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Transport of coliphage in the presence and absence of manure suspension.

Mechanisms of coliphage transport and fate in the presence and absence of manure suspension were studied in saturated column experiments. In the presence of manure suspension, little inactivation of indigenous somatic coliphage occurred and the transport was controlled by deposition. The deposition followed a power law distribution with depth, and the magnitude increased with decreasing sand size. Comparison of the cumulative size distribution of manure components in the suspension initially and after passage through sand, suggested that particles retained by mechanical filtration and/or straining decreased the effective pore size and potentially induced straining of the somatic coliphage. A 2-site kinetic deposition model was used to estimate the magnitudes of attachment and straining in the presence of manure suspension, and provided a good description of the data. Modeling results indicated that straining accounted for 16 to 42% of the deposited somatic coliphage, and that both straining and attachment increased with decreasing sand size due to smaller pores and higher surface area, respectively. In the absence of manure suspension, phiX174 (a representative somatic coliphage) and MS2 (a male-specific RNA coliphage) transport was controlled by inactivation induced by the solid phase. This conclusion was based on comparison of coliphage transport behavior at 5 and 20 degrees C, mass balance information, and numerical modeling. Comparison of somatic coliphage transport data in the presence and absence of manure suspension revealed much higher effluent concentrations in the presence of manure. This difference was attributed to lower inactivation and higher detachment rates. The observed coliphage transport behavior suggests that survival of viruses may be extended in the presence of manure suspensions, and that transport studies conducted in the absence of manure suspension may not accurately characterize the transport potential of viruses in manure-contaminated environments.

Animals↗

Pressure-flow relationship of erythrocyte suspension in perfusion of nuclepore membrane and red cell deformability.

The hemodynamic characteristics of Nuclepore (NP) membrane filtration were evaluated from a pressure (P)-flow rate (Q) relationship of erythrocyte suspension obtained by the vertical-tube method (Nichol et al., 1951) with a slight modification. It became evident that the vertical-tube method was a more quantitative and simple method than the conventional steady flow perfusion method using a variable speed pump. The P-Q relationship of erythrocyte suspensions in the perfusion of NP membrane consisted of a smooth curve convex to the P-axis at low P tending to a straight line at high P. The extrapolated linear segments of P-Q curves of erythrocyte suspension did not converge to the same point on the negative Q-axis, that is, the value of the negative intercept increased as flow decreased. This observation indicated clearly an obstruction or plugging of the pores by erythrocytes. It was made clear that flow rate measured with NP membrane filtration was influenced not only by intrinsic red cell deformability but also by several different factors, namely, the different distribution of pore size of NP membrane, microdust contaminated inevitably in red cell suspension, total volume of cell suspension through NP membrane, stagnation or retention of erythrocyte suspension and the hematocrit value of suspension. In conclusion, the present study shows that the precise definition of deformability depends on the method or rheological conditions, such as hematocrit value of suspension, used to measure it, even if confined within NP membrane filtration.

Blood Flow Velocity↗

The pressure-flow relation in resting rat skeletal muscle perfused with pure erythrocyte suspensions.

In spite of numerous investigations of erythrocyte rheology, there is limited information about the influence of erythrocyte suspensions on whole organ pressure-flow relationships. In this study, we present whole organ pressure-flow curves for resting vasodilated gracilis muscle of the rat, in which the microanatomy and vessel properties have been determined previously. For pure erythrocyte suspensions from donor rats, the organ resistance increases only mildly with perfusion time (less than a 5% shift over a one-hour perfusion time), while in contrast, erythrocyte suspensions containing leukocytes show an increases of resistance near 100% over a period of 25 min. Variation in pressure-flow curves in the muscle at the same arterial hematocrit between different rats is less than 15%. The pressure-flow relation for pure erythrocyte suspensions depends on hematocrit. Shear thinning is exhibited at high hematocrits, while Newtonian behavior is approached at arterial hematocrits below 15%. The whole organ apparent viscosity for pure erythrocyte suspensions (normalized by cell-free plasma resistance) is a non-linear function of hematocrit; at physiological pressures, it reaches values comparable to those of apparent viscosities measured in rotational viscometers or in in vitro tube flow (diameters greater than 0.8 mm). The apparent viscosities estimated from the whole organ experiments tend to be higher than those measured in straight tubes under in vitro conditions. The pressure-flow curves for pure erythrocyte suspensions are shifted towards lower pressures than the curves for mixed suspensions of erythrocytes at the same hematocrit and with leukocytes at physiological cell counts. These acute experiments show that pure erythrocyte suspensions yield highly reproducible resistances in the skeletal muscle microcirculation with dilated arterioles. Relative apparent viscosities measured in vivo are higher than those measured in straight glass tubes of comparable dimesions.

Animals↗

Human platelet suspension stimulates porcine retinal glial proliferation and migration in vitro.

PURPOSE: To characterize the cellular and molecular mechanisms underlying the efficacy of autologous platelet suspension adjuvant therapy in the treatment of macular hole. METHODS: Platelet suspensions were: paid from whole blood samples obtained from informed volunteers. For proliferation assays, platelet suspensions or purified growth factors were added to semi-confluent cultures of porcine real glial cells for 24 hours, followed by [3H]thymidine for 15 hours, after which time cells were washed, solubilized, and counted for uptake of radioactive tracer. For cell migration assays, confluent glial cultures were scrape wounded and maintained in the presence or absence of platelet suspension or identified platelet constituents. Cell migration into the denuded area was scored as a function of time. In certain cases, specific pharmacologic inhibitors of growth factor action were added at the same time as platelet adjuvant or growth factors. RESULTS: Platelet suspension adjuvant induced strong mitogenic and chemotactic responses in cultured glia, in a dose-dependent manner. Maximal incorporation of thymidine was two- to threefold that of control levels, with an ED50 approximately 5 x 10(6) platelets/ml, and migration was enhanced up to 80-fold after 48 hours. Platelet suspension-induced proliferation was completely blocked by addition of 25 microM genistein, a tyrosine kinase receptor inhibitor. However, the same concentration only partially blocked the cell migration response. Addition of any single growth factor or protein identified from ELISA analysis, or a combination of all factors, did not significantly stimulate proliferation or cell migration. CONCLUSIONS: Human platelet suspensions exert both proliferative and chemotactic influences on retinal glial cells in vitro, suggesting that the same responses may occur in platelet-induced macular hole repair in humans. Growth factors or proteins that have been identified within the suspensions do not mimic these responses in vitro, implying that additional currently unidentified trophic activities are also present.

Animals↗

Corneal astigmatic effects of conventional recession vs suspension recession ("hang-back") strabismus surgery: a pilot study.

INTRODUCTION: Changes in refractive error after strabismus surgery occur secondary to changes in corneal curvature. The change in refractive error is usually transient but may lead to a temporary decrease in vision. We compared the change in corneal curvature following strabismus surgery in eyes utilizing a suspension (so-called "hang-back") recession technique to eyes undergoing conventional recession surgery. METHODS: Sixteen patients undergoing bilateral medial or lateral rectus recessions were prospectively entered into the study. One eye was randomly selected to undergo conventional strabismus surgery and the other eye underwent strabismus surgery using the suspension technique. Keratometry measurements were taken in the operating room immediately prior to and immediately after surgery. The change in corneal curvature was calculated and analyzed for each technique. RESULTS: The mean change in corneal curvature was -0.06 diopters (D) for the suspension group and +0.18 D for the conventional group, confirming prior reports. However, all eyes undergoing suspension surgery had a change within 1 D whereas only 75% of those eyes undergoing conventional surgery fell within the same range. Overall there was twice the variation in the degree of astigmatism in the conventional group when compared with the suspension group. CONCLUSIONS: No eye undergoing suspension surgery experienced a change in corneal curvature greater than 1 D while 25% of those undergoing conventional surgery did. Therefore, possible benefits to the suspension recession technique might include less overall variability of astigmatism change and decreased amounts of induced astigmatism. Patients undergoing strabismus surgery using a suspension technique may be less likely to notice a change in their vision in the immediate postoperative period.

Astigmatism↗

The role of sex and genotype on antiorthostatic suspension effects on the mouse peripheral skeleton.

Previous antiorthostatic suspension studies have used a single sex and strain of rat or mouse. Nonetheless, broadly similar effects of suspension on the two species indicates a generalized effect of suspension not attributed to specific genetic, behavioral, or sex-linked etiology. In order to directly test genetic and sex-linked factors, the effects of suspension on the appendicular bone of male and female BALB-CJ, C57BL-6J, and DBA-2J mice were compared. These genotypes were selected based on their widely different developmental and behavioral characteristics as well as on past research involving a heterogeneous strain derived from these strains. The effects of suspension on the geometric, mechanical, and material properties of the femora, humeri, and tibiae were determined. Among the bone types, the femora were most significantly affected by suspension. The effects of suspension were similar in nature in male and female mice aged 1.7 months. Strain-dependent suspension effects may be indicative of bone developmental differences in the strains at the age chosen.

Animals↗

Bioavailability of sulfonamide suspensions I: Dissolution profiles of sulfamethizole using paddle method.

A comparative bioavailability study was performed using two commercially available, chemically equivalent brands of sulfamethizole suspension. One gram of each suspension was administered to 12 different subjects following a completely randomized crossover design. Serum levels and derived pharmacokinetic parameters were compared statistically. There were no significant differences in the extent of sulfamethizole absorption from the two suspensions as evidenced by the area under the serum level--time curves. Significant differences (p less than 0.05) in the mean serum levels at 0.5 and 0.75 hr and differences in Cmax and tmax indicated that the absorption rate differed for the two products. In vitro tests including particle-size analysis and dissolution studies were performed. The size--frequency distribution of particles in the suspensions was studied using a resistance particle counter. The dissolution characteristics of the two products were studied using the Food and Drug Administration's paddle method and the spin-filter apparatus. Suspension A had a significantly greater amount of drug dissolved at 15 and 30 min using either method. It also had a greater percentage of particles at the smaller size range, indicating that the greater dissolution rate may be related directly to the decreased particle size. A comparison of the in vivo and in vitro results demonstrated a definite rank-order correlation between the dissolution performance of the two suspensions and the in vivo parameters reflecting the absorption rate. Suspension A had a greater amount of drug dissolved at 15 and 30 min and resulted in higher serum levels at 0.5 and 0.75 hr, a higher Cmax, and a shorter tmax.

Adult↗

Effect of photocorrosion on cadmium sulfide suspensions applied in animal inhalation studies with CdS particles.

Cadmium sulfide aerosol (90 micrograms Cd/m3) was generated from an aqueous suspension for 12 weeks and the ratio of Cd++/Cdtotal in the suspension and the resulting aerosol was determined. After 4 weeks the concentration of Cd++ in the suspension and the aerosol leveled off at 43.5 +/- 11.4% and 35.8 +/- 6.8%, respectively. Therefore, lung tumors in rats observed after inhalation exposure to such CdS aerosols (Glaser et al. 1990) may have been caused not only by the effect of CdS but also by the influence of inhaled Cd++ or CdSO4. The contribution of CdS particles to the observed lung tumor rate depends on the bioavailability of CdS retained in the lungs. The photochemical decay of CdS in aqueous suspensions only occurred when exposed to light and adjusting the suspension up to pH 3 did not increase the decomposition rate of CdS. Ethanolic suspensions of CdS are much more stable than aqueous ones and experiments with suspensions kept under shield gases showed that the decay of CdS is not dependent on oxygen.

Administration, Inhalation↗

Adriamycin-lipiodol suspension for i.a. chemotherapy of hepatocellular carcinoma.

Physicochemical properties of two types of adriamycin preparation, suspensions and emulsions prepared for i.a. chemotherapy of hepatocellular carcinoma, were investigated. A suspension was prepared by dispersing adriamycin directly into the lipid contrast medium, Lipiodol, whereas an emulsion was obtained by emulsifying an aqueous solution of adriamycin into Lipiodol. The dispersibility of the drug in each preparation was examined microscopically. The chemical stability of and drug release from the preparation were determined by high-performance liquid chromatography and spectrophotometry, respectively. The suspension was then given to ten patients with primary hepatocellular carcinoma. The suspension maintained good dispersibility without coagulation of drug particles, whereas coalescence of aqueous droplets and the resultant phase separation occurred 4 h after preparation of the emulsion. Both preparations maintained the initial drug content for at least 1 week at room temperature. The release of adriamycin was more prolonged in the suspension than in the emulsion. After i.a. administration of the suspension, a selective accumulation of Lipiodol in the tumor and decrease in serum alpha-fetoprotein (AFP) levels were found in most patients. A significant amount of adriamycin was still detected in hepatic specimens resected from two patients 1 and 2 months after treatment. These findings suggest that the adriamycin-Lipiodol suspension may be a useful preparation for targeting chemotherapy to hepatocellular carcinoma.

Adult↗

A pooled analysis of seven randomized crossover studies of the palatability of cefdinir oral suspension versus amoxicillin/clavulanate potassium, cefprozil, azithromycin, and amoxicillin in children aged 4 to 8 years.

OBJECTIVE: This analysis of the results of 7 trials compared the taste and smell acceptability scores of cefdinir oral suspension and 4 other pediatric antibiotic oral suspensions--amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin--using a visual smile-face scale. METHODS: Data from 7 randomized, single-blind, cross-over trials were pooled and analyzed. In each study, children aged 4 to 8 years were asked to taste and smell 2 different antibiotic suspensions and assign preference using a visual smile-face scale. Ratings were converted to a numeric score ranging from 5 (really good) to 1 (really bad). RESULTS: A total of 1011 healthy subjects were randomly assigned to 1 of 2 treatment-order groups; 965 were evaluable for the taste and smell analyses. Baseline demographics of evaluable subjects were similar among test groups. Approximately even proportions of participants were female or male (50.1 % vs 49.9%), most (84.1%) were white, and slightly more participants were aged 7 or 8 years rather than younger (age 4 years, 16.0%; age 5 years, 17.4%; age 6 years, 18.7%; age 7 years, 23.2%; age 8 years, 24.8%). Of the 965 children who tasted both antibiotic suspensions and determined their preference, 798 (82.7%) rated the taste of cefdinir as really good or good (the highest possible ratings); 712 (73.8%) assigned the same ratings to amoxicillin/clavulanate potassium, cefprozil, azithromycin, or generic amoxicillin (P < or = 0.001). With regard to smell, 671 (69.5%) rated the smell of cefdinir as really good or good; 636 (65.9%) assigned these same ratings to the comparator agents (P = NS). CONCLUSION: In this pooled analysis of data from 7 randomized, single-blind, crossover trials, children between the ages of 4 and 8 years preferred the taste of cefdinir oral suspension to that of other pediatric antibiotic suspensions. Based on smile-face scores, subjects found the smell of cefdinir oral suspension to be at least as good as that of the comparators.

Administration, Oral↗

Effect of ethanol on protection of urinary bladder function by grape suspensions.

OBJECTIVES: To compare the protective effects of grape suspensions prepared in an aqueous vehicle with grape suspensions prepared in an 8% ethanol vehicle in rabbits subjected to partial outlet obstruction. The hypothesis was that the presence of ethanol would increase the absorption of the beneficial components of the grape suspensions and thus increase their protective ability. The use of ethanol in these studies was not to simulate wine. METHODS: A total of 48 New Zealand white rabbits were separated into eight groups of 6 rabbits each. Groups 1 and 3 were pretreated by oral gavage for 3 weeks with grape suspensions in water; groups 2 and 4 were treated with vehicle. Groups 5 and 7 were treated with the grape suspensions in 8% ethanol, and groups 6 and 8 were treated with ethanol vehicle. Groups 1, 2, 5, and 6 underwent sham operations, and groups 3, 4, 7, and 8 underwent partial outlet obstruction. Three weeks after surgery, the rabbits were evaluated. RESULTS: The bladder weight had significantly increased in all obstructed groups. The contractile responses to field stimulation and carbachol were reduced in all obstructed groups, although the responses in both grape-treated groups were greater than both vehicle-treated groups. The contractile responses to potassium chloride were significantly reduced by partial outlet obstruction in both obstructed groups similarly. CONCLUSIONS: Both grape suspensions provided protection against obstructive-induced bladder dysfunction. The ethanol preparation of the grape suspension was not better than the aqueous preparation.

Animals↗

Effect of solution and suspension type aerosol of formoterol on tremor response and airways in patients with asthma.

BACKGROUND: Aerosol delivery and deposition to the oropharynx and the lungs have been found to be different for solution-type and suspension-type metered-dose aerosols used for treatment of asthma. We investigated possible differences in clinical effects between solution and suspension metered-dose formoterol aerosols. METHODS: A total of 24 patients with asthma (forced expiratory volume in 1 second, < or = 70% predicted) inhaled single doses (12 micrograms or 24 micrograms) of formoterol solution and suspension so that we could investigate the immediate tremor, airway, and cardiovascular responses in a randomized, double-blind, crossover trial. Fenoterol suspension aerosol (400 micrograms) was used for comparison (single-blind, poststudy, nonrandomized administration). Fenoterol (400 micrograms) as a rescue medication was inhaled after 120 minutes on each of the 5 study days. RESULTS: The order of mean (+/- SEM) maximum tremor acceleration was as follows: 12 micrograms formoterol solution (67.92 +/- 4.54 cm x sec-2) < 24 micrograms solution (73.46 +/- 4.51 cm x sec-2) < 12 micrograms suspension (80.87 +/- 5.08 cm x sec-2) < fenoterol (84.13 +/- 4.21 cm x sec-2) < 24 micrograms formoterol suspension 88.54 +/- 6.26 cm x sec-2). Maximum increase in specific airway conductance ranged from 0.48 +/ 0.03 to 0.55 +/- 0.04 sec-1 x kPa-1 for all drugs (p > 0.05). No change in cardiovascular parameters occurred (p > 0.05). CONCLUSION: No difference in the bronchial response to either formulation of formoterol was found. Tremor response to suspension aerosol (24 micrograms > 12 micrograms) was higher than that to solution aerosol (24 micrograms > 12 micrograms), indicating possible differences in systemic absorption because of a different deposition pattern. Rescue medication demonstrated systemic effects on tremor that were additive to those of formoterol.

Adult↗

Physical stability of a microcrystalline beta-sitosterol suspension in oil.

Sterols have been shown to reduce plasma cholesterol by blocking the absorption of cholesterol from the gut. The physical properties of crystalline plant sterols limit their use in foods. A coarse-grained structure can be avoided by recrystallisation, a method that affords a reduction in the particle size. A previous work described how to produce a microcrystalline beta-sitosterol suspension. The present study deals with the stability of that suspension. Recrystallisation was carried out by two different methods; one based on rapid the other based on slow cooling, whereby six different compositions were made containing 5-30% of beta-sitosterol and secondly either 5 or 20% water was added. The particle size and habit were evaluated during a 16 weeks storage period (+4 or -19 degrees C) by way of optical microscopy. The crystal structure and degree of crystallinity was analysed by X-ray diffraction. Suspensions can, in most cases, be stored for 16 weeks without any changes to the size and habit. The only evidence of crystal growth came from a suspension with a low sterol concentration at a temperature of +4 degrees C. This is due to the dissolution-diffusion process which is affected by temperature and viscosity. Suspensions containing higher amounts of sterol remained stable, if stored at +4 or -19 degrees C, for 16 weeks. The suspensions included both hemihydrous and monohydrous beta-sitosterol crystals. Suspensions containing less sterol showed greater amounts of monohydrated crystals. This illustrates more water penetration into the crystals. A higher sterol concentration led to a larger number of smaller crystals creating reflections similar to hemihydrated crystals.

Cholesterol↗

Application of co-grinding to formulate a model pMDI suspension.

The objective of this study was to investigate the effect of co-grinding the model drug, triamcinolone acetonide (TAA), with a polymeric surfactant on the in vitro performance of a model pMDI suspension system. The physicochemical properties of TAA after co-grinding with the surfactant, Pluronic F77, were determined by laser light diffraction, helium pycnometry and equilibrium solubility measurements. TAA-surfactant interaction was investigated by differential scanning calorimetry and Fourier transform infrared spectroscopy (FTIR). The suspension characteristics of pMDI formulations prepared with co-ground TAA and surfactant were investigated by determining their in situ sedimentation, rheological profiles and vapor pressure. The performance characteristics of the pMDI formulations were determined by cascade impaction and dose delivery through-the-valve (DDV) measurements. It was found that the presence of Pluronic F77 decreased the solubility of TAA in the propellant medium. Co-grinding TAA particles with Pluronic F77 influenced the particle size distribution, sedimentation and flocculation characteristics of the pMDI suspension formulation. The addition of Pluronic F77 decreased the viscosity of the pMDI formulation. Formulating the suspension pMDI system with co-ground TAA and Pluronic F77 decreased the mass median aerodynamic diameter (MMAD) of the emitted aerosol and increased the percent respirable fraction (%RF). The co-ground TAA and Pluronic F77 pMDI suspension formulation exhibited greater physical stability which was due to the influence of the co-grinding technique on the physicochemical properties of the TAA particle surface and the propellant dispersion medium. The changes induced by co-grinding with Pluronic F77 improved the performance characteristics of a pMDI suspension formulation by stabilizing the suspension and influencing the flocculation characteristics. Co-grinding is a process which may be useful when developing new pMDI systems containing HFA propellants.

Administration, Inhalation↗

In vivo validation of the release rate and palatability of remoxipride-modified release suspension.

Remoxipride, a D2-dopamine receptor antagonist, is well tolerated and completely absorbed after oral administration. Because of its extremely bitter taste, an oral palatable suspension was developed by using a taste-masking microencapsulation. The bioavailability of remoxipride was investigated in two studies in healthy volunteers after administration of a 100-mg dose in suspension. The first study used a capsule as reference, and the second study a plain solution. Taste assessment was carried out in the second study. The extent of bioavailability was the same when comparing the oral suspension to a capsule and to a plain solution. However, the rate of absorption is delayed, and Tmax was 3.0 hr after the suspension, 1.0 hr after the oral solution, and 1.6 hr after the capsule. The release rate in vitro from the suspension was determined by applying the USP-paddle method. By using numerical convolution and deconvolution, the release rates in vivo and in vitro were shown to be similar when using water with 0.5% sodium lauryl sulfate as dissolution liquid. The taste-masked oral suspension is suitable for full-scale production, with good control of the encapsulation process and of the preparation of a suspension.

Adult↗

A preliminary study of microcapsule suspension for hemolysis evaluation of artificial organs.

A microcapsule suspension, a substitute for animal blood in hemolysis tests, has been developed for evaluation of the absolute hemolytic properties of circulatory artificial organs. The microcapsule suspension was made by dispersing microcapsule slurry into an ethylene glycol sodium chloride solution. The microcapsule slurry was composed of a leuco dye solution and polyurethane membrane made by the reaction between aliphatic poly-isocyanate and polyamine by interfacial polycondensation. The microcapsule was a small particle containing dye inside. The microcapsule suspension was white; the diameter of the microcapsules was from 5 to 100 microns. The specific gravity of the suspension was 1.024, and the membrane was elastic. The fluid showed Newtonian characteristics, different from animal blood, and its viscosity was approximately 5.8 mPa.s. After the microcapsules were destroyed, the leuco dye was extracted with n-hexane from the suspension and was measured by spectroscopy after being colored with acid ethanol. Hemolysis can be regarded as a fatigue fracture of cell membranes rather than a static fracture. The destruction of microcapsules by a Potter type tissue grinder was observed at a low stroke number region and was compared to rat blood. Moreover, hemolysis tests of a commercially available centrifugal blood pump and the prototype of our centrifugal pump for mechanism checks were carried out with bovine blood. The hemolysis level of the prototype pump increased with time while the hemolysis level of the commercial blood pump did not change as much as that of the control when both pumps were tested with the microcapsule suspension. These results are similar to tests utilizing bovine blood. Therefore, hemolysis tests of circulatory artificial organs completed with microcapsule suspension are expected to provide results similar to tests with animal blood.

Animals↗

Stability of pentoxifylline in an extemporaneously prepared oral suspension.

The stability of pentoxifylline in an extemporaneously prepared suspension was studied. Twelve 400-mg pentoxifylline tablets were crushed and mixed with water to prepare a 20-mg/mL suspension. The suspension was transferred to 10 amber glass and 10 amber plastic prescription bottles. Five glass and five plastic bottles were stored at 25 degrees C, and the rest were stored at 4 degrees C. Samples were collected before storage and on days 7, 14, 21, 28, 42, 56, 70, and 91 and analyzed in duplicate by stability-indicating reverse-phase high-performance liquid chromatography. Pentoxifylline was stable in the suspension under all storage conditions for the duration of the study. The color, odor, and pH of the suspension did not change appreciably. Some settling of the suspension was noted in all bottles beginning on day 21, but shaking resuspended the settled material. Pentoxifylline 20 mg/mL was stable in an extemporaneously prepared suspension for at least 91 days at 25 or 4 degrees C.

Chromatography, High Pressure Liquid↗

Overview of the pharmacology of clarithromycin suspension in children and a comparison with that in adults.

The pharmacokinetics of clarithromycin after oral administration of clarithromycin granules for suspension formulation were investigated in adult volunteers and pediatric patients. A 250-mg single dose study conducted in adults revealed that the extent of absorption of clarithromycin from the suspension formulation was not significantly different from that of the reference tablet formulation, whereas the extent of formation of the active 14-hydroxy (14-OH) metabolite was significantly lower with the suspension formulation. In addition coadministration of the suspension formulation with food did not significantly alter the extent of absorption of clarithromycin or formation of the 14-OH metabolite. A single/multiple dose study conducted in adults revealed a delay in the time to attain peak plasma clarithromycin and 14-OH metabolite concentrations after suspension administration as compared with data obtained after tablet administration in previous studies. Steady state was achieved by Dose 5 in the multiple dose phase (250 mg every 12 hours for seven doses). In addition the mean plasma concentration-vs.-time data after suspension administration compared favorably with that noted after multiple oral dose administration of 250-mg tablets in adults. A single/multiple dose study conducted in pediatric patients revealed that coadministration of the suspension formulation with food did not significantly alter the extent of absorption of clarithromycin or formation of the 14-OH metabolite. During the multiple dose phase (7.5 mg/kg every 12 hours for 4 or 5 days), mean plasma concentration-vs.-time data compared favorably with that noted after multiple oral dose administration of 250-mg and 500-mg tablets in adults.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗