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At least 181 records · Page 10Linked to original sources

PubMed1981

Interaction of tablet disintegrants and magnesium stearate during mixing I: Effect on tablet disintegration.

The effect of magnesium stearate on the disintegration of tablets was studied. Three different preblends, containing a slightly or a strongly swelling disintegrant, were mixed before compression with magnesium stearate for different time periods. The results show that a strongly swelling disintegrant, such as sodium starch glycolate in contrast to potato starch, can reduce the deteriorating effect of hydrophobic lubricants on tablet disintegration. However, the interaction between magnesium stearate and potato starch or sodium starch glycolate and the resulting differences in disintegration characteristics can be masked by the use of disks in the USP disintegration apparatus.

Aspirin↗

PubMed1982

Aspirin--a national survey V: Determination of aspirin and impurities in enteric coated tablets and suppository formulations and in vitro dissolution of enteric coated tablets.

The results of a national survey on the quality of enteric coated aspirin tablets and aspirin suppositories are presented. The tablets were analyzed for strength, salicylic acid content, in vitro dissolution rate, and related aspirin impurities. The suppositories were analyzed for strength and salicylic acid content. The methods of analysis and validation of data are also presented.

Aspirin↗

PubMed1991

Comparative absorption of calcium from carbonate tablets, lactogluconate/carbonate effervescent tablet, and chloride solution.

Intestinal absorption of calcium from three different labelled calcium preparations (all containing 500 mg elemental calcium) was determined using the whole body retention and urinary excretion of 47Ca in 14 normal subjects. Chewable calcium carbonate tablets showed a significantly (p less than 0.05) better mean minimum absorption of calcium (25.6% in exp. I, 22.8% in exp. II) than calcium given in the form of a lactogluconate/carbonate effervescent tablet, (17%), but similar to calcium in a chloride solution (24.7%). The minimum calcium absorption varied from 85 to 128 mg. All the preparations were taken with standardized low calcium test meals.

Adult↗

PubMed2001

Comparison of the efficacy of extended-release clarithromycin tablets and amoxicillin/clavulanate tablets in the treatment of acute exacerbation of chronic bronchitis.

BACKGROUND: Clarithromycin has established efficacy and safety in the treatment of respiratory infections. OBJECTIVE: This study examined the efficacy and safety of a new extended-release formulation of clarithromycin compared with amoxicillin/clavulanate in the treatment of acute exacerbation of chronic bronchitis (AECB). METHODS: This phase IIIB, multicenter, randomized, parallel-group, investigator-blinded study in patients with AECB and productive cough with purulent sputum compared treatment with extended-release clarithromycin (two 500-mg tablets once daily for 7 days) and amoxicillin/clavulanate (one 875-mg tablet twice daily for 10 days). Assessments were performed before treatment, between study days 10 and 12 (or within 48 hours after premature discontinuation), and between study days 17 and 21 (test of cure). RESULTS: Of 287 patients randomized and treated, 270 were clinically evaluable (137 clarithromycin, 133 amoxicillin/clavulanate). Treatment groups were well matched in terms of demographic characteristics, medical condition, and history. Among clinically evaluable patients at test of cure, 85% and 87% of clarithromycin- and amoxicillin/clavulanate-treated patients, respectively, demonstrated clinical cure (as defined in 1998 draft US Food and Drug Administration guidelines); among clinically and bacteriologically evaluable patients, 92% versus 89%, respectively, demonstrated bacteriologic cure. Overall pathogen eradication rates were similar in the 2 groups (88% clarithromycin, 89% amoxicillin/clavulanate). Rates of premature discontinuation of study drug for any reason differed between treatments: 3% (4/142) of clarithromycin-treated patients versus 12% (17/145) of amoxicillin/clavulanate-treated patients (P = 0.005). One percent (2/142) and 6% (8/145) of the respective treatment groups discontinued study drug because of adverse events. Adverse events generally occurred with a similar frequency in the 2 groups; however, taste alteration was more common with clarithromycin (9/142 [6%]) than with amoxicillin/clavulanate (1/145 [1%]; P = 0.01). Mean severity scores for gastrointestinal adverse events showed a significant difference between groups (1.16 for clarithromycin-treated patients and 1.58 for amoxicillin/clavulanate-treated patients: P = 0.016). CONCLUSIONS: The results of this study demonstrate the clinical and bacteriologic equivalence and improved gastrointestinal tolerability of a 7-day course of once-daily extended-release clarithromycin relative to a 10-day course of twice-daily amoxicillin/clavulanate in the treatment of AECB.

Acute Disease↗

PubMed2000

Montelukast adult (10-mg film-coated tablet) and pediatric (5-mg chewable tablet) dose selections.

Montelukast is a selective leukotriene receptor antagonist that has been shown to be effective in the treatment of chronic asthma. It is approved in more than 70 countries for patients 6 years of age and older. For adults (> or = 15 years of age), a 10-mg film-coated tablet (FCT) is available, and for children (aged 6 to 14 years), a 5-mg chewable tablet (CT) is available. The adult montelukast dose (10-mg FCT) was selected on the basis of classic dose-ranging studies as the lowest dose that produces maximal improvement in both measures of airway function and patient-reported outcomes in chronic asthma and in the attenuation of exercise-induced bronchoconstriction. The strategy used for the pediatric dose selection for montelukast was based on the determination of a CT dose that would provide an overall systemic exposure to montelukast in children similar to that in adults who receive a 10-mg FCT dose. Because montelukast was to be given chronically for the treatment of asthma, the area under the plasma concentration-time curve was considered to be the pharmacokinetic measurement that best represented systemic exposure to the drug. A 5-mg CT yielded a comparable single-dose area under the plasma concentration-time curve profile to that of the adult 10-mg FCT dose and, therefore, was selected as the pediatric dose for children aged 6 to 14 years with asthma. Subsequently, 2 studies of efficacy and tolerability validated the choice of the 5-mg CT dose.

Acetates↗

PubMed2004

Efficacy and tolerability of cancer pain management with controlled-release oxycodone tablets in opioid-naive cancer pain patients, starting with 5 mg tablets.

BACKGROUND: We conducted an open-label, dose titration study to assess the efficacy and tolerability of controlled-release oxycodone in the therapy of cancer pain management, starting with a newly developed 5 mg tablet every 12 h. METHODS: Twenty-two Japanese cancer patients with pain who had not been taking opioid analgesics over the previous 2 weeks were enrolled. The length of time and the dose needed to attain stable and adequate pain control were evaluated in addition to the assessment of analgesic efficacy and safety during the study period. RESULTS: Eighteen patients in the efficacy population (18 out of 20, 90%) attained stable, adequate pain control. Two-thirds of the patients attained stable, adequate pain control without any dose titration. The mean length of time was 1.2 days. In these patients, the pain was significantly reduced in intensity, even at 1 h after the initial dose intake. Fifteen patients (68%) reported at least one side effect, but only one patient had to withdraw from the study because of a side effect. CONCLUSION: The results suggest that controlled-release oxycodone tablets offered stable and adequate pain control within a short period of time in most Japanese cancer patients who have not been taking opioid analgesics, and could be effectively titrated against pain from a starting dose of 5 mg every 12 h. This indicates that a lower strength controlled-release oxycodone formulation may make it possible to start and titrate the dose more appropriately and carefully in patients who are sensitive to opioid analgesics.

Aged↗

PubMed2006

Comparison of the efficacy and safety of Eudragit-L-coated mesalazine tablets with ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis.

BACKGROUND: There are no comparative studies of coated mesalazine. AIM: To compare the efficacy and tolerability of Eudragit-L- and ethylcellulose-coated mesalazine tablets in patients with mild to moderately active ulcerative colitis. METHODS: A double-blind, double-dummy, randomized parallel group trial was performed across 18 centres in Australia, and 20 in Eastern Europe. Patients were treated with 3 g mesalazine for 8 weeks with the primary efficacy end point being clinical remission. RESULTS: Of 215 patients, 69% achieved clinical remission in both treatment groups (P < 0.001; chi-square test) with no differences in frequency of adverse events. In the Australian cohort (n = 63), the Eudragit-L group had a higher remission rate (73% vs. 36%) and responded 13 days faster, compared with those in the European group (67% vs. 84%, and 2 days respectively). No clear reasons for differences in treatment responses were identified. CONCLUSIONS: Eudragit-L and ethylcellulose-coated mesalazine tablets are well tolerated and equally effective in achieving remission in mild-moderately active ulcerative colitis over 8 weeks.

Administration, Oral↗

PubMed1979

The effect of food and tablet formulation on plasma prednisolone levels following administration of enteric-coated tablets.

1 Plasma prednisolone levels have been compared following the administration of enteric-coated prednisolone to fasted and non-fasted subjects. The effect on plasma levels of altering the formulation of the enteric-coating has also been studied. 2 The presence of food in the stomach at the time of administration does not affect the absorption of enteric-coated prednisolone tablets. 3 There was considerable inter-subject variation in plasma prednisolone levels after administration of shellac based enteric-coated tablets. However, plasma levels were more consistent when a preparation whose formulation was based upon cellulose acetate phthalate (CAP) was given. 4 It is concluded that the pattern of absorption and plasma prednisolone levels depend on the formulation of the enteric coating. The bioavailability of the CAP based preparation is similar to that of plain prednisolone.

Adult↗

PubMed2006

Pharmacokinetics of olanzapine after single-dose oral administration of standard tablet versus normal and sublingual administration of an orally disintegrating tablet in normal volunteers.

Olanzapine (OLZ) is a second-generation antipsychotic agent available in 2 solid oral dosage forms, a standard oral tablet (SOT) and an orally disintegrating tablet (ODT). This study assessed the absorption of each by different routes of administration. Secondarily, the influence of P-glycoprotein (P-gp) genotype was assessed. It was hypothesized that more rapid absorption of the OLZ ODT would occur when administered sublingually versus standard oral administration. A randomized, 3-way crossover study assessed the 5-mg OLZ formulations in healthy volunteers (n = 10). Blood was collected (0-8 hours) to assess OLZ pharmacokinetics using liquid chromatography/mass spectrometry. Both routes of ODT administration resulted in more measurable early concentrations relative to SOT. However, there were no statistically significant differences observed between any of the OLZ exposures for observed pharmacokinetic parameters (C(max), T(max), AUC(0-8h)). The homozygous TT genotype for P-gp resulted in an increased AUC of OLZ for SOT administration but not for either condition where sublingual absorption could occur.

ATP Binding Cassette Transporter, Subfamily B↗

PubMedDate not supplied

Controlled release salbutamol tablets versus sustained release theophylline tablets in the control of reversible obstructive airways disease.

A crossover pilot study was undertaken to compare the acceptability of controlled release salbutamol tablets (8 mg twice daily) with a sustained release theophylline preparation (400-800 mg given once each night) in patients with reversible obstructive airways disease. A 2-week run-in period was used to titrate the theophylline dosage. Patients were then allocated at random to one of the treatments before being immediately crossed over to the other for a further 4 weeks. Thirty-two patients, aged 17-66 years, entered the trial. Seventeen patients (53%) were withdrawn. The majority of the 13 withdrawals due to side-effects of theophylline occurred during the run-in period. There were no statistically significant differences between treatments for either lung function tests performed at the clinic or for peak expiratory flow rate recorded by the patients. The non-asthma symptom score was significantly higher with theophylline than with the salbutamol preparation. A preference for treatment with the controlled release salbutamol tablets was expressed by 11/15 patients.

Administration, Oral↗

PubMed2006

A pharmacokinetic study investigating the rate of absorption of a 500 mg dose of a rapidly absorbed paracetamol tablet and a standard paracetamol tablet.

OBJECTIVE: A rapidly absorbed tablet formulation of paracetamol containing sodium bicarbonate (PS) has been previously shown to be absorbed at least twice as fast as a standard paracetamol tablet (P) at a 1 g dose. In South America and Asia it is customary for patients to take a 500 mg dose of analgesic. The objective of this pharmacokinetic study was to compare the rate of absorption of PS versus P at a 500 mg dose. RESEARCH DESIGN AND METHODS: An open, randomized, single dose, cross-over study. Thirty Hispanic healthy volunteers randomly received a 500 mg dose taken orally with 50 mL of water 2 h after a standard breakfast. Blood samples were taken up to 10 h post-dose. Plasma concentrations of paracetamol were determined by HPLC with UV detection. MAIN OUTCOME MEASURES: AUC(0-30 min), C(plasma 30 min) and T(max) were analyzed non-parametrically by the Wilcoxon's rank sum test. A linear mixed effects model was used to analyze the logarithmically transformed AUC(0-alpha) and C(max). Bioequivalence was accepted if the 90% confidence intervals (CI) for the ratio of the means of the primary pharmacokinetic variable AUC(0-alpha) lay completely within the range 0.80-1.25. RESULTS: AUC(0-30 min) and C(plasma 30 min) were significantly greater and T(max) was significantly shorter (all p < 0.0001) for PS versus P. The formulations were bioequivalent for AUC(0-alpha) (90% CI 0.99:1.05) and no statistical difference was seen for C(max) (95% CI 0.91:1.14). CONCLUSIONS: Paracetamol was absorbed at least twice as fast from PS compared to P at a 500 mg dose. The extent of absorption was equivalent for both formulations.

Absorption↗

PubMed1986

Bioavailability and pharmacological effects of two slow-release theophylline preparations: intrasubject tablet-to-tablet variability.

The bioavailability and pharmacological effects of slow-release preparations oxtriphylline (Choledyl SA) and anhydrous theophylline (Theo-Dur) were compared in a single-blind, randomized, crossover study in 10 normal men. Subjects were administered three doses from the same lot of each preparation at weekly intervals. Plasma concentration of theophylline was measured at timed intervals for 33 hr by high-pressure liquid chromatography. Pharmacokinetic analysis showed that Choledyl SA peaked earlier (4.7 +/- 1.0 hr) than did Theo-Dur (9.6 +/- 8.2 hr), with higher peak concentrations, 6.4 +/- 0.7 micrograms/ml versus 4.1 +/- 0.5 micrograms/ml for Theo-Dur, and greater are under the curve, 102.4 +/- 15.7 micrograms/ml X hr versus 75.3 +/- 9.1 micrograms/ml X hr for Theo-Dur. 88% absorption was achieved in 6 hr with Choledyl SA versus 10 hr with Theo-Dur. Wide intra- and intersubject variations were observed with both preparations. Likewise, variable effects on systolic and diastolic blood pressure and pulse were observed with both preparations. The effects of both theophylline preparations on urine flow, osmolar clearance, and glomerular filtration rate were compared. Osmotic diuresis without detectable changes in the glomerular filtration rate was observed in subjects who received Choledyl SA versus Theo-Dur. Differences in the bioavailability and renal effects were observed between Choledyl SA and Theo-Dur. Wide intra- and intersubject tablet-to-tablet variability were observed with both preparations.

Adolescent↗

PubMed1975

Investigation of some materials as dry binders for direct compression in tablet manufacture. Part 7: Formulation and evaluation of ascorbic acid and phenobarbitone tablets.

Directly compressible powder blends containing either ascorbic acid or phenobarbitone, and utilizing tragacanth, Carbowax 4000, Plasdone, and mannitol as dry binders, were formulated. The flowability of the powder mixes prior to compression was determined. Furthermore, the tablets prepared according to the suggested formulae were tested for hardness, friability, uniformity of weight, distribution of active ingredient, disintegration, and dissolution. The effect of aging on the qualities of the tablets was also studied.

Ascorbic Acid↗

PubMed2003

Alendronate daily, weekly in conventional tablets and weekly in enteric tablets: preliminary study on the effects in bone turnover markers and incidence of side effects.

Bisphosphonates are now in the vanguard of osteoporosis treatment. Frequently, gastro-oesophageal symptoms are associated with these drugs. The objective of this study was to compare side effects and bone turnover markers in postmenopausal women who had received alendronate daily or weekly in tablets with or without enteric coating. We conducted a randomised, double-blind, 3-month trial. The trial involved 75 volunteers, aged 45-58 with moderate to severe osteopenia (T-score lower than -2 SD) assessed by quantitative ultrasound. Women were assigned randomly to receive: (a) alendronate 10mg/day: (b) alendronate 70 mg once a week: or (c) enteric alendronate 70 mg per week. We recorded side effects, C-telopeptide, osteocalcin and urine hydroxyproline at the start of the study and at 3 months. After 3 months, pyrosis (heartburn) was noted by seven women in group A (28%), three in group B (12%) and two in group C (8%); nausea: by one woman in group B; and headache by one patient in each group. C-telopeptide (A: 40.7%; B: 34.1% and C: 38.5%); hydroxyproline (A: 31.1%;B: 25.3% and C: 31.5%) and osteocalcin (A: 27.0%; B: 25.4% and C: 25.1%) decreased similarly in the three groups. Weekly intake of alendronate, whether conventional or enteric-coated; is associated with less heartburn and nausea. Enteric alendronate has a similar action to the conventional tablets on biochemical markers.

Administration, Oral↗

PubMed2003

Comparative efficacy of flubendazole chewable tablets and a tablet combination of febantel, pyrantel embonate and praziquantel against Trichuris vulpis in experimentally infected dogs.

Fourteen of 23 dogs developing patent Trichuris vulpis infections by 120 days p.i. with 5000 embryonated eggs were allocated into three groups. One group was treated with flubendazole 220 mg chewable tablets (Flubenol) at the recommended dose regimen once daily for 3 days. The second group was given the recommended single treatment with a tablet containing 150 mg febantel, 144 mg pyrantel embonate and 50 mg praziquantel in combination (Drontal Plus). The third group remained untreated. All dogs were necropsied for worm counts 10 or 11 days after (first) treatment. No worms were recovered from the flubendazole treated dogs resulting in a significant worm count reduction of 100%. In contrast, 2 of 5 animals treated with the combination of febantel, pyrantel embonate and praziquantel remained infected; the geometric mean worm burden was reduced by 99.4% as compared to the control group but did not differ significantly from those of the controls.

Animals↗

PubMedDate not supplied

[The evaluation of the teratogenesis and embryotoxicity of the pharmaceutical product Boicil tablets. II. The effect of the pharmaceutical product Boicil tablets on early embryogenesis, organogenesis and the fetus in 3 successive generations of rats and mice].

The effect of Boicil tablets on early embryogenesis (the first 3 gestational days), organogenesis (the 10th, 11th and 12th gestational days) and fetus (the 18th and 19th gestational days) by its intraamniotic administration was followed up in three successive generations of mice and rats. Two doses were used (2 mg/kg body weight and 20 mg/kg body weight), estimated in relation with the maximum therapeutic daily dose in man, being administered in a single dose, per os. No inborn malformations or somatic abnormalities were recorded both in mothers and in their descendents for three successive generations. It is concluded that Boicil tablets is not teratogenic.

Abnormalities, Drug-Induced↗

PubMed1989

Comparison of the dissolution behaviour of tablets containing the drug in a polyethyleneglycol solid dispersion with direct compressed tablets.

Higher dissolution rates of diazepam were noted with tablets containing the drug in polyethyleneglycol solid dispersion compared to these containing a physical mixture of the drug granulated with polyethyleneglycol or to directly compressed tablets. The shape factor and t63% depend strongly on the method of incorporation of the drug in the compressed mass. The dissolution of the drug becomes pH independent when it is present as a solid dispersion, which may be advantageous for the bioavailability.

Chemistry, Pharmaceutical↗

PubMed1985

The treatment of Trichomonas vaginalis vaginitis. An open controlled prospective study comparing a single dose of metronidazole tablets, benzoyl metronidazole suspension and tinidazole tablets.

Metronidazole tablets, benzoyl metronidazole suspension and tinidazole tablets each given as a single 2 g bolus dose in an open controlled prospective study were found to be effective forms of treatment for Trichomonas vaginalis vaginitis. The cure rates on wet smear preparations were 100%, 100% and 94,8% respectively, and symptomatic and observed improvements were excellent. There was a statistically significant difference between the response rates associated with both metronidazole preparations and tinidazole. The results of this study indicate that single-dosage bolus therapy can confidently be recommended in trichomonal infections and that it has a number of advantages.

Adult↗