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PubMed1990

[Dental fluorosis in relation to the use of fluoride tablets].

The prevalence of dental fluorosis on the buccal tooth surfaces was investigated in 15-year-old children in the towns Tiel and Culemborg, using the Tylstrup-Fejerskov scoring system. A study done in 1980 revealed that at the age of six, 53% of the children in Tiel and 30% of the children in Culemborg took one or more fluoride tablets (0.25 mg F-) daily. In Tiel the tablets were provided free of charge in a centre for child dental care. On the basis of the number of tablets supplied in the age period 1.5-6 years, most of the 15 year olds in Tiel could be classified as regular, irregular or non-tablet user. Only mild fluorosis (TF-score 1, 2 or 3) was found. The percentage of children with one or more buccal surfaces affected with fluorosis was 24 in Tiel and 22 in Culemborg. The percentages of buccal surfaces with fluorosis were 6 (Tiel) and 7 (Culemborg). In Tiel the percentages of surfaces with fluorosis in the groups regular, irregular and non-tablet users were 12%, 5% and 2% respectively.

Adolescent↗
PubMed1998

Relative bioavailability of rapidly dispersing, plain, and microencapsuled acetylsalicylic acid tablets after single dose administration.

UNLABELLED: Extent and rate of absorption of acetylsalicylic acid (ASA) from rapidly dispersing (Acesal Extra) and plain tablets (Acesal) relative to reference 1 (plain tablets, Aspirin) and from microcapsuled tablets (Micristin) relative to comparable listed tablets (reference 2, Colfarit) were assessed in 2 single-dose (0.5 g ASA), open, randomized, crossover studies with intervals of 14 days between 2 periods. Both studies were performed in 24 male and female healthy volunteers each (age 18-32 years, body weight 48-90 kg, body height 161-190 cm). ASA and its metabolite salicylic acid (SA) were measured with an HPLC method validated for ASA between 0.2 and 20 microg/ml and for SA between 0.4 and 40 microg/ml. The test tablets were considered bioequivalent with reference in extent of absorption if the 90% confidence limits of the AUC0 to infinity ratio were within the range of 0.80-1.25, and in rate of absorption if the confidence limits of the Cmax/AUC0 to infinity ratios were within 0.70-1.43. RESULTS: Geometric means and 90% confidence limits for the test/reference ratios of the comparisons Acesal vs reference 1, Acesal Extra vs reference 1 and Micristin vs reference 2 were 1.05 (0.97-1.13), 1.13 (1.05-1.22), 1.02 (0.92-1.14) for ASA AUC0 to infinity and 1.02 (0.96-1.07), 1.05 (0.99-1.11), 0.98 (0.91-1.04) for SA AUC0 to infinity, respectively. The results for Cmax/AUC of ASA were 1.16 (1.00-1.34), 1.72 (1.49-1.99), 0.83 (0.73-0.94) and of SA 1.02 (0.98-1.07), 1.07 (1.02-1.12), 0.93 (0.88-0.97). CONCLUSION: Acesal and Micristin were bioequivalent with the respective references in both extent and rate of absorption. Acesal Extra and reference 1 were bioequivalent with regard to extent only. Acesal Extra was absorbed faster.

Adult↗
PubMed1986

Application of a radiotelemetric system to evaluate the performance of enteric coated and plain aspirin tablets.

The bioavailability of enteric coated and plain aspirin tablets was studied in four beagle dogs. Blood sampling for enteric coated tablets was planned with the aid of a radiotelemetric system. The release of aspirin from its dosage form was detected by monitoring the change in intestinal pH. Aspirin and salicylic acid levels in plasma obtained from the enteric coated dosage form exhibited familiar concentration versus time absorption profiles. Variation in the plasma concentrations of these two compounds within each dog studied (four runs each) was relatively small when time zero was adjusted to the commencement of tablet dissolution. The plasma levels obtained from plain aspirin (three runs each), however, show atypical absorption. The estimated absolute bioavailability was 0.432 +/- 0.0213 and 0.527 +/- 0.0260 for enteric coated and plain aspirin, respectively. Other pharmacokinetic parameters for these two dosage forms such as the highest observed plasma concentration (Cmax) (10.9 +/- 0.535 microgram/mL versus 13.6 +/- 1.88 micrograms/mL) and the time to reach Cmax (tmax) (26.6 +/- 1.94 min versus 31.0 +/- 7.04 min) agree well. The mean values for gastric emptying time, in vivo coating dissolution time, and in vivo disintegration/dissolution time of the tablet core for enteric coated aspirin are 48.7 +/- 7.23 min, 44.3 +/- 3.80 min, and 34.7 +/- 2.04 min, respectively.

Animals↗
PubMed2003

Automated determination of selected water-soluble vitamins in tablets using a bench-top robotic system coupled to reversed-phase (RP-18) HPLC with UV detection.

The determination of folic acid, nicotinamide, nicotinic acid, riboflavin, riboflavin-5'-phosphate, pyridoxine and thiamine in tablets has been successfully automated using a bench-top robotic system (Zymark Tablet Processing Workstation II) coupled to reversed-phase (RP-18) HPLC with UV-detection. The new automated methods have been validated and were found to be applicable in routine analysis for all common types of multivitamin tablets. The precision is exemplified by relative standard deviations of 5.4% for folic acid, 2.1% for nicotinamide, 1.6% for pyridoxine, 0.7% for riboflavin and 1.1% for thiamine using film-coated tablets as sample. Mean recoveries obtained during spiking experiments were in the range of 95.2-103.9%.

Autoanalysis↗
PubMed1964

RATES OF DISSOLUTION OF TOLBUTAMIDE TABLETS.

An investigation was made of the pharmaceutical properties and the in vitro dissolution rates of 18 commercially available brands of tolbutamide tablets, all of which met the limits set by the Food and Drug Regulations for tablets sold in Canada.A marked variation in dissolution rates was found, which bore no relation to the official disintegration time. These wide variations in dissolution rate point to a need for (a) a comprehensive study of the in vivo effects of different tolbutamide tablets, and (b) an official test that sets limits for the rate of dissolution of tolbutamide tablets, in addition to the one that places limits on disintegration time.

Absorption↗
PubMed1996

Relative bioavailability of four clomipramine hydrochloride tablet products.

The relative bioavailability of clomipramine was determined in two single-blind, single-dose, randomized, crossover studies. In the first study, the relative bioavailability of the test product, 2 x 25 mg clomipramine hydrochloride tablets (Noristan Ltd.), with respect to the reference product, Anafranil 2 x 25 mg tablets (clomipramine HCl; Ciba-Geigy (Pty) Ltd.) was determined. In the second study, the relative bioavailability of the test product, 5 x 10 mg clomipramine hydrochloride tablets (Noristan Ltd.), with respect to the reference product, Anafranil 5 x 10 mg tablets (clomipramine HCl; Ciba-Geigy (Pty) Ltd.), was determined. The geometric mean values for the variable Cmax were 31.3 ng mL-1 for the reference and 31.6 ng mL-1 for the test product in study 1. The geometric mean values for the variable AUC were 736 ng h mL-1 and 753 ng h mL-1 for the reference and test, respectively. In study 2, the geometric mean Cmax values were 25.8 ng mL-1 and 23.9 ng mL-1 for the reference and test respectively; the geometric mean AUC values were 569 ng h mL-1 and 547 ng h mL-1. The 90% confidence intervals for the 'test/reference' mean ratios of the plasma clomipramine pharmacokinetic variables Cmax and AUC(0-infinity) (as measures of the rate and extent of absorption of clomipramine, respectively) fall within the conventional bioequivalence range of 80-125% for both studies. The test products (clomipramine HCl) are therefore bioequivalent to the reference products (Anafranil) with respect to the rate and the extent of absorption of clomipramine in both 10 mg and 25 mg strengths.

Administration, Oral↗
PubMed1989

Oral controlled-release morphine sulfate. Analgesic efficacy and side effects of a 100-mg tablet in cancer pain patients.

Fifty-one cancer pain patients with limited opioid exposure participated in a randomized, double-blind, repeated-dose, parallel-group comparison of two dosage strengths of the controlled-release morphine preparation, MS Contin tablets (The Purdue Frederick Company, Norwalk, CT). The patients were first stabilized on immediate-release oral morphine 30 mg every 4 hours, with 15 mg available every 2 hours as needed for breakthrough pain ("rescue" dose). Each patient then received either one 100 mg MS Contin tablet or three 30-mg MS Contin tablets every 12 hours, with rescue medication as needed, for 3 days. Analysis of study power revealed sufficient sensitivity to detect clinically relevant differences in pain intensity and use of rescue medication. The two tablet strengths yielded similar pain relief, use of rescue medication, and frequency of side effects. In addition, pain and use of rescue medication did not change from the beginning to the end of the 12-hour dosing intervals in either group. In the study population as a whole, pain intensity was lower and total morphine intake higher during the period on controlled-release morphine. These data establish comparable analgesic efficacy and side effect potential of these two dosage strengths and confirm a 12-hour duration of effect for both. The improved analgesia on the controlled-release morphine may be attributable to increased consumption of drug resulting from improved compliance.

Administration, Oral↗
PubMedDate not supplied

The relative bioavailability of a commercial propranolol hydrochloride tablet in man.

A relative bioavailability study of conventional tablet of propranolol hydrochloride was conducted in a group of 18 healthy volunteers employing the innovator's product as the reference tablet formation. Based on plasma levels of propranolol for the 24 h following administration of 2 x 40 mg oral propranolol hydrochloride tablets, the relative extent of availability was shown to be 100.8 per cent for the test tablet formulation; no significant differences were detected between formulations with respect to any of the pharmacokinetic parameters examined. Large intersubject variations in plasma propranolol concentrations and the subsequently calculated areas under the plasma concentration/time curves were attributed to substantial presystemic biotransformation differences.

Adolescent↗
PubMedDate not supplied

Bioavailability of seven furosemide tablets in man.

A seven-way crossover study was conducted in 14 healthy male volunteers to evaluate the relative bioavailability of seven different marketed 40 mg furosemide tablets. Each dose was administered as a single tablet after an overnight fast, and blood samples were obtained for 16 hours. Plasma was assayed by HPLC. There were no statistically significant differences among the seven products for the mean peak concentration (1.01-1.29 micrograms/ml), mean time of peak (1.2-2.1 h) or mean area under the plasma concentration-time curves, which differed by less than 14 per cent. However, one product exhibited greater intersubject variability, and on this basis was considered inequivalent to the other six products. Furosemide is a potent and widely used diuretic. Currently the United States Food and Drug Administration (USFDA) has granted approval to at least twelve manufacturers of 40 mg furosemide tablets, based in part on bioavailability data obtained in human subjects. In addition, the USFDA has granted an 'AB' therapeutic equivalence evaluation to each of these products, which is understood by many to indicate the therapeutic equivalence and interchangeability of these products. The objective of the present investigation was to directly compare the bioavailability of seven 40 mg furosemide tablet products which had previously been approved by the Food and Drug Administration.

Adult↗
PubMed2006

Epinephrine for the treatment of anaphylaxis: do all 40 mg sublingual epinephrine tablet formulations with similar in vitro characteristics have the same bioavailability?

Epinephrine autoinjectors are underutilized in the first aid emergency treatment of anaphylaxis in the community; so non-invasive sublingual epinephrine administration is being proposed. In order to determine the effect of changing excipients on the bioavailability of sublingual epinephrine, four distinct fast-disintegrating epinephrine 40 mg tablet formulations, A, B, C and D, were manufactured using direct compression. All formulations were evaluated for tablet hardness (H), disintegration time (DT) and wetting time (WT). In a prospective 5-way crossover study, four sublingual formulations and epinephrine 0.3 mg i.m. as a control were tested sequentially in a validated rabbit model. Blood samples were collected before dosing and at intervals afterwards. Epinephrine plasma concentrations were measured using HPLC-EC. All tablet formulations met USP standards for weight variation and content uniformity, and resulted in similar mean H, DT and WT (n=6). The area under the curve (AUC), maximum concentration (C(max)) and time at which C(max) was achieved (T(max)) did not differ significantly after the sublingual administration of formulation A and epinephrine 0.3 mg i.m. The AUC after B, C and D were significantly lower (p<0.05) than after epinephrine 0.3 mg i.m. These results suggest that the selection of excipients used in these tablet formulations can affect the bioavailability of sublingually administered epinephrine.

Administration, Sublingual↗
PubMed1990

A comparison of a controlled release (CR/ZOK) formulation of metoprolol, once daily, with conventional metoprolol tablets, twice daily, in mild to moderate hypertension.

In a randomized double-blind multicenter study in 100 hypertensive patients, the effect of once daily (od) dosing with a new controlled release (CR/ZOK) formulation of metoprolol was compared with that of twice daily (bid) dosing with metoprolol conventional tablets. Eligible patients had a resting seated diastolic blood pressure (DBP) greater than or equal to 95 mm Hg and less than 110 mm Hg at the end of a 6-week open placebo run-in. The active treatment phase lasted 8 weeks. The starting dose was 100 mg od in the CR/ZOK group (N = 53) and 50 mg bid in the tablet group (N = 47). The dose was increased to 200 mg od and 100 mg bid, respectively, in nonresponders (DBP greater than 95 mm Hg) at the end of the first 4-week period. Approximately 40% of both groups received concomitant diuretic therapy throughout the study. The SBP, DBP and HR were reduced compared to baseline in both treatment groups after 4 and 8 weeks. After 4 weeks, 85% of the CR/ZOK group and 74% of the tablet group had DBP less than 95 mm Hg. After another 4 weeks, the corresponding figures were 93% and 93%. There was no statistically significant difference between the treatment groups in the decrease in either SBP, DBP or HR, nor was there any difference in the percentage of responders. Both treatments were equally well tolerated. In conclusion, the antihypertensive effect of once daily dosing (100-200 mg) with the new CR/ZOK formulation of metoprolol is as effective as that of twice daily dosing (50-100 mg) with conventional metoprolol tablets.

Adult↗
PubMed1994

Comparison of the pharmacokinetics of naproxen tablets and suspension in children.

Twenty-three children, aged 8 to 14 years, with postoperative pain, were randomly assigned to receive a fixed 250-mg dose (4.66-7.58 mg/kg) of naproxen as either a liquid suspension or tablet. After an overnight fast, the serum concentrations were measured before and at 0.5, 1, 2, 3, 4, 8, 12, 18, and 24 hours after administration of naproxen. The concentration versus time data were best fit to a one-compartment open model. The area under the concentration versus time curve, apparent volume of distribution (VDss/F), and elimination parameters (CL/F, Ke, elimination half-life) were similar in children who received suspension or tablets. Although the apparent maximum peak plasma concentration (Cmax) was greater in children who received tablets compared with those who received the suspension, Cmax/area under the curve (AUC), apparent time to maximum peak concentration (tmax), Ka, and estimated time to 10%, 50%, and 90% absorption (T10, T50, T90) were not different. The dose range was relatively narrow; hence, direct relationships between dose and elimination parameters, VDss/F, apparent tmax, Ka, T10, T50 or T90 were not observed. Neither VDss/F or CL/F were age related over the relatively narrow range of ages that were studied. Elimination of naproxen in our patients was more rapid than has previously been reported in children or adults, however. From a practical standpoint, naproxen tablets and suspension seem to be bioequivalent in fasting children ages 8 to 14 years.

Administration, Oral↗
PubMed1976

A unified mathematical model for diffusion from drug-polymer composite tablets.

The derivation and experimental verification of a unified mathematical model for the estimation of drug release rate from drug-polymer composite tablets are presented. Cylindrical coordinates are utilized in the solution of the diffusion equation for a three-dimensional system. The model is applicable to tablets that range from the shape of a flat disk (radius greater than thickness) to that of a cylindrical rod (radius less than thickness). The general solution for the fraction of drug released at a time t is (see article). This approach to a three-dimensional system, utilizing cylindrical coordinates, presents a comprehensive method for the estimation of drug release rates from sustained release tablets with drug distributed homogeneously throughout a polymer matrix. The calculated and experimental drug diffusion rate of pyrimethamine from pyrimethamine-silicone rubber composite tablets that range in shape from that of a disk to a cylinder, and of hydrocortisone from EVA, polycaprolactone, and PVA terpolymer, are compared.

Caprolactam↗
PubMed2006

Multiscale modelling methodology for virtual prototyping of effervescent tablets.

Computational methodology for virtual tablet prototyping has been developed. The methodology consists of two steps: construction of virtual particle compacts of varying composition using the discrete element method (DEM), and the simulation of their dissolution by eroding individual components from the tablet microstructure according to their intrinsic dissolution rates, using the volume-of-fluid (VOF) method. The effective erosion rate obtained from simulations at the particle assembly length-scale is used for the calculation of dissolution time at the tablet length-scale. The methodology is demonstrated on the case of a simple effervescent formulation consisting of sodium bicarbonate-acetic acid effervescent system, sodium chloride as a model active substance, and lactose filler. The experimentally measured dependence of tablet dissolution time on composition and compaction force was found to be in very good agreement with outputs from computer simulations.

Citric Acid↗
PubMed2006

Influence of solid phase and formulation processing on stability of Abbott-232 tablet formulations.

Abbott-232 is a chemically stable, highly water soluble non-hygroscopic compound selected for development as a potent uroselective alpha(1A) agonist. An anhydrate, a monohydrate, and an amorphous phase were isolated. The anhydrate was chosen for formulation development based on solid-state characterization. Excipients for immediate release (IR) tablet formulations were selected according to compatibility studies. However, the prototype IR tablets designed for clinical trials were found to be chemically unstable. Thus, process-induced phase transformation was investigated as the likely cause of the observed instability. Since the drug loading in the formulations was low (1%), model granulations containing 30% drug were evaluated to test this hypothesis. Investigation using a variety of analytical techniques indicated that the observed degradation was, indeed, a result of a solution-mediated phase transformation from anhydrate to amorphous Abbott-232 during wet granulation. A new direct compression formulation was, therefore, developed to prevent the solution-mediated process induced phase transition. Since the drug loading was low, a polarized light microscope (PLM) method was used to evaluate the solid phase in the new formulation. PLM confirmed that the original anhydrate form remained unchanged in tablets manufactured by the dry process. Stability studies confirmed that both IR and extended release (ER) tablets of Abbott-232 were successfully developed for clinical trials using direct compression.

Adrenergic alpha-Agonists↗
PubMed2007

Effect of moisture and pressure on tablet compaction studied with FTIR spectroscopic imaging.

FTIR spectroscopic imaging using a diamond ATR accessory has been applied to examine the influence of moisture and compression pressure on the density and components distribution of compacted pharmaceutical tablets. The model drug and excipient used within this study are ibuprofen and hydroxypropylmethylcellulose (HPMC). Chemical images of these compacted tablets were captured in situ without removing the tablet between measurements. A powder mixture of both, drug and excipient, prior to compaction, were subjected to a controlled environment, using a controlled humidity cell. Histograms were plotted to assess the density distribution quantitatively. This FTIR spectroscopic imaging approach enabled both measurement of water sorption and enhanced visualization of the density distribution of the compacted tablets.

Drug Stability↗
PubMed1975

Effect of aging on physical properties of phenylbutazone tablets.

A study was made of the influence of age on the physical properties of phenylbutazone tablets BP, with special reference to in vitro dissolution rates. Past batches of tablets showed a progressive decrease in dissolution rate with age. This effect could be simulated in short periods by using elevated temperatures. The effect appears to be connected with the subcoat layer of the sugar coating of the tablet which adheres more strongly to the tablet core and slows down its disintegration.

Carbohydrates↗
PubMed1976

Stability of vitamin C (ascorbic acid) in tablets.

Stability of ascorbic acid (vitamin C) in various tablet formulations and the nature and extent of formation of decomposition products (dehydroascorbic acid, diketogulonic acid, and oxalic acid) were determined under normal conditions of storage and in simulated use tests. IR spectrophotometric, colorimetric, fluorometric, titrimetric, polarographic, and chromatographic methods were applied. Recent implications concerning the instability of ascorbic acid in tablets and the potentially harmful nature of the breakdown products are shown to be unfounded. Under normal storage conditions, commerical-type ascorbic acid tablets are stable for over 5 years (greater than 95% potency retention). The amounts of all three breakdown products formed under the various storage conditions constitute a small percentage of the ascorbic acid content and pose no dietary hazard. IR spectroscopy was inadequate as a quantitative method for evaluating ascorbic acid potency in tablet formulations. The official titration methods and TLC, colorimetric, and polarographic determinations correlate well and define accurately the stability of ascorbic acid in these dosage forms.

Ascorbic Acid↗