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PubMedDate not supplied

Tail-suspension induced hyperthermia: a new measure of stress reactivity.

The tail suspension test (TST), an antidepressant screening paradigm, uses the uncontrollable, inescapable stressor of tail suspension to elicit immobility. As hyperthermia occurs following numerous stressors, hyperthermia might exist following the TST. We tested whether tail suspension induced hyperthermia (TSIH) was a distinct variable for TST. Hyperthermia was measured by two methods: a rectal probe and a subcutaneously implanted microchip (ELAMS()). In outbred ICR male mice, TSIH was robustly demonstrated compared to control (No-TST) mice. TSIH peaked after TST and remained elevated at 120 min. Among five (129/SvEvTac, A/J, C57BL/6J, NMRI and ICR) strains examined for TSIH, significant strain variations were detected. NMRI showed the highest temperature rise (2.3 degrees C) and A/J mice showed the lowest (0.6 degrees C). Sex differences were found for the C57BL/6J and NMRI strains on TSIH. TSIH and duration of immobility were not significantly correlated (r=0.22, P=0.17) in outbred mice. Both duration of TST immobility and TSIH were measured when ICR male mice were administered diazepam, imipramine (a TCA antidepressant), venlafaxine (a SNRI antidepressant), sertraline and paroxetine (SSRI antidepressants), propranolol and nadolol (beta-adrenergic receptor blockers), CP-154,526 (a CRF(1) receptor antagonist), and indomethacin (a cyclo-oxygenase inhibitor). Diazepam dose-dependently increased immobility and decreased TSIH. Propranolol blocked TSIH, but nadolol had no effect. Antidepressants showed more complex patterns of effects with venlafaxine, sertraline, and paroxetine inhibiting TSIH. TSIH demonstrated inter-strain variability, sex differences and a distinct pharmacology, suggesting that TSIH provides an independent, robust physiologic parameter to supplement the TST paradigm. This TSIH method may prove useful for pharmacologic, transgenic, and mechanistic studies.

Animals↗
PubMed1999

Compliance of pediatric patients with treatment involving antibiotic suspensions: a pilot study.

In collaboration with 11 German pediatricians in private practice, this pilot study assessed the treatment compliance of 289 pediatric patients (56.1% male: mean age, 53.9+/-35.6 months) who were given antibiotic suspensions (selection and duration determined by the pediatrician) to treat the following bacterial infections: acute otitis media, 34.6%; group A streptococcal tonsillopharyngitis/scarlet fever, 28.7%; lower respiratory tract infection, 18.3%; sinusitis/sinobronchitis, 9.3%; and other infections, 9.0%. The most frequently used antibiotics were amoxicillin (26.3%), erythromycin estolate (19.0%), penicillin V benzathine (14.2%), and cefaclor (13.5%). Compliance was assessed by means of a standardized telephone interview and a urine test that detects antibacterial activity using a Bacillus subtilis spore suspension. Overall compliance (positive urine test result at the end of the planned treatment period) was 79.6% (230 of 289 patients). Compliance was highest with erythromycin estolate (94.5%), followed by penicillin V benzathine (85.4%), cefaclor (76.9%), and amoxicillin (71.1%). Good compliance was also significantly associated with a patient age of > or =3 years and a treatment duration of > or =7 days. Compliance was not significantly influenced by the underlying bacterial infection. In summary, 20.4% of patients were noncompliant when treated with antibiotic suspensions.

Anti-Bacterial Agents↗
PubMed1997

Low-molecular weight lanthanide contrast agents: evaluation of susceptibility and dipolar effects in red blood cell suspensions.

Red blood cell (RBC) suspensions, containing low-molecular weight (LMW) dysprosium (Dy) and gadolinium (Gd) chelates, were selected as a two-compartment system for the evaluation of the magnetic dipolar and susceptibility contributions to the transverse (T2) relaxation of solvent water protons. The influence of RBC geometry and degree of metal chelate compartmentalization on T2 was investigated by variation of the osmolality and hematocrit (HC), respectively. The T2-relaxation ability of Dy-chelates was markedly improved in RBC suspensions, in comparison to aqueous solutions, due to the presence of susceptibility effects that more than compensated for the low dipolar relaxation efficacy. Despite a smaller susceptibility effect, the Gd-chelates were still the most efficacious in shortening T2 due to their comparatively larger dipolar relaxation contribution. The results obtained with the Dy-chelates allowed the evaluation of the relative contributions of susceptibility and dipolar mediated relaxation for the Gd-chelates. The RBC geometry and degree of compartmentalization influenced strongly the T2 relaxation efficacy of Dy-chelates, as opposed to the Gd-chelates. Hemolysis eliminated the susceptibility effect, essentially removing the T2 relaxation ability of Dy-chelates. The T2 relaxation efficacy of Gd-chelates was improved by hemolysis due to enhancement of the dipolar relaxation. As a conclusion, RBC suspensions have clearly been shown to be a suitable ex vivo model with which to distinguish the different contrast mechanisms of LMW Dy- and Gd-based MRI contrast agents.

Contrast Media↗
PubMed1999

Determination of indinavir, potassium sorbate, methylparaben, and propylparaben in aqueous pediatric suspensions.

A gradient, reversed phase, HPLC method was developed for simultaneous analysis of potassium sorbate, methylparaben, propylparaben, and indinavir in aqueous suspensions that contain a proprietary orange flavoring and Magnasweet sweetener enhancer (MacSanrews and Forbes Company, Magnasweet product brochure). The chromatographic separation is performed on an Eclipse XDB-C8 column using a gradient run with an analysis time of 35 min. The mobile phase consists of acetonitrile and acetonitrile:citrate buffer, pH 4.0 (20:80 v/v). The method successfully separates the three preservatives, indinavir (active ingredient), the orange flavoring, the Magnasweet species, and the indinavir lactone degradate. Recovery, linearity, and precision results for the three preservatives and indinavir are described. The method applies to two types of formulations: Xanthan Gum suspension and NanoSystems suspension.

Anti-HIV Agents↗
PubMed1999

Effect of a 14-day hindlimb suspension on beta-adrenoreceptors in rats.

Exposure to long-term simulated microgravity exhibits reduced sympathetic nervous system activity. This study tested the hypothesis that the hypersensitivity of adrenoreceptors would explain partly many other features of the hemodynamic consequences of return from space. The biochemical properties of the beta adrenoreceptors (betaAR) were determined using 125I-cyanopindolol (125I-CYP) binding in three rat groups: (1) The first experimental group consisted of 24 h-restrained orthostatic rats in the horizontal position, to test the early effect of the attachment to the suspension device; (2) the second experimental group consisted of 24 h-restrained antiorthostatic rats, to test the early effect of the suspension; (3) the third experimental group consisted of 14 day-restrained antiorthostatic rats, to test the long term effect of the suspension. The study was performed in two organs involved in blood pressure regulation, i.e. the heart (atria and ventricles were separated) and kidneys. The Scatchard analysis of 125I-cyanopindolol binding in both organs indicated no significant alterations in the dissociation constant (Kd) and the maximum binding capacity (Bmax) in the three experimental groups. These results do not allow the conclusion about the SNS adaptation pattern to simulated microgravity. Thus, the hypothesis that betaAR are involved in the cardiovascular adaptation to simulated microgravity is not verified in this model where, as a matter of fact, cardiovascular deconditioning is not verified even if this model is widely used.

Adrenergic beta-Antagonists↗
PubMed1997

Control of ocular inflammation after cataract extraction with rimexolone 1% ophthalmic suspension.

PURPOSE: To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction. SETTING: Twelve independent investigational centers in the United States METHODS: This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP). RESULTS: Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP. CONCLUSION: Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.

Administration, Topical↗
PubMed1999

Rheological behavior of drug suspensions in Gelucire mixtures and proxyphylline release from matrix hard gelatin capsules.

Mixtures of Gelucires 50/02 and 50/13 showing different hydrophilic-lipophilic balances (HLB) and of proxyphylline were used to prepare suspensions at a concentration of 25% and to manufacture extended release hard gelatin capsules by cooling. The rheological behaviors of Gelucire mixtures with and without drug were determined by adjustment of the rheograms to the Ostwald power-law and by statistical assessment of the flow index. Pure Gelucire mixtures were very slightly shear thickening whereas proxyphylline suspensions had a thixotropic shear thinning behavior. These rheological behaviors can be explained by the chemical composition and by the ratio of the two Gelucires used. Extended release of proxyphylline was obtained with all these mixtures. Drug release increased with Gelucire mixture HLB owing to higher erosion. A viscosity-release relationship was found and allowed, with these two Gelucires of extreme HLB and viscosities, to define the formulations which will give an optimal drug release, by the determination of their suspension viscosity. Modeling of dissolution kinetics has generally shown the predominance of surface erosion of the plugs relative to drug diffusion inside the matrix. This was confirmed by the better linearization of percentage released, according to Hixson-Crowell as compared with Higuchi.

Aminophylline↗
PubMedDate not supplied

Nerve blocks with 5% butamben suspension for the treatment of chronic pain syndromes.

BACKGROUND AND OBJECTIVES: Butamben is a non-water-soluble local anesthetic that can be prepared as an aqueous suspension for nerve blocks. This report describes the use of 5% butamben suspension for the treatment of chronic pain of cancer and noncancer origin. METHODS: The clinical courses of 75 consecutive patients were analyzed following 5% butamben nerve blocks (35 epidural blocks only, 33 peripheral nerve blocks only, and 7 had both epidural and peripheral nerve blocks). Epidural blocks were performed as a series of four with additional blocks offered if needed. Peripheral nerve blocks were done as a single block with repeat injections if needed. Injection volumes varied between 15 and 25 mL for epidural injections and 5 and 20 mL for peripheral nerve blocks. Successful therapy was defined as a -75% reduction in subjective pain assessments for -4 weeks or until death. Daily opioid requirements were also recorded. RESULTS: Fifty-four of the 75 patients (72%) were successfully treated. This included 48 of 67 cancer patients (71.6%) and 6 of 8 noncancer patients (75%). Median duration of pain relief was 12 weeks (range, 1-96) in the cancer patients and 10 weeks (range, 6-166) in the noncancer patients. Mean reduction in opioid requirements in successfully treated cancer patients was 74+/-5%. Pain on epidural injection occurred in half of the patients and was the most prevalent complication of treatment. Five patients had signs of intravascular injection. There were no serious long-term sequelae. CONCLUSIONS: When used as described in this report, 5% butamben suspension appears to be effective for treatment of chronic pain of both cancer and noncancer origin and has a low incidence of adverse sequelae.

Anesthetics, Local↗
PubMed2002

Chemoembolization of oral and oropharyngeal cancer using a high-dose cisplatin crystal suspension and degradable starch microspheres.

The aim of the study was to achieve intensification of intraarterial chemotherapy of head and neck cancer with high-dose cisplatin by establishing a new method of chemoembolization which can be routinely used without the earlier drawbacks of the method (low drug dosage due to early occlusion of the small head and neck vessels, danger of local damage). Thirty two patients with previously untreated oral and oropharyngeal squamous cell carcinomas of all stages were treated by at least one superselective chemoembolization via femoral approach using a new preparation format of 150 mg/m(2) cisplatin which is an aqueous crystal suspension. In defined cases, combination with the delivery of degradable starch microspheres (DSM). Systemic neutralization with sodium thiosulfate. Primary end points were tolerance and response. Subsequent treatment was surgery or radiation. Chemoembolization succeeded in all 37 interventions to date. Overall response after one cycle was 64.7% using the cisplatin crystal suspension only (n=17) and 86.6% using additional DSM chemoembolization (n=15), as assessed 3 weeks after treatment. Systemic toxicity was extremely low, local side-effects (pain, swelling, small necrosis) were pronounced after additional delivery of DSM. There have been three complications (tracheotomy due to swelling, temporary facial paralysis twice due to embolization of the geniculate ganglion). Using the high-dose cisplatin crystal suspension, chemoembolization can routinely be used in the head and neck area as neoadjuvant therapy. Response was better than with former comparable regimens. The additional delivery of DSM was complicated, restricted to certain areas and unreliable in the dosage needed and might be omitted, therefore.

Adult↗
PubMed1990

A new continuum model for suspensions of gyrotactic micro-organisms.

A new continuum model is formulated for dilute suspensions of swimming micro-organisms with asymmetric mass distributions. Account is taken of randomness in a cell's swimming direction, p, by postulating that the probability density function for p satisfies a Fokker-Planck equation analogous to that obtained for colloid suspensions in the presence of rotational Brownian motion. The deterministic torques on a cell, viscous and gravitational, are balanced by diffusion, represented by an isotropic rotary diffusivity Dr, which is unknown a priori, but presumably reflects stochastic influences on the cell's internal workings. When the Fokker-Planck equation is solved, macroscopic quantities such as the average cell velocity Vc, the particle diffusivity tensor D and the effective stress tensor sigma can be computed; Vc and D are required in the cell conservation equation, and sigma in the momentum equation. The Fokker-Planck equation contains two dimensionless parameters, lambda and epsilon; lambda is the ratio of the rotary diffusion time Dr-1 to the torque relaxation time B (balancing gravitational and viscous torques), while epsilon is a scale for the local vorticity or strain rate made dimensionless with B. In this paper we solve the Fokker-Planck equation exactly for epsilon = 0 (lambda arbitrary) and also obtain the first-order solution for small epsilon. Using experimental data on Vc and D obtained with the swimming alga, Chlamydomonas nivalis, in the absence of bulk flow, the epsilon = 0 results can be used to estimate the value of lambda for that species (lambda approximately 2.2; Dr approximately 0.13 s-1). The continuum model for small epsilon is then used to reanalyse the instability of a uniform suspension, previously investigated by Pedley, Hill & Kessler (1988). The only qualitatively different result is that there no longer seem to be circumstances in which disturbances with a non-zero vertical wavenumber are more unstable than purely horizontal disturbances. On the way, it is demonstrated that the only significant contribution to sigma, other than the basic Newtonian stress, is that derived from the stresslets associated with the cells' intrinsic swimming motions.

Animals↗
PubMedDate not supplied

Crossflow microfiltration of yeast suspensions in tubular filters.

Crossflow microfiltration experiments were performed on yeast suspensions through 0.2-microns pore size ceramic and polypropylene tubes at various operating conditions. The initial transient flux decline follows dead-end filtration theory, with the membrane resistance determined from the initial flux and the specific cake resistance determined from the rate of flux decline due to cake buildup. For long times, the observed fluxes reach steady or nearly steady values, presumably as a result of the cake growth being arrested by the shear exerted at its surface. The steady-state fluxes increase with increasing shear rate and decreasing feed concentration, and they are nearly independent of transmembrane pressure. The steady-state fluxes for unwashed yeast in deionized water or fermentation media are typically 2-4 times lower than those predicted by a model based on the properties of nonadhesive, rigid spheres undergoing shear-induced back-diffusion. In contrast, the steady-state fluxes observed for washed yeast cells in deionized water are only 10-30% below the predicted values. The washed yeast cells also exhibited specific cake resistances that are an order of magnitude lower than those for the unwashed yeast. The differences are due to the presence of extracellular proteins and other macromolecules in the unwashed yeast suspensions. These biopolymers cause higher cell adhesion and resistance in the cake layer, so that the cells at the top edge are not free to diffuse away. This is manifested as a concentration jump from the edge of the cake layer to the sheared suspension adjacent to it.(ABSTRACT TRUNCATED AT 250 WORDS)

Biotechnology↗
PubMedDate not supplied

Mechanical stability of immobilized biocatalysts (CLECs) in dilute agitated suspensions.

Cross-linked enzyme crystals (CLECs) are a novel form of immobilized biocatalyst designed for application in industrial biotransformation processes. In this work we have investigated the mechanical stability of agitated CLEC suspensions in relation to the design and scale-up of bioconversions carried out in stirred-tank reactors. By careful control of the crystallization conditions yeast alcohol dehydrogenase I (YADHI) microcrystals of different size were first prepared having either an hexagonal (approximately 12 microm) or rod-shaped (approximately 4.6 microm) morphology. These were then cross-linked with glutaraldehyde to form CLECs. The rate of breakage of the CLEC suspensions was subsequently measured in a rotating disk shear device (total volume, 11 mL) by monitoring the change in crystal size distribution with time. This device is designed to mimic the shear and energy dissipation rates found in a range of process scale equipment and may be used to study the mechanical stability of any immobilized biocatalyst preparation. Experiments were performed as a function of the speed and duration of disk rotation, CLEC concentration (0.26-2.5 mg.mL(-1)) and energy dissipation rate (2.2 x 10(3) to 6.8 x 10(5) W.kg(-1)). No breakage of the rod-shaped CLECs was observed over the entire range of experimental conditions investigated. Breakage of the larger hexagonal-shaped CLECs did occur, however, at energy dissipation rates, epsilon(max), above 1.0 x 10(5) W.kg(-1), where the calculated length scale of turbulence was around 2.0 microm. Based on visual observation of the sheared CLEC suspensions and models of crystal breakage, it was concluded that breakage of the hexagonal-shaped CLECs occurred due to shear induced attrition. Measurement of the catalytic activity of both the hexagonal and rod-shaped CLECs showed no significant change in activity before and after shearing.

Alcohol Dehydrogenase↗
PubMedDate not supplied

Production and glycosylation of recombinant beta-interferon in suspension and cytopore microcarrier cultures of CHO cells.

Microcarriers are suitable for high-density cultures of cells requiring surface attachment and also offer the advantage of easy media removal for product recovery. We have used the macroporous microcarriers Cytopore 1 and 2 for the growth of CHO cells producing recombinant human beta-interferon (beta-IFN) in stirred batch cultures. Although these cells may grow in suspension, in the presence of Cytopore microcarriers they become entrapped in the inner bead matrix where they can be maintained at high densities. Cell growth rates were reduced in microcarrier cultures compared to suspension cultures. However, the beta-IFN yield was up to 3-fold greater as a result of an almost 5-fold higher specific productivity. Maximum productivity was found in cultures containing 1.0 mg/mL of Cytopore 1 or 0.5 mg/mL of Cytopore 2 with a cell/bead ratio of 1029 and 822, respectively. Beta-IFN molecules aggregated in the later stages of all cultures, causing a decrease in response by ELISA. However, the degree of aggregation was significantly less in the microcarrier cultures. The N-linked glycans from beta-IFN were isolated and analyzed by normal phase HPLC. There was no apparent difference in the profile of glycans obtained from each of the suspension and Cytopore culture systems. This suggests that Cytopore microcarriers may be useful in bioprocess development for enhanced recombinant glycoprotein production without affecting the glycosylation profile of the protein.

Animals↗
PubMedDate not supplied

Transient gene expression in suspension HEK-293 cells: application to large-scale protein production.

Recent advances in genomics, proteomics, and structural biology raised the general need for significant amounts of pure recombinant protein (r-protein). Because of the difficulty in obtaining in some cases proper protein folding in bacteria, several methods have been established to obtain large amounts of r-proteins by transgene expression in mammalian cells. We have developed three nonviral DNA transfer protocols for suspension-adapted HEK-293 and CHO cells: (1) a calcium phosphate based method (Ca-Pi), (2) a calcium-mediated method called Calfection, and (3) a polyethylenimine-based method (PEI). The first two methods have already been scaled up to 14 L and 100 L for HEK-293 cells in bioreactors. The third method, entirely serum-free, has been successfully applied to both suspension-adapted CHO and HEK-293 cells. We describe here the application of this technology to the transient expression in suspension cultivated HEK-293 EBNA cells of some out of more than 20 secreted r-proteins, including antibodies, dimeric proteins, and tagged proteins of various complexity. Most of the proteins were expressed from different plasmid vectors within 5-10 days after the availability of the DNA. Transfections were successfully performed from the small scale (1 mL in 12-well microtiter plates) to the 2 L scale. The results reported made it possible to establish an optimized cell culture and transfection protocol that minimizes batch-to-batch variations in protein expression. The work presented here proves the applicability and robustness of transient transfection technology for the expression of a variety of recombinant proteins.

Bioreactors↗
PubMed1993

Differential enhancement of benzophenanthridine alkaloid content in cell suspension cultures of Sanguinaria canadensis under conditions of combined hormonal deprivation and fungal elicitation.

An elicitation protocol, resulting in the accumulation of sanguinarine in suspension cultures of Papaver bracteatum, was assessed for induction of the same alkaloid in Sanguinaria canadensis. Although only a trace constituent of P. bracteatum plants, sanguinarine is a major alkaloid (1-3% dry wt) of S. canadensis rhizomes. By combining hormonal deprivation for various intervals and a 3-day fungal (Verticillium dahliae) elicitation, benzophenanthridine alkaloid accumulation was induced in S. canadensis cell suspensions. Chelirubine content increased (0.1-1.3% dry wt) consistently in elicited cell cultures while chelerythrine (0.01-0.10% dry wt) and sanguinarine (0-0.02% dry wt) levels were considerably less. Alkaloid accumulation always occurred upon removal of hormone but only at certain time intervals in the log phase upon fungal elicitation. Levels of dopamine, a precursor of the alkaloids, fluctuated over the incubation period, but displayed a 2- to 6-fold increase in cell suspensions grown without hormone. In some experiments dopamine accumulated to levels > 20% dry wt, and these increases were enhanced by the addition of fungal elicitor. Although the same fungal elicitor induces benzophenanthridines in taxonomically related S. canadensis and P. bracteatum, it did not elicit the accumulation of the same alkaloid in the two different plant cultures.

Alkaloids↗
PubMed2000

Oral bioavailability of phenobarbital: a comparison of a solution in Myvacet 9-08, a suspension, and a tablet.

PURPOSE: A three-way crossover study with seven healthy male volunteers was conducted to determine the relative bioavailability of phenobarbital after single dose administration of 100 mg of phenobarbital as oral solution in Myvacet 9-08, and as a suspension, compared with a 100 mg phenobarbital tablet. MATERIALS AND METHODS: At 4-week intervals each subject received the solution in Myvacet 9-08, the suspension and the tablet in randomized order. Blood samples were collected for 48 h after each dose for analysis of phenobarbital. From the individual serum concentration-versus-time curves Cmax and Tmax were determined and AUC0-48 was calculated. RESULTS: All three oral dosage forms of phenobarbital are bioequivalent. No significant differences in Tmax were observed. CONCLUSION: The oral solution in Myvacet 9-08, and the suspension of phenobarbital proved to be bioequivalent to a tablet.

Adult↗
PubMed2002

Children's ibuprofen suspension for the acute treatment of pediatric migraine.

OBJECTIVE: To compare the efficacy of a single over-the-counter dose (7.5 mg/kg, p.o.) of children's ibuprofen suspension vs. placebo for the acute treatment of pediatric migraine. BACKGROUND: Migraine occurs in 4% of young children. There is a paucity of controlled clinical research in the treatment of childhood migraine and there are currently no approved drugs in the USA for treatment of migraine in children < or = 12 years of age. The purpose of this study is to assess the efficacy and tolerability of a single OTC dose of ibuprofen suspension for the acute treatment of childhood migraine. METHODS: Prospective, double-blind, placebo-controlled, parallel group, randomized study of children 6-12 yrs with migraine (I.H.S.-R 1997) treating 1 attack with a 7.5 mg/kg liq. ibuprofen vs matching placebo. Efficacy measures: (1). Headache severity based upon a 4 pt scale (severe, mod., mild, no headache) at 30, 60, 90, 120, 180 and 240 minutes post dose, and (2). nausea, vomiting, and photo/phonophobia at 120 min. The 1 degrees endpoint was cumulative % of responders (severe or mod. headache reduced to mild or none) by 120 minutes. Secondary endpoints were headache recurrence within 4-24 hours and need for rescue medicines within 4 hours. RESULTS: 138 enrolled; 84 treated/completed diary. 45 active agent, 39 placebo. The 2 groups were comparable (active: placebo) - Ages: 9: 9.1, gender boy/girl - 1.25: 1.6, and diagnosis: migraine w/o aura - 86%: 79%. Concomitant use of prophylactic Rx: 24%: 10% (Table 3). Nausea was eliminated in 60% of the ibuprofen treated patients and 39% of the placebo group (p<0.001). Vomiting, photophobia and phonophobia had marginal, but not statistically significant, decreases at 2 hours. A striking gender difference was noted (Table 4): No AE's were reported. CONCLUSION: Children's ibuprofen suspension at an OTC dose of 7.5 mg/kg is an effective and well-tolerated agent for pain relief in the acute treatment of childhood migraine, particularly in boys. There is a striking difference in gender response rates and placebo responder rates between girls and boys. The boys responded at a statistically significant rate, and girls failed to do so because of a very high placebo responder rate. Multi-center trials are recommended.

Acute Disease↗
PubMed2004

Assessment of the bioequivalence of different formulations containing azithromycin (tablets and suspension).

Azithromycin (CAS 11772-70-0) is an orally administered macrolide antimicrobial drug, structurally related to erythromycin, with a similar spectrum of antimicrobial activity. The aim of the present studies, performed in two different groups of volunteers, was to compare the bioavailability of azithromycin (Azro) 500 mg tablets (study 1) and azithromycin (Azro) 200 mg/5 mL suspensions (study 2) with originator products. Each study was conducted according to an open, randomized, single-dose, two-period cross-over design in 24 healthy volunteers with a wash-out period from 14 to 21 days. Blood samples were taken up to 96 h post dosing, and concentrations of azithromycin were determined by HPLC method. In the first study, the 90% confidence interval for intra-individual ratios (test vs. reference) of AUC0-t and Cmax of azithromycin were between 0.82 and 1.04 for AUC0-t and 0.81 and 1.11 for Cmax, and thus within the acceptance ranges for bioequivalence trials. The 90% confidence interval for intra-individual ratios of AUC0-t and Cmax of azithromycin administered as suspension were between 0.89 and 1.22 and 0.91 and 1.23, respectively. These values were also within the acceptance range. Concerning the secondary parameter tmax the 90% confidence interval for the intra-individual differences for azithromycin were between -0.49 - 0.50 in the first and between -0.50 - 0.25 in the second study, respectively. In the light of the results of the studies reported here it can be concluded that azithromycin test formulations, i.e. tablet and suspension are bioequivalent to the respective reference formulations.

Adolescent↗