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At least 847 records · Page 47Linked to original sources

PubMed2006

Effect of decrease in both postprandial blood glucose (PBG) and fasting blood glucose (FBG) levels in normal beagle dogs with nateglinide enteric coated granules and immediate release tablets.

Nateglinide is a new quick action/short duration (QRSD) type of oral blood glucose regulator, and nateglinide immediate release tablets are used for patients with mild diabetes under the trade name of Fastic((R)) tablets. In this study, we attempted to determine if it was possible to control both post-prandial blood glucose level (PBG) and fasting blood glucose level (FBG) for moderate or severe diabetes through controlled release of nateglinide. Enteric coated granules were selected for the administration form for controlled release of nateglinide, and three types of enteric coated granules were prepared having dissolution pH values of 5.5, 6.5 and 7.2. The three types of enteric coated granules were each administered separately or the enteric coated granules having an dissolution pH of 6.5 were administered simultaneous to administration of nateglinide immediate release tablets to normal beagle dogs just before feeding followed by measurement of plasma nateglinide concentration, plasma insulin concentration and blood glucose level. In the case of administering enteric coated granules alone (nateglinide: 9 mg/kg), the absorption of nateglinide was confirmed to tend to be delayed as the dissolution pH increased. In the case of an dissolution pH of 5.5, decreases in both PBG and FBG were observed. In the case of dissolution pH values of 6.5 and 7.2, only decrease in FBG was observed. In case of nateglinide immediate release tablets (nateglinide: 9 mg/kg), only decrease in PBG was observed. Decreases in both PBG and FBG were observed in the case of simultaneous administration of dissolution pH 6.5 enteric coated granules and nateglinide immediate release tablets just before feeding (nateglinide: 90 mg/head+60 mg/head). A correlation was observed between plasma nateglinide concentrations and blood glucose levels. On the other hand, there were no correlations observed between changes in plasma insulin concentrations and blood glucose levels. In case of nateglinide immediate release tablets (nateglinide: 150 mg/head), Decreases in both PBG and FBG were observed. However, the nateglinide controlled release formulation is more useful than the nateglinide immediate release tablets from the view point of avoidance of side effect, or of easy control of both PBG and FBG. On the basis of these results, the design of a controlled release formulation that contains nateglinide was suggested to enable control of both PBG and FBG for moderate and severe diabetes patients.

Administration, Oral↗

PubMed2006

Spray dried excipient base: a novel technique for the formulation of orally disintegrating tablets.

Orally disintegrating tablets (ODT) are gaining popularity over conventional tablets due to their convenience in administration and suitability for patients having dysphagia. Moreover no water is required for swallowing the tablets and hence suitable for geriatric, pediatric and traveling patients. The purpose of this study is to assess the suitability of spray dried excipient base in the formulation of ODTs of Valdecoxib (low aqueous solubility) and Metoclopramide (high aqueous solubility). Spray dried excipient base was prepared using Scientech spray drier. Super disintegrants (such as Ac-Di-Sol, Kollidon CL, sodium starch glycolate), diluent (mannitol) alongwith sweetening agent (aspartame) were used in the formulation of tablets. The tablets were evaluated for hardness, friability, water absorption ratio, disintegration time (DT) and in vitro drug release. Using the same excipients, the tablets were prepared by direct compression and were evaluated in the similar way. Maximum drug release and minimum DT were observed with Kollidon CL excipient base as compared to tablets prepared by direct compression, showing the superiority of the spray dried excipient base technique over direct compression technique.

Absorption↗

PubMed1991

[The relationship between dividing properties of scored tablets and dynamic characteristics of powder].

The relationship between dividing properties of the scored tablet and dynamic characteristics of the powder was investigated for proving the effects of physical characteristics of the powder on dividing properties of the scored tablet. Lactose, microcrystalline cellulose, corn starch, synthetic aluminum silicate and Perfiller were used as excipients. The dynamic characteristics of the powder, such as tensile strength (T), cohesive force (C), angle of friction (delta), flow factor (FF), shear index (n), C/T(K) and constants of Kawakita's equation of tapping compaction (a, 1/b) were measured. No correlations between coefficient of variation of divided tablet weight and each dynamic characteristics of the powder were found. However, from the result of the multiple regression analysis, multiple regression equation containing C and a as variables was obtained. Then a significant correlation was obtained between coefficient of variation of divided tablet weight and C/a, and also between logarithms of dividing strength of scored tablets and C/a. As a result, coefficient of variation of divided tablet weight decreased and dividing strength of scored tablets increased with decreasing C/a value.

Chemical Phenomena↗

PubMedDate not supplied

Weight variability of pharmacist-dispensed split tablets.

OBJECTIVE: To determine the level of weight uniformity of fragments from tablets split into halves and dispensed by pharmacists. DESIGN: Pre-post comparison. SETTING: Laboratory analysis of split tablets returned unused from four long-term care facilities. INTERVENTIONS: Twenty-two dispensed prescriptions containing 560 split tablet halves were collected, and fragment weights (FWs) were determined. Theoretical weights (TWs) of split tablets of the same medications were determined mathematically. MAIN OUTCOME MEASURES: Comparison of the mean FW with the mean TW of each dispensed prescription and determination of whether fragments met United States Pharmacopeia 24 (USP) criteria for weight variation of whole tablets. RESULTS: A significant difference (P < .05) between mean TW and mean FW was found in 2 (9.1%) of the 22 dispensed prescriptions. Overall, 30 (5.4%) of 560 fragments, contained in 10 (45.5%) of the 22 dispensed prescriptions, had weights that deviated by more than 15% from the mean FW. Of the 560 fragments, 32 (5.7%), contained in 10 (45.5%) of 22 dispensed prescriptions, had weights that deviated by more than 15% from mean TW. A total of 15 (68.2%) of the 22 dispensed prescriptions had standard deviations (SDs) that were more than 6% of the mean FW. None of the TWs displayed an SD greater than the USP limit of 6%. Only 7 (31.8%) of the 22 dispensed prescriptions met USP standards, with FWs not exceeding 15% of mean FW and SDs of no greater than 6%. CONCLUSION: Tablet splitting resulted in an unacceptably high incidence of weight variation. Standards should be developed to ensure uniformity of split tablets.

Drug Compounding↗

PubMedDate not supplied

Evaluation of cost savings to a state Medicaid program following a sertraline tablet-splitting program.

OBJECTIVES: To evaluate the economic impact of implementing a sertraline (Zoloft--Pfizer) tablet-splitting program on the Nebraska Medicaid program based on the change in total and per-member-per-month (PMPM) prescription drug costs and to identify any real or perceived problems with tablet splitting using switches among selective serotonin reuptake inhibitors (SSRIs) as a proxy indicator. DESIGN: Retrospective study of prescription claims before and after the tablet-splitting program was implemented. SETTING: Nebraska Medicaid. PATIENTS: All 14,520 patients who received an SSRI during the study period, including 5,466 patients who received at least one prescription for sertraline. INTERVENTIONS: The Nebraska Medicaid program implemented a mandatory tablet-splitting program for sertraline. Pharmacists were paid a supplemental fee to split tablets. MAIN OUTCOME MEASURES: Total costs, PMPM costs, and switches among SSRIs. RESULTS: Using regression analysis, sertraline was the only SSRI that showed a downward slope in total cost per month, although the decrease was not statistically significant (P = .1156). Fluoxetine (Prozac--Eli Lilly) and paroxetine (Paxil--GlaxoSmithKline) both showed an upward slope, but the increases were not statistically significant (P = .1164 and .0671, respectively). Citalopram (Celexa--Forest) and fluvoxamine showed significantly positive upward slopes (P = .0001 and .0391, respectively). Sertraline was also the only SSRI that showed a downward slope in PMPM costs (P = .0093). Citalopram, fluvoxamine, fluoxetine, and paroxetine all showed an upward slope in PMPM costs (P = .4494, .0008, .0448, and .0482, respectively). The tablet-splitting program was not associated with a net change in patients being switched to or from sertraline. CONCLUSION: Implementing the sertraline tablet-splitting program significantly decreased the PMPM cost of sertraline prescriptions, but it did not significantly decrease total costs of sertraline, nor did it result in disproportionate numbers of patients switching from sertraline to other SSRIs. Total costs and PMPM costs of the other four SSRI drugs did not decrease.

Cost Control↗

PubMed2002

Effect of tablet splitting on serum cholesterol concentrations.

OBJECTIVE: To evaluate the effects of tablet splitting on low-density lipoprotein (LDL) cholesterol and total cholesterol values in patients taking simvastatin and atorvastatin. DESIGN: A retrospective chart review of total cholesterol and LDL cholesterol values of patients instructed to split simvastatin or atorvastatin between January 1999 and November 2000. SETTING: Veterans Affairs Medical Center in Huntington, WV. PATIENTS: Patients were included if they were taking simvastatin or atorvastatin with regular lipid management and follow-up laboratory results. Patients were required to remain on the same milligram-per-day dose at least 6-8 weeks before and after tablet-splitting initiation and have cholesterol values drawn at least 6 weeks after initiation of both whole-tablet and half-tablet dosing. Patients were excluded if they had a triglyceride level > 400 mg/dL or were noncompliant on the basis of pharmacy records and provider notes. MEASUREMENT OUTCOMES: The primary end points were changes in total cholesterol and LDL cholesterol values before and after the patient was switched to half-tablet therapy. RESULTS: The overall results for this review demonstrated no statistically significant increase in total cholesterol and LDL cholesterol concentrations. Total cholesterol and LDL cholesterol values actually decreased from presplitting to postsplitting, p = 0.017 and p = 0.003, respectively. CONCLUSIONS: The investigation showed that half-tablet dosing was as effective as whole-tablet dosing. The program will be continued as a part of quality patient care at the Huntington Veterans Affairs Medical Center.

Atorvastatin↗

PubMed2004

Tolerability profile of metformin/glibenclamide combination tablets (Glucovance): a new treatment for the management of type 2 diabetes mellitus.

It is important to manage blood glucose intensively in patients with type 2 diabetes mellitus in order to reduce the risk of long-term complications. Oral combination therapy that addresses insulin resistance and beta-cell dysfunction is a proven means of improving glycaemic control when monotherapy becomes insufficiently effective. Metformin/glibenclamide (glyburide) combination tablets were developed to provide a means of applying this strategy while minimising polypharmacy. This review examines the tolerability profile of this treatment from four double-blind, randomised clinical trials in a total of 2342 type 2 diabetic patients with hyperglycaemia despite treatment with diet and exercise, a sulphonylurea or metformin. Treatment with combination tablets was associated with markedly superior blood glucose control, at lower doses of metformin and glibenclamide, compared with monotherapies. The incidence of symptoms of hypoglycaemia varied between dosages and trials, though the incidence of severe or biochemically confirmed hypoglycaemia or withdrawals from clinical trials for this reason was consistently low and comparable with glibenclamide alone. No patient required third-party assistance for hypoglycaemia. Significantly fewer diet-failed patients receiving low-dose combination tablets reported gastrointestinal adverse effects compared with metformin alone, with a comparable incidence between metformin and combination tablets in post-monotherapy studies. The incidence of other adverse events, including serious adverse events, was similar for combination tablets and monotherapies. The lower doses of metformin and glibenclamide with the combination tablet approach, and the design of the combination tablets themselves, may underlie the beneficial tolerability profile of this treatment.

Body Weight↗

PubMedDate not supplied

Effect of compression pressure on physical properties and dissolution characteristics of disintegrating tablets of propranolol microspheres.

Propranolol HCl was encapsulated with cellulose acetate butyrate by an emulsion-solvent evaporation method. Three direct compression diluents were blended with appropriate size fractions of the microspheres and each formulation was compressed at several pressures to give tablets that readily disintegrated in water. Tablets with microcrystalline cellulose (MC) as the diluent had the highest tablet crushing strength at any given compression pressure. Heckel plots of all the microsphere-diluent blends were nonlinear, indicating that the consolidation may result from crushing and rearrangement of the individual particles in addition to plastic deformation. Tablet properties and estimated yield pressures showed that MC was the most suitable diluent for compression of propranolol HCl microspheres. Drug release from compressed tablets was always faster than from uncompressed microspheres, but useful sustained-release characteristics were retained. Dissolution tests of MC formulations of the tableted microspheres showed increased release rate constants and decreased 50 per cent dissolution times compared to microspheres that had not been compressed. This result indicated that rupture of some of the microspheres had occurred. The drug release rate increased at higher compression pressures due to the rupture of a greater proportion of microspheres. Larger changes in release rate and t50 percent were observed with larger microspheres sizes. Generally, the least compression pressure that gives tablets with acceptable properties is preferred.

Cellulose↗

PubMed1998

Effects of drug solubility, drug loading, and polymer molecular weight on drug release from Polyox tablets.

This study investigated the effects of polymer molecular weight, drug solubility, addition of a water-soluble excipient, and drug loading on zero-order release kinetics and elucidated the release mechanism of a drug from directly compressed tablets. Directly compressed tablets consisting of polyethylene oxides (PEO) (MW = 0.9, 2.0 and 4.0 x 10(6)) and drugs (solubility ranging from 290 to 25,000 mg/l) were formulated with or without a water-soluble excipient (lactose). For PEO tablets (MW = 0.9 x 10(6)), drug release is primarily swelling/erosion controlled for drugs for which solubility is below 1%, resulting in zero-order release kinetics. For PEO tablets (MW = 4.0 x 10(6)), drug release is controlled at a zero-order rate by the dissolution rate of the drug at high loading (39%). At low loading (20%), drug diffusion through the swollen gel layer becomes the governing release mechanism. For a highly water-soluble drug (e.g., diclofenac Na), drug diffusion is the controlling mechanism regardless of the molecular weight of the PEOs. Zero-order release kinetics can be achieved with PEO tablets (MW = 0.9 x 10(6)) for drugs for which solubility is below 1%. PEO tablets (MW = 2.0 x 10(6)) provided zero-order release for poorly water-soluble drugs (below 0.2%) at 39% drug loading. It is possible to attain zero-order release kinetics with PEO tablets (MW = 4.0 x 10(6)) using a drug which has a solubility of less than 0.1%.

Diclofenac↗

PubMed1999

Characterization of norfloxacine release from tablet coated with a new pH-sensitive polymer, P-4135F.

A new pH-sensitive polymer, P-4135F, was evaluated as a colon delivery device for norfloxacine (NFLX) which is used for the therapy of patients with Vero toxin-producing Escherichia coli gastroenteritis. P-4135F has a dissolution threshold pH of 7.2 which is higher than the conventional pH-sensitive polymers, Eudragit S100 and L100. To compare the dissolution site of P-4135F coated tablets with other enteric polymer coatings, mini-tablets containing sodium fluorescein (FL) as a model drug were prepared by coating them with the three polymers. After oral administration of FL mini-tablets to rats, the first-appearance time, Ti, of FL into the systemic circulation was measured. The Tis were 0.7+/-0.2 h for Eudragit L100, 1.8+/-0.4 h for S100 and 2.0+/-0.3 h for P-4135F. Direct inspection of the dissolution process of the FL mini-tablets after oral administration to rats was performed by abdominal incision studies. All of the coated FL mini-tablets started to dissolve in the rat ileum. The dissolution sites were identified to be proximal to the ileocecal junction for P-4135F, at the middle part of the ileum for Eudragit S100 and at the proximal part of the ileum for Eudragit L100. NFLX tablets with different membrane thicknesses of P-4135F were prepared and were orally administered to beagle dogs. The colon delivery efficiency was evaluated by measuring the Ti of NFLX into the systemic circulation. The mean Tis were 1.33+/-0.33 h for 56.8+/-0.5 microm membranes, 3.75+/-0.25 h for 64.6+/-0.7 microm membranes, 4.00+/-1.00 h for 70.5+/-0.5 microm membranes and 3.00+/-1.00 h for 74.9+/-0.4 microm membranes. By comparing the Ti, 4.33+/-0.33 h, obtained after oral administration of NFLX in a pressure-controlled colon delivery capsule, and the colon arrival time, 3.5+/-0.3 h, determined by a sulfasalazine test in beagle dogs. P-4135F coated NFLX tablets appeared to dissolve and disintegrate before reaching the colon. Studies using rats and beagle dogs have suggested that P-4135F dissolves in the lower part of the small intestine, i.e., the ileum. These studies also suggest that this new polymer will be useful for the delivery of NFLX to the lower part of the small intestine.

Acrylic Resins↗

PubMed1997

Sustained release of acetaminophen from heterogeneous matrix tablets: influence of polymer ratio, polymer loading, and co-active on drug release.

The aim of this research was to investigate the effect of pseudoephedrine (PE), polymer ratio, and polymer loading on the release of acetaminophen (APAP) from hydroxypropyl methyl cellulose (HPMC)/polyvinylpyrrolidone (PVP) matrices. Granules formulated with APAP or both APAP and PE, and various blends of HPMC and PVP were compressed into tablets at varying compression forces ranging from 2000 to 6000 Ib. In vitro drug release from the matrix tablets was determined and the results correlated with those of tablet water uptake and erosion studies. Drug release from the formulations containing both APAP and PE was slower than those containing only APAP (P < 0.05, F = 3.10). Drug release from tablets formulated with APAP only showed an initial burst at pH 1.16 or 7.45, and at high total polymer loading (> or = 9.6%). Formulations containing both APAP and PE showed slower drug release at pH 1.16 than at pH 7.45. At pH 1.16, a decline in the percentage of APAP released occurred after 18 hours. This was due to the hydrolysis of APAP to p-aminophenol. The drug dissolution data showed good fit to the Korsmeyer and Peppas model, and the values of the release exponents ranged from 0.20 to 0.62, indicating a complex drug release pattern. Tablet erosion studies indicated that the amount of APAP released was linearly related to the percentage of tablet weight loss. The kinetics of tablet water uptake was consistent with a diffusion and stress relaxation controlled mechanism. Overall, the results of this study indicated that PE, as a co-active in the formulation, modified the matrix, and hence retarded APAP release.

Acetaminophen↗

PubMed2001

Systemic bioavailability of nasally applied chlorphenamine maleate (0.4% nasal spray) relative to tablets administered perorally.

AIM: This study investigated the bioavailability of single doses of 1.12 and 2.24 mg chlorphenamine maleate applied intranasally (0.4% nasal spray) relative to a single peroral dose of 8 mg chlorphenamine maleate (tablets). METHODS: Twenty-four (24) subjects were treated with single nasal doses of 1.12 mg and 2.24 mg chlorphenamine maleate (0.4% nasal spray) and two 4 mg chlorphenamine maleate tablets (Piriton) on 3 separate study days according to a 3-way cross-over design with a 7-day wash-out between periods. Blood was sampled before and at 0.25, 0.50, 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12, 16 and 24 hours after drug administration. Additional blood samples were obtained 36, 48 and 72 hours after peroral administration only. All subjects were included in the pharmacokinetic analysis. RESULTS: Nasally applied chlorphenamine maleate was readily absorbed, reaching peak plasma levels after 0.25 to 3.0 hours. The dose-normalized estimated mean Cmax values were 1.24, 1.43 and 1.21 ng/ml for the peroral tablet and the 1.12 mg and 2.24 mg nasal dose, respectively. The dose-normalized estimated mean AUC(0-infinity) values were 25.91, 26.44 and 25.56 ng x h/ml for the tablet and the 1.12 and 2.24 mg nasal dose, respectively. The estimated treatment ratios (nasal dose to tablet) of the dose-normalized values for the 1.12 mg nasal dose were 1.15 (900 CI: 1.0-1.32) and 1.02 (90% CI: 0.88-1.18) for Cmax and AUC(0-infinity), respectively, for the 2.24 mg nasal dose they were 0.98 (90% CI: 0.85-1.13) and 0.99 (90% CI: 0.85-1.13) for Cmax and AUC(0-infinity), respectively. The other pharmacokinetic characteristics (tmax, t(1/2), lambda(z), AUC(0-tf), MRTtot, CL/f and Vz/f) were comparable across all treatments. These data indicate that the disposition of chlorphenamine maleate was independent of the route and dose of administration. CONCLUSIONS: Chlorphenamine maleate is readily absorbed after nasal application using a 0.4% nasal spray. The nasal administration showed that the systemic bioavailability at the two dose levels used was comparable to that for the tablet. Maximum concentrations on the low dose, however, were higher and those on the high dose were comparable to those for the tablet. The nasal application of chlorphenamine maleate does not alter the overall systemic exposure compared to the oral route.

Administration, Intranasal↗

PubMed2004

Amoxicillin/clavulanic acid (875/125): bioequivalence of a novel Solutab tablet and rationale for a twice-daily dosing regimen.

A new amoxicillin/clavulanic acid tablet formulation (Solutab tablet, Forcid Solutab) containing amoxicillin/clavulanic acid (875/125) has been developed. The aim of the present study was to demonstrate bioequivalence between the new tablet formulation (test), taken as an intact tablet and after prior dispersal, versus the originator product viz. Augmentan film-coated tablet (875/125) used as reference. The study was performed in 48 healthy volunteers according to an open, single-dose, crossover design. Bioequivalence was demonstrated using Cmax and AUC(0-infinity) as primary parameters of evaluation for both amoxicillin and clavulanic acid with 90% confidence intervals of the ratios Solutab tablet/Augmentan within the range of 0.8-1.25. The duration of the plasma concentration exceeding the amoxicillin minimal inhibitory concentration (MICs) was calculated using individual plasma concentration-time curves and compartmental analysis. The data showed that the bioavailability characteristics of the test tablet, taken intact or in dispersed form, and the reference tablets were very similar. The analysis, moreover, also confirmed the appropriateness of using a b.i.d. dosage regimen for both formulations, taking into account the pharmacodynamic breakpoint values for some major pathogens.

Adult↗

PubMed1999

Effect of direct compression excipients on the stability of ascorbic acid (vitamin c) tablets.

The effects of four directly compressible excipients such as Avicel, Dipac, Ditab and Emdex on the stability of ascorbic acid tablets were evaluated. Ascorbic acid tablets were formulated by the direct compressive method at constant temperature and pressure. In vitro tablet properties such as weight uniformity, hardness, friability, moisture content, disintegration time and dissolution rate were evaluated. The tablets were also subjected to temperature and moisture stresses in order to assess their stability. The results obtained indicated that moisture and temperature affect the stability of ascorbic acid tablets. All the tablet batches exhibited very short shelf lives in the presence of the stress conditions of temperature and moisture. None of the four excipients could be recommended for use in tableting ascorbic acid based on the shelf lives.

Ascorbic Acid↗

PubMed2000

[Mucoadhesive oral tablets--a modern dosage form with controlled drug release].

The review paper summarizes the principal pharmaceutical and medical information about the hitherto achieved results in the development of bioadhesive dosage form concentrating on mucoadhesive oral tablets. The site of administration of the tablets is the facial pocket. Due to specific properties of the mucous layer on the buccal mucosa and mucoadhesive polymers from which the tablets are manufactured, tablets adhere to the mucosa. The adhesion may take a certain period of time and during the whole period the active ingredient is gradually released. Absorption of the drug through the mucous membrane of the oral cavity has a number of advantages, in particular with respect to the stability of the drug. Various types of mucoadhesive tablets are being developed. The system releasing the drug only in one direction, i.e. direct to the mucosa, seems to be very advantageous. In the evaluation of mucoadhesive tablets, two parameters are of particular importance, the bioadhesive force and the rate of drug release. Oral mucoadhesive tablets can be employed in the treatment of both systemic and local diseases.

Adhesiveness↗

PubMed2000

Bioavailability study of oral liquid and tablet forms of alpha-difluoromethylornithine.

The purpose of this study was to assess the bioavailability of two oral preparations of difluoromethylornithine (DFMO). The current preparation of DFMO is a liquid with a concentration of 0.2 gram/ml that must be drawn up into a syringe and dispensed into a small medicine glass. This form of DFMO causes wastage of the medication. The liquid form also makes compliance and blinding difficult. Recently, a new coated tablet preparation has become available from Ilex Oncology Services (San Antonio, TX). The coated tablets are 0.25 gram and are scored. The tablet form should increase compliance by making it much easier for the subject to take the medication. This report compares the bioavailability of both preparations with the goal of demonstrating equivalence of the preparations. Ten normal subjects entered the cross-over study in which the order in which they would receive the liquid or tablet preparation of DFMO was randomized. The study was designed with the objective of establishing the bioequivalence of a tablet preparation of DFMO at daily dose 0.5 gram/m2 and a liquid preparation of DFMO at the same daily dose. The mean area under the time-by-concentration curves (microM x hours) for the liquid and tablet preparations was 368.2 and 370.4, respectively. The peak concentrations for the liquid and tablet preparations were 47.3 and 48.2 microM, respectively. No statistically significant differences were seen in these parameters, in time to peak concentration, or in serum half-life.

Administration, Oral↗

PubMed2000

Pharmacokinetics and bioavailability of a metformin/glyburide tablet administered alone and with food.

Two randomized crossover studies were conducted to evaluate the pharmacokinetics (including food effect) of fixed-combination metformin/glyburide tablets. Pharmacokinetics and bioavailability of two strengths (500 mg/2.5 mg and 500 mg/5 mg) of metformin/glyburide tablets were assessed relative to coadministered metformin and glyburide tablets in study 1. The effect of a high-fat meal on the bioavailability of a metformin/glyburide (500 mg/5 mg) tablet was assessed relative to the fasted condition in study 2. The fixed combination metformin/glyburide tablets showed bioequivalence for the metformin component with the reference metformin tablet and comparable bioavailability for the glyburide component with the reference glyburide tablet. Food does not appear to affect the bioavailability of either component to an appreciable extent.

Adolescent↗

PubMed1976

Digoxin tablets--a review of the bioavailability problems.

A review is presented of the more significant aspects of recent bioavailability studies on digoxin tablets that have led to the identification of variations among commercially available tablets and of the correlation of the methods commonly used in such bioavailability evaluations. Pharmacopeial requirements for tablet-to-tablet uniformity of content do not automatically yield uniformity of bioavailability. In vitro dissolution rate of digoxin tablets generally has been shown to correlate with in vivo bioavailability, and this has led to new governmental and pharmacopeial requirements for digoxin tablets. However, some recent reports have shown that in vitro dissolution rate may not always correlate well with bioavailability. The relevance and significance of digoxin tablet bioavailability to clinical effects and therapeutics are briefly discussed.

Biological Availability↗