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PubMedDate not supplied

Efficacy and safety of reformulated, micronized glyburide tablets in patients with non-insulin-dependent diabetes mellitus: a multicenter, double-blind, randomized trial.

The subjects were 206 patients (123 men, 83 women) with non-insulin-dependent diabetes mellitus, aged 33 to 80 years. For at least 4 weeks prior to the study each subject had been taking 5-mg tablets of original, nonmicronized glyburide (Micronase tablets) in doses of 5, 10, 15, or 20 mg daily. In a double-blind 12-week study, the subjects were randomly assigned to continue receiving 5-mg tablets of original glyburide or to substitute 3-mg tablets of reformulated, micronized glyburide (Glynase PresTab tablets) for the original tablets. Glyburide tablets had been reformulated to improve their bioavailability. Baseline mean fasting serum glucose levels in the groups taking reformulated and original glyburide were 169.3 and 168.3 mg/dl, respectively; at study end point, their respective serum glucose levels were 186.0 and 177.0 mg/dl. The differences between groups were not significant; in both groups, however, end point glucose levels were significantly higher than baseline levels. Baseline hemoglobin A1C levels in the groups taking reformulated and original glyburide were both 7.6%; at study end point, hemoglobin A1C levels had improved slightly in each group to 7.4% and 7.5%, respectively. The differences between and within groups at end point were not significant. No between-group differences at baseline or at end point were found in mean levels of postprandial serum glucose, fasting C-peptide, or postprandial C-peptide. Medical events experienced by the subjects in the two groups were similar in nature and number. Changes in other laboratory test results, vital signs, and weight were not clinically meaningful.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1996

Comparison of the effects of ranitidine effervescent tablets and magnesium hydroxide-aluminium oxide on intragastric acidity. A single-centre, randomised, open cross-over study.

In previous studies measuring intragastric pH in healthy volunteers it was shown that there was a faster onset of action with ranitidine (CAS 66357-35-5) 300 mg effervescent tablets (Zantac) compared to standard tablets. In a single-centre, randomised, open cross-over study the pH-values obtained over 6 h following the administration of one ranitidine 150 mg effervescent tablet were compared with those after aluminium oxide-magnesium hydroxide (algeldrate, CAS 1330-44-5, Al-Mg-hydroxide) 10 ml and placebo in healthy volunteers. 24 healthy male subjects between 19 and 32 years of age entered the study, 19 subjects were available for all three measurements. After an overnight fast, intragastric pH was monitored for 7 h using a glass electrode and a digital data recorder. The time in % during which the pH was > or = 3.5 and the area under the curve of the obtained pH-curves were compared. There was a highly statistically significant difference between ranitidine effervescent tablets versus Al-Mg-hydroxide and placebo whereas there was no such difference between Al-Mg-hydroxide and placebo. The onset of action of ranitidine effervescent tablets was almost immediate. It is concluded that there was a clear superiority of ranitidine effervescent tablets in healthy volunteers and it is suggested that pH-metry in patients with acidity-related diseases should be investigated for a better understanding of the function of effervescent tablets.

Adult↗
PubMed1997

[Clinical evaluation of 2-mg granisetron tablet for nausea and vomiting induced by anticancer drugs including cisplatin].

The antiemetic effects on nausea and vomiting induced by anticancer drugs and safety of a 2-mg granisetron tablet were studied in cancer patients, particularly in the field of gynecology, who had been treated with anticancer drugs including cisplatin (CDDP) at 50 mg/m2 or more. The 1-mg granisetron tablet is already commercially available and used widely in clinical practice by oral administration of two tablets per dosage. In this investigation, the clinical efficacy, safety and usefulness of a 2-mg tablet, which can be taken more easily, were studied. The 2-mg granisetron tablet was judged to be "remarkably effective" or "effective" for nausea and vomiting in 22 (66.7%) of 33 patients. For safety, neither adverse experiences nor abnormal laboratory values were judged to be of clinical significance. The 2-mg granisetron tablet was considered "extremely useful" or "useful" in 22 (66.7%) of 33 patients. The above results confirmed the excellent antiemetic effect on nausea and vomiting induced by anticancer drugs including CDDP and the high degree of safety of a 2-mg granisetron tablet.

Adult↗
PubMedDate not supplied

Accuracy of tablet splitting.

We attempted to determine the accuracy of manually splitting hydrochlorothiazide tablets. Ninety-four healthy volunteers each split ten 25-mg hydrochlorothiazide tablets, which were then weighed using an analytical balance. Demographics, grip and pinch strength, digit circumference, and tablet-splitting experience were documented. Subjects were also surveyed regarding their willingness to pay a premium for commercially available, lower-dose tablets. Of 1752 manually split tablet portions, 41.3% deviated from ideal weight by more than 10% and 12.4% deviated by more than 20%. Gender, age, education, and tablet-splitting experience were not predictive of variability. Most subjects (96.8%) stated a preference for commercially produced, lower-dose tablets, and 77.2% were willing to pay more for them. For drugs with steep dose-response curves or narrow therapeutic windows, the differences we recorded could be clinically relevant.

Adult↗
PubMed1982

Effect of food on the bioavailability and pattern of release of a sustained-release theophylline tablet.

The effect of food on the bioavailability, time to peak level, and pattern of release of a sustained-release theophylline preparation was examined in six normal volunteers. The average bioavailability for the 100- and 300-mg tablets was 98 +/- 0.03% (S.E.M.). This is consistent with previously published data. Food decreased measured theophylline concentration during the first 4 hours for the 100-mg tablets and at the fourth-hour sample following the 300-mg tablets. The decreased rate of absorption resulted in a shift of the absorption curve to the right with a delay in the time to peak level. Peak serum concentrations for tablets given with a meal occurred 6 hours after the 100-mg tablets and 8 hours after the 300-mg tablets, as opposed to 4 and 6 hours, respectively, for tablets in the fasting state. The release pattern of the theophylline preparation approximated zero-order kinetics for all fasting and food treatments.

Adult↗
PubMed1995

Clinical equivalence of two tablet formulations of felodipine. A placebo-controlled study of 24-hour blood pressure control and tolerability.

OBJECTIVE: This study was performed to assess whether a new formulation of felodipine extended release (FER) tablets with a 9 mm diameter is similar to the presently used 11 mm diameter FER formulation with respect to antihypertensive effect and tolerability in patients with essential hypertension. A randomised, double-blind, placebo controlled, three-way cross-over study design was used. PATIENTS: Twenty-four patients with a supine diastolic blood pressure (DBP) of 95-115 mmHg after a 4-week placebo run-in period were given FER 5 mg 9 mm tablets, FER 5 mg 11 mm tablets and placebo in randomised order. The tablets were given once daily and each double-blind treatment period lasted for two weeks. METHODS: Twenty-four hour ambulatory blood pressure monitoring was performed at the end of each treatment period. The primary effect variable was mean DBP over 24 hours. Nineteen patients had 24-hour blood pressure data valid for analysis using an analysis of variance with patient, treatment, period and carry-over as factors. RESULTS: Both formulations of FER 5 mg tablets significantly reduced the mean 24-hour DBP compared to placebo. The 9 and 11 mm tablets resulted in, on average, 4.7 and 3.4 mmHg lower mean 24-hour DBP than placebo. There was, however, no significant difference between the two different FER formulations. Both FER formulations were well tolerated and similar to placebo in this respect. CONCLUSION: Both FER 5 mg tablet formulations (9 and 11 mm diameter), given once daily, were clinically equivalent with respect to antihypertensive effect and tolerability in patients with mild to moderate essential hypertension.

Adolescent↗
PubMed1996

Development of calcitonin gene-related peptide slow-release tablet implanted in CSF space for prevention of cerebral vasospasm after experimental subarachnoid haemorrhage.

The calcitonin gene-related peptide (CGRP), a known potent intrinsic cerebral vasodilator, is contained in the sensory nerves from trigeminal ganglia that inervate the cerebral arteries. We previously reported that human alpha CGRP (hCGRP) dilates spastic cerebral arteries after experimental subarachnoid haemorrhage (SAH) in rabbits. In the present study, we investigated the prophylactic potential of a sustained higher cerebrospinal fluid level of hCGRP against experimental cerebral vasospasm. An hCGRP slow-release tablet (hCGRP s-r tablet) was developed for cisternal implantation. Experimental SAH was induced by percutaneous cisternal injection of autologous arterial blood. Angiography was initiated on day 1 (before SAH) and performed everyday. The hCGRP s-r tablet was implanted into the cisterna magna on day 2 in the treated groups. The spastic response of the basilar artery was maximized on day 4 in the non-treated (80.7% of day 1) and the placebo-treated (79.3%) groups. In contrast, the arterial diameters on day 4 were 96.1% and 90.5% of day 1 in the groups implanted with hCGRP 24 micrograms and 153 micrograms s-r tablets, respectively. We also measured the concentration of hCGRP in the cerebrospinal fluid (CSF) following implantation of the hCGRP 24 micrograms s-r tablet in the cisterna magna. The hCGRP concentration before implantation was below the dectable level. Following implantation, the hCGRP level in the CSF was 23.12 nmol/L on the second day and remained at elevated levels until the fifth day. These experiments suggest that the intrathecal single implantation of the hCGRP s-r tablet could produce an elevated concentration of hCGRP in the CSF over five days and have prevented the cerebral vasospasm after SAH in the rabbit. The hCGRP s-r tablet may be clinically applicable in the treatment of patients with SAH against cerebral vasospasm.

Animals↗
PubMed2006

Impurity profiling of ecstasy tablets seized in Hong Kong by gas chromatography-mass spectrometry.

In Hong Kong, ecstasy tablets are more commonly known as "Fing Tau Yuen", literally meaning "Shake Head Pills". The tablets contain mainly amphetamine-type stimulants (ATS) including 3,4-methylenedioxymethamphetamine (MDMA), 3,4-methylenedioxyamphetamine (MDA), methamphetamine (MA) and/or ketamine. Adulterant such as caffeine was also detected in the tablets. This paper reports a study on the impurity profiles of ecstasy tablets from 89 seizures in Hong Kong from 2002 to early 2004. Tablet samples were extracted by diethyl ether under alkaline condition and then analyzed by gas GC-MS. The chromatograms obtained were compared. A total of 19 identified impurities were selected as markers for impurity profiling. They are different precursors, intermediates and by-products. The data matrices were examined by hierarchical cluster analysis (HCA), and then the ecstasy tablets were classified into different groups. Cluster analysis of ecstasy tablets is shown to be capable of providing intelligence on clandestine laboratory networks.

Journal Article↗
PubMed2006

Characteristics and trends of 3,4-methylenedioxymethamphetamine (MDMA) tablets found in Taiwan from 2002 to February 2005.

One hundred and eighty-one 3,4-methylenedioxymethamphetamine (MDMA) containing tablets were sampled from confiscated drugs received by the Taiwan National Bureau of Controlled Drugs for testing from 2002 to February 2005. Sample tablets demonstrated various colors and logos. The appearances, contents of MDMA and other components in these tablets were analyzed in order to understand the characteristics and trends of MDMA use. Samples were analyzed using GC-MS methodology. Deuterated internal standards were used for drug quantification. The MDMA contents varied from 16 to 193 mg/tablet. 66-71% of the tablets seized each year contained only MDMA, and the content of MDMA in MDMA only tablets varied from 89 to 133 mg/tablet. There was a decreasing trend in MDMA content in these tablets over time. Other components commonly found besides MDMA included caffeine (18%), methamphetamine (7%), 3,4-methylenedioxyethylamphetamine (MDEA) (7%) and amphetamine (4%). 3,4-Methylenedioxyamphetamine (MDA), ketamine, ephedrine, diazepam, chlorzoxazone and nicotinamide were also detected. During the study period, the number of other drugs found as well as the combinations of different drugs detected in these tablets increased.

Journal Article↗
PubMed2000

Pharmacokinetic comparison of oral solution and tablet formulations of citalopram: a single-dose, randomized, crossover study.

BACKGROUND: Citalopram tablets fulfill most dosing needs in the treatment of depression, but some patients may have difficulty swallowing tablets and thus may be less likely to comply with their medication regimen. A liquid formulation of citalopram could be beneficial for such patients. OBJECTIVE: This study was undertaken to compare the pharmacokinetic profiles of oral solution and tablet formulations of citalopram in healthy volunteers. METHODS: In this open-label, single-dose, randomized, crossover, bioequivalence study, healthy volunteers alternately received one 60-mg dose of citalopram as an oral solution (10 mg/5 mL) and one 60-mg dose as a tablet. Doses were separated by a 14-day interval. RESULTS: Of 24 subjects enrolled (mean age 27 years), 24 (16 men and 8 women) received the citalopram oral solution and 23 (15 men and 8 women) received the tablet; 1 subject discontinued before receiving the tablet. Citalopram was rapidly absorbed, with peak plasma concentrations occurring at approximately 4 hours with both formulations. The rate and extent of absorption were similar between the 2 formulations, and no statistically significant differences were observed in half-life or oral clearance between formulations. Similarly, the pharmacokinetic profile for demethylcitalopram (the major metabolite of citalopram) did not differ between the 2 formulations. Both formulations were well tolerated, with no serious adverse events reported. CONCLUSION: The oral solution and tablet formulations of citalopram 60 mg were determined to be bioequivalent in this population.

Administration, Oral↗
PubMed1986

Clinitest tablet ingestion: an in vitro investigation concerned with initial emergency management.

To help establish a rational approach to the initial management of Clinitest tablet ingestion, we investigated the effect of number of tablets, volume of diluent, and type of diluent on dissolution time (TD), temperature generation (delta T), and pH. Dissolution time was independent of the number of tablets and the volume of fluid; however, it was dependent on the type of fluid used. The thermal generation (delta T) was dependent on the number of tablets and volume of fluid, but was independent of the type of fluid used. The pH changes were independent of the number of tablets and volume of fluid; however, they were greatly dependent on the type of fluid. These data suggest that dissolution is rapid (in seconds) and, therefore, the most effective intervention may occur shortly after ingestion of the tablets; the larger the volume of diluting fluid, the smaller the risk of thermal damage from these ingestions; and orange juice should be considered as a possible diluent because it is capable of reducing the pH of the Clinitest tablet without increasing thermal generation.

Animals↗
PubMed1991

In vitro and in vivo evaluation of whole and half tablets of sustained-release adinazolam mesylate.

The mechanism of release from sustained-release adinazolam mesylate tablets was assessed by the Higuchi equation and by analysis of drug release profiles through 60% released using the Peppas equation. Computed values of the diffusional exponent, n, ranged from 0.59 to 0.66. Values of n in this range are consistent with a mixed mechanism of release, with diffusion of drug through the hydrated polymer matrix and relaxation of this matrix being the principal processes controlling release. The rate of in vitro drug release was increased for half tablets relative to whole tablets and is attributed to an increase in the surface to volume ratio of half tablets of about 16%. This increase in surface-to-volume ratio of half tablets was reflected by an increase in the constant, k, from the Peppas equation of 20-23% and by an increase in the slope of Higuchi plots of 12-18% for four lots of tablets. In vivo/in vitro relationships from two bioavailability studies were thoroughly evaluated. Using either a linear or a quadratic relationship, an in vivo/in vitro correlation exists for sustained-release adinazolam mesylate tablets.

Adolescent↗
PubMed1995

Intra- and inter-subject variabilities of CGP 33101 after replicate single oral doses of two 200-mg tablets and 400-mg suspension.

PURPOSE: The purpose of this study was to use a replicate designed trial to assess the overall, intra- and inter-subject variabilities in pharmacokinetic parameters of CGP 33101 after oral administration of tablets relative to that of powder suspended in water, and to determine the relative proportion of the intra-subject variance to the overall variability. METHODS: Sixteen healthy subjects were randomly assigned to four groups to receive tablets and suspension twice in four different treatment sequences. The plasma concentration-time profile of CGP 33101 was characterized in terms of Cmax, Tmax, and AUC. Bioavailability of tablets relative to suspension and intra- and inter-subject variability were assessed by statistical analysis. RESULTS AND CONCLUSIONS: The overall variabilities in absorption kinetics of CGP 33101 in healthy subjects were small with CV's of the population mean values for AUC and Cmax less than 26% for both tablets and suspension. Contribution of intra-subject variability to the overall variability was also small (approximately 20%). Both the overall and intra-subject variabilities of AUC and Cmax after suspension were larger than after the tablets. However, the differences in variability between tablets and suspension were not statistically significant (p > 0.05). The tablet formulation was bioequivalent to suspension in terms of rate and extent of absorption based on 90% conventional confidence intervals (for AUC and Cmax) and Wilcoxon rank-sum test (for Tmax).

Administration, Oral↗
PubMed1993

The influence of thermal treatment on the physical-mechanical and dissolution properties of tablets containing poly(DL-lactic acid).

Five molecular weight grades of poly(DL-lactic acid) (PLA) were incorporated as organic and aqueous pseudolatex binders into matrix tablet formulations containing microcrystalline cellulose and the model drug theophylline. The tablets were thermally treated to temperatures above and below the glass transition temperature (Tg) of the PLA. The results of the dissolution studies showed that thermally treating the tablets to temperatures above the Tg of the PLA significantly retarded the matrix drug release compared to tablets which were not thermally treated. The retardation in drug release could be attributed to a stronger compact and a more efficient redistribution of polymer throughout the tablet matrix, based on fundamental principles of annealing. In addition, results from tablet index testing supported the dissolution results. The bonding index of the compact formulations increased after thermal treatment above the Tg of the PLA. Gel permeation chromatography and differential scanning calorimetry studies demonstrated that thermal treatment had no significant effect on the molecular weight and the glass transition temperature of (PLA) alone and in combination with other components of the tablet formulation.

Calorimetry, Differential Scanning↗
PubMed2002

Safety and efficacy of two reduced dosing regimens of sodium phosphate tablets for preparation prior to colonoscopy.

OBJECTIVES: To evaluate the safety and efficacy of two reduced dosing regimens of sodium phosphate tablets (Visicol, InKine Pharmaceutical Co. Inc., Blue Bell, PA, USA) for colon cleansing prior to colonoscopy. METHODS: In a randomized, multicentre, endoscopist-blinded clinical study, adults undergoing colonoscopy received either 28 tablets (42 g) or 32 tablets (48 g) of sodium phosphate for colon cleansing. The endoscopist used a validated four-point scale to rate the overall quality of colon cleansing, as well as cleansing in the ascending colon. Adverse events were collected and evaluated. RESULTS: The quality of overall colon cleansing was 'excellent' or 'good' in 84% or more of both groups, with no significant difference between the two doses. No patient had a preparation rated as 'inadequate' or required a repeat procedure. All patients were able to complete the assigned dose of tablets, and there were no deaths, serious adverse events or dropouts from the study. CONCLUSIONS: A reduced tablet regimen for sodium phosphate tablets, using either 28 or 32 tablets, is well tolerated and effective for colon cleansing prior to colonoscopy.

Cathartics↗
PubMed2000

Reduction of tobacco withdrawal symptoms with a sublingual nicotine tablet: a placebo controlled study.

Many smokers are unable to use gum as a cessation aid due to fillings, bridgework and dyspepsia or they reject it for esthetic reasons. The nicotine sublingual tablet is a new alternative to the nicotine polacrilex chewing gum that does not necessitate chewing. Twenty subjects used 2-mg sublingual nicotine tablets and placebo in a double-blind randomized crossover study of 2-day smoke-free periods. Craving and other withdrawal symptoms were rated on 100-mm visual analog scales (VAS) nine times over each 2-day period. Plasma nicotine concentrations in the afternoon of each study day were determined. A blood sample was also taken in the afternoon of a 2-day period with normal smoking. The mean number of nicotine tablets was 10 and seven on days 1 and 2, respectively. The corresponding number for placebo tablets was six and five. No subject used less than five tablets on any study day. The degree of nicotine substitution, defined as the quotient between the plasma levels achieved with the sublingual tablet and smoking, was 43, 30 and 23% for smokers with FTQ < or = 6, FTQ = 7 and FTQ > or = 8 (Fagerström Tolerance Questionnaire), respectively. Active treatment was significantly superior in decreasing craving and other withdrawal symptom scores compared to placebo treatment. Mean total scores were reduced by approximately 50%. Adverse events were mainly symptoms of local irritation such as a burning sensation in the throat or under the tongue, a lump in the throat and heartburn. These results demonstrate partial relief of the tobacco withdrawal syndrome with use of the sublingual tablet similar to that achieved from other forms of nicotine replacement.

Administration, Sublingual↗
PubMed2001

Abuse of Coricidin HBP cough & cold tablets: episodes recorded by a poison center.

Cases involving ingestion of a dextromethorphan-containing product recorded at a poison control center were studied. A retrospective review of all consultations involving the ingestion of Coricidin HBP Cough & Cold tablets recorded by the California Poison Control System was conducted for the period from January 1 to October 1, 2000. Computerized charts on the consultations were reviewed to obtain data on patient age and sex, number of tablets taken, reason for tablet ingestion, symptoms, treatment, disposition, and outcome. A total of 92 charts (for 92 patients) documenting Coricidin HBP Cough & Cold tablet ingestion were reviewed. The reason for tablet ingestion was classified as abuse in 65 patients (71%), a suicide attempt in 8 (9%), misuse in 1 (1%), malicious administration in 1 (1%), and normal use (but with an adverse drug reaction) in 1 (1%); 16 patients (17%) consumed the tablets for an unknown reason. The 92 patients comprised 42 males and 50 females. Among all patients, 78 (85%) were 13-17 years old, and among those classified as having abusive intent, 58 (89%) were in the same age range. The most commonly reported signs and symptoms associated with ingestion were tachycardia (50 patients), hypertension (29), lethargy (40), mydriasis (20), agitation (15), ataxia or dizziness (20), and vomiting (9). Sixty-one patients (66%) had some alteration in mental status. Fifty-six (61%) were treated in the emergency department; 11 (12%) were admitted. All patients recovered completely. Information on the ingestion of Coricidin HBP Cough & Cold tablets recorded at a poison control center indicated a high rate of abuse of the product among teenagers.

Adolescent↗
PubMed1995

Effect of Food on the Multiple-Peak Behavior After a Single Oral Dose of Diclofenac Sodium Slow-Release Tablet in Humans.

This study evaluated the effect of a standard meal on the multiple-peak behavior of diclofenac sodium following oral administration of a 100-mg slow-release (SR) wax-matrix tablet. The study was a randomized, 3 × 3 Latin-square trial balanced for residual effects, in which 18 subjects were randomly assigned to treatment sequences consisting of three treatments: (A) one 100-mg SR tablet, fasted; (B) one 100-mg SR tablet, fed; and (C) 100-mg diclofenac sodium buffered aqueous solution, fasted. Blood samples were obtained over a 24-h period for Treatments A and B, and over an 8-h period for Treatment C. Food did not significantly affect the extent of absorption but generally delayed the onset of absorption from the SR tablet. The plasma concentration-time profile for the SR tablet under fasted conditions was characterized by multiple-peak behavior. Under fed conditions, the SR tablet showed a more consistent absorption pattern, with a single peak occurring usually between 5 and 6 h. The concentration-time profile of the buffered aqueous solution showed a very rapid absorption phase followed by a rapid decline and a terminal elimination half-life of approximately 1.8 h. A single peak was observed following the buffered aqueous solution. This observation, in conjunction with evidence from other studies, leads to the conclusion that gastrointestinal pH may be responsible for the multiple-peak behavior observed following diclofenac sodium dosing. As compared to the solution, the was-matrix tablet under both fasted and fed conditions showed slow-release, characteristics.

Journal Article↗