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At least 667 records · Page 37Linked to original sources

PubMed1993

Correlation between the disintegration time and the bioavailability of vitamin C tablets.

The goal of this study was to examine if the current USP disintegration standard for vitamin C tablets (max. 30 min in water at 37 degrees C with disks) is adequate or if a tighter disintegration standard (e.g., European compendia max. 15 min) should be recommended based on bioavailability considerations. Four formulations of 500-mg vitamin C tablets ranging in mean disintegration time from 9 to 120 min were compared with a standard vitamin C solution in a double-blind clinical trial with 15 subjects. The products were administered with a standard breakfast. The data show that a solution of vitamin C and a fast-disintegrating tablet (8-9 min) have equal but significantly lower bioavailability than tablets with longer disintegration times (30, 60, 120 min). Tablets with a mean disintegration time of 60 min showed the highest bioavailability. When the disintegration test was performed without disks, disintegration times increased so much that only the tablets with the fastest disintegration time (which were also the tablets with the lowest bioavailability) met the current USP disintegration time limit. Based on the results of the study, changes in the USP standard to omit the disks or to shorten the disintegration time will not achieve enhanced bioavailability but will result in reduced vitamin C absorption. In vitro dissolution of vitamin C tablets did not show the traditional relationship with bioavailability.

Adult↗

PubMed1994

Effect of moisture sorption on tabletting characteristics of spray dried (15% amorphous) lactose.

Spray dried (15% amorphous) lactose absorbs moisture when exposed to humidity. At 57% relative humidity (RH), the moisture uptake was 1.5%. It is suggested that the moisture is preferentially taken up in the amorphous regions, thereby increasing the actual moisture content in the amorphous parts up to 10%. The moisture uptake reduced the glass transition temperature below the operating temperature and thereby transformed the amorphous regions from a glassy to a rubbery state, setting up conditions for crystallisation of the lactose. Compaction of dry spray dried lactose led to a relatively low initial tablet strength. However, when pre-exposed to 57% RH for a short time period (2 to 4 hours) before compaction, the initial tablet strength increased markedly. This was due to moisture uptake which resulted in a higher molecular mobility of the amorphous spray dried lactose, and to an increase in plastic flow. Post compaction storage of tablets containing amorphous regions of spray dried lactose at 57% RH resulted in an increased tablet strength after 4 hours due to crystallisation. Spray dried lactose exposed to 57% RH for more than 6 hours before compaction led to the lowest initial tablet strength. Crystallisation of the amorphous regions of the spray dried lactose occurred before tabletting. No increase in tablet strength was noted on post compaction storage for these tablets.

Calorimetry, Differential Scanning↗

PubMed2000

Initial potency of lansoprazole and omeprazole tablets on pentagastrin-stimulated gastric acid secretion-a placebo-controlled study in healthy volunteers.

BACKGROUND: The new tablet formulation of omeprazole (Losec MUPS), is thought to have a stronger acid inhibition than the previously marketed capsules. METHODS: The effects of the proton pump inhibitors lansoprazole and omeprazole tablets on pentagastrin-stimulated acid secretion were compared in Helicobacter pylori-negative healthy male volunteers (n=12). The study was placebo-controlled, crossover matched and double-blind for lansoprazole (Agopton) and placebo, and single-blind for omeprazole tablets. Gastric acid response to sub-maximal pentagastrin-stimulation (0.6 microg. h/kg b.w.) was determined from 12.5 to 14.5 h after the first and second dose of the test drugs. RESULTS: Lansoprazole 15 mg and 30 mg as well as omeprazole 20 mg tablets caused a marked decrease in gastric acid secretion, showing equipotency for 15 mg lansoprazole and 20 mg omeprazole tablets. Their efficacy, however, was lower than 30 mg lansoprazole. In addition, the inter-individual variation after omeprazole tablets was higher than following lansoprazole. Neither 7.5 mg lansoprazole nor 10 mg omeprazole tablets were clearly different from placebo on the first 2 days. The drugs were well-tolerated. No clinically relevant influence was found on either laboratory screen or cardiovascular parameters. CONCLUSION: Lansoprazole 15-30 mg shows a stronger acid inhibition and a lower inter-individual variability than the new omeprazole 20 mg tablets on days 1 and 2 of dosing.

2-Pyridinylmethylsulfinylbenzimidazoles↗

PubMed2001

Improving adherence to malaria treatment for children: the use of pre-packed chloroquine tablets vs. chloroquine syrup.

Malaria is a major cause of morbidity and mortality among children under five in sub-Saharan Africa. Prompt diagnosis and adequate treatment of acute clinical episodes are essential to reduce morbidity and prevent complications and mortality. In many countries, chloroquine syrup is the mainstay of malaria treatment for children under five. Not only is syrup more expensive than tablets, adherence to the prescribed dose at home is a problem because mothers use wrongly sized measuring devices or have difficulty with the instructions. We investigated the impact of introducing pre-packed tablets for children on adherence to treatment and compared the total cost of the tablets with that of syrup. Children aged 0--5 years diagnosed with malaria at the clinic over a 6-week period received either pre-packed tablets or syrup by random assignment. The principal caregivers were interviewed at home on day 4 after attending the clinic. Of the 155 caregivers given pre-packed tablets, 91% (n=141) adhered to the recommended dosage, while only 42% (n=61) of 144 who were provided syrup did. Only 20% of caregivers who received syrup used an accurate 5 ml measure. The cost of treatment with tablets was about one-quarter that of syrup and 62% (n=96) of caregivers preferred tablets. Pre-packed chloroquine tablets are a viable alternative to syrup.

Antimalarials↗

PubMed2003

Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin.

BACKGROUND: A cohort of patients with type 2 diabetes, prescribed glyburide/metformin tablets, experienced significantly greater improvements in glycaemic control compared to patients receiving glyburide co-administered with metformin. AIM: To compare the change in A1C for type 2 diabetic patients new to combination therapy with fixed-dose glyburide/metformin tablets vs. glyburide co-administered with metformin in a usual-care setting. METHODS: This retrospective cohort study analysed medication usage via an administrative pharmacy claims database and the patients' corresponding laboratory results. Patients were new to antidiabetic combination therapy with glyburide/metformin tablets or glyburide co-administered with metformin between August 2000 and July 2001 and had A1C measurements at baseline and within 76-194 days of initiating combination therapy. The change from baseline in A1C was analysed using statistical regression to adjust for significant covariates (baseline A1C and dosage). Adherence with therapy was also compared. RESULTS: The cohort consisted of 950 patients who received glyburide/metformin tablets and 471 taking glyburide co-administered with metformin. Glyburide/metformin patients were younger (mean age = 56 vs. 60 years, p < 0.0001) and received lower doses of each drug than patients taking glyburide co-administered with metformin (glyburide mean final dose = 6 vs. 10 mg/day, p < 0.0001; metformin = 893 vs. 1297 mg/day, p < 0.0001). The mean decrease from baseline A1C, adjusted for baseline A1C and dosage, of 2.02% for glyburide/metformin tablets was significantly (p < 0.0001) greater than the decrease of 1.49% for glyburide co-administered with metformin. Glyburide/metformin patients with baseline A1C >/= 8 experienced a significantly (p < 0.0001) greater decrease in A1C of 2.93% compared to 1.92% for glyburide co-administered with metformin. For patients with baseline A1C < 8%, the difference between the A1C responses remained significant, even though the reductions in A1C were smaller for both glyburide/metformin tablets and glyburide co-administered with metformin (0.54% and 0.23%, p = 0.0017). Patients were more adherent with glyburide/metformin tablets (84% vs. 76%, p < 0.0001), though regression analysis indicated that adherence was not a significant predictor of change in A1C. CONCLUSIONS: The lower medication doses delivered by glyburide/metformin tablets provided a significantly greater reduction in A1C than did glyburide co-administered with metformin in patients with type 2 diabetes, especially when baseline A1C >/= 8%.

Adult↗

PubMed2002

Comparison of triptan tablet consumption per attack: a prospective study of migraineurs in Spain.

OBJECTIVES: To compare patient self-reported tablet consumption of rizatriptan 10 mg per attack (24 hours) with that of sumatriptan 50 mg, zolmitriptan 2.5 mg, and naratriptan 2.5 mg on an unselected, prescription-based, Spanish migraine population. METHODS: One hundred twenty community pharmacies recruited patients with migraine, who used their pharmacies, to fill a triptan prescription. In diaries, patients recorded baseline pain intensity and the number of triptan tablets and additional medication taken per attack. Patients treated a maximum of three attacks. Analysis of variance or the Student t test and chi-square or Fisher exact tests were used for univariate comparisons. Hochberg corrections were used for multiple-group comparisons. A generalized estimating equation method was used to correct for within-subject correlation. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: Two hundred thirty-one patients (84% women) treated 589 evaluable migraine attacks (sumatriptan, n = 135; naratriptan, n = 90; zolmitriptan, n = 149; rizatriptan, n = 149). Triptan tablet consumption per attack (mean +/- SD) for rizatriptan (1.24 +/- 0.56) was significantly lower than that of sumatriptan (1.75 +/- 1.2; P< .05), zolmitriptan (1.61 +/- 0.86; P < .05), or naratriptan (1.46 +/- 0.62; P= .05). The average number of triptan tablets taken and additional medication use increased according to baseline pain severity. More attacks were treated with one tablet of rizatriptan (81.2%) than with one tablet of sumatriptan (51.9%), zolmitriptan (55.7%), or naratriptan (60%). The probability of using more than one triptan tablet per attack (24 hours) was more than three times greater for sumatriptan (adjusted OR = 3.71; CI, 2.05 to 6.7; P = .001) and zolmitriptan (adjusted OR = 3.32; CI, 1.82 to 6.17; P = .001), and more than two times greater for naratriptan (adjusted OR = 2.66; CI, 1.36 to 5.21; P =.004) than for rizatriptan. CONCLUSIONS: Rizatriptan was associated with significantly lower triptan tablet use and additional medication use per attack than the other triptans. Additional randomized studies are needed to confirm the conclusions of this study.

Female↗

PubMed2006

Fluidity and tableting characteristics of a powder solid dispersion of the low melting drugs ketoprofen and ibuprofen with crospovidone.

A powder solid dispersion system (SD) of ketoprofen (KP) or ibuprofen (IP), which possess low melting points, plus crospovidone (CrosPVP), have good fluidity characteristics and can be used to formulate tablets. Tablets of KP or IP in the SD of adequate hardness within a narrow weight range can be prepared by direct compression. Addition of microcrystalline cellulose (MCC) resulted in greater hardness characteristics and less variation in tablet weight. Forces during the tableting process were measured with a tableting process analyzer (TabAll) equipped with a single-punch for determining capping and sticking properties during the tableting process. Pressure transmission ratio from the upper to the lower punch and die wall force were increased by adding 1% magnesium stearate (MS) to the SD. Ejection force decreased when MS was added to the SD. When tablets of the IP SD were prepared without excipient, scraper pressure (SP) was large, resulting in sticking. However, addition of 1% MS, lowered the SP value and eliminated sticking. Thus, an SD of compounds with a low melting point such as KP or IP is suitable for tablet manufacture by direct compression with the addition of 1% MS.

Cellulose↗

PubMed2004

In-vitro and in-vivo evaluation of mesalazine-guar gum matrix tablets for colonic drug delivery.

The aim of this study was to develop colon-specific delivery systems for mesalazine (5-ASA) using guar gum as a carrier. A colon specific matrix tablet of mesalazine with guar gum was evaluated by in vitro and in vivo X-ray studies in humans. Two different types of guar gum were used in the experiments. Tablets were prepared by the slugging method. The physical properties of tablets were tested and in vitro release studies were performed by a flow-through cell apparatus with and without galactomannanase enzyme. The type and the amount of guar gum affected the in vitro release of drug from the matrix tablets. High viscosity guar gum, in the form of a matrix tablet was capable of protecting the drug from being released in the upper region of gastrointestinal (GI) system, i.e. stomach and small intestine. X-ray imaging technique was used to monitor the tablets throughout the GI system on 8 healthy volunteers. Barium sulphate was used as a marker in the tablets for in vivo studies. These results showed that, the matrix tablets reached the colon; not being subjected to disintegration in the upper region of the GI system in all the subjects.

Administration, Rectal↗

PubMedDate not supplied

Design and evaluation of buccal adhesive hydrocortisone acetate (HCA) tablets.

Many studies have shown that topical buccal therapy with steroid anti-inflammatory drugs is useful in controlling ulcerative and inflammatory mucosal diseases. This local treatment is based on the concept that a high activity of steroids can be produced at the site of administration and, at the same time, the degree of systemic side effects can be minimized or avoided. In this study we developed a new formulation consisting of a mucoadhesive tablet formulation for buccal administration of hydrocortisone acetate (HCA). Three types of tablet were developed containing three mucoadhesive components: hydroxypropylmethyl cellulose (Methocel K4M), carboxyvinyl polymer (Carbopol 974P), and polycarbophyl (Noveon AA1); the first polymer is a cellulose derivative, the others are both polyacrylic acid derivatives. For each of those, three tablet batches were produced changing the quantity of the mucoadhesive component (10, 20, and 30%), resulting in 9 different formulations. The compatibility of HCA with all excipients using Differential Scanning Calorimetry (DSC) was assessed. Tablets were manufactured by wet granulation followed by compression. Technological controls on granulates (Hausner index, Carr index, granulometry and Karl-Fischer percentage humidity) and tablets (thickness, diameter, friability, hardness, uniformity of content, weigh uniformity and dissolution kinetic) were carried out. Mucoadhesion properties, ex vivo permeability through porcine buccal mucosa, in vivo behavior and compliance were evaluated. Technological controls have demonstrated that the increase in the (percentage) of mucoadhesive causes an increase in granulometry followed by a reduction in the granulate flowability, however all the tablets have given satisfactory technological results and conformed to the 3rd Ed. European Pharmacopoeia specifications. Mucoadhesion, ex vivo permeability and in vivo behavior results notably differed among tablets, depending on the quality and quantity of the mucoadhesive component. An overall comparison of results showed the tablets containing Carbopol 20% resulted to be the best formulation among those developed.

Acrylates↗

PubMed1999

Evaluation of rapidly disintegrating tablets prepared by a direct compression method.

To make rapidly disintegrating tablets with sufficient mechanical integrity as well as a pleasant taste, microcrystalline cellulose (MCC), Tablettose (TT), and crosslinked sodium carboxymethyl cellulose (Ac-di-sol) or erythritol (ET) were formulated. Tablets were made by a direct compression method (I). Tablet properties such as porosity, tensile strength, and disintegration time were determined. The tensile strength and disintegration time were selected as response variables, tablet porosity and parameters representing the characteristics of formulation were selected as controlling factors, and their relation was determined by the polynomial regression method. Response surface plots and contour plots of tablet tensile strength and disintegration time were also constructed. The optimum combination of tablet porosity and formulation was obtained by superimposing the contour diagrams of tablet tensile strength and disintegration time. Rapidly disintegrating tablets with durable structure and desirable taste could be prepared within the obtained optimum region.

Cellulose↗

PubMed2001

A comparison of reflectance and transmittance near-infrared spectroscopic techniques in determining drug content in intact tablets.

Drug contents of intact tablets were determined using non-destructive near infrared (NIR) reflectance and transmittance spectroscopic techniques. Tablets were compressed from blends of Avicel PH-101 and 0.5% w/w magnesium stearate with varying concentrations of anhydrous theophylline (0, 1, 2, 5, 10, 20 and 40% w/w). Ten tablets from each drug content batch were randomly selected for spectral analysis. Both reflectance and transmittance NIR spectra were obtained from these intact tablets. Actual drug contents of the tablets were then ascertained using a UV-spectrophotometer at 268 nm. Multiple linear regression (MLR) models at 1116 nm and partial least squares (PLS) calibration models were generated from the second derivative spectral data of the tablets in order to predict drug contents of intact tablets. Both the reflectance and the transmittance techniques were able to predict the drug contents in intact tablets over a wide range. However, a comparison of the results of the study indicated that the lowest percent errors of prediction were provided by the PLS calibration models generated from spectral data obtained using the transmittance technique.

Bronchodilator Agents↗

PubMed2001

Effect of processing methods and heat treatment on the formation of wax matrix tablets for sustained drug release.

The objective of this study was to evaluate the effects of processing methods and heat treatment on matrix formation and subsequent drug release from wax matrix tablets for controlled release. Phenylpropanolamine hydrochloride (PPA) and Compritol were processed with appropriate diluent(s) using either dry blending (DB), wet granulation (WG), partial melt granulation (PMG), or melt granulation (MG). Then the tablets were heat-treated at 80 degrees C. Particle size distribution and compressibility, along with drug release, tablet micro-morphology, wettability, porosity, and tortuosity were investigated. The drug release was different for the four processing methods even though the tablet formulation was identical. Heat treatment further retarded drug release and its effect was related to the previous manufacturing processes. Scanning Electron Microscopy (SEM) showed that heat treatment redistributed the wax and formed a film-like structure covering drug and excipients. The contact angle of tablets made from DB, WG, and PMG methods increased after heat treatment, while that of tablets made from MG remained constant. Tablet tortuosity calculated from drug release rate constants increased dramatically after heat treatment. Drug release from the wax tablets with or without heat treatment was best described by the Higuchi equation. Different processing methods produced different matrix structures that resulted in different drug release rates. Heat treatment retarded drug release mainly by increasing tortuosity of the matrix. Contact angle measurement and SEM analysis indicated that heat treatment caused the wax to melt, redistribute, coat the drug and diluents, and form a network structure.

Delayed-Action Preparations↗

PubMed2002

A novel technique to quantify film--tablet interfacial thickness.

The purpose of the project was to develop an x-ray photoelectron spectroscopic technique to quantify film-tablet interfacial thickness. Tablets containing 99% dibasic calcium phosphate were coated with an acrylic polymer containing chlorine (Eudragit RL 30 D). The film-tablet interface was defined as the region where phosphorous from the tablet and chlorine from the film coating were detected simultaneously. Five-minute intermittent ion-sputtering was used in conjunction with the conventional x-ray photoelectron spectroscopy to achieve depth profiling of the sample. The slow ion-sputtering rate of approximately 56 nm/min was overcome through sample preparation and analysis from the tablet side of the sample. This process eliminated the need to sputter through the entire film coating to reach the area of interest. Initially, only phosphorous from the tablet was detected. As the depth profiling proceeded, the chlorine signal increased and the relative intensity of the phosphorous decreased. By plotting the relative intensities of each element against the ion-sputtering time and using linear regression, the point at which the two lines intersected (tmid) was determined. By doubling tmid and multiplying by the estimated ion-sputtering rate, the thickness of the film-tablet interface was estimated to be approximately 34 microns. Further studies are needed to correlate the film-tablet interfacial thickness with the adhesive properties of coated solids.

Tablets↗

PubMed2002

The effect of controlled release tablet performance and hydrogel strength on in vitro/in vivo correlation.

The impact of controlled release (CR) formulations having different gel strength values (gamma) on in vivo tablet performance and the in vitro/in vivo correlation of the formulations was investigated. The CR tablets containing either hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), or carbomer were formulated with theophylline and Fast Flo lactose to produce tablets with a polymer content of 8 and 30% w/w. gamma was measured using a previously reported method. Male beagle dogs were utilized. Results showed that dissolution profiles were similar for all three polymers at the same % w/w level of polymer, irrespective of media (DI H2O, 0.1 N HCl, and pH 6.8 phosphate buffer). Mean gamma values were significantly different (p < or = 0.05) and were in order of HPMC K100MP > HPC HXF > carbomer 971P (same 30% w/w) with absolute gamma values at 30% w/w in DI H2O of 6600, 4600, and 1600 ergs/cm3, respectively. Drug profiles in plasma for the 30% HPMC K100MP tablets were consistent with in vitro dissolution profiles and gamma values. Plasma profiles for the 30% HPC HXF tablets were similar in vivo as the HPMC tablets. Plasma profiles for the 30% carbomer 971P formulation showed much higher drug concentrations (compared to HPMC and HPC) in vivo in all dogs. This findings is not consistent with the slow drug release found in the dissolution profiles but consistent with its low in vitro gamma values. Assessment of the predictability of a level A in vitro/in vivo correlation was quantified by absolute mean percent prediction error (PE). Formulations having gamma approximately 6000 ergs/cm3 have acceptable PE < 20%, and low standard deviation (sigma). Results showed that gamma values of CR hydrogel tablets in vitro will affect the in vivo performance (i.e., absorption kinetics of the drug) of the tablets and were also found to better assess (compared to in vitro dissolution profiles alone) the predictability of in vitro/in vivo correlations (level A and multiple level C).

Acrylic Resins↗

PubMed2003

Design of salbutamol EOP tablets from pharmacokinetics parameters.

Salbutamol elementary osmotic pump (EOP) tablets were developed, and fundamental variables affecting their release characteristics were evaluated. The effects of film thickness and compression force on drug release from the tablets containing fixed amount of sodium chloride used as osmogent were evaluated. The core tablets were directly compressed at four compression forces and coated with 3% wt/vol cellulose acetate in acetone to levels of 2%, 3%, and 4% wt/wt. Coated tablets were drilled with CO2 laser beam to form drug delivery orifice of approximately 400 microm in diameter. The drug release was found to follow zero order fashion. The release rate decreased with the increased film thickness and was not affected by the compression force or porosity. The tablets coated to 3% and 4% levels exhibited the release rates within the range calculated from pharmacokinetic data. To illustrate the effect of osmogent content, the tablets were prepared at four osmogent levels and compressed at a constant compression force. The core tablets were coated to a level of 3% wt/wt. The release rate was initially increased with osmogent content and then decreased. At higher osmogent contents, the drug fraction in soluble component was decreased and resulted in the reduction of drug release. In conclusion, film thickness and osmogents played important roles in drug release from EOP tablets.

Albuterol↗

PubMed2005

Tablets prepared by single-step granulation/tabletting: interparticulate binding mechanism and stability.

The binding mechanism of tablets prepared by single-step granulation/tabletting (SSGT), a novel technique for the production of tablets, was evaluated. SSGT yielded hard tablets having a short disintegration time due to their porous, spongelike internal structure. Calculation of the interaction factor and electrical conductance tests confirmed the presence of solid bridges that provided a higher tensile strength to these compacts in comparison to tablets prepared by conventional tabletting techniques. At high relative humidity, moisture sorption and glass-to-rubber transition of the binder (polyvinylpyrrolidone), or condensation of moisture on the internal pore surface, reduced the tensile strength of the SSGT-manufactured tablets. Contrary to tablets prepared by granulation and compression, the SSGT tablets did not harden during storage under conditions of varying relative humidity (alternating the relative humidity every 24 hr between 33% and 75%).

Drug Stability↗

PubMed1985

Alternatives to optimal administration of tablets.

This controlled investigation of 27 volunteers compared the effect of cold and lukewarm tap water and carbonated water on the passage through the esophagus of a large circular tablet containing barium sulphate and of the same size and specific gravity as an acetylsalicylic acid tablet (Kodimagnyl). The influence of yoghurt on the passage of the same tablet was also examined. The investigation emphasized the importance of taking tablets together with 100 ml of liquid. A comparison of the transit times for tablets taken together with 100 ml of cold carbonated water and 100 ml of lukewarm tap water showed a significantly better passage when the tablets were taken with cold carbonated water (p = 0.01). A similar advantage of carbonated liquids was seen when tablets were taken with 25 ml of lukewarm tap water as compared with 25 ml of cold carbonated water (p = 0.01). Administration of a tablet in a tablespoon of yoghurt is a good alternative, even though the bioavailability of certain preparations may be reduced.

Administration, Oral↗

PubMed1976

Influence of food on the absorption from different types of iron tablets.

The influence of a standardized breakfast meal on the absorption of iron from two types of iron tablets - rapidly-disintegrating and slow-release tablets - was studied in 24 healthy subjects, using a serum iron technique and whole-body counter measurements. The meal markedly reduced the absorption of iron from both types of tablets. An 8-fold reduction was found with the rapidly-disintegrating tablets and a 3-fold reduction with the slow-release tablets. Under fasting conditions the rapidly-disintegrating tablets were significantly better absorbed than the slow-release tablets, whereas the reverse was found when the tablets were given with the meal.

Adult↗