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At least 199 records · Page 11Linked to original sources
PubMed1984

[The effect of dehydration loss of tablet excipients on the energy- distance diagram and on tablet characteristics].

Four tabletting agents of the micro-crystalline cellulose type (Heweten 10, Heweten 12, Heweten 40 and Avicel PH 101) as well as a potato starch lactose granulate had been tabletted on an instrumented slow-motion eccentric press (1 r. p. m.) following storage at different relative humidities. The data resulting from force-punch displacement measurements had been related to the radial steadiness to breakage and the dehydration loss of the relevant agent.

Cellulose↗
PubMed1981

Metoprolol in angina pectoris complicated by essential hypertension. A clinical comparison of the antianginal efficacy of metoprolol slow-release tablets (Durules) given once daily and propranolol tablets given twice daily.

The clinical efficacy of propranolol and metoprolol slow-release tablets (Durules) was compared in 20 patients with typical angina pectoris and concomitant hypertension. During a four-week run-in period all patients were given 80 mg propranolol b.i.d. in a single-blind fashion. Thereafter they were randomised in a double-blind fashion to treatment with either propranolol tablets, 80 mg b.i.d., or metoprolol Durules, 200 mg o.m. After four weeks, treatment was changed according to a cross-over design. The number of anginal attacks and nitroglycerin consumption were recorded by the patients in diary-cards. At the control visits, blood pressure was assessed in the supine and standing positions. No differences were found between the drugs as regards either antianginal or antihypertensive efficacy. Metoprolol Durules 200 mg o.m. are considered to be as effective as propranolol, 80 mg b.i.d. and may be preferred by some patients because of the simple dosage regimen.

Adult↗
PubMed1993

Discrepancy among dissolution rates of commercial tablets as a function of dissolution method. Part 5: In vitro/in vivo correlation for chlorpromazine hydrochloride tablets.

The bioavailability of seven commercially available batches of chlorpromazine hydrochloride tablets belonging to three different brands was assessed by measuring the intensity of miotic response to the tablets in six normal human subjects according to a cross-over design system. The following pharmacodynamic parameters were computed, viz., maximum miotic response intensity, tmax, half-peak time as well as the area under the percentage miotic response intensity versus time curve from time 0 to 8 h. Attempts to correlate two in vitro dissolution parameters, that is, dissolution efficiency and percentage weight of drug dissolved after 30 min to the in vivo parameter of the area under percentage miotic response intensity versus time curve revealed that the second in vitro parameter correlates better than the first one with the in vivo parameter regardless of the dissolution method. On the other hand, the two in vitro dissolution parameters obtained by the USP rotating basket method show good correlation with the in vivo parameter.

Adult↗
PubMed1995

Relative bioavailability of rifampicin, isoniazid and ethambutol from a combination tablet vs. concomitant administration of a capsule containing rifampicin and a tablet containing isoniazid and ethambutol.

Twenty male volunteers who were slow metabolisers of isoniazid, completed this single-blind, single-dose, randomised, cross-over study to compare the bioavailability of rifampicin (CAS 13292-46-1), isoniazid (CAS 54-85-3) and ethambutol (CAS 1070-11-7) from Myrin tablets (test preparation) with the bioavailability of these drugs from a combination of capsules containing rifampicin and tablets containing isoniazid and ethambutol (reference). There were 2 treatment periods and on clinic days volunteers were given either the reference (300 mig rifampicin plus 200 mg isoniazid and 600 mg ethambutol HCl), or the test preparation (300 mg rifampicin, 150 mg isoniazid and 600 mg ethambutol HCl). Serial blood samples were drawn from the volunteers and rifampicin, isoniazid and ethambutol assays were performed. The results of this study indicate that the test preparation is equivalent to the reference with respect to both the rate and the extent of absorption of rifampicin, isoniazid (after adjustment for the different doses of isoniazid and ethambutol).

Adolescent↗
PubMed2005

Comparative observation on the effects of Radix tripterygium hypoglaucum tablet and Tripterygium glycosides tablet in treating erosive oral lichen planus.

OBJECTIVE: To compare the therapeutic effects of Radix Tripterygium hypoglaucum tablet (THT) and Tripterygium glycosides tablet (TGT) in treating erosive oral lichen planus (EOLP). METHODS: The patients were randomized into two groups, and they were treated with THT (n = 47) or TGT (n = 47), respectively. The therapeutic effects were evaluated after 3 months treatment. RESULTS: For the patients of grade 1, the total efficacy in TGT group was 85.71%, compared with 52.38% in THT group, the efficacy was statistically greater in the group receiving TGT (P = 0.043). However, for the patients of grade 2, the difference was not statistically significant (P = 0.173). CONCLUSION: TGT is more effective in treating EOLP than THT for grade 1 patients. However, TGT is not suitable for patients of child bearing age.

Adult↗
PubMedDate not supplied

A multinational, multicentre, non-blinded, randomized study of moxifloxacin oral tablets compared with co-amoxiclav oral tablets in the treatment of acute exacerbation of chronic bronchitis.

The aim of this study was to compare the efficacy and safety of once daily dosing with moxifloxacin (BAY 12-8039) with that of coamoxiclav given three times daily for the treatment of acute exacerbation of chronic bronchitis (AECB). Moxifloxacin (one 400 mg tablet daily) was administered orally for 5 days and co-amoxiclav (three 625 mg tablets daily) was given orally for 7 days. The study was randomized, non-blinded, multinational (12 countries) and multicentre (68 centres). A total of 575 patients, all with clear signs of AECB, were treated, 292 with moxifloxacin and 283 with co-amoxiclav. Of these, 512 patients were evaluable for efficacy (261 in the moxifloxacin group and 251 in the co-amoxiclav group). The primary efficacy parameter was clinical response at 14 days in the evaluable population. A clinical success was classified as resolution or improvement of symptoms. Variables used to assess clinical response included wheeze, cough, dyspnoea, sputum volume, rales and rhonchi. The success rate for moxifloxacin in the evaluable patients was 96.2% and that for co-amoxiclav was 91.6%. The 95% confidence intervals for this difference (0.4%; 8.7%) indicate equivalence in the treatments. Sputum samples were taken from patients and 140 of these contained a pathogen, Haemophilus influenzae being the most frequently isolated. Moraxella catarrhalis and Streptococcus pneumoniae were also commonly isolated pathogens. The eradication rate at 14 days in the evaluable patients was 87.7% in the moxifloxacin group and 89.6% in the coamoxiclav group. Both drugs were well tolerated with no significant differences in the numbers of drug-related adverse events or the numbers of patients withdrawing because of an adverse event. These results and the broad spectrum of antibacterial activity make moxifloxacin a promising and safe alternative to conventional therapy for the empirical treatment of AECB.

Acute Disease↗
PubMed2003

[Acid-supressing capacity of omeprazole 20 mg tablets vs pantoprazole 20 and 40 mg tablets. A pilot study in volunteers].

OBJECTIVE: To compare the acid-supressing capacity of omeprazole (OZ) 20 mg tablets vs pantoprazole (PZ) 20 and 40 mg tablets, in healthy volunteers, with 24-h intragastric pH-metry. MATERIAL AND METHODS: Open, randomized, cross-over trial in 10 healthy volunteers; on days 0.8 and 22, 24-h intragastric pH-metry. Day 0, basal, thereafter 7 days with OZ or PZ 20 mg/day; day 8, pH-metry, then "wash out" for 7 days and thereafter 7 more days' therapy with PZ or OZ. On day 22 a 24-h intragastric pH control was performed again. In the last treatment stage, all of them were administered pantoprazole 40 mg/day for 8 days again with a 24-h pH recording at the end. RESULTS: 24-h pH-metry expressed as the time (hours) in which the pH was < or = 4 and the values as mean +/- standard deviation. BASAL 22.12 +/- 1.54, POST-OZ 9.78 +/- 6.72, POST-PZ 20 15.65 +/- 5.65, POST-PZ 40 8.57 +/- 5.93. Statistical evaluation with two way repeated measures ANOVA p < 0.0001. Newman Keuls post-hoc test: (1) vs (2) p < 0.003; (1) vs (3) p < 0.03; (2) vs (4) 0.65. CONCLUSIONS: According to the results it might be stated that both proton pump inhibitors have acid-supressing capacity and omeprazole in equal dosis is more effective than pantoprazole as acid-supressor, with statistically significative differences. There was no difference between 20 mg omeprazole and 40 mg pantoprazole.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1997

Therapeutic equivalence of diclofenac sustained-released 75 mg tablets and diclofenac enteric-coated 50 mg tablets in the treatment of painful osteoarthritis.

Efficacy and tolerability of diclofenac sustained-released (SR) 75 mg tablets taken b.i.d. were compared with that of enteric-coated diclofenac sodium 50 mg tablets given t.i.d. in a seven-day, randomised, double-blind, double-dummy, parallel groups study in 294 outpatients suffering from painful femorotibial or hip osteoarthritis. Primary efficacy criteria were spontaneous joint pain assessed on serial visual analogue scales during the first 36 hours and after 48 hours of treatment. The two treatments had equivalent efficacy since all the 90% confidence intervals of differences between means for pain intensity between the two groups were included within the interval (-10 mm; +10 mm). Rates of overall efficacy judged good to excellent ranged from 74.3-78.5% in both groups. One or more drug-related adverse events, mainly gastrointestinal, was reported by 24.5% and 27.2% of patients in diclofenac SR 75 mg and diclofenac 50 mg groups, respectively. Percentage of good compliance (i.e. > 90%) was higher with diclofenac SR 75 mg (p < 0.001).

Adolescent↗
PubMed1976

Comparative evaluation of tablet lubricants: effect of application method on tablet hardness and ejectability after compression.

The effect of four lubricants (stearic acid, magnesium stearate, calcium stearate, and talc) on the ejectability and hardness of statically compressed tablets of a lactose granulation was examined. Two methods of application of these lubricants, incorporation into the granulation and mixing with the granulation, were compared. In both methods, the energy consumption curves during ejection and the hardness curves with lubricant concentration were similar and showed complicated behavior at a lower concentration. The mixing method gave better results for ejectability and hardness than the incorporation method.

Drug Compounding↗
PubMed1990

Pharmacokinetic and pharmacodynamic comparison of an osmotic release oral metoprolol tablet and the metoprolol conventional tablet.

Four double-blind, Latin-square studies were conducted to compare the pharmacokinetics and pharmacodynamic bioavailability of metoprolol OROS (oral osmotic) and the conventional tablet (CT) of metoprolol. Metoprolol OROS (7/95 mg or 14/190 mg) was administered once daily in doses equivalent to 100 mg of metoprolol CT given once, twice, thrice, and four times a day. In all four studies, lower peak plasma concentrations and longer times to peak were observed after metoprolol OROS than after metoprolol CT, indicating a controlled-release profile for metoprolol OROS. beta-Adrenergic blockade, as measured by reductions in exercise heart rate, was lower after metoprolol OROS than after metoprolol CT, but metoprolol OROS provided a smoother and more sustained beta-blockade. All four doses of metoprolol OROS at steady state produced relative pharmacodynamic bioavailability that ranged from 87% to 104% of that produced by equivalent doses of metoprolol CT.

Administration, Oral↗
PubMed1998

Associations of parameters characterizing the time course of the tabletting process on a reciprocating and on a rotary tabletting machine for high-speed production.

A series of modern direct-compression excipients with differing mechanisms of deformation and densification, Karion Instant Pharma, Vivacel 200, Cellactose, Tablettose, and Parmcompress, after admixing magnesium stearate, have been tabletted (400 mg, 10 mm flat-faced punches) on an eccentric machine, Fette E XI at 43.6 rpm, and on a rotary machine, Fette PT 2090 at 20, 60, and 90 rpm, to graded maximum forces (3, 5, 10, 15 kN, respectively). Force/time (E XI and PT 2090) and displacement/time (E XI) curves were recorded. From the data on the E XI, parameters of a modified Weibull function, slopes of the Heckel function, quotients of partial areas under the curves, and the differences between times of maximum forces and the respective maximum densifications, t(diff), were calculated. From the data on the PT 2090, partial areas under the curves for the upper punch, various quotients of these areas, and the peak-offset times, t(off), the times of maximum force relative to the middle of the dwell time, t(dwell), were calculated. Close associations were found between the area A1 reI during the precompression phase (PT 2090) and the Heckel slope (E XI), between the quotient of partial areas before and after the middle of t(dwell) (PT 2090) and that of partial areas before and after maximum densification (E XI), and between t(off) (PT 2090) and t(diff) (E XI). However, certain materials (e.g. Karion Instant, Vivacel) showed marked deviations in behavior by particular parameters on the two machines. The results from both machines with respect to densification behavior complement one another.

Chemistry, Pharmaceutical↗
PubMed2004

Gastrointestinal tolerability of extended-release metformin tablets compared to immediate-release metformin tablets: results of a retrospective cohort study.

OBJECTIVE: Metformin, a biguanide antihyperglycemic medication, lowers blood glucose in patients with type 2 diabetes with minimal risk of hypoglycemia. Most common side effects include diarrhea, nausea and vomiting. Extended-release metformin (Glucophage XR)*, a once-daily tablet using the patented GelShield Diffusion System release mechanism, may be better tolerated than immediate-release metformin (Glucophage). This retrospective chart review examined the overall gastrointestinal (GI) tolerability of both formulations. RESEARCH DESIGN AND METHODS: Patient charts were reviewed and data were collected from October 2001 to May 2002. Adult patients with type 2 diabetes started on extended-release metformin (metformin-XR) or switched from immediate-release metformin to metformin-XR within the previous 2 years were eligible for inclusion in the metformin-XR cohort. Patients started on immediate-release metformin within the previous 2 years were eligible for inclusion in the immediate-release metformin cohort. Previous experience of GI side effects while taking immediate-release metformin did not prevent inclusion in either cohort, though patients with significant underlying GI disease or moderate to severe hepatic or renal impairment were excluded. GI tolerability was assessed during the first year of treatment with immediate-release metformin or metformin-XR. Primary endpoints were overall GI tolerability and frequency of diarrhea during the first year of treatment. RESULTS: A total of 471 patients' charts were reviewed and data were collected from four diabetes clinics; 310 (metformin-XR) and 158 (immediate-release metformin) eligible patients were included. Patients were, on average, 56 years old, and overweight (mean body mass index 33 kg/m2). The majority of patients were Caucasian (50%), Hispanic (24%) or Black (19%). Mean daily doses were 1258 mg (range 500-2500 mg) for metformin-XR and 1282 mg (range 500-2550 mg) for immediate-release metformin. About 25% of the metformin-XR cohort had been switched from immediate-release metformin due to a history of GI adverse events (AE). Despite this, the frequency of any GI AE was similar between metformin-XR and immediate release metformin (11.94 vs. 11.39%, p = 0.86). The incidence of individual GI AE also did not differ significantly between cohorts. In a cohort of 205 patients started on immediate-release metformin and switched to metformin-XR, the frequency of any GI AE was 26.34% (while taking immediate release metformin; n = 205) vs. 11.71% (after switching to metformin-XR; n = 205) (p = 0.0006) and the frequency of diarrhea was 18.05% (while taking immediate-release metformin) vs. 8.29% (after switching to metformin-XR) (p = 0.0084). CONCLUSIONS: In this retrospective chart review, patients switched from immediate-release metformin to metformin-XR experienced fewer GI side effects on comparable doses of the extended-release metformin.

Administration, Oral↗
PubMed1992

[Examination of anti-emetic effect, safety and usefulness of single oral dose of ondansetron tablet in nausea and emesis induced by anti-cancer drugs--dose-finding study of ondansetron tablet in patients receiving non-platinum anti-cancer drugs].

Inhibitory effects on acute nausea and emesis, safety and usefulness of a single oral dose of Ondansetron tablet were evaluated in 3 different dose levels for comparison by telephone registration system, in patients receiving non-platinum anti-cancer drugs. A single dose of ondansetron at 4 mg, 8 mg or 12 mg was given orally at 2 hrs before the initial administration of anti-cancer drugs. The patients were observed for 24 hours after administration of anti-cancer drugs, for occurrence of nausea and emesis. Efficacy rates of inhibitory effects on nausea and emesis were 83.3% (10/12 cases) in 4 mg dose group, 78.6% (11/14 cases) in 8 mg dose group and 84.6% (11/13 cases) in 12 mg dose group, without statistically significant difference. Side effects were observed in 3 cases (headache, cold feeling and trembling in limbs, sleepiness) in 12 mg dose group, but these symptoms were not severe and disappeared after several hours or several days. No abnormality in clinical laboratory findings attributable to Ondansetron was observed. From the above, it was considered that Ondansetron was a clinically useful anti-emetic for nausea and emesis induced by non-platinum anti-cancer drugs and that 4 mg once daily was the optimal dose.

Administration, Oral↗
PubMed1992

The bioavailability of morphine in controlled-release 30-mg tablets per rectum compared with immediate-release 30-mg rectal suppositories and controlled-release 30-mg oral tablets.

The bioavailability of controlled-release morphine 30-mg tablets (MSC) administered orally or rectally and immediate-release morphine (RMS) 30-mg suppositories per rectum, was compared in this 14-subject, randomized, single-dose, analytically blinded, crossover study. Rectal MSC plasma morphine area under the curve from 0-24 hours (AUC0-24) was 50.8% of RMS and was similar for MSC administered by either route (rectal MSC = 90% oral MSC). Rectal MSC had a significantly delayed time to peak plasma level (5.4 vs 1.07 and 2.5 hrs for rectal MSC vs RMS and oral MSC, respectively) and a significantly attenuated time to maximum concentration (6.1 vs 25.4 and 9.7 ng/ml, respectively). Proctoscopy 24 hours after insertion revealed seven instances of mild, transient mucosal erythema or edema with rectal MSC and 12 with RMS. The number of nonlocal adverse effects was 14 with rectal MSC, 19 with RMS, and 18 with oral MSC. Further studies must determine the therapeutic consequences of pharmacokinetic differences and establish guidelines for rectal MSC use. The product is currently not recommended by the manufacturer for rectal administration.

Administration, Oral↗
PubMed1991

[The solubility kinetics of enteric-resistant tablets using riboflavin test tablets. 6. Pharmaceutic-technologic and analytic studies on gastric juice-resistant dosage forms].

To examine the dissolution kinetics of enteric coatings in vivo a test system with riboflavine was developed. This system allows to realize the beginning of disintegration in the small gut because riboflavine is excreted in urine already within 1 h after ingestion, and to locate the area of dissolution of the tablet in vivo, because riboflavine absorption is reduced in the great gut and colon. Thus the test system allows to examine and improve coating compositions in vivo and to demonstrate changes of drug dissolution in vivo conditioned by storage of enteric coated pharmaceuticals.

Chemistry, Pharmaceutical↗
PubMed1982

A comparative trial of a controlled-release iron tablet preparation ('Ferrocontin' Continus) and ferrous fumarate tablets.

A single-blind, crossover comparative study was carried out in 40 patients with iron deficiency anaemia to assess the clinical efficacy and tolerance of once daily treatment with a controlled-release preparation of ferrous glycine sulphate ('Ferrocontin' Continus) and ferrous fumarate. Patients were allocated at random to receive 1 tablet (equivalent to 100 mg elemental iron) daily of one or other preparation for 4 weeks and were then crossed over to the alternative preparation for a further 4 weeks. The results showed that the significant increases in haemoglobin, packed cell volume and mean corpuscular volume were similar with both preparations. Seventeen patients reported gastro-intestinal side-effects on one or both preparations and the incidence was slightly less in patients whilst receiving the ferrous glycine sulphate preparation. In 3 patients, side-effects were sufficiently severe whilst taking ferrous fumarate to warrant interruption of treatment in 2 and withdrawal from the study in the other.

Adult↗
PubMed1980

[The dynamics of the drug release from tablets. Part 7: Comparison of three liberation models on Cholestil tablets (author's transl)].

The liberation of hymecromone from Cholestil tablets (0.2 g) has been determined by three procedures; half-change method, stationary-basket method, and rotating-basket method. The release rate was highest when determined by the rotating-basket method. The other two methods yielded comparable, but considerably lower values. Artificial gastric and intestinal juices according to the Polish Pharmacopoeia IV have been used in this study.

Chemistry, Pharmaceutical↗