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PubMed1984

Controlled release of radioprotective agents from matrix tablets--effect of preparative conditions on release rates.

Release rates of radioprotective agents from insoluble matrix tablets were measured as a function of ethylcellulose/stearic acid ratio and active ingredient concentration in the matrix. The influence of the compacting pressure applied during tablet formation on the release of these aminothiol compounds was also examined. The kinetic data conformed with the Higuchi square root equation and first order release. As both plots were linearly acceptable, a statistical method for release mechanism identification using the kinetic experimental results obtained without any further transformation was used. This non-linear regression search procedure accompanied by the chi 2-square test has shown that that aminothiol release from the matrix tablets definitely follows the Higuchi square root equation. Increasing the ethylcellulose amount in the matrix consequently improves the degree of wettability and leads to a faster rate of solvent penetration. This tends to release the aminothiols more rapidly from the matrix tablets. Solvent penetration, which also follows a square root of time relationship, is probably the rate-limiting factor in the release process. The linear increase in release rates of the aminothiols observed with ethylcellulose concentration is explained by a parallel increase in the porosity of the matrix tablets. Increase in the drug concentration in the tablet increases the cysteine hydrochloride release rate and decreases the cysteamine hydrochloride release rate. A similar effect was also observed by applying increasing compacting pressure during matrix tablet formation. It was suggested that these two experimental factors differently affect the internal structure of the matrix during the preparation process.(ABSTRACT TRUNCATED AT 250 WORDS)

Cellulose↗

PubMed2007

Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin. Effect of body weight, gender, and race on systemic exposures of each drug.

Bioavailability of pioglitazone and metformin, in 2 dose strengths, given either as a fixed-dose combination tablet or as coadministration of commercial tablets (coad), was studied in young healthy subjects in 2 separate studies. In study I (n = 63), single oral doses of 15-mg pioglitazone/500-mg metformin fixed-dose combination tablets or equivalent doses of commercial tablets were administered, in a fasting state, in an open-label, randomized, crossover study with a 7-day washout period between treatments. Study II (n = 61) was similar in design to study I, except the 15/850-mg fixed-dose combination tablet and coad treatments were evaluated. Least squares mean (fixed-dose combination/coad) ratios and 90% confidence intervals of the ratios for the 15/500-mg dose strength for the maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time 0 to infinity (AUC(infinity)) were 0.95 (0.86-1.05) and 1.02 (0.98-1.08), respectively, for pioglitazone and 0.99 (0.95-1.03) and 1.03 (0.98-1.08), respectively, for metformin. Bioequivalency for pioglitazone and metformin between fixed-dose combination tablets and coad treatments was met for both strengths of fixed-dose combination tablets. In a post hoc meta-analysis of combined data from the 2 studies (n = 124), there was considerable overlapping in AUC(infinity) values between gender and race (Caucasians, Blacks, and Hispanics), making neither gender- nor racial-based dosing of pioglitazone or metformin necessary.

Administration, Oral↗

PubMed2001

Pharmacokinetics of metformin gastric-retentive tablets in healthy volunteers.

The single-dose pharmacokinetics of two gastric-retentive, extended-release tablet formulations of metformin hydrochloride in fed, healthy volunteers were compared with those of the currently marketed immediate-release metformin hydrochloride product. The plasma concentration-time profiles demonstrated extended-release characteristics from the gastric-retentive tablets. The mean bioavailability from each gastric-retentive tablet was approximately 115%, relative to the immediate-release (IR) product. Cmax values were lower and tmax values were greater for the gastric-retentive tablets compared with the IR product. In contrast to conventional extended-release metformin tablets reported in the literature, these gastric-retentive tablets showed extended-release plasma concentration profiles of metformin hydrochloride and increased bioavailability compared with the immediate-release tablet.

Adult↗

PubMed2005

Functionality comparison of 3 classes of superdisintegrants in promoting aspirin tablet disintegration and dissolution.

The aims of this study are (1) to compare the disintegration efficiency, and (2) to develop a discriminating test model for the 3 classes of superdisintegrants represented by Ac-Di-Sol, Primojel, and Polyplasdone XL10. Using a digital video camera to examine the disintegration process of tablets containing the same wt/wt percentage concentration of the disintegrants, Ac-Di-Sol was found to disintegrate tablets rapidly into apparently primary particles; Primojel also apparently disintegrated tablets into primary particles but more slowly; Polyplasdone XL10 disintegrated tablets rapidly but into larger masses of aggregated particles. The differences in the size distribution generated in the disintegrated tablets likely contribute to the drug dissolution rate differences found for aspirin tablets with similar disintegration rates. The aspirin tablet matrix is proposed as a model formulation for disintegrant efficiency comparison and performance consistency testing for quality control purposes.

Aspirin↗

PubMedDate not supplied

Effects of a tablet-splitting program in patients taking HMG-CoA reductase inhibitors: analysis of clinical effects, patient satisfaction, compliance, and cost avoidance.

OBJECTIVE: The primary objective was to determine the effect of a hydroxymethylglutaryl- CoA reductase inhibitor (HMG) tablet-splitting program on laboratory outcomes (lipid panel and liver enzyme tests). Other objectives were to assess patient compliance and satisfaction with splitting tablets and to measure the reduction in drug acquisition costs. METHODS: Patients at a Veterans Affairs Health Care System facility were included in this study if they participated in the HMG tablet-splitting program between April and September 2000. Patients taking the same drug and dosage before and after implementation of the program were asked to complete a mailed questionnaire designed to measure satisfaction and compliance with the program. Data collected through electronic charts included patient demographics, prescribed medication, and the values for lipid panel and liver function tests. RESULTS: A total of 2,019 patients were included in the study. The total cost avoidance achieved over one year for atorvastatin, lovastatin, and simvastatin was 138,108 dollars (N=2,019). The majority of patients who responded to the questionnaire were satisfied and compliant with tablet splitting. In the laboratory analysis (N=512), there was no difference between prevalues and postvalues for total cholesterol and triglycerides. There was a statistically, but not clinically, significant decrease in LDL (102 versus 97, P<0.001) and increase in HDL (46 versus 48, P<0.001), AST (26 versus 28, P<0.001), and ALT (24 versus 26, P=0.006) after the initiation of tablet splitting. CONCLUSION: Tablet splitting of HMGs had no short-term negative effects on laboratory outcomes and favorable effects on humanistic outcomes as measured by patient satisfaction and compliance. Tablet splitting of HMGs is an effective way to reduce costs and nearly double the number of patients who can be treated for the same expense.

Journal Article↗

PubMed2003

An analysis of muscular load and performance in using a pen-tablet system.

The present paper aims to investigate two characteristics; task performance and muscular load during skill process for the pen-tablet input system with the mouse input system on the PC in order to determine the comprehensive usability for the pen-tablet system. Two computer tasks were designed for the study: task SL and task PT. Task SL was a repetitive computer-drawing including typical mouse motions such as clicking and drag-dropping. Task PT was a polygon tracing task requiring fine-controlled movements with the input device. Surface electromyography (EMG) and performance data were measured during the task. When the pen-tablet was being used, low amplitudes of EMGs for the biceps brachii, the flexor digitorum superficialis, and the extensor digitorum were found, whereas no EMG difference for the trapezius was found for both tasks. On the first day, the performance with the mouse was much higher than the performance with the pen-tablet in terms of error rates and the number of completed trials. However, the performance with the pen-tablet exceeded the performance with the mouse from the second day on, and the subjects performed better with the pen-tablet than with the mouse. Current results imply that the skill process for the pen-tablet system was very short and the subjects felt comfortable to use the new system from the beginning.

Adult↗

PubMed2005

Acceptability of and adherence to dispersible zinc tablet in the treatment of acute childhood diarrhoea.

Zinc treatment is now recommended by the World Health Organization as part of the routine management of acute childhood diarrhoea. A dispersible zinc tablet formulation was developed taking into account the taste, cost, and feasibility to distribute and store. Only limited information is available on the acceptability of and adherence to dispersible zinc tablet. No study has formally assessed whether the formulation is acceptable to children and if caretakers can adhere to the instructions regarding preparation, dosage, and duration of treatment. This community-based study aimed at determining the acceptability of and adherence to a dispersible zinc tablet formulation in a cohort of children (n=320) aged less than five years. Caretakers of children with acute childhood diarrhoea were prescribed zinc tablet treatment and followed up after 2-3 weeks. The formulation was acceptable to children; 90.1% of 303 caretakers perceived that the tablets were equally or even more acceptable to their children compared to other medicines. Ninety-eight percent of the children received the standard dose of one tablet per day, and 55.8% completed the full 10-day course of zinc treatment. Adherence rates did not vary by age or gender of the child. These findings indicate that the tablet formulation is acceptable, but further efforts are required to enhance adherence.

Acute Disease↗

PubMed1986

Effect of food on bioavailability of metronidazole from sugar-coated tablets having different dissolution rates in subjects with low gastric acidity.

The effect of food on the bioavailability of metronidazole from three commercial sugar-coated tablets varying markedly in drug dissolution behavior relative to pH was determined after oral administration in healthy male subjects with low gastric acidity. Four subjects, whose gastric acidities were evaluated as low (hypo- or anacidity) by using a non-intubation method (Gastrotest tablets administration method), received, in a cross-over fashion, a single 250 mg dose in sugar-coated tablet during periods of fasting and non-fasting. The tablet having the fastest and most pH-independent dissolution rate gave significantly higher Cmax and AUC0-32 than the other tablets having extremely slow dissolution at pH 5 or 7.2, when the drug was administered in the fasting state. However, there were no statistically significant differences in the above parameters among the tablets tested when they were administered postprandially. The improvement of the bioavailability of the tablets exhibiting poorer dissolution in the pH range of 5 to 7.2 is ascribed to suggestible vigorous agitation in the digestive tract stimulated by food intake.

Adult↗

PubMed1981

Absorption of theophylline from conventional and sustained-release tablets.

Healthy adults were treated in periods of 4 days with fast-dissolving theophylline tablets (Oxyphyllin, Draco, Sweden) and sustained-release tablets (Theo-Dur, Draco, Sweden). To some of the volunteers a single dose of i.v. aminophyllamine was administered. The absorption of theophylline, calculated from single dose administration of uncoated tablets (Oxyphyllin) was completed within 2 hrs, whereas the absorption from sustained-release tablets (Theo-Dur) continued for 12 hrs. There was no significant difference in bioavailability between aminophylline i.v., Oxyphyllin tablets and Theo-Dur tablets. The slow-release tablet gave a stable plasma level in steady state that implies the possibility of using 12-hr dosage intervals and still achieving a stable theophylline concentration in steady state with a small difference between peak and trough concentrations. This investigation shows that it is possible to simulate the plasma concentration of theophylline in steady state by means of oral administration, using the simple one-compartment model calculated from data registered after a single i.v. dose.

Adult↗

PubMedDate not supplied

Accelerated stability of Ibuprofen-Eudragit RSPM sustained release tablets, IR and DSC solid stability testing.

Preformulated Ibuprofen-Eudragit RSPM sustained release tablets were subjected to accelerated stability testing at 25, 37 and 45 degrees C for 6 months. The stored tablets were evaluated for the intact drug in the formula, drug-polymer interaction and compatibility of the drug with the formulated excipients using infra red spectroscopy (IR) and differential scanning calorimetry (DSC). The IR spectrum of Ibuprofen in the tablets prepared by 15% w/v Eudragit RSPM as a granulating agent and containing 23% w/v Avicel pH 102 as an excipient is similar to the IR of standard Ibuprofen. There is no change in the IR spectra of the tablet components before and after storage of those tablets at the different investigated temperatures for 1, 3 and 6 months. The DSC thermograms of the Ibuprofen stored tablets show that the drug was still in the highly pure (> 98%) crystalline form and there was no significant degradation after storage indicating the stability of the drug on storage. In detecting Ibuprofen purity in the stored tablets, plotting of the sample temperature versus the reciprocal of the fraction of Ibuprofen melted showed deviation from Van 't Hoff linear plot.

Acrylic Resins↗

PubMed1975

Effect of surface roughness and coating solvent on film adhesion to tablets.

The adhesion of a polymer film to selected tablet substrates was studied. The effect of tablet surface roughness and film-coating solvent on the adhesion of the film to the tablet was determined. A film-coating solvent having a solubility parameter close to that of the polymer was found to produce a stronger adhesional bond than a solvent having a lower surface tension. An increase in tablet surface roughness also increased film adhesion to the tablet. The adhesion was measured as the force required to peel a section of film from the tablet with a stress-strain analyzer.

Acacia↗

PubMed1980

Semiautomated method for analysis of enteric-coated and plain coated diethylstilbestrol tablets.

A semiautomated fluorometric method for the analysis of enteric-coated and plain coated diethylstilbestrol tablets is presented. To eliminate interferences from tablet excipients, diethylstilbestrol is extracted into an organic solvent and then into a basic aqueous solution. After UV irradiation, a product of diethylstilbestsrol is formed from which a fluorophore is produced chemically. The fluorescence is measured at an excitation wavelength of 335 nm and an emission wavelength of 410 nm. The coefficient of variation measured for the semiautomated procedure was 0.59%. Assay results agreed well with the USP procedure for tablets containing greater than 1 mg of diethylstilbestrol. Tablet dyes and excipients interfered in the USP procedure, which yielded low results for tablets containing less than 1 mg of diethylstilbestrol. Standard recovery data and assays of tablet composites showed that dyes and other excipients do not interfere with semiautomated procedure.

Autoanalysis↗

PubMed2004

Compaction of enteric-coated pellets: influence of formulation and process parameters on tablet properties and in vivo evaluation.

The aim of this study was to investigate the influence of formulation and compression parameters on the properties of tablets, containing enteric-coated pellets, and on the integrity of the enteric polymer of the individual pellets after compression. In addition the piroxicam plasma concentrations were determined after single and multiple oral administration of powder, pellet and tablet formulations at a dose of 0.3 mg piroxicam/kg bodyweight to dogs. Tablets consisted of enteric-coated pellets (containing 2.5% (w/w) piroxicam in combination with microcrystalline cellulose and sodium carboxymethylcellulose (using Avicel PH 101 and Avicel CL 611 in a ratio of 1-3), cushioning waxy pellets and 10% Kollidon CL (as an external disintegrator). From the D-optimality experimental design it was concluded that the ratio of coated pellets to cushioning pellets (CoP/CuP) affected all tablet properties evaluated. Variation of the pellet size and the CoP/CuP ratio resulted in different in vitro tablet disintegration times. Enteric coating of the pellets or compression of the coated pellets did not have a significant influence (P >0.05) on AUC(0-->72 h). Cmax values obtained after oral administration of coated pellets and compressed coated pellets were significantly lower than for the other formulations. Differences in in vitro tablet disintegration times were not reflected in the onset of the piroxicam plasma concentrations. A dosing interval of 48 h prevented piroxicam accumulation following multiple dose administration.

Carboxymethylcellulose Sodium↗

PubMed1999

Influence of the coating thickness and type of oral delivery system (tablets, pellets) on the stability towards degradation by neutron irradiation. Validation of neutron activation III.

Enteric coated dexchlorpheniramine maleate (DCPA) tablets and pellets with varying coating thickness were subjected to several in vitro tests after irradiation by thermal neutrons in a flux of 1. 1 x 10(13) n cm-2 s-1 for 2, 4 or 15 min. The appearance of the tablet formulation changed extensively after exposure of the tablets to pile radiation. The irradiation caused the film to loosen from the surface of the core, indicating the generation of gases during the irradiation process. Already after irradiating the tablets for 2 min the disintegration and dissolution behaviour were significantly changed. The extent of tablet damage increased with increasing time of exposure and increasing thickness of the coating. Compared with the tablet formulation, the cores could resist a larger amount of irradiation since dissolution behaviour of the cores was only affected after 15 min of irradiation. This indicates that the irradiation procedure initially affects the coating of the formulation. Although the dissolution behaviour of the pellet formulations changed significantly after the irradiation procedure, the changes were too small to be attributed exclusively to radiation damage.

Anti-Inflammatory Agents, Non-Steroidal↗

PubMed1978

[Properties and stability of tetracycline hydrochloride tablets].

Three forms of tetracycline hydrochloride tablets were studied, i.e. the uncoated tablets, sugar-coated tablets and the tablets with gastric-soluble film coating. The film-coated tablets had advantages in the main quality characteristics, i.e. the contents of the tetracycline-like admixtures, the active substance and solubility rate. The possibility of the tablet stability investigation by the method of "accelerated aging" was shown.

Drug Stability↗

PubMed2000

Determination of erythromycin and related substances in enteric-coated tablet formulations by reversed-phase liquid chromatography.

An isocratic method for the identification and quantitation of erythromycin and related substances in enteric-coated tablet formulations using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection at 205 nm is described. A novel method for sample preparation using a molecular weight centrifuge filter to reduce the interferences observed from polymeric tablet coating material is also presented. Erythromycin HPLC assays are best run at high pH; therefore, various polymer columns were evaluated. The resulting HPLC method that was developed has several advantages over current pharmacopeial assay methods for enteric-coated erythromycin tablets. Comparative data from both methods for the same batch of EryTab tablets are presented. The method can also be applied to various other erythromycin formulations, including particle-coated tablets, erythromycin stearate tablets, and erythromycin ethylsuccinate suspensions and fermentation broths. A C18 Polymeric column is used with a mobile phase composition of 0.02 M potassium phosphate dibasic buffer (pH 9): acetonitrile (60:40) and flow rate of 1 mL/min. This method is more sensitive, specific, and rugged than the pharmacopeial method.

Chemistry, Pharmaceutical↗

PubMed1992

Pharmacokinetics of nitroglycerin and its metabolites after administration of sustained-release tablets.

Nitroglycerin was administered to eight healthy volunteers in the form of sublingual tablets, oral sustained-release tablets, and an oral solution. Blood samples were collected for measurement of nitroglycerin and its two isomeric glyceryl dinitrate metabolites. Blood pressure and pulse rate were monitored; subjective evaluations of headache, dizziness, facial flushing, skin irritation, and gastrointestinal upset were made. Nitroglycerin itself was virtually undetectable after the solution and tablet preparations; the metabolites were consistently detectable from a few minutes after dosing to 24 h later. Mean total (nitroglycerin plus metabolite) concentrations were comparable in the 15 min following sublingual administration, and the 8 h following tablet administration. The relative bioavailability of the tablets in comparison with the oral solution was 70 per cent based on metabolite concentrations. Nitroglycerin sustained-release tablets appear to exert their beneficial effects in the prolonged prophylaxis of angina through active metabolites.

Administration, Oral↗

PubMed2002

Is epinephrine administration by sublingual tablet feasible for the first-aid treatment of anaphylaxis? A proof-of-concept study.

PURPOSE: In order to explore the feasibility of sublingual administration of epinephrine tablets as a non-invasive first-aid treatment for anaphylaxis, we studied epinephrine absorption from this dosage form in an animal model. METHODS: In a prospective, randomized, four-way crossover study, six rabbits received epinephrine 2.5 or 10 mg as a sublingual tablet, epinephrine 0.03 mg (0.3 ml) by intramuscular (IM) injection (positive control), and 0.9% NaCl (0.3 ml) IM (negative control). Pre- and post-dose blood samples were obtained for measurement of plasma epinephrine concentrations by HPLC-EC. RESULTS: After administration of epinephrine 2.5 mg as a sublingual tablet, the mean (+/-SEM) C(max) was 2369+/-392 pg/ml, and the t(max) was 20.8+/-5.7 min. After administration of epinephrine 10 mg sublingually, the C(max) was 10836+/-2234 pg/ml, and the t(max) was 21.7+/-5.4 min. After IM epinephrine, the C(max) was 6445+/-4233 pg/ml, and the t(max) was 15.8+/-4.7 min. After IM 0.9% NaCl, the C(max) (endogenous epinephrine) was 518+/-142 pg/ml. The t(max) after both of the sublingual epinephrine tablet doses did not differ significantly from the t(max) after IM epinephrine, and the C(max) after the 10 mg sublingual epinephrine tablet dose did not differ significantly from the C(max) after IM epinephrine. CONCLUSIONS: In this proof-of-concept study, administration of epinephrine as a sublingual tablet formulation resulted in rapid achievement of peak plasma epinephrine concentrations. Absorption studies in humans are needed. DEFINITIONS: HPLC-high performance liquid chromatography; EC - electrochemical detection; C(max) - maximum plasma epinephrine concentration after dosing; t(max) - time of maximum plasma epinephrine concentration.

Administration, Sublingual↗