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PubMed1990

A disintegration test for vaginal tablets: comparison with BP test.

To improve the disintegration test for vaginal tablets described in the British Pharmacopoeia (BP), a monitoring apparatus was added, and tested with seven effervescent and five non-effervescent tablets. A tablet was placed on the metal disc of the BP disintegration apparatus, and the guided plate was placed on the tablet. The guided plate moved downward smoothly in a cylinder as the tablet disintegrated. The movement was recorded by using a kymograph. The end-point and process of disintegration of the tablet were automatically recorded and the results obtained suggest that the modified test is a useful tool for the quality control of vaginal tablets.

Female↗

PubMed1991

Effects of temperature and pressure during compression on polymorphic transformation and crushing strength of chlorpropamide tablets.

The effects of temperature on the polymorphic transformation of chlorpropamide during compression and on the physical properties of the tablet have been investigated. A heater and liquid nitrogen pool were mounted on the die of a single punch eccentric tableting machine, and the die temperature was controlled by a thermocontroller. A tableting machine with two load cells (upper and lower punches) and a non-contact displacement transducer were used to measure compression stress, distance and energy. The X-ray diffraction profiles of the deagglomerated compressed sample powder were measured to calculate the polymorphic content. The amount of form C transformed from form A at 45 degrees C was about twice that at 0 degree C with the same compression energy. The amount of form A transformed from form C by compression at 45 degrees C was almost the same as that at 0 degree C. This suggests that the mechanochemical effect of form A depended on the compression temperature, but that of form C was independent of temperature. The crushing strength of tablets of form A was about twice that of form C, even at the same porosity. The plots of log (crushing strength of tablet) against porosity of form A tablets compressed at 0 and 45 degrees C were linear with the same slope; the slope for form C tablets compressed at 45 degrees C was less than that at 0 degree C.

Chemistry, Pharmaceutical↗

PubMed1991

Formulation effects on the mechanical properties of metronidazole tablets.

The individual and interaction effects of nature of binder (N), concentration of binder (C) and the physical form of the formulation (P) on the tensile strengths (T--a measure of the bond strength of tablets) and the brittle fracture index values (BFI--a measure of the lamination tendency of tablets) of metronidazole tablets have been studied using a 2(3) factorial experimental design in each case. Changing binder concentration from a 'low' to a 'high' level increased T and reduced the BFI of the tablets. Methylcellulose 20 exhibited stronger binding effect and greater ability to reduce the lamination tendency of the tablets than polyvinylpyrrolidone of molecular weight 44,000. Granular formulations produced tablets with lower T values but also with lower BFI values than tablets produced from powdered formulations. The ranking of these individual effects on tensile strength was P greater than C greater than N while the ranking for the BFI was P greater than N greater than C. For the interaction effects, the ranking for tensile strength was P-N much greater than N-C greater than P-C while the ranking for the BFI was N-C much greater than P-C greater than P-N.

Chemistry, Pharmaceutical↗

PubMed1991

Effects of compaction variables on porosity and material tensile strength of convex-faced aspirin tablets.

The porosity and tensile strength of convex-faced aspirin tablets formed under a compaction pressure in the range 40-320 MPa and at punch velocities in the range 0.008 to 500 mm s-1 have been determined. The material tensile strength, sigma f, was calculated from the observed fracture load, Ps, using the equation of Pitt et al (1988): sigma f = 10 Ps/pi D2(2.84 t/D - 0.126 t/W + 3.15 W/D + 0.01)-1 where D is the tablet diameter, t is the overall tablet thickness and W is the central cylinder thickness. Tablets formed at lower compaction pressures had a higher porosity and lower tensile strength than those formed at higher compaction pressures. Tablets of face curvature ratio (D/R) in the range 0.25-0.67 and a normalized cylinder length (W/D) of 0.2 had the optimum tensile strength. (R is the radius of curvature of the tablet face.) Tablets formed at high compaction rates were significantly weaker than those formed at lower compaction rates.

Aspirin↗

PubMed1995

Tableting characteristics of micro-aggregated egg albumin particles containing paracetamol.

The tableting characteristics of micro-aggregated egg albumin particles containing paracetamol were evaluated and compared with non-micro-encapsulated paracetamol and coagulated egg albumin particles. Mean yield pressure values of micro-aggregated egg albumin particles containing paracetamol and coagulated egg albumin particles were 30.5 and 49.3 MPa, respectively, which were lower than the mean yield pressure obtained for paracetamol (97.5 MPa). Paracetamol tablets obtained with micro-aggregated egg albumin particles did not show the capping characteristic of conventional paracetamol tablets. Crushing strength of paracetamol tablets obtained with egg micro-aggegated particles was similar to that obtained using paracetamol granulated with povidone and gelatin as binders at 3 and 6% (w/w) concentrations. Drug release from the paracetamol tablets depends on the choice of excipients. Crospovidone showed good protective characteristics for the tableting of micro-aggregated particles. Crushing strength of paracetamol tablets formed from egg albumin-coated particles could be increased using crospovidone or microcrystalline cellulose as fillers and was decreased by the use of magnesium stearate. Nevertheless, magnesium stearate was useful to decrease the ejection force.

Acetaminophen↗

PubMed1998

Distribution of fluoride in the oral cavity after application of a bioadhesive fluoride-releasing tablet.

Bioadhesive fluoride tablets are fluoride-releasing devices that can be applied to the oral mucosa by the patient and release fluoride for several hours. From earlier research, it is known that a single fluoride source in the mouth can lead to an uneven distribution of fluoride in the oral cavity. In this study, fluoride concentrations were determined at different sites of the oral cavities of 13 healthy human volunteers after the application of a bioadhesive fluoride tablet containing 0.5 mg fluoride. The sites were: (1) labial surfaces of the upper central incisors, (2) lingual surfaces of the lower central incisors, (3) labial surface of the first upper left molar, and (4) labial surface of the lower right first molar. The tablet was fixed either centrally on the palate or in the lower labial sulcus in two consecutive experiments. Saliva was sampled with polyethylene sponges 5, 10, 20, 30, 60, 120, 180, and 240 minutes after tablet insertion. Fluoride was determined electrochemically. It could be shown that the area under the curve (AUC) values were significantly (p < 0.05) higher after tablet insertion in the lower labial sulcus at sampling site 1, a trend (p = 0.06) could be calculated for sampling sites 2 and 3, and no difference was found at sampling site 4. Fluoride could be detected in concentrations above 0.01 mmol.L-1 at all sampling sites after tablet insertion in the lower labial sulcus. This location seems to be a more appropriate tablet location than the palate.

Adhesives↗

PubMed2007

Single-dose and steady-state pharmacokinetics of fentanyl buccal tablet in healthy volunteers.

This study evaluated the single-dose and steady-state pharmacokinetics of fentanyl buccal tablet 400 microg in healthy adult volunteers. After receiving naltrexone 50 mg to block opioid receptor-mediated effects of fentanyl, subjects received fentanyl buccal tablet 400 microg on day 1, then every 6 hours from day 4 to day 9 (21 doses). Naltrexone 50 mg was administered every 12 hours throughout the study. Plasma fentanyl concentrations were determined for 72 hours after administration of fentanyl buccal tablet 400 microg on day 1 and the last dose of fentanyl buccal tablet 400 microg on day 9. Following single- and multiple-dose administration of fentanyl buccal tablet, the median time to maximum concentration (tmax) was 52.2 and 49.8 minutes, respectively. Peak plasma concentration of fentanyl (Cmax) was 0.88 ng/mL for the single-dose regimen and 1.77 ng/mL for the multiple-dose regimen. Steady state was reached within 5 days, consistent with the observed median half-life of approximately 22 hours following multiple doses. Observed accumulation of fentanyl after multiple doses of fentanyl buccal tablet was slightly greater than would be expected based on the single-dose data. This was attributed to the redistribution of fentanyl from a deep tissue compartment into the plasma. This study indicates that fentanyl buccal tablet has predictable pharmacokinetics following multiple-dose administration.

Administration, Buccal↗

PubMed2006

Properties of tableted high-amylose corn starch-pectin blend microparticles intended for controlled delivery of diclofenac sodium.

This study reports the properties of tableted microparticles based on high-amylose corn starch (HACS)-pectin blend polymers as the controlled release system for diclofenac sodium (DS). HACS-pectin blend microparticles are prepared through a modified process by the spray drying technique, which is a widely used microencapsulation technique in the pharmaceutical industry. The mean particle size of various formulations of blend microparticles is in the range of 5.8-7.3 mum. Fourier transform infrared (FTIR) spectroscopy study reveals the absence of well-defined interaction between HACS-pectin and polymers-DS. The blend microparticles thus prepared were compressed into tablets using the directly compressible excipients. A cross-sectional view of the tablet reveals the presence of nearly spherical shaped particles in the tablet, suggesting that the system chosen is ideal for tableting. In vitro drug release study indicates that tableted microparticulate system is found to be suitable for the manipulation of release behavior for DS in the gastrointestinal tract. Release mechanism of the DS from tableted microparticles is by Fickian diffusion since the value of n approaches 0.5.

Amylose↗

PubMed2001

Multispectral imaging of tablets in blister packaging.

This experiment tested the hypothesis that using near-infrared (IR) imaging spectrometry on tablets through blister packs permits the identification and composition of multiple individual tablets to be determined simultaneously. Aspirin was selected for this study because its breakdown mechanism is well understood. Near-IR cameras were used to collect thousands of spectra simultaneously from a field of packaged aspirin tablets. Tablets were selected by a principal component analysis selection algorithm. Graphs of the columns of the transformation matrix showed that salicylic acid and acetylsalicylic acid in the samples were modeled by the principal components. The bootstrap error-adjusted single-sample technique chemometric-imaging algorithm was used to draw probability-density contour plots that revealed tablet composition. Choice of color was used to represent constituent identity, whereas intensity represented concentration. The percentage of usable pixels in the indium antimonide (InSb) array was 99.9%. The SEP was 0.06% of the tablet mass for both water uptake and salicylic acid production. The number of tablets that a typical near-IR camera can currently analyze simultaneously was also estimated to be approximately 1300.

Aspirin↗

PubMed2004

Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique.

The purpose of this research was to develop mouth dissolve tablets of nimesulide. Granules containing nimesulide, camphor, crospovidone, and lactose were prepared by wet granulation technique. Camphor was sublimed from the dried granules by exposure to vacuum. The porous granules were then compressed. Alternatively, tablets were first prepared and later exposed to vacuum. The tablets were evaluated for percentage friability, wetting time, and disintegration time. In the investigation, a 32 full factorial design was used to investigate the joint influence of 2 formulation variables: amount of camphor and crospovidone. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of camphor and a higher percentage of crospovidone. A contour plot is also presented to graphically represent the effect of the independent variables on the disintegration time and percentage friability. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. Sublimation of camphor from tablets resulted in superior tablets as compared with the tablets prepared from granules that were exposed to vacuum. The systematic formulation approach helped in understanding the effect of formulation processing variables.

Administration, Oral↗

PubMed1985

Biopharmaceutical evaluation of methylcellulose as an excipient for nitroglycerin tablets.

To examine the bioavailability of nitroglycerin in sublingual tablet, 5 healthy adult volunteers underwent simultaneous sublingual administration of a tablet prepared with methylcellulose and a tablet prepared with lactose containing 0.15 mg of nitroglycerin and 0.15 mg of nitroglycerin-15N3, respectively. In 4 of 5 volunteers, no difference in plasma concentration determined by gas chromatography-mass spectrometry (GC-MS) was observed between 2 tablets described above, so it was well accepted that nitroglycerin in tablets prepared with methylcellulose had a similar bioavailability to that in tablets prepared with lactose. The simultaneous administration of the 2 nitroglycerin tablets to a healthy volunteer, one of which containing the drug labeled with a stable isotope followed by GC-MS assay, seems to be the most suitable method for a precise comparison of bioavailability of the formulations.

Adult↗

PubMed1991

Dissolution of solid dosage form. II. Equations for the dissolution of nondisintegrating tablet under the sink condition.

An equation for dissolution from the whole surface of a nondisintegrating single component tablet under the sink condition was derived. Also, equations for several dissolution manners of the tablet under the sink condition were derived in the postulation of the dominant dissolution rate constant which determines the dissolution manner. The applicability or validity of these equations were examined by the dissolution measurements with nondisintegrating single component tablets. About one-tenth the amount of the amount needed to saturate the solution was used to prepare a tablet, and dissolution measurements were carried out with the tablet whose flat or side surface was masked with an adhesive tape in accordance with the conditions for derivation of equations. Among the derived equations, dissolution from the whole surface of a tablet was expressed by a form similar to the cube root law equation for particles. Hence, a single component tablet compressed by the use of a suitable amount was thought to behave like a single crystal. Also, equations derived for several dissolution manners were thought to be applicable for the dissolution of a nonspherical particle and crystal concerning the crystal's habit and its dissolution property, and the extended applicability was examined by converting the crystal into a simplified or idealized form, i.e., rectangle or plate.

Mathematics↗

PubMed1998

Optimization of the granulation process for designing tablets.

A computer optimization technique based on surface response methodology was applied to optimize the wet granulation process for designing tablets. Physical properties (mean granule size, granule size distribution, compressibility, granule strength) of a model granule formulation containing ethenzamide were accurately described by a second polynomial equation based on two independent variables (amounts of binder and binder solution). This regression equation also gave a good correlation for three physical properties of tablets (distintegration time, compactibility, compression force variance), but the correlation for tablet hardness and weight variation was poor. These results imply that not only the above physical properties of granules but also the rheological behavior and porous structure of granules are closely related to tablet properties. Using an optimization of five tablet properties using the generalized distance function, the predicted values of the physical properties of both granules and tablets agreed well with experimental values. This agreement indicates that the computer optimization technique is useful for optimizing the granulation process for designing tablets.

Computers↗

PubMed1998

Influence of pH and phospholipid species on release of acetaminophen from tablets containing phospholipids.

The release of acetaminophen (AAP) from tablets containing phospholipids was examined using hydrogenated soybean phospholipid (HSL) and its main components, phosphatidylcholine (PC), phosphatidylethanolamine (PE) and phosphatidylinositol (PI), although the PI was not well purified (PI rich). Tablets compressed with 400 kgf had about 9% porosity and 2-4 kgf hardness. The release patterns of AAP from the tablets were fitted to Higuchi's square root of time law. The release rate was influenced by the pH of the medium, though solubility of AAP did not change with pH. PC tablets showed faster release at pH of less than 3 than that at pH of above 3, whereas PI rich and HSL tablets showed faster release at pH of above 3 than that at pH of less than 3. The release rate from PE tablets was little affected by pH. A linear relationship exists between the release rate of AAP and the rate of water absorption by the tablet. The ionization state of the phospholipids changes with the pH of the medium, and affects the hydration characteristics. The fully ionized state, at pH of less than 3 in the case of PC and above 3 in the case of PI is most effective on hydration. PE does not fully ionize because of intermolecular hydrogen bonding.

Absorption↗

PubMed2002

Eudragit NE30D based metformin/gliclazide extended release tablets: formulation, characterisation and in vitro release studies.

Metformin/Gliclazide extended release tablets were formulated with Eudragit NE30D by wet granulation technique. Two batches were prepared in order to study influence of drug polymer ratio on the tablet formation and in vitro drug release. The formulated tablets were characterized by disintegration time, hardness, friability, thickness, weight variation, and in vitro drug release. The percentage of polymer, with respect to Metformin/Gliclazide, required to produce tablets with acceptable qualities was 9 to 13.45. The percentage of polymer below this range released the drug immediately and above this range produced granules not suitable for tablet formation. The quantity of Metformin/Gliclazide present in the tablets and the release medium were estimated by a validated HPLC method. The formulated tablets had acceptable physicochemical characters and released the drug over 6-8 h. The data obtained from in vitro release studies were fitted with various kinetic models and was found to follow Higuchi kinetics.

Chemistry, Pharmaceutical↗

PubMed2004

Application of nilvadipine solid dispersion to tablet formulation and manufacturing using crospovidone and methylcellulose as dispersion carriers.

Nilvadipine (NIL) solid dispersion using crospovidone (Cross-linked-N-vinyl-2-pyrolidone, cl-PVP) and methylcellulose (MC) as carriers was applied to tablet formulation. Several grades of cl-PVP and MC were used, and their influence on tablet properties such as hardness, disintegration, dissolution and chemical stability were investigated. The agitation granulation method was used for preparation of solid dispersion granules, and the granules were compressed using a rotary tableting machine, and finally the obtained tablets were coated with film. As the particle size of cl-PVP decreased, hardness and apparent solubility were increased, while dissolution rate was lowered. When a higher viscosity grade of MC was used, hardness and dissolution rate were increased, and apparent solubility did not change. All batches of tablets were chemically stable at 40 degrees C, 75% relative humidity (R.H.) for six months. Finally, tablets with enhanced dissolution properties were obtained by using Polyplasdone XL-10 and Metolose SM-25 as the grades of cl-PVP and MC, respectively. These formulation tablets showed higher solubility and dissolution rate during storage as well as initial indicating good physical stability.

Drug Compounding↗

PubMed2004

Effect of moisture on impact toughness of sugar-coated tablets manufactured by the dusting method.

The purpose of this study was to clarify the effect of moisture on the impact toughness of sugar-coated tablets manufactured by the dusting method. We demonstrated that moisture plays an important role in the impact toughness of sugar-coated tablets. Moisturizing the sugar-coating layer resulted in enhancement of impact toughness of sugar-coated tablets, while reducing moisture in the sugar-coating layer resulted in weakening of the impact toughness. This was due to the characteristics of sucrose, the main ingredient of the sugar-coating layer, which is a soft and non-fragile material at high moisture levels, but hard and fragile at low moisture levels. We also demonstrated that friability as an indicator of impact toughness changed with time, and friability should be measured at 14 d after manufacture. This is due to moisture movement from outer sugar-coating layer into the inner sugar-coated tablets. Incorporating microcrystalline cellulose (MCC) in the subcoating layer resulted in sugar-coating layers with high resistance against impact even though moisture content of sugar-coated tablets was low. We confirmed the high impact toughness of the sugar-coated tablets with MCC whose moisture content was low from the results of both free fall and friability tests. We suggest that the dusting method using dusting powder containing MCC is a useful method for the production of sugar-coated tablets containing moisture sensitive drugs.

Carbohydrates↗

PubMed2005

Evaluation of the compaction properties of a solid dispersion of indomethacin with crospovidone by tableting process analyzer.

A powder solid dispersion system (SD) of indomethacin (IM) with crospovidone (CrosPVP) possesses good fluidity and can be used for tablet formulation. Tablets of SD can be prepared by direct compression and have adequate hardness and a small variation in weight. Forces during the tableting process were measured with a tableting process analyzer (TabAll) equipped with a single-punch. The pressure transmission ratio (PTR) from the upper to the lower punch and the die wall force (DWF) were examined during the tableting process. Ejection force (EF) and scraper pressure (SP) were measured for determining the capping and sticking properties during the tableting process. Adding 1% magnesium stearate (MS) to the SD resulted in high PTR and DWF values and a low EF value. PTR and DWF values increased and EF value decreased when MS and microcrystalline cellulose (MCC) were added to the SD. A thousand tablets could be manufactured without problems such as sticking or capping when 1% MS and 50% MCC were added to the SD containing 25% IM.

Anti-Inflammatory Agents, Non-Steroidal↗