of the secondary criteria, Cmax/AUC(0-infinity) and t 1/2, were also within the equivalence range. Median tmax of Reference and Test was identical. Both formulations revealed comparable dissolution profiles with high batch conformity and homogeneity releasing > 80% omeprazole within 1 hour. Both study formulations were well tolerated without relevant differences. CONCLUSION: The encapsulation of omeprazole MUPS 20 mg tablets does not influence the extent and rate of absorption as indicated by the AUC and Cmax ratios. Thus, bioequivalence could be demonstrated.

Adult↗
PubMedDate not supplied

Pharmacokinetics of sustained release and conventional tablets of theophylline plus hydroxyethyltheophylline and its comparison with tablet aminophylline.

Pharmacokinetics of a sustained release (SR) and conventional formulations of theophylline plus hydroxyethyltheophylline was compared with tablet aminophylline. Time concentration curve of serum theophylline with the three formulations after single and multiple dosage schedules revealed significantly retarded absorption with the SR preparation. SR tablet was also seen to produce uniform steady state levels with fluctuation of serum concentrations within the therapeutic range for a duration of over 12 hours. In comparison, aminophylline and conventional theophylline hydroxyethyltheophylline tablets produced sharp swings in steady state levels with trough levels dipping to subtherapeutic concentrations within 4-6 hours. SR formulation, therefore, is likely provide consistent serum levels and better therapeutic control in comparison to the other two conventional tablets.

Adult↗
PubMed1987

Kinetics of piretanide tablets, penbutolol tablets and the fixed combination of both drugs in healthy male subjects after a single oral dose.

In an open-labelled cross-over study, ten healthy males received an oral dose of piretanide (6 mg tablet), penbutolol (40 mg film-coated tablet) or the fixed dose combination (film-coated tablet). Serum pharmacokinetics and 48 h urinary excretion of each drug were determined for the three dose regimens. The serum pharmacokinetics and excretion of penbutolol were unchanged in combination with piretanide. In combination with penbutolol the maximum serum concentration (Cmax) of piretanide was lowered by 40% (p less than 0.05) and time to reach Cmax delayed from 1.0 h to 1.6 h (p less than 0.05). However, areas under the serum concentration-time curves over 12 h and excretion of piretanide were unchanged, and its diuretic effect was undiminished. Thus the bioavailability of piretanide was unaffected by combination with penbutolol. The above changes in the pharmacokinetics of piretanide were explained entirely by differences in dissolution of the conventional and film-coated tablets. The drugs were safe and well tolerated.

Adult↗
PubMed1987

[The polymorphism of drugs in powders and tablets. 4. The effect of the polymorphism of drugs on the physical properties and drug release of phenobarbital tablets].

Four products of phenobarbital (I, II1, II2, III) are manufactured into tablets with the dry binders Avicel PH 101 or Heweten 40 using different pressures by direct tabletting. The physical properties of the resulting tablets are different according to the modification of phenobarbital, the binders used and the pressure during tabletting. The dissolution behaviour of the drug may be changed by the different technological and physical parameters.

Chemical Phenomena↗
PubMed1980

[In vivo testing of a 3-hydroxymethylpyridine hydrogen tartrate matrix tablet. Part 2: Comparison between the in vivo drug release from the matrix form and that from Radecol-tablets (author's transl)].

The release characteristics of 3-hydroxymethylpyridine hydrogen tartrate matrix tablets (3-hydroxymethylpyridine = HMP) were studied in vivo by determining the metabolites excreted in the urine and compared with those of commercially available Radecol tablets. After the liberation of an initial dose, the drug is release little by little from the matrix tablet. The ingested silicone matrix is not altered by the passage through the gastrointestinal tract, it is excreted unchanged. No side-effects were seen after the application of two matrix tablets (approximately 150 mg HMP).

Adult↗
PubMed2002

A controlled, double-blind, multicenter study comparing clarithromycin extended-release tablets and levofloxacin tablets in the treatment of community-acquired pneumonia.

BACKGROUND: Macrolides and fluoroquinolones are frequently used for the empiric treatment of community-acquired pneumonia (CAP). OBJECTIVE: The aim of the study was to compare the safety profile and efficacy of clarithromycin extended-release (ER) tablets with those of levofloxacin tablets for the treatment of CAP in ambulatory adult patients. METHODS: In a Phase III, double-blind, randomized, parallel-group, multicenter study, ambulatory adult patients (> or = 18 years) with signs and symptoms of CAP received a 7-day course of treatment with either clarithromycin ER (two 500-mg tablets once daily) or levofloxacin (two 250-mg tablets once daily). A diagnosis of CAP was confirmed by radiography of the chest and physical examination, and sputum samples were analyzed to identify etiologic pathogen(s). Tolerability was assessed through subjective reports of adverse events and through changes in physical findings, concomitant medications, and laboratory values. RESULTS: There were no statistically significant differences between treatment groups in terms of sex, age, race, or body weight. The mean age was 50 years (range, 18-91 years). Of 299 patients randomized and treated, 252 were clinically evaluable (128 clarithromycin ER, 124 levofloxacin). The 95% CI for the difference between cure rates demonstrated equivalence of the 2 treatments. Among clinically evaluable patients at the test-of-cure visit, clinical cure rates were 88% (113/128) and 86% (107/124), and radiographic success rates were 95% (117/123) and 88% (104/118) for clarithromycin ER and levofloxacin, respectively. Both treatment regimens were effective in resolving and improving clinical signs and symptoms of CAP. Among clinically and bacteriologically evaluable pa- tients, bacteriologic cure rates were 86% (80/93) and 88% (85/97) for clarithromycin ER and levofloxacin, respectively. No statistically significant differences were observed between the 2 treatment groups in the overall incidence of adverse events. CONCLUSIONS: Clarithromycin ER demonstrated equivalent efficacy and tolerability to the fluoroquinolone levofloxacin in a group of ambulatory adult patients with CAP. Clarithromycin ER also appeared to be safe in the population studied.

Adult↗
PubMed1986

Terbutaline slow-release tablets in children with bronchial asthma. Effect and pharmacokinetics compared with plain terbutaline tablets.

The effect of terbutaline sulphate in slow-release (SR) tablets (Bricanyl Depot), 5 mg twice daily, was compared with that of terbutaline sulphate in ordinary tablets (Bricanyl), 2.5 mg three times daily, in a double-blind, randomized, cross-over study during 2 consecutive weeks in 10 asthmatic children. Plasma concentrations and urinary excretion of terbutaline were measured at various times during both treatment periods. The SR tablets produced a higher mean plasma concentration in the morning and a smaller peak-trough variation over the day than the ordinary ones. No differences between the two treatments were observed concerning FEV1 (forced expiratory volume in 1 s). Tremor, measured with an opto-electronic tremorgraph, was about the same for two treatments and not significantly different from tremor seen in healthy children. The reported side effects were less frequent in the SR tablet period.

Adolescent↗
PubMed1986

[Relative bioavailability of paracetamol from tablets and suppositories as well as of paracetamol and codeine in a combination tablet].

Eight healthy male volunteers took part in this study to determine the relative bioavailability of Treuphadol oblong tablets (500 mg paracetamol), Treuphadol Plus oblong tablets (500 mg paracetamol, 30 mg codeine phosphate) and Treuphadol suppositories (750 mg paracetamol) against commercial tablets (500 mg paracetamol). Plasma levels of paracetamol and codeine, plus saliva levels of paracetamol for the two paracetamol only formulations, were determined by HPLC and the pharmacokinetic parameters established. The AUC data for paracetamol showed that all four preparations were bioequivalent. The saliva levels of paracetamol demonstrated a good correlation to the corresponding plasma levels. The pharmacokinetic data of codeine from the Treuphadol Plus tablet were compared with corresponding data from the literature. The bioequivalence of codeine when based on this comparison can also be assured.

Acetaminophen↗
PubMed1986

One-day treatment of vulvovaginal candidiasis with a 500-mg clotrimazole vaginal tablet compared with a three-day regimen of two 100-mg vaginal tablets daily.

In a randomized, double-blind trial, the efficacy and safety of a new single-dose clotrimazole vaginal tablet were compared with that of three-day clotrimazole therapy. Forty-two patients with clinically and mycologically confirmed vulvo-vaginal candidiasis received either one 500-mg clotrimazole tablet for one day or two 100-mg tablets daily for three days. Follow-up visits were performed approximately one week and one month after treatment. Thirty-six patients were evaluated for drug efficacy. There was no significant difference in clinical and mycological responses to the two regimens (P = 1.00, Fisher's exact test). At the final visit, 16 (89%) of the 18 patients receiving one-day treatment showed mycological and clinical clearance of infection, as compared to 15 (83%) of the 18 patients receiving three-day therapy. One patient in the three-day treatment group presented moderate edema of the vulva which was judged to be remotely related to treatment. The findings indicate that a single 500-mg tablet of clotrimazole is as effective and safe in the treatment of vulvovaginal candidiasis as a three-day course of 200 mg/day.

Adult↗