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PubMed1983

Bioavailability of naproxen tablets and suppositories in steady state.

Serum profiles were obtained from patients with rheumatoid arthritis after treatment with naproxen tablets and suppositories for 10 days to assure steady state conditions. The serum concentrations immediately before dose intake correlated well with the area under the concentration curve (AUC) when 250 mg naproxen tablets were taken 12-hourly (r = 0.85) and when 500 mg naproxen was given as tablets or as suppositories once daily in the evening (r = 0.83). These fixed times for blood samplings should be used in clinical trials with naproxen. Naproxen was measured by mass fragmentography. The mean steady state concentration and the mean half-life, calculated from the 12-hourly dosage schedule, were 45.0 +/- 1.7 mg/l and 15.2 +/- 1.4 hours, respectively. Doubling the dose from 250 mg to 500 mg b.i.d. increased the AUC by 30%. Average serum profiles for tablets and suppositories were very similar and gave a relative bioavailability of suppositories compared to tablets of 103% +/- 4%, suggesting comparable efficacy of the two administration forms.

Adult↗
PubMed1984

Fluorine concentration in primary tooth enamel in 6-year-olds after 3 years of daily intake of fluoride-containing tablets (Fludent).

The purpose of this study was to determine the posteruptive uptake of fluorine in primary tooth enamel after daily consumption of a fluoride-containing sucking tablet for three years. The material consisted of 17 children, who had been advised to suck on 1 NaF tablet (Fludent, 0.25 mg F) daily at bedtime from 3 to 6 years of age (test group), and 17 children without tablet supply (control group). No other fluoride preparation was used during the period. A chemical biopsy method, described by Koch et al. (1982), was used to determine the fluorine concentration in enamel at the age of 6. Two consecutive layers on the upper central primary incisors of each child were etched off by perchloric acid. Chemical analysis of the test solutions was used to determine the thickness of the enamel layers and the fluorine content. Statistical evaluations were performed by analysis-of-variance. The results showed that fluorine was incorporated in primary tooth enamel as a topical effect of the fluoride tablet intake. There was a statistically significant difference (p less than 0.05) between the groups regarding fluorine measured on the layers combined and in the out layer (approximately equal to 5 micron thick), but not in the inner layer (approximately equal to 8 micron). It was concluded that the posteruptively increased enamel fluorine concentration probably contributes to the caries-preventive effect of NaF tablets.

Biopsy↗
PubMed1983

Rapid high pressure liquid chromatographic determination of amitriptyline hydrochloride in tablets and injectables: collaborative study.

A previously reported high pressure liquid chromatographic method for the determination of amitriptyline hydrochloride in dosage forms was modified to permit its use as a stability-indicating method. The modified method, entailing a nitrile bonded microparticulate column, a methanol-0.005M ammonium acetate (90 + 10) mobile phase, and photometric detection at 239 nm, was collaboratively tested by 10 laboratories. Each collaborator received samples of synthetic and commercial tablets and injections. The recovery from a synthetic injection at the 10.06 mg/mL spiking level averaged 98.6%. The amount of declared found in commercial injections averaged 103.1%. The pooled reproducibility SD (CV%) and repeatability SD (CV%) were +/- 2.12 (2.15) and +/- 1.81 (1.84), respectively. The recovery from synthetic tablet composite at the 7.45% spiking level averaged 102.0%. The amount of declared found for commercial 25 mg and 100 mg tablets averaged 96.7 and 97.9%, respectively. The pooled reproducibility SD (CV%) and repeatability SD (CV%) for these 3 tablet samples were +/- 1.89 (1.86) and +/- 1.66 (1.64), respectively. Content uniformity analysis of commercial 25 mg and 100 mg tablets (n = 10) gave amounts of declared values averaging 100.5% (range 92.4-108.8%) and 99.3% (range 89.6-107.0%), respectively. The pooled reproducibility SD (CV%) and repeatability SD (CV%) were +/- 3.23 (3.2) and +/- 2.78 (2.8), respectively. A commercial injectable preparation spiked with dibenzosuberone was also collaboratively analyzed by a thin layer method. The method was adopted interim official first action.

Amitriptyline↗
PubMed1984

The use of directly compressible vehicles for the preparation of vitamin B1 tablets.

The classical method for the preparation of vitamin B1 tablets led to tablets of doubtful and/or shorter stability. Dipac , Emdex , Nu-Tab and Sugartab , were evaluated as direct compression vehicles for the preparation of vitamin B1 tablets. Avicel was also employed as a traditional vehicle for comparison. These vehicles were evaluated at different concentrations compared with vitamin B1 tablets available in the Egyptian market and prepared by the classical method. Generally, it was found that increasing the concentration of the vehicles in the tested vitamin B1 formulations improved the physical standards and mechanical strength of the tablets produced. Avicel was found to be the most suitable vehicle, followed by Dipac and Emdex . However, Sugartab and Nu-Tab were found to be the worst in this respect.

Drug Compounding↗
PubMed1983

Why do apparently healthy people use antacid tablets?

Proprietary antacids represent a multimillion dollar business in this country. Marketing surveys have shown that approximately one-half of American adults have used antacids. Twenty-seven percent of adults take 2 or more doses per month. Seventy-five percent of total antacid consumption is by heavy users, defined as greater than 6 doses per week (less than 5% of adults). We investigated why apparently healthy people are heavy antacid users. Thirty-seven heavy users were evaluated. The median duration of antacid use was 20 years, and most took antacids 2-6 times per day, concentrated through the work week. The primary diagnosis was reflux esophagitis in 31 (84%), peptic ulcer disease in one, and nonulcer dyspepsia in five. Ninety-five percent had symptoms consistent with reflux esophagitis. Thirty-three completed a 1 month double-blind, randomized cross-over trial of antacid tablets (14 mEq neutralizing capacity per tablet) versus placebo. Twenty-nine correctly identified the antacid product (p less than 0.0001). Twenty-three subjects underwent Bernstein tests and endoscopy; 21 had positive Bernstein tests, 13 had definite esophagitis as determined endoscopically. We conclude 1) heavy proprietary antacid tablet use in the adult male is not an expression of functional disease but is due to reflux esophagitis, 2) tablet use can be effective symptomatic treatment, and 3) history is an adequate evaluation for most heavy antacid tablet users.

Antacids↗
PubMed1981

The influence of binder type and concentration on the physical characteristics of calcium carbonate granules and their corresponding tablets.

Most studies involving binders are concerned with the properties of the final product. Very little has been done at comparing the mechanical properties of the granules, the force required to crush the tablets and the compression behavior. The aim of this investigation was to study the effect of different concentrations of five binders namely gelatin, PVP, methylcellulose, syrup and Eudragit E on the mechanical and physical properties of calcium carbonate granules and correlating that with the characteristics of the corresponding tablets. A template method was used for the preparation of calcium carbonate granules. The wet granules were dried for 34 h in air oven at 60 degrees C and were conditioned for a minimum of 2 h at 50% relative humidity before testing or tableting as this corresponds approximately to ambient conditions. The granules, were separated into different size fractions using the sieve analysis method, and were then measured for crushing strength (K), friability (%), flow ability, bulk volume and tap density. The granules possessing the best mechanical and physical characteristics were used for tableting. The compact obtained were also evaluated for both mechanical and physical properties. It was found that increasing the binder concentration was followed by an increase in the mean particle diameter, harder granules (-kt = ln Wa divided by W + Wb . db divided by W . da) and reduction in tap density. Except for those prepared with 2% methylcellulose and 30% syrup, all tablets prepared from granules with optimum properties are found to satisfy U.S.P. requirements of weight, thickness, disintegration time and mechanical properties.

Calcium Carbonate↗
PubMed1994

Formulation of water disinfectant tablets for rural communities in Nigeria.

A water disinfectant tablet containing calcium hypochlorite as the main ingredient has been developed using a variety of excipients to improve the tablet characteristics. Avicel, polyvinylpyrrolidone, sodium hydrogen carbonate, calcium carbonate, sodium chloride and potassium chloride were used. Inclusion of polyvinylpyrrolidone together with calcium carbonate gave better tablet characteristics. Avicel though gave better tablet characteristics, promoted loss of chlorine from the tablets. Inclusion of inorganic salts were not satisfactory as they, enhanced atmospheric water absorption.

Calcium Compounds↗
PubMed1994

[Relative bioavailability of paracetamol in suppositories preparations in comparison to tablets].

Relative Bioavailability of Paracetamol as Suppositories Compared to Tablets. The relative bioavailability of paracetamol (CAS 103-90-2) in ben-u-ron 500 mg and ben-u-ron 1000 mg suppositories (test formulations) was compared with that of Benuron tablets 500 mg (reference product) in an open, intraindividual, 3-period-changeover-study in 18 healthy subjects. Plasma concentrations of paracetamol were determined using a specific and sensitive HPLC method with UV detection. For the assessment of bioavailability AUC, Cmax, tmax and HVD were used as pharmacokinetic characteristics. Bioequivalence of the rectal formulations was tested by calculating 90% confidence intervals using the Two-one-sided-t-tests-procedure and log-transformed data of AUC and Cmax. For AUC the confidence intervals were required to be in the 80 and 125% range, for Cmax between 70 and 143% (inclusion rule). Data from 17 subjects could be evaluated. Bioavailability of paracetamol was 89 and 90% for the 500 and 1000 mg suppositories, respectively compared with that of the 500 mg reference tablets. Mean maximum paracetamol plasma concentrations (Cmax) were 3.55 and 6.02 or 7.16 mg/l after administration of the 500 and 1000 mg suppositories or the 500 mg tablets, respectively. These maximum concentrations were achieved 2.0, 2.7 and 0.6 h (tmax) after administration of the respective preparations. The corresponding HVD values were 4.3, 5.2 and 2.0 h, respectively. After dose adjustment of the results for the 1000 mg suppositories relative bioavailabilities of paracetamol from both rectal formulations exceeded 80% of that from the tablets.(ABSTRACT TRUNCATED AT 250 WORDS)

Acetaminophen↗
PubMed1994

[Deformation of tablets according to breaking hardness].

The authors were the first to test the breaking process of tablets in home respect. In experiments on the breaking of tablets a tablet hardness tester developed by the Chemical and Pharmaceutical Works Ltd. Chinoin (Budapest) was used. With an appropriate program, this permitted not only a qualitative evaluation of the breaking curves (Fig. 2-4.) also an assessment of the breaking work relating to the breaking strength and even the work needed for various deformation processes (Tab. I-II.). The concept of the breaking factor was introduced: this allows a differentiation of tablets even if the breaking strengths are the same (see Tab. III. 1-2 tablets; with two samples analysis; p < 0.05.) It is concluded that such breaking strength examinations contribute to a better understanding of the behaviour of substances during compression. These results can be very useful both in preformulation examinations and in tests on the prepared products.

Stress, Mechanical↗
PubMed1994

Qualitative and quantitative determination of two new antitumor agents from 1-8 naphthalimides in tablets. Validation of a high performance liquid chromatography method.

A high performance liquid chromatography (HPLC) method for the qualitative and quantitative determination of amonafide (CAS 69408-81-7) and mitonafide (CAS 54824-17-8), two new antineoplastic molecules, in finished pharmaceutical dosage forms (tablets) is developed and validated. The results submitted in this work suggest that HPLC method is linear (range 0.54 microgram to 2.70 micrograms for amonafide, and 1.40 micrograms to 5.25 micrograms for mitonafide), sensitive (discriminator capacity 0.1098 microgram for amonafide and 0.1324 microgram for mitonafide), precise (coefficient of variation < or = 2.39% within run, < or = 1.18% between run for tablets with amonafide, and < or = 1.38% within run and < or = 0.96% between run for tablets with mitonafide), accurate (mean recovery 97.55, 98.85, 98.905% for the three different kinds of tablets with amonafide, and 100.73, 101.54% for the two types of tablets with mitonafide) and selective, even when degradation products are present. The volume of extractor liquid must be specially taken into account with regard to the accuracy of the method, because drug extraction can be influenced by the nature of the excipients.

Adenine↗
PubMed1993

Oral pharmacokinetics of carbamazepine in dogs from commercial tablets and a cyclodextrin complex.

The extent of absorption of carbamazepine from a 2-hydroxypropyl-beta-cyclodextrin/carbamazepine complex was significantly greater and the rate of absorption was faster when compared with an immediate-release carbamazepine tablet in the dog. Six dogs were dosed orally in a two-way crossover study in which the tablet was compared with an equivalent dose of the complex in solution. The area under the curve of concentration versus time for the complex was 5.6 times greater than the tablet, whereas the mean time to reach maximum concentration for the tablet was 1.4 hours versus 0.5 hours for the complex. The complex, therefore, had a greater rate and extent of absorption. A rapidly acting and better absorbed carbamazepine product has the potential to decrease the daily dose of carbamazepine, increase its utility as emergency treatment of epileptic seizures, and provide an acceptable alternative dosage form in patients who are unable to swallow tablets.

Administration, Oral↗
PubMed1993

[Studies on the bioavailability and pharmacokinetics of nimodipine tablet in human body].

The article determined the bioavailability and pharmacokinetic parameters of two kinds of nimodipine tablets produced by Tianjin Center Pharmaceutical Factory in 6 healthy volunteers using HPLC method. The commercially available conventional tablet A and the tablet formulation B were compared with the reference solution C in vivo. The pharmacokinetic parameters of nimodipine in vivo were estimated by using PKBP--N1 program on the basis of one compartment open model. After administration of 120 mg dose of B, the pharmacokinetic parameters were as follows: Tp = 0.977 h, Cmax = 44.28 ng/ml, ka = 2.02 h-1, t1/2 = 1.63 h, Vd = 26.25 L/kg, AUC = 136.56 ng.h-1.ml-1. The result imply that nimodipine is absorbed rapidly, distributed widely in the body, and also eliminated at a fairly rapid rate. The bioavailability of A and B relative to C was 16.01% and 82.39% respectively. The new tablet formulation B is superior to tablet A.

Biological Availability↗
PubMed1995

Relative bioavailability of DL-oxyfedrine HCl after single-dose oral administration of tablets as compared to equimolar solutions.

The pharmacokinetics and comparative bioavailability of oxyfedrine after single-dose oral administration of oxyfedrine*HCl tablets in comparison to an equimolar aqueous solution of oxyfedrine*HCl were investigated in 12 healthy male subjects. Six of them received 96 mg DL-oxyfedrine*HCl as tablets and solution and the remaining 6 subjects received 16 mg DL-oxyfedrine*HCl as tablets and solution in a randomized cross-over design. For evaluation of the relative bioavailability of the tablet formulation, the main metabolite norephedrine (expressed as hydrochloride) was analyzed in plasma for all 12 subjects. Furthermore, for determination of the parent drug, samples of whole blood were analyzed for DL-oxyfedrine*HCl. Relevant concentrations of the parent drug were found only in the high dosage group. There was no evidence of dose-linearity referring to AUC and Cmax of norephedrine between 16-mg and 96-mg doses of DL-oxyfedrine*HCl. The relative bioavailability of the tablet formulation after administration of 16 mg DL-oxyfedrine*HCl, based on the metabolite norephedrine*HCl was for AUC: 85.37% within a 90% confidence interval of 69.29-105.17% and for Cmax: 78.79% within a 90% confidence interval of 59.19-104.90%. The figures for the 96 mg dose strength were: AUC: 107.85% (90.06-129.15%) and for Cmax: 74.74% (62.48-89.42%).

Administration, Oral↗
PubMed1996

Two-week oral mucosal irritation study with ramosetron orally disintegrating tablets in Syrian hamsters.

The potential of ramosetron ((R)-5-[(1-methyl-3-indolyl)carbonyl]-4,5,6,7-tetrahydro-1 H-benzimidazole hydrochloride, CAS 132907-72-3, YM060) orally disintegrating tablets to cause irritation to the oral mucosa was assessed in a group of six male and six female Syrian hamsters. Each animal was given one tablet containing 0.1 mg YM060 into the right cheek pouch once daily for 14 consecutive days. A neck collar was fitted for 1 h after each administration to ensure that the tablet was not expelled. A similarly constituted group of hamsters received placebo tablets and acted as a contemporaneous control. Left and right cheek pouches were examined before dosing each day, and on the day following the last treatment. At the end of the treatment period the animals were killed, the cheek pouches excised and examined macroscopically. The cheek pouches of all animals were assessed for histopathological change. There were no signs to indicate systemic or local reactions to treatment in any animal. Macroscopic and microscopic examination of the cheek pouches did not reveal any treatment-related effect. It is concluded that YM060 orally disintegrating tablets are non-irritant to the hamster oral mucosa.

Animals↗
PubMed1996

In vitro and in vivo studies on microcapsules and tabletted microcapsules of cephradine.

Cephradine was microencapsulated by coacervation. Ethyl cellulose was used as the polymer and a core/wall ratio of 1:1 was selected. The repose angle, apparent and tapped density, particle size distribution of cephradine microcapsules (CM) and of cephradine powder were examined. Then flat-surfaced tablets of CM were prepared using Avicel PH 101 and magnesium stearate. In vitro and in vivo properties of CM and tabletted CM (both equivalent to 150 mg cephradine) were compared with commercial capsules (equivalent to 250 mg cephradine). The dissolution studies were carried out by the rotating basket method and the agar diffusion method was applied for quantitative determinations. Among the investigated kinetic models for the release of cephradine from CM and tabletted CM the best fit was found with the Higuchi model. In vivo studies were made in rabbits. Bioavailabilities of CM and their tabletted form were higher than that of the commercial capsules. In vitro/in vivo correlations between mean residence time (MRT) and mean dissolution time (MDT) for CM and tabletted CM were calculated. A good correlation was found between the in vitro and in vivo results.

Animals↗
PubMedDate not supplied

Liquid chromatographic determination of thalidomide in tablets, capsules, and raw materials.

A simple, isocratic liquid chromatographic method for assay of thalidomide in tablets, capsules, and raw materials was developed. The method uses a Nova-Pak octadecylsilane bonded-phase column (150 x 3.9 mm, 4 microns particle size), a mobile phase of acetonitrile-water (15 + 85), a flow rate of 1 mL/min, detection at 237 nm, and phenacetin as internal standard. Phosphoric acid was used in preparation of sample solutions to inhibit thalidomide hydrolysis. Assays ranged from 99.3 to 100.4% in raw materials from 4 manufacturers, from 79.7 to 104.8% in tablets from 7 manufacturers, and from 75.3 to 102.6% in capsules from 4 manufacturers. Assay method precisions for triplicate analyses on 5 days were 0.30% for tablets, 0.22% for capsules, and 0.22% for raw materials. Recovery from simulated tablet formulations was 100%. The method has been used to analyze individual tablets and capsules for determination of content uniformity.

Acetonitriles↗
PubMed1977

Comparison of methods for determining probenecid in tablets and flavored oral suspensions containing ampicillin.

Several methods for quantitating probenecid were compared: USP XIX method for probenecid in tablets, a modified USP extraction method for probenecid in tablets, a new column extraction method for probenecid in tablets and oral suspensions containing ampicillin, and a high pressure liquid chromatographic (HPLC) method for probenecid in tablets and oral suspensions containing antibiotics. The first 3 methods were satisfactory for probenecid in bulks and tablets but proved unsatisfactory for oral suspeonsions containing flavors. The flavors gave positive interference for probenecid in oral suspensions. The HPLC method, although more time-consuming, separated probenecid from excipients, thus eliminating positive interference from flavors.

Ampicillin↗
PubMed1990

Beta-galactosidase tablets in the treatment of lactose intolerance in pediatrics.

Lactose-intolerant children manifest diminished or nonexistent intestinal lactase activity, resulting in flatulence, abdominal pain, and diarrhea. To assess the hydrolytic capability of lactase-containing tablets taken immediately before oral lactose challenge, we studied 18 children previously identified as being lactose intolerant and having no underlying organic gastrointestinal disease. Subjects had a mean (+/- SEM) age of 11.4 +/- 3.4 years; 72% were male. At time of the study, lactase-containing tablets or placebo tablets were ingested (double-blind) immediately before drinking a solution of lactose. Breath samples were obtained for hydrogen analysis at 30-minute intervals during a 2-hour period, and clinical symptoms were monitored. In lactose-intolerant patients, hydrogen production was significantly greater following placebo (maximum hydrogen excretion, approximately 60 ppm) compared with lactase-containing tablets (maximum hydrogen excretion, 7 ppm). Increased hydrogen production was associated with clinical symptoms including abdominal pain (89% of subjects following placebo ingestion), bloating (83%), diarrhea (61%), and flatulence (44%). These results indicate, therefore, that coingestion of lactose and lactase-containing tablets significantly reduces both breath hydrogen excretion and clinical symptoms associated with lactose intolerance.

Abdominal Pain↗