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PubMedDate not supplied

The effect of omeprazole pre-treatment on rafts formed by reflux suppressant tablets containing alginate.

Alginate-based reflux suppressant preparations provide symptom relief by forming a physical barrier on top of the stomach contents in the form of a neutral floating gel or raft. This study investigated whether reduced acidity in the stomach brought about by omeprazole pre-treatment affected the formation and gastric residence time of alginate rafts. It was a balanced, cross-over study in 12 healthy non-patient volunteers following a single dose of two indium-111-labelled alginate tablets in the presence or absence of 3 days' pre-treatment with omeprazole. Raft formation and gastric residence, in the presence of a technetium-99m-labelled meal, were assessed by gamma scintigraphy for 3 h after alginate tablet administration. The relative raft-forming ability of alginate tablets after omeprazole compared with alginate tablets alone was 0.950 with 95% confidence intervals of 0.882 and 1.018. Pre-treatment and co-administration with omeprazole has no significant effect on the raft-forming ability of alginate tablets.

Adult↗
PubMed2004

Bioequivalence of ximelagatran, an oral direct thrombin inhibitor, as whole or crushed tablets or dissolved formulation.

OBJECTIVE: To investigate whether crushed or dissolved tablets of the oral direct thrombin inhibitor ximelagatran are bioequivalent to whole tablet administration. Ximelagatran is currently under development for the prevention and treatment of thromboembolic disorders. RESEARCH DESIGN AND METHODS: This was an open-label, randomised, three-period, three-treatment crossover study in which 40 healthy volunteers (aged 20-33 years) received a single 36-mg dose of ximelagatran administered in three different ways: I swallowed whole, II crushed, mixed with applesauce and ingested and III dissolved in water and administered via nasogastric tube. RESULTS: The plasma concentrations of ximelagatran, its intermediates and the active form melagatran were determined. Ximelagatran was rapidly absorbed and the bioavailability of melagatran was similar after the three different administrations, fulfilling the criteria for bioequivalence. The mean area under the plasma concentration-versus-time curve (AUC) of melagatran was 1.6 micromol.h/L (ratio 1.01 for treatment II/I and 0.97 for treatment III/I), the mean peak concentration (C(max)) was 0.3 micromol/L (ratio 1.04 for treatment II/I and 1.02 for treatment III/I) and the mean half-life (t(1/2)) was 2.8 h for all treatments. The time to C(max) (t(max)) was 2.2h for the whole tablet and approximately 0.5 h earlier when the tablet was crushed or dissolved (1.7-1.8 h), due to a more rapid absorption. The study drug was well tolerated as judged from the low incidence and type of adverse events reported. CONCLUSION: The present study showed that the pharmacokinetics (AUC and C(max)) of melagatran were not significantly altered whether ximelagatran was given orally as a crushed tablet mixed with applesauce or dissolved in water and given via nasogastric tube.

Adult↗
PubMed1984

Pharmacokinetics of an oral frusemide/amiloride combination tablet.

A randomized four-way crossover study was carried out in 12 healthy volunteers to investigate the pharmacokinetics of a new oral combination of frusemide (40 mg) and amiloride (5 mg), formulated as a single tablet. The experimental design of this bioequivalence study used commercially-available 40 mg frusemide tablets and 5 mg amiloride tablets as reference drugs, administered either separately or concomitantly. From a statistical analysis of plasma levels of frusemide and amiloride, no significant differences between the reference drugs alone and the combination tablet were seen in peak plasma levels, mean times to peak or mean areas under the plasma concentration-time curves (AUCs). The ratio of AUCs of the combination tablet to the reference drugs approached a limiting value many hours prior to complete elimination of the drug and hence reliable bioavailability comparisons were possible with blood sampling up to 24 hours post-dose.

Administration, Oral↗
PubMed2002

Mucoadhesive vaginal tablets as veterinary delivery system for the controlled release of an antimicrobial drug, acriflavine.

The aim of the study was the development of mucoadhesive vaginal tablets designed for the local controlled release of acriflavine, an antimicrobial drug used as a model. The tablets were prepared using drug-loaded chitosan microspheres and additional excipients (methylcellulose, sodium alginate, sodium carboxymethylcellulose, or Carbopol 974). The microspheres were prepared by a spray-drying method, using the drug to polymer weight ratios 1:1 and 1:2 and were characterized in terms of morphology, encapsulation efficiency, and in vitro release behavior, as MIC (Minimum Inhibitory Concentration), MBC (Minimum Bacterial Concentration), and killing time (KT). The tablets were prepared by direct compression, characterized by in vitro drug release and in vitro mucoadhesive tests. The microparticles have sizes of 4 to 12 microm; the mean encapsulation yields are about 90%. Acriflavine, encapsulated into the polymer, maintains its antibacterial activity; killing time of the encapsulated drug is similar to that of the free drug. In vitro release profiles of tablets show differences depending on the excipient used. In particular Carbopol 974, which is highly cross-linked, is able to determine a drug-controlled release from the matrix tablets for more than 8 hours. The in vitro adhesion tests, carried out on the same formulation, show a good adhesive behavior. The formulation containing microspheres with drug to polymer weight ratios of 1:1 and Carbopol 974 is characterized by the best release behavior and shows good mucoadhesive properties. These preliminary data indicate that this formulation can be proposed as a mucoadhesive vaginal delivery system for the controlled release of acriflavine.

Acriflavine↗
PubMedDate not supplied

Exploring patient reactions to pen-tablet computers: a report from CaReNet.

PURPOSE: We wanted to study patient receptivity to using pen-tablet computers for collecting data in a practice-based research network. METHODS: We analyzed exit interviews and field notes collected by trained research assistants as part of a larger Colorado Research Network (CaReNet) study comparing pen-tablet and paper-pencil methods to collect data for the Primary Care Network Survey (PRINS). RESULTS: A total of 168 patients completed a patient exit interview after completion of the pen-tablet-based survey instrument. Analyses of these brief interviews and field notes indicated that patients had favorable reactions to using pen-tablet computers. The most common barriers were related to glitches in the technology; the voice recognition software was the most problematic, with patients (as well as clinicians) finding this feature to be frustrating. CONCLUSIONS: Patients were able and willing to use pen-tablet computers for completing forms within busy primary care offices. Increasing patient involvement in practice-based research may be even more practicable through the use of this novel technology, which can allow patient-directed data collection at a single point in time as well as longitudinally.

Attitude to Computers↗
PubMed2005

Selegiline orally disintegrating tablets for the treatment of Parkinson's disease.

Selegiline orally disintegrating tablet is a potent, selective and irreversible inhibitor of monoamine oxidase type B. It is delivered in an innovative formulation that largely bypasses the gut and first-pass hepatic metabolism by allowing transbuccal absorption. Selegiline orally disintegrating tablet dissolves in the mouth within seconds and is rapidly absorbed directly into the systemic circulation, increasing parent drug bioavailability and lowering plasma metabolites compared with conventional oral formulations. Adding selegiline orally disintegrating tablet to levodopa in patients experiencing 'wearing-off' episodes significantly decreases off time and increases dyskinesia-free 'on' time. Adding selegiline orally disintegrating tablet to levodopa also significantly improves Unified Parkinson's Disease Rating Scale motor scores and patients' and physicians' ratings of disease severity. Selegiline orally disintegrating tablet has been demonstrated to be safe and well tolerated in placebo-controlled clinical trials.

Administration, Oral↗
PubMed2006

Long-lasting effects of a Bacillus thuringiensis serovar israelensis experimental tablet formulation for Aedes aegypti (Diptera: Culicidae) control.

Dengue is a growing public health problem in many tropical and subtropical countries worldwide. At present, the only method of controlling or preventing the disease is to eliminate its vector, Aedes aegypti (L.) (Diptera: Culicidae). In the current study, an experimental larvicide tablet formulation XL-47 based on Bacillus thuringiensis serovar israelensis (Bti) and containing 4.8% of technical powder was developed. This formulation was evaluated against Ae. aegypti in three different sets of experiments, under field-simulated conditions: two experiments were indoors and under partial sunlight exposure and one experiment was outdoors with sunlight exposure. Larvae were added throughout the experiment two times per week, and the residual larvicidal activity was recorded daily. Pupal formation was reduced in the containers with Bti by > 80% in relation to the containers without treatment for 12 wk; to our knowledge, this is the longest period of control reported for a Bti tablet formulation outdoors under sunlight exposure. Moreover, samples from the top, middle, and bottom of the water column were collected to perform bacterial plate counts and toxicity assays. The Bti population and the active ingredient of the tablet formulation remained mainly at the bottom of the containers and mosquito larvae reached the formulation by diving and shredding the tablet's material. In conclusion, the experimental tablet formulation XL-47 showed an inhibition of pupal formation that lasted for long periods under sunlight exposure.

Aedes↗
PubMed2004

Towards single-tablet therapy for type 2 diabetes mellitus. Rationale and recent developments.

Type 2 diabetes mellitus emerges as a result of multiple pathophysiologic changes. If the pharmacotherapy of type 2 diabetes should be tailored to the underlying pathophysiology, it would be necessary to use a combination of agents with complementary mechanisms of action. The two principal defects in type 2 diabetes are insulin deficiency and insulin resistance. Therefore, combining an insulin-providing agent with an insulin-sensitizing agent will augment the efficacy of current antihyperglycemic agents. This is the rationale for the development and marketing of sulfonylurea/metformin combination tablets.Randomized double-blind clinical trials have shown the safety and efficacy of these fixed combination tablets in both drug-naive individuals as well as in those individuals not achieving glycemic goals on sulfonylurea or metformin monotherapy. These studies have also shown that these tablets may be associated with better postprandial glycemic control compared with monotherapy. However, the risk of hypoglycemia is increased with the use of combination tablets, especially in drug-naive individuals with baseline glycosylated hemoglobins of <8.0%. Combining two insulin-sensitizing agents that have different mechanisms of action and that target different biochemical pathways, would also enhance efficacy. This can be accomplished by combining metformin with rosiglitazone or pioglitazone. The recently developed fixed formulation tablet of metformin/rosiglitazone is available for use as second-line therapy in individuals who have not reached their glycemic goals while on metformin. The advantages of combining several agents in one tablet include convenience and enhanced adherence to therapy. The main disadvantage is the loss of administration flexibility.

Diabetes Mellitus, Type 2↗
PubMed1991

Systemic or local treatment of erythrasma? A comparison between erythromycin tablets and Fucidin cream in general practice.

In a Danish multi-practice study the efficacy of erythromycin tablets (Abboticin 500 mg tablets), fusidic acid cream (Fucidin cream), and placebo was compared in 86 patients (71 men and 15 women) with erythrasma. The patients were treated 'double-blind' for 14 days with either active tablets + placebo cream, placebo tablets + active cream, or placebo tablets + placebo cream. The signs of erythrasma, i.e. colour intensity, demarcation, and scaling of the affected area, as well as degree of fluorescence under Wood's light, were recorded before treatment, after one and two weeks, and at follow-up four weeks later. Cure/improvement was obtained in 77% of the cases in the erythromycin group, 87% in the fusidic acid group, and 42% in the placebo group. There was no difference between the active preparations, whereas both were significantly better than placebo, P = 0.01.

Adolescent↗
PubMed2003

Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial.

OBJECTIVE: To assess efficacy and safety of diclofenac-K 12.5 mg tablets in the treatment of acute low back pain (low back pain). MATERIAL/METHOD: A multiple dose, double-blind, double-dummy, randomized, placebo-controlled, parallel group trial compared diclofenac-K (12.5 mg; n = 124) with ibuprofen (200 mg; n = 122) and placebo (n = 126) in patients with moderate-to-severe acute low back pain. The treatment consisted of an initial dose of 2 tablets followed by 1 or 2 tablets every 4-6 hours as needed (maximum 6 tablets/day) for 7 days. The primary efficacy outcome for the initial dose was TOTPAR-3, the summed total pain relief over the first 3 hours. Secondary initial dose outcomes included TOTPAR-6, summed pain intensity differences SPID-3 and SPID-6, time to rescue medication or remedicate, and the End of First Dose global efficacy assessment. The primary efficacy outcome for the flexible multiple dosing regimen was the End of Study global efficacy assessment. Secondary outcomes for multiple dosing included time to rescue medication over the entire study, the End of Day global efficacy assessments (daily over Days 1-7), pain intensity differences on the VAS measured at Visit 2 and 3, and change in Eifel algofunctional index. Safety/tolerability was assessed by recording adverse events. RESULTS: Diclofenac-K 12.5 mg demonstrated superiority vs placebo on the primary efficacy parameter and almost all secondary initial dose outcomes. With respect to the initial dose, diclofenac-K 12.5 mg was also significantly superior to ibuprofen 200 mg on SPID-3. Ibuprofen 200 mg was superior to placebo only on the End of First Dose global efficacy assessment. The flexible multiple dosing regimens of diclofenac-K and ibuprofen were both significantly superior to placebo on the End of Study global efficacy assessment, time to rescue medication over the entire study period, the End of Day global efficacy assessment on Days 1-2, pain intensity difference on the VAS at Visit 3 and the Eifel algofunctional index at Visit 3 (also at Visit 2 in diclofenac-K 12.5 mg group). Both active treatments were as well tolerated as placebo. CONCLUSIONS: The flexible multiple dosing regimen of diclofenac-K 12.5 mg (initial dose of 2 tablets followed by 1-2 tablets every 4-6 hours, max. 75 mg/day) is an effective and safe treatment of acute low back pain.

Acute Disease↗
PubMed1999

A double blind observation for therapeutic effects of the tong luo kai bi tablets on rheumatoid arthritis.

The therapeutic effects of the Tong Luo Kai Bi Tablets [symbol: see text] in 120 patients with rheumatoid arthritis were observed in this clinical trial by the randomized double blind method. Both the observed group and the control group each had 60 patients. In the observed group treated with the Tong Luo Kai Bi Tablets, 1 case (1.7%) was cured clinically, 27 cases (45.0%) improved markedly, 26 cases (43.3%) improved, with a total effective rate of 90.0%. In the control group treated with Rheumatic Semen Strychni Tablets [symbol: see text], no case was cured, 16 cases (26.7%) improved markedly, 33 cases (55.0%) improved, with a total effective rate of 81.7%. Statistical data showed the Tong Luo Kai Bi Tablets had much better therapeutic effectiveness clinically than the Rheumatic Semen Strychni Tablets (P < 0.05).

Adult↗
PubMed1998

[Experimental study of Yishou tiaozhi tablet on inhibiting hyperlipemia and atherosclerosis].

OBJECTIVE: To observe the effect of Yishou Tiaozhi tablet on lipid-metabolism and aortic intimal atherosclerotic plaque coverage in rabbit's model of experimental hyperlipemia and atherosclerosis. METHODS: Thirty-two rabbits were divided randomly into four groups, group A, B, C and D, 8 in each group. Forage with cholesterol and lipid plus 1.59 g/kg of Yishou Tiaozhi tablet was fed to the group A every day; to the group B, 22.54 mg/kg gypenoside tablet was added to forage with cholesterol and lipid; to the group C, forage with cholesterol and lipid was fed; and to the group D, ordinary forage only. Biochemical parameters were measured and pathomorphological examination were carried out 6 weeks later. RESULTS: (1) Yishou Tiaozhi tablet obviously lowered the levels of serum TC, TG, AI, ApoB, LP (a), ox-LDL, HYP, plasma Ca2+, TXB2 and increased the levels of serum HDL-ch, ApoA1, ApoA1/APoB, plasma 6-keto-PGF1 alpha(P < 0.01). (2) Pathomorphological examination showed that in the group A aortic intimal atherosclerotic plaque area and arterial intima thickness obviously reduced, smooth muscle cell hyperplasia and elastic fibers were not seen. CONCLUSION: Yishou Tiaozhi tablet can inhibit experimental hyperlipemia and atherogenesis. It is an ideal and effective medicine in preventing and treating hyperlipemia and atherosclerosis.

Animals↗
PubMed2002

Bioequivalence study of enalapril tablets in healthy Thai male volunteers.

The bioequivalence study of 5-mg enalapril tablets, Enaril (Biolab, Thailand) compared to Renitec (Merck Sharp & Dohme, USA) was conducted in 14 healthy Thai male volunteers following a single dose, two-period, crossover design. Each subject received 4 tablets of 5-mg enalapril tablets of both formulations with a 1-week washout period. Plasma samples collected over a 24-hour period after administration were analyzed by LC/MS/MS. Pharmacokinetic parameters were determined by using non-compartmental analysis. Regarding bioequivalence testing, the 90 per cent confidence intervals of Cmax and AUC(0-infinity) ratios (Enaril/Renitec) of enalapril were 86.3-126.1 per cent and 93.0-118.5 per cent and those of enalaprilat were 86.4-124.1 per cent and 90.3-116.8 per cent. Based on the European bioequivalence guideline, the 90 per cent confidence interval of Cmax and AUC(0-infinity) ratios of both parent and metabolite forms were within acceptable ranges of 70-143 per cent and 80-125 per cent, respectively. It was concluded that Enaril 5 mg tablet was bioequivalent to Renitec 5 mg tablet.

Adolescent↗
PubMed1998

Novel Techniques for Testing of Esophageal Irritancy of Liquids and Tablets in Dogs.

Esophageal irritation is a potential side effect of oral medications in humans. However, this complication is rarely evaluated in animal studies, in which test compounds are usually delivered directly into the stomach via gavage. The toxicology unit at our institution required development of a model to test compounds in liquid and tablet form for esophageal irritancy. To deliver liquids, an endotracheal tube (internal diameter, 5.0 mm) was passed into the esophagus of anesthetized dogs, with the cuff inflated directly caudal to the larynx. A rubber catheter (size, 8 French) was then passed through the tube, extending caudally 1 in past the end of the tube. An infusion pump delivered the test liquid through the catheter over a 30-min period. The cranial portion of the dog was elevated, so that the liquid would flow aborally. The infusions were generally administered for 5 consecutive days, and the dogs euthanized on the fifth day for gross and histopathologic examination of the esophagus. This technique was performed successfully on 80 dogs, without serious complication. For delivery of compounds in tablet form, a clear tube was passed into the cranial third of the esophagus. The tablet, tied to a pre-measured length of silk suture, was then introduced into the esophagus through the tube by using endoscopic retrieval forceps. The tablets were left in place for 1 h, and the dogs were then euthanized and examined. These techniques allowed for accurate and reliable testing in dogs of the esophageal irritancy of compounds in either the liquid or tablet form.

Journal Article↗
PubMed2002

Comparative study of salivary and urinary fluoride levels and clearance patterns between fluoridated chewing gum and fluoride tablets in children.

AIM: The aim of the present study was to compare the effect of a chewing gum containing 0.50 mg fluoride with two tablets containing 0.25 mg fluoride as NaF, on the salivary and urinary fluoride concentration in children. MATERIALS AND METHODS: Whole saliva and urine were sampled from twenty 5-9 years-old children to assess the baseline fluoride concentrations. The day after, the subjects were asked to chew the fluoridated chewing gum for 15 minutes and saliva samples were collected 5, 10, 30, 60, 120, 240 minutes after ceasing the use of the chewing gum. Urine samples were collected 1, 2, 4 and 24 hours after the use of the gum. After a washout period of one week, the subjects were recalled and were asked to completely dissolve two 0.25 mg fluoride tablets in their mouth. Saliva and urine samples were collected in the same way. Fluoride concentration in saliva and urine was determined using a fluoride specific electrode. RESULTS: No significant differences were found in the concentrations of fluoride in saliva or urine using fluoridated chewing gum and tablets. CONCLUSION: The NaF tablets and chewing gum studied had approximately the same clearance pattern in saliva and urine. These data show that the chewing gum examined could be a valid alternative to the use of NaF tablets in caries prevention.

Journal Article↗
PubMed1992

Effect of slow release nifedipine tablets in patients with essential hypertension.

The antihypertensive effect of slow release nifedipine (CAS 21829-25-4) tablets (20 mg, Adalat) administered once or twice daily was studied in patients with essential hypertension of WHO stage I or II. Ambulatory blood pressure was monitored by a finger volume oscillometric device every 5 min for 24 h before and during the treatment with nifedipine. Whether administered once or twice daily, nifedipine tablets dit not change the pattern of circadian blood pressure variation; i.e. diurnal rise and nocturnal fall. Twice daily administration induced a significant downward shift in the blood pressure pattern. In other words, further hypotensive effect was observed during the night when the blood pressure was already low. On the other hand, administration once daily in the morning lowered daytime blood pressure without affecting blood pressure during the night. The duration of action of nifedipine tablets administered once daily was 12 h or more. In the acute experiment using 20 mg tablets of nifedipine, plasma concentration of nifedipine was well correlated with the percentage change in mean blood pressure. The minimal effective plasma concentration of nifedipine was estimated to be 13.4 ng/ml. However, in chronic treatment, nifedipine lowered blood pressure at the plasma concentration of 10 ng/ml. The results indicate that nifedipine tablets administered once daily provide an effective antihypertensive regimen for controlling daytime hypertension with minimal antihypertensive effect during the night.

Adult↗
PubMed2003

[Experimental study on estrogenic function of triphasic contraceptive tablets].

OBJECTIVE: To assess the estrogenic effect and activity of oral triphasic contraceptive tablets and provide the theoretical foundation for the use of homemade Kalirui in the treatment of metrorrhagic, menometrorrhagic, oligomenorrheic, and polymenorrheic dysfunctional uterine bleeding. METHODS: The vaginal smears of mice treated by triphasic contraceptive tablets (Kalirui and Trinordiol) were examined using light microscope. Radiational receptor analysis was made to measure the estrogenic effect of Kalirui and Trinordiol on Compared with the control group, the three dosage groups of homemade (Kalirui) rabbit uterus. RESULTS: triphasic contraceptive tablets and the import tablets (Trinordiol) group all showed obviously accelerate vagina kera-epithelium forming (P < 0.01), especially in the first phase and second phase. Both Kalirui and Trinordiol were found to have higher affinity to estrogenic receptor, and there were no significant differences between them Kalirui and Trinordiol triphasic oral contraceptive and the estrogenic standard sample (P > 0.05). CONCLUSION: tablets have apparently estrogenic effect and activity.

Animals↗
PubMed2006

Specific immunotherapy with high dose SO standardized grass allergen tablets was safe and well tolerated.

BACKGROUND: Sublingual immunotherapy with grass allergen tablets may be the future treatment for grass pollen allergy because it reduces symptoms and medication use, improves quality of life and is easy to use. Rhinoconjunctivitis and asthma co-exist and we aimed to find a safe dose range of a self-administered grass allergen tablet (ALK Abello A/S) in patients suffering from rhinoconjunctivitis and asthma. METHODS: Four doses were investigated in a randomised, double-blind, placebo-controlled, dose escalation trial. Outside the pollen season 4 groups of 12 patients commenced treatment in a staggered manner, at intervals of 1 week. For 28 days doses of 75000 (approximately 15microg Phleum pratense protein 5), 150,000, 300,000, 500,000 standardised quality tablet (SQ-T) units or placebo were given once daily as sublingual tablets. RESULTS: Fourty three patients were randomised to receive either active treatment or placebo (3:1). Each dose group consisted of 12 patients except the 500000 SQ-T group (5 active, 2 placebo). No asthma exacerbations were seen and no serious or severe adverse events were reported. The majority of adverse events were local reactions. The number of adverse events was dose related. No patients withdrew from the study. CONCLUSIONS: Treatment with grass allergen tablets in doses up to 500000 SQ-T in patients with asthma and rhinoconjunctivitis was safe and well tolerated.

Administration, Sublingual↗