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PubMed2004

Development of oral controlled-release tablet formulations based on diltiazem-carrageenan complex.

Diltiazem HCl and lambda carrageenan react in distilled water to give a slightly soluble interaction product. The aim of this work was to verify the possible employment of lambda carrageenan-diltiazem (DTZ) complex in controlled-release formulations. The influence of complex particle size, compression force, pH of the dissolution medium, and tablet dimensions on drug release has been evaluated. The results confirm the suitability of the DTZ-carrageenan interaction product for controlled-release formulations. Good compaction properties allow tablets to slowly erode, with only the addition of the amount of hydroxypropyl methylcellulose (HPMC) necessary as a binding agent. The use of the finest sieve fraction results in the highest crushing strength values and in the slowest release rate, both in pH 1.2 and in pH 6.8. The force of compression does not affect the drug release for values over 16 kN. The release rate increases when the geometry of the tablet is varied so the surface/ volume ratio of the tablet is increased, suggesting a release mechanism involving surface dissolution/erosion.

Administration, Oral↗
PubMed2005

Prediction of tablets disintegration times using near-infrared diffuse reflectance spectroscopy as a nondestructive method.

The goals of this study are to user near-infrared reflectance (NIR) spectroscopy to measure the disintegration time of a series of tablets compacted at different compressional forces, calibrate NIR data vs. laboratory equipment data, develop a model equation, validate the model, and test the model's predictive ability. Seven theophylline tablet formulations of the same composition but with different disintegration time values (0.224, 1.141, 2.797, 5.492, 9.397, 16.8, and 30.092 min) were prepared along with five placebo tablet formulations with different disintegration times. Laboratory disintegration time was compared to near-infrared diffuse reflectance data. Linear regression, quadratic, cubic, and partial least square techniques were used to determine the relationship between disintegration time and near-infrared spectra. The results demonstrated that an increase in disintegration time produced an increase in near-infrared absorbance. Series of model equations, which depended on the mathematical technique used for regression, were developed from the calibration of disintegration time using laboratory equipment vs. the near-infrared diffuse reflectance for each formulation. The results of NIR disintegration time were similar to laboratory tests. The near-infrared diffuse reflectance spectroscopy method is an alternative nondestructive method for measurement of disintegration time of tablets.

Algorithms↗
PubMed2003

Tablet formulation of levothyroxine is absorbed less well than powdered levothyroxine.

The comparative bioavailability of oral doses of levothyroxine (LT(4)) formulation taken as tablets, after being crushed, or chewed before swallowing has not been well studied. Three patients with hypothyroidism who showed persistent elevation of serum thyrotropin (TSH) despite taking 200, 150, and 125 microg of LT(4) tablets per day are presented. They did not show signs and symptoms of gastrointestinal illness that could interfere with the absorption of LT(4) nor history of such a condition. They did not concurrently take medications known to affect the absorption of LT(4) from the gut. Their serum TSH levels normalized when the tablets were taken after being pulverized. The difference appeared attributable to the slow dissolution of the tablets in the gut of these patients.

Adult↗
PubMed1990

Determination of cardiac glycosides in digitoxin tablets and deslanoside injections by micro-HPLC.

A micro high-performance liquid chromatographic (micro-HPLC) procedure for the assay of digitoxin tablets and deslanoside injections has been developed. Micro-HPLC is performed on an ODS micro column, with acetonitrile-methanol-water (10:20:17) for digitoxin tablets and acetonitrile-water (21:70) for deslanoside injections. The effluent is monitored by UV absorption at 220 nm. Quantitation of cardiac glycosides in tablets and injections is carried out by the internal standard method. The composite assay results for digitoxin tablets and deslanoside injections provide average values of 101.2 and 99.9% with standard deviations of 1.2 and 0.93%, respectively. This micro-HPLC method is sensitive, quantitative, and reproducible. It is suitable for use in examining the content uniformity of pharmaceutical preparations.

Chromatography, High Pressure Liquid↗
PubMed1998

Investigation of primary and secondary modifiers for the subcritical extraction of lovastatin from MEVACOR tablets with carbon dioxide.

The subcritical fluid extraction of lovastatin from tablet powder mixtures prepared in this laboratory and MEVACOR tablets is successfully demonstrated. Methanol modifier percentage, additive type (acidic, basic, or neutral), and additive concentration on the extraction efficiency are examined. The extraction recoveries of lovastatin from MEVACOR tablets are shown to be highly dependent on methanol concentration and additive type. Isopropylamine is shown to be the most successful additive investigated. An optimized extraction method is developed, and lovastatin recoveries of 99.5% were achieved with a relative standard deviation of 1.2% from MEVACOR tablets with 15% (v/v) (1.0% [v/v] isopropylamine) methanol-modified CO2.

Anticholesteremic Agents↗
PubMed1999

Pharmacokinetics of natural progesterone administered in the form of a vaginal tablet.

Our study was conducted to assess the pharmacokinetics of natural progesterone administered in the novel formula of an effervescent vaginal tablet. Fifty post-menopausal women, with a median age of 43.5 years (range 28-55), volunteered to participate in the research. All women discontinued their hormonal replacement therapy 1 month prior to the study. The pharmacokinetics of 50 and 100 mg of progesterone administered as a vaginal tablet were evaluated. After the initial administration of 50 mg or 100 mg, a mean serum Cmax of 20.43 +/- 8.01 nmol/l and 31.61 +/- 12.62 nmol/l (P < 0.0004) was reached at a Tmax of 6.1 +/- 2.63 and 6.4 +/- 3.35 h respectively. The terminal half-life was 13.18 +/- 1.3 and 13.7 +/- 1.05 h respectively. Continuous use of the 100-mg tablet resulted in a mean serum progesterone concentration of 26.08 +/- 13.96 nmol/l and 21.42 +/- 16.32 nmol/l after 14 and 30 days respectively. Women >40 years were found to have a significantly lower Tmax compared to younger women (P = 0.02). The continuous use of vaginal progesterone did not influence the hormonal, liver or lipid profiles evaluated. Only three (6%) women suffered from mild vaginal irritation. Natural progesterone given as a vaginal tablet is well tolerated, safe and an easily administered treatment. Even in a non-oestrogenized vagina the absorption was efficient and the 100 mg dosage resulted in adequate serum progesterone concentrations.

Absorption↗
PubMed1999

Oral bioequivalence of three ciprofloxacin formulations following single-dose administration: 500 mg tablet compared with 500 mg/10 mL or 500 mg/5 mL suspension and the effect of food on the absorption of ciprofloxacin oral suspension.

The oral bioequivalence and tolerability of two ciprofloxacin formulations (tablet and suspension) and the effect of food on the absorption of ciprofloxacin oral suspension were investigated. Sixty-eight young, healthy male subjects participated in two separate, randomized, crossover studies. In study 1, ciprofloxacin as a single 500 mg tablet or as 500 mg/10 mL oral suspension was administered in a fasted state on day 1. In study 2, subjects participated in a three-way crossover study in which ciprofloxacin suspension was administered as 500 mg/10 mL in a fasted state, or 500 mg/10 mL with food, or 500 mg/5 mL in a fasted state. Plasma ciprofloxacin concentrations were measured by high-performance liquid chromatography. Standard pharmacokinetic parameters were estimated using non-compartmental methods. In study 1, geometric mean Cmax values of ciprofloxacin following the single 500 mg tablet and 500 mg/10 mL suspension doses were 2.36 and 2.18 mg/L, respectively; corresponding geometric mean t(max) values were 1.1 and 1.6 h, respectively. Geometric mean AUC(0-infinity) values were 12.0 and 11.8 mg x h/L, respectively. In study 2, geometric least squares mean Cmax values following ciprofloxacin 500 mg/10 mL and 500 mg/5 mL suspension during fasted conditions were 1.54 and 1.59 mg/L, respectively. Corresponding geometric least squares mean AUC(0-infinity) values were 7.3 and 8.0 mg x h/L. Administration of ciprofloxacin 500 mg/10 mL suspension, in either a fasted or fed state, was not associated with significant changes in Cmax (1.54 mg/L for fasted vs 1.37 mg/L for fed) or AUC(0-infinity) values (7.28 mg x h/L for fasted vs 8.19 mg x h/L for fed). Each ciprofloxacin formulation was well tolerated for the duration of each study. These studies demonstrated bioequivalence between ciprofloxacin 500 mg tablet and two strengths of ciprofloxacin suspension (500 mg/10 mL and 500 mg/5 mL). Bioavailability was unaltered by food.

Administration, Oral↗
PubMed1998

The chewable barium tablet slow tracking of oral and pharyngeal swallowing dysfunction.

Dysphagia can be due to oral or pharyngeal dysfunction as well as to esophageal causes. Oral and pharyngeal disturbances, however, are more common in older people because of their attendant risks of laryngeal, tracheal, and pulmonary aspiration. To guide any dietary prescriptions it is important to establish whether the patient can best tolerate liquids, soft foods, solid chewable boluses, all, or none of these. It therefore becomes important to supplement liquid barium swallowing studies with soft and chewable boluses mixed with barium. Here I describe the novel introduction of chewable barium tablets in conjunction with routine swallowing studies. Chewable barium tablets, if used properly, are safe, supply needed information, and can shorten the evaluation of oral and pharyngeal dysfunction studies. Because of the granular appearance of the tablets, aspiration due to this solid chewable bolus can be distinguished from liquid aspiration. Moreover, if the barium tablets are swallowed whole, they can help delineate esophageal strictures if the oral and pharyngeal phases of swallowing are normal.

Administration, Oral↗
PubMed2000

Assessment of gustatory function by means of tasting tablets.

OBJECTIVE: To develop a simple test for the screening of gustatory function in clinical settings. STUDY DESIGN: We tested 101 healthy volunteers (44 male and 57 female volunteers; mean age, 47 y) with the following gustatory test: the substances sucrose (sweet), citric acid (sour), sodium chloride (salty), and caffeine (bitter) were presented as tablets (diameter 4 mm) similar to common sweetener tablets. For quantitative assessment of whole-mouth gustatory function we used six different dosages with dilutions of each tastant in 50% steps. The highest dosage could be easily detected (sucrose, 30 mg; citric acid, 3 mg; sodium chloride, 2 mg; caffeine, 2 mg), and the lowest concentration was within threshold range. METHODS: Twenty-eight tablets (six different dosages of the four basic tastes plus four tasteless tablets) were tried in a randomized order. The entire test required 15 to 20 minutes. To evaluate the within-subject test-retest reliability, sessions were repeated after 1 week. Results were compared with those obtained by means of a conventional three-drop, forced-choice procedure using the method of ascending limits. RESULTS: Results of the new gustatory test were significantly correlated with those obtained using the three-drop, forced-choice procedure (correlation coefficient [r] = 0.66, P<.001). In general, women performed better than men. Furthermore, younger subjects exhibited a significantly higher gustatory sensitivity in both tests compared with older subjects. CONCLUSIONS: This quantitative test of whole-mouth gustatory function is easy to use, can be self-administered, requires little time, and has a long shelf-life. It appears to be suited for routine clinical assessment of gustatory function.

Adult↗
PubMed1992

Iron absorption from chewable vitamins with iron versus iron tablets: implications for toxicity.

The medical literature contains few, if any, reports of severe iron (Fe) poisonings from ingestion of chewable multivitamins with iron. One possible explanation for this observation is that iron from multivitamins is more poorly absorbed than iron from iron tablets. To compare iron absorption from multivitamins with iron absorption from ferrous fumarate tablets, male adult volunteers were given 6 mg of elemental Fe/kg body weight as chewable multivitamins with iron or as crushed ferrous fumarate tablets in a crossover study. Serum Fe and total iron binding capacity (TIBC) were determined prior to administration of the tablets and one, two, four, and six hours after ingestion. Statistical analyses demonstrated increased and more rapid absorption of Fe from the multivitamin preparation. These results suggest that iron is well absorbed from chewable multivitamins with iron and should theoretically have the potential for producing serious toxicity when taken in overdose. The reasons that such toxicity is not commonly seen clinically are discussed, and a plan for further investigation of this issue is proposed.

Adult↗
PubMed2005

Remember to crush the tablets after esophageal stent insertion.

The main mode of palliation for inoperable esophageal cancer is by insertion of expandable metallic stents. While major complications include occlusion by tumor ingrowth and migration, impaction by food has been reported in as many as 10% of cases. Although patients are routinely instructed to follow a soft and finely minced diet after insertion of esophageal stents, stent blockage can still occur if patients swallow large-sized tablets. We report a case of stent blockage by 2 large-sized tablets, about which the endoscopist did not forewarn the patient or his family. The tablets were eventually dislodged easily through a repeat endoscopy. We caution about the possibility of such complication after esophageal stenting. We recommend inspection of patients' medication before the stenting procedure as well as instructing patients, their family, and care providers to crush their large-sized tablets before consumption.

Aged↗
PubMed2005

Novel bismuth-metronidazole-tetracycline triple-layer tablet for treatment of Helicobacter pylori.

BACKGROUND: Current anti-Helicobacter pylori treatment regimens are costly and because of the increasing antibiotic resistance, are becoming ineffective. AIM: To evaluate a triple-layer tablet containing 100 mg bismuth subcitrate, 250 mg metronidazole, and 250 mg tetracycline in a single triple-layer tablet. METHODS: H. pylori-infected adult patients received bismuth-metronidazole-tetracycline (two tablets, t.d.s.) and ranitidine (300 mg) once daily for 14 days. Efficacy was determined using 13C-urea breath testing. RESULTS: Thirty-three of 35 enrolled patients were available for evaluation; using the protocol-specified modified intention-to-treat analysis, five failed treatment, two were lost to follow-up (cure rate per-protocol = 85.7%, intention-to-treat = 78.7%). The cure rate among metronidazole-susceptible strains was 100% (22 of 22) (95% confidence interval 84-100%) compared with 55% (five of nine intention-to-treat) (95% confidence interval 21-86%) among metronidazole-resistant strains. In four cases, therapy was truncated at 4-7 days because of side-effects; yet the treatment was effective in three. The three metronidazole-susceptible but clarithromycin-resistant infections were cured. CONCLUSION: This novel triple-layer tablet combination therapy was effective in all patients with metronidazole-susceptible H. pylori and many of those with resistant organisms. A greater degree of acid suppression may further improve effectiveness.

Adolescent↗
PubMed1988

An evaluation of different doses of soluble aspirin and aspirin tablets in postoperative dental pain.

1. The efficacy of three different single doses (600, 900 and 1200 mg of soluble aspirin and aspirin tablets) was determined in a randomized placebo-controlled parallel study in 140 patients (70 females) with postoperative pain after removal of impacted third molars. 2. Patients treated with soluble aspirin 600 mg, 900 mg, 1200 mg and aspirin tablet 1200 mg reported significantly less pain (P less than 0.01) throughout the investigation period than those treated with placebo. 3. Overall pain scores after treatment with aspirin tablets 600 and 900 mg did not differ significantly from those after treatment with placebo (P greater than 0.05). 4. On a comparative dose basis, soluble aspirin was significantly more potent (P less than 0.05) than aspirin tablets.

Adolescent↗
PubMed1990

Effect of excipients on the stability of levothyroxine sodium tablets.

Levothyroxine sodium tablets from two different manufacturers were analysed using the USP-NF method of analysis, a stability-indicating high pressure liquid chromatographic (HPLC) procedure. The results indicate that one particular manufacturer's 0.2-mg pink tablets contain some excipient(s) which act as a catalyst to hasten decomposition after extraction of levothyroxine for analysis. The same tablets from a different batch showed an additional long peak in the chromatogram, which indicated that the excipient(s) may have been changed. The same manufacturer has also used three different types of bottles/lids for the same product during the last year. Good manufacturing practice requires that new compatibilities/stability studies be conducted to assure the quality of the product. Ongoing stability studies are required by the Food and Drugs Administration (FDA). The use-life of 0.2-mg pink tablets of this manufacturer may be short.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1986

Bioavailability and pharmacokinetics of ampicillin and amoxycillin from tablets, capsules and long-acting preparations in the homing pigeon (Columba livia).

Three ampicillin and three amoxycillin formulations (tablets and capsules, administered orally, and oily suspensions, injected intramuscularly (i.m.) and subcutaneously (s.c.] were studied in twenty adult homing pigeons (Columba livia). Bioavailability, pharmacokinetics and recovery were determined for each product and administration route. A standard dose of 50 mg/pigeon or 100 mg/kg was used in each study. The mean availability calculated for each of these preparations was 7% for ampicillin anhydrate tablets, 22% for amoxycillin trihydrate tablets, 17% for ampicillin trihydrate capsules, 67% for amoxycillin trihydrate capsules, 46% for ampicillin oily suspension i.m., 67% for amoxycillin oily suspension i.m. and 43% for amoxycillin oily suspension s.c. The blood concentration-time curves for the tablets were very scattered, which was far less the case for the capsules. The maximum blood concentration (Cmax) for amoxycillin was twice as high as for ampicillin. The Cmax resulting from the oily suspensions administered i.m. were low (4.35 +/- 1.05 and 5.04 +/- 1.36 mg/l, for ampicillin and amoxycillin, respectively). The Tmax for ampicillin was 10 h and for amoxycillin it was 0.9 h after administration. Both curves showed biphasic absorption, the initial peak representing an absorption and a distribution phase and the second part reflecting the 'depot-nature' of the drug. After the s.c. administration of the amoxycillin oily suspension the same pattern was found, but the Cmax, which was found at 2.13 +/- 1.03 h after administration, was low (2.81 +/- 0.68 mg/l).(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗
PubMed1996

Pharmacokinetics and anti-trichomonal efficacy of a dimetridazole tablet and water-soluble powder in homing pigeons (Columba livia).

The anti-trichomonal efficacy and pharmacokinetics of dimetridazole were investigated in the homing pigeon (Columba livia). Dimetridazole was formulated for drinking water medication and as a prolonged-release tablet. To suppress a Trichomonas gallinae infection successfully, medicated drinking water containing dimetridazole (400 mg/L) had to be administered for at least 3 days. A two-day treatment with a dimetridazole tablet (20 mg/tablet) in fasted, as well as in fed, pigeons was shown to be ineffective. After intravenous administration of 20 mg dimetridazole, the drug plasma concentration-time profile fitted a one-compartment open model with a mean half-life of 3.9 h. The absolute bioavailability of the tablet in fasted pigeons was 83.8%. The bioavailability of the tablet administered with food was reduced by 20%. Dimetridazole was rapidly metabolised to (1-methyl-5-nitroimidazol-2-yl) methanol.

Animals↗
PubMed2005

Village-scale evaluation of mosquito nets treated with a tablet formulation of deltamethrin against malaria vectors.

A field trial was carried out in the Sundargarh district of Orissa, India on the efficacy of mosquito nets treated with a tablet formulation of deltamethrin (K-O TAB) against malaria vectors. Treated nets were used in one village, and in the two control villages, one used untreated nets and the other used indoor spraying with DDT, without nets. In this area the primary malaria vectors are Anopheles culicifacies Giles sensu lato (Diptera: Culicidae) and An. fluviatilis James s.l., which are both endophagic and endophilic, and fully susceptible to deltamethrin. Treatment of a 10-m(2) mosquito net with one of the tablets gave a deltamethrin deposit of 25 mg/m(2). Bioassays repeated on domestically used nets over 7 months showed persistence of almost 100% mortality of An. fluviatilis, whereas An. culicifacies showed a decline from 100% to 71% mortality over this period, after which the nets were re-treated and bioassays were not continued. The sum of collections of mosquitoes resting in village houses and those in exit traps and dead on floor sheets showed a reduction in the numbers of the two vector species due to the treated nets, compared with untreated or no nets, but no reduction in other anophelines or Culex species. Large proportions of the collections of the vector and non-vector anophelines were dead on the floor sheets, but among Culex, mortality was delayed. Treated and untreated nets reduced the proportion of anophelines that had blood-fed; the treated nets did so more effectively than the untreated in the case of An. culicifacies and of Culex mosquitoes. In rooms with treated nets a larger proportion of the total collections [dead + live] were in the exit traps, which can be attributed to the excito-repellent effect of deltamethrin. It is easier to pack and handle tablets of insecticide than liquid concentrate and the use of one tablet per net may be preferable to making up a large volume of diluted insecticide and dipping many nets at a time.

Animals↗
PubMed2006

An open label randomized comparison of mefloquine-artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand.

BACKGROUND: Delivering drugs in a fixed combination is essential to the success of the strategy of artemisinin-based combination therapy. This prevents one drug being taken without the protection of the other, reducing the chance of emergence and spread of drug resistant strains of Plasmodium falciparum. A lower tablet burden should also facilitate adherence to treatment. A new fixed combination of mefloquine plus artesunate has been developed. This was compared with the conventional regimen of separate tablets for the treatment of uncomplicated multidrug-resistant falciparum malaria. METHODS: On the north-western border of Thailand 500 adults and children with uncomplicated falciparum malaria were randomized to receive either the new fixed combination or separate tablets. They were followed up weekly for 63 days. RESULTS: The day 63 polymerase chain reaction-adjusted cure rates were 91.9% (95% CI 88.2-95.6) in the fixed combination group and 89.2% (85.0-93.4) in the loose tablets group (P=0.3). There was a lower incidence of early vomiting in the group receiving the fixed combination. CONCLUSION: This new fixed combination of mefloquine and artesunate was efficacious, well tolerated and convenient to administer.

Adolescent↗