Exploring therapeutic options for mild diabetic-related foot infections: a comparative in vitro study of cefditoren versus amoxicillin/clavulanic acid.

Skin and soft tissue infections (SSTIs), and particularly diabetic-related foot infections (DFI), present diagnostic and therapeutic complexities, often leading to severe complications. This study aims to evaluate the in vitro efficacy of cefditoren and amoxicillin/clavulanic acid against typical DFI pathogens. Clinical samples from 40 patients with mild SSTIs were analyzed, revealing a predominance of Staphylococcus spp. and Streptococcus spp. species. Cefditoren exhibited activity against 90% of isolates, with superior potency over amoxicillin/clavulanic acid. These findings underscore the utility of cefditoren in empirical treatment of DFI, although a larger sample size would be desirable for further validation.

A 40-month multicentre, randomised placebo-controlled study to assess the efficacy and carry-over effect of repeated intra-articular injections of hyaluronic acid in knee osteoarthritis: the AMELIA project.

OBJECTIVE: AMELIA (OsteoArthritis Modifying Effects of Long-term Intra-articular Adant) was designed to compare against placebo the efficacy and safety of repeated injections of hyaluronic acid (HA) and its effect on disease progression over 40 months. METHODS: A multicentre, randomised, patient and evaluator-blinded, controlled study in 306 patients fulfilling American College of Rheumatology criteria for knee osteoarthritis, radiological grades II-III (Kellgren-Lawrence) and joint space width ≥ 2 mm. Patients received four cycles of five intra-articular HA or placebo injections with a follow-up of 6 months after the first and second cycles, and 1 year after the third and fourth cycles. Osteoarthritis Research Society International (OARSI) 2004 responder criteria were used to assess efficacy. The consumption of rescue medication was a secondary outcome. Adverse events were recorded for safety purposes. RESULTS: At the 40-month visit significantly more patients responded to HA compared with placebo (OARSI 2004, p=0.004). The number of responders to HA increased through the study, whereas those to placebo did not change. Significant differences were also found in favour of HA for each individual component of the OARSI 2004. No safety problems were recorded. CONCLUSIONS: The results of AMELIA offer pioneer evidence that repeated cycles of intra-articular injections of HA not only improve knee osteoarthritis symptoms during the in-between cycle period but also exert a marked carry-over effect for at least 1 year after the last cycle. In this respect, it is not possible to establish if this carry-over effect reflects true osteoarthritis remission or just a modification of the disease's natural course. ClinicalTrials.gov number, NCT00669032.

Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections.

INTRODUCTION: A high number of individuals in the population are exposed to antibiotics for the treatment of respiratory tract infections. It is important to review the adverse events profile related to antibiotic exposure during the clinical development of drugs that are or have been recently included in the therapeutic armamentarium. MATERIAL AND METHODS: Safety data from all 13 clinical trials of cefditoren on community acquired respiratory infections were reviewed. Safety population was defined as all randomized patients with at least one dose intake. Adverse events considered by investigators as related during antibiotic exposure were considered. RESULTS: The overall safety population consisted in 4,592 patients for cefditoren and 2,784 for comparators. Overall reported diarrhoea related to cefditoren administration was significantly higher (p < or = 0.001) than comparators (9.9% vs 6.9%) due to the significant difference in the pooled pharyngotonsillitis studies (8.3% vs 3.2%), while no significant differences in others pathologies were found, with 9.4% (with cefditoren) vs 10.3% (with comparators) in the case of community-acquired pneumonia (CAP). Dyspepsia and abdominal pain were reported as adverse events in < 2.7% patients regardless the treated disease. In females population lower related vaginosis rate was found in cefditoren vs comparators, mainly due to differences among patients treated for sinusitis (4.5% vs 8.1%) and CAP (2.3% vs 5.5%) although differences were not significant (p = 0.017 and p = 0.008, respectively). CONCLUSION: This study analysing reported adverse events from clinical trials showed an adverse events profile of cefditoren similar to those of standard antibiotics used in the treatment of respiratory tract infections.

Beta-lactam activity against penicillin-resistant Streptococcus pneumoniae strains exhibiting higher amoxicillin versus penicillin minimum inhibitory concentration values: an in vitro pharmacodynamic simulation.

BACKGROUND: Activity of simulated serum concentrations after oral therapy with 400 mg cefditoren pivoxil b.i.d., 500 mg cefuroxime axetil b.i.d. and 875/125 mg amoxicillin/clavulanic acid b.i.d. and t.i.d. regimens was explored over 24 h against Streptococcus pneumoniae. METHODS: Computerized pharmacodynamic simulations were performed against strains with penicillin/amoxicillin/cefuroxime/cefditoren minimum inhibitory concentrations (MICs, microg/ml) and serotypes: strain 1 (0.25/0.12/1/0.12; serotype 6A), strain 2 (2/4/ 2/0.25; serotype 6B), strain 3 (4/16/4/0.5; serotype 14), and strain 4 (4/16/8/1; serotype 14). RESULTS: Bactericidal activity (> or =3 log(10) reduction) at 12 and 24 h was obtained against all strains with cefditoren, against strains 1 and 2 with cefuroxime and amoxicillin/clavulanic acid t.i.d., but only against strain 1 with amoxicillin/clavulanic acid b.i.d.. Bactericidal activity at 24 h was related to T > MIC of >30% dosing interval, 1.7-2.0 log(10) reductions with T > MIC of 20-30%, and <1 log(10) reduction or regrowth with T > MIC of 0%. CONCLUSIONS: It is difficult to achieve pharmacodynamic coverage and bactericidal activity by physiological concentrations of oral beta-lactams against penicillin-resistant pneumococcal strains exhibiting higher amoxicillin versus penicillin MICs. Cefditoren may offer alternatives.

Efficacy of cefditoren in the treatment of upper respiratory tract infections: a pooled analysis of six clinical trials.

OBJECTIVE: A pooled analysis of all upper respiratory tract infection studies performed with cefditoren (CDN) was performed. METHODS: Studies were prospective, comparative, multicentre and randomised. Comparators were penicillin V (pharyngitis) and cefuroxime or amoxicillin/clavulanate (sinusitis). A total of 1,322 patients were randomized, 1,241 included in intention-to-treat (ITT) and 1,010 in per-protocol populations (PP) in pharyngotonsillitis studies, and 1,819 randomized, 1,726 included in ITT and 1,589 in PP in acute sinusitis studies. RESULTS: No significant differences in pharyngitis clinical response were found (success rates: 89.4 % to 95.3 %). S. pyogenes eradication was higher with cefditoren at end of therapy (EOT) (90.4% vs. 82.7%; p=0.002) and follow-up (84.7% vs. 76.7%; p=0.008), although no statistically significant (p<0.001). In both groups, clinical failures were significantly higher (p<0.001) in patients showing S. pyogenes persistence than in those showing eradication (> or =98.5% vs. 51.4 %). No differences in sinusitis clinical response were found between CDN and comparators both at EOT (80.2% vs. 84.8%) and at end of follow-up (71.2% vs. 77.4%). CONCLUSION: Cefditoren had similar point estimates of clinical efficacy to comparators in pharyngotonsillitis and sinusitis, and a tendency to higher S. pyogenes eradication in pharyngotonsillitis.

beta-lactam susceptibility of Escherichia coli isolates from urinary tract infections exhibiting different resistance phenotypes.

Susceptibility to beta-lactams was determined in 203 recent Spanish E. coli isolates from urinary tract infections exhibiting different resistance phenotypes: a) susceptible (n = 60); b) quinolone-resistant (n = 45); c) penicillinase (n=64); d) hyperproduction of penicillinase (n=8); e) inhibitor resistant TEM (IRT) (n=18), and f) extended spectrum betalactamase (ESBL) (n=8).Minimum inhibitory concentration (MIC) determination by agar dilution and susceptibility tests for ESBL detection by macrodilution were performed following CLSI recommendations. All the beta-lactams tested showed high activity against susceptible and penicillinase phenotypes, with close to 100 % susceptibility. Hyperproduction of penicillinase increased MIC90 values for all antibiotics except for meropenem, with 100% resistance to cefuroxime and amoxicillin/clavulanic acid, and 100% susceptibility to cefotaxime, piperacillin/tazobactam and meropenem. All the antibiotics, except for amoxicillin/clavulanic acid, exhibited high activity against IRT. Meropenem, cefminox and piperacillin/tazobactam exhibited the highest activity against ESBL, followed by amoxicillin/clavulanic acid. The most active compound among the parenteral antibiotics was meropenem, regardless of the resistance phenotype. Among the oral antibiotics, the most active compound was cefditoren with the exception of ESBL where amoxicillin/clavulanic acid where the MIC90 value was one dilution lower.

Antimicrobial susceptibilities of amoxycillin-non-susceptible and susceptible isolates among penicillin-non-susceptible Streptococcus pneumoniae.

Antimicrobial susceptibilities of 244 amoxycillin-non-susceptible and 81 amoxycillin-susceptible pneumococcal isolates from 15 Spanish hospitals were determined and clonal relationships were investigated by pulsed-field gel electrophoresis after SmaI restriction. Amoxycillin-non-susceptible isolates exhibited higher rates of resistance to cefuroxime, cefixime, cefpodoxime and clarithromycin, but not to levofloxacin and cefotaxime. Cefditoren exhibited MIC(90) values one dilution lower than those of cefotaxime. Higher numbers of the Spain(14)-5 and Spain(6B)-2 clones, but not the Spain(9V)-3 and Spain(23F)-1 clones, were found among amoxycillin-non-susceptible isolates. Spain(14)-5 was the most problematic clone in terms of antibiotic resistance.

Pharmacokinetic/pharmacodynamic serum and urine profile of cefditoren following single-dose and multiple twice- and thrice-daily regimens in healthy volunteers: a phase I study.

The objectives of this randomized, double-blind study were to evaluate the pharmacokinetics, and the pharmacodynamic and gastrointestinal (GI) tolerance of cefditoren pivoxil in healthy adult male volunteers when it is administered three times a day. Twenty healthy volunteers were included in the study. On day 1, 10 subjects received a 200-mg single dose of cefditoren pivoxil and 10 received a 400-mg dose. After a washout period of 8 days, eight subjects received cefditoren pivoxil 400 mg b.i.d., eight received 400 mg t.i.d., and four received placebo for 10 days. Medication was taken 30 min after meals. Blood and urine collections were carried out on days 1, 9, 14 and 19. Volunteers were asked about any GI change, especially about bowel habits, nausea, vomiting and abdominal pain. The maximum cefditoren concentration (C(max)) had a mean value of 3.77+/-0.66 mg/l, and was reached between 1.5 and 3 h in the thrice-daily administration. In the twice-daily regimen, the C(max) was 3.27+/-0.64 mg/l. The mean time above breakpoint minumum inhibitory concentration (MIC), calculated with data from each pharmacokinetic profile, was always above 40%, in both the twice- and thrice-daily regimens. The half-life of cefditoren was 1.19+/-0.2 h and 1.36+/-0.2 h in the twice-daily and thrice-daily regimens, respectively. The C(max) of cefditoren in urine was reached between 2 and 4 h postadministration, with a mean value of 154.53 mg/l in the twice-daily regimen, and 186.59 mg/l in the thrice-daily administration. There were no differences between the groups in the incidence of GI adverse events. The present data show that the administration of cefditoren pivoxil 400 mg t.i.d. is possible because it is well tolerated, and it increases the probability of success when the MIC of the causative bacteria is close to the susceptibility breakpoint. The high concentrations of active drug in the urine enable cefditoren to be considered as a useful candidate for the treatment of uncomplicated urinary tract infections (UTIs).

Comparative study of hyaluronic derivatives: rheological behaviour, mechanical and chemical degradation.

Depolymerisation by oxytetracycline (OTC) as well as the progressive cleavage of hyaluronic acid induced by ultrasound was investigated in nine commercially available hyaluronic polymers. Sample solutions differed in molecular weight, from 500 to 7000 kDa, and in their source. The hyaluronic acid concentration in each sample was analysed by HPLC. The concentration range was over 8.39-10.18 mg ml(-1) in samples with a nominal concentration of 1%, and 14.05 mg ml(-1) in one sample with a nominal concentration of 1.5%. It was found that stability was dependent on both molecular weight and the concentration of the samples. The rheological parameters n (power law index) and K (consistency coefficient) were good predictors regarding the degradation behaviour. Although many factors are involved in obtaining a therapeutic response, the results obtained in this work support the notion that both mechanical and chemical degradation are reduced in hyaluronate solutions with low molecular weight, the final concentration of the product being a critical factor.

Comparison of sensory, microbiological, and biochemical parameters of microwave versus indirect UHT fluid skim milk during storage.

Shelf-stable milk could benefit from sensory quality improvement. Current methods of heating cause flavor and nutrient degradation through exposure to overheated thermal exchange surfaces. Rapid heating with microwaves followed by sudden cooling could reduce or eliminate this problem. The objectives for this study were focused on designing and implementing continuous microwave thermal processing of skim fluid milks (white and chocolate) to compare sensory, microbiological, and biochemical parameters with conventionally prepared, indirect UHT milks. All test products were aseptically packaged and stored at ambient temperature for 12 mo. Every 3 mo, samples were taken for microbiological testing, reactive sulfhydryl determinations, active enzyme analysis, instrumental viscosity readings, color measurements, and descriptive sensory evaluation. Microbiological plate counts were negative on all milks at each time point. Enzymatic assays showed that plasmin was inactivated by both heat treatments. 5,5'-dithio-bis(2-nitrobenzoic acid) analysis, a measure of reactive sulfhydryl (-SH-) groups, showed that the initial thiol content was not significantly different between the microwave-processed and UHT-treated milks. However, both heating methods resulted in an increased thiol level compared with conventionally pasteurized milk samples due to the higher temperatures attained. Sulfhydryl oxidase, a milk enzyme that catalyzes disulfide bond formation using a variety of protein substrates, retained activity following microwave processing, and decreased during storage. Viscosity values were essentially equivalent in microwave- and UHT-heated white skim milks. Sensory analyses established that UHT-treated milks were visibly darker, and exhibited higher caramelized and stale/fatty flavors with increased astringency compared with the microwave samples. Sweet aromatic flavor and sweet taste decreased during storage in both UHT and microwave milk products, whereas stale/fatty flavors increased over time. Sensory effects were more apparent in white milks than in chocolate varieties. These studies suggest that microwave technology may provide a useful alternative processing method for delivery of aseptic milk products that retain a long shelf life.

Geographical patterns of onchocerciasis in southern Venezuela: relationships between environment and infection prevalence.

Onchocerciasis is a chronic filarial infection transmitted by Simulium flies that has a focal geographical distribution in Latin America. The southern Venezuelan focus has a gradient of endemicity that includes the largest number of hyperendemic communities in the continent, many of them in remote forest and mountainous areas, where it is an important public health problem among the Yanomami indigenous population. The recent introduction of Geographical Information Systems (GIS) tools and a landscape epidemiology approach for study of vector borne diseases is helping to understand relationships between environment and transmission dynamics of onchocerciasis. Striking differences in the transmission dynamics of onchocerciasis between different river courses were detected. A significant relationship between onchocerciasis and temperature was also demonstrated. The geologic substrate, kind of landscape and vegetation seemed also to influence the transmission of onchocerciasis. In the Venezuelan Amazon, different kinds of landscapes associated with distinctive vector species, show different intensities of transmission of onchocerciasis. In this sense, landscape analysis aided by GIS, may prove to be a useful tool for better identification of the spatial distribution of onchocerciasis risk in the Orinoco basin.

Estimation of extracellular and total body water by multiple-frequency bioelectrical-impedance measurement.

This study evaluated a new technology of bioelectrical-impedance (BI) measurement that makes use of multiple frequencies (5, 50, and 100 kHz) for estimation of extracellular and total body water. In 36 healthy males, resistance and reactance at three frequencies were compared with extra-cellular water (ECW) and total body water (TBW) determined by isotope dilution. ECW was best predicted by resistance measured at 5 kHz, corrected for height and weight (R = 0.930, SEE = 1.94 L) whereas TBW was best predicted by resistance at 100 kHZ and weight (R = 0.947, SEE = 2.64 L). Cross-validation analysis on two randomly selected subsets (n = 18 each) indicated that the prediction equations were reproducible and valid. Thus, BI at dual frequencies is valid for determination of body-water compartments and may be useful in the nutritional assessment of patients in whom body water and hydration is of clinical concern.

Reliability of the measurement of postprandial thermogenesis in men of three levels of body fatness.

To determine the reliability of the measurement of postprandial thermogenesis by indirect calorimetry and to clarify further the relationship of obesity to thermogenesis in men, the thermic effect of a 720-kcal, mixed liquid meal was compared in 13 lean men (mean +/- SEM, 11.2% +/- 1.4% body fat), 10 average men (22.4% +/- 1.6% body fat), and 12 obese men (33.4% +/- 1.6% body fat) on two occasions. Resting metabolic rate (RMR) was measured for 3 hours: (1) in the fasted state, and (2) after a 720-kcal mixed liquid meal, on two occasions. The thermic effect of the meal, calculated as the postprandial energy expenditure minus the fasting RMR (kcal/3h), was greater for the lean and average men than for the obese men during both trials (P less than .001), but was only marginally different between the lean and average groups (P = .16). The mean values for the two trials were similar and the measurement of thermogenesis was highly reproducible with a reliability coefficient of r = .932 (P less than .001). Across all groups, thermogenesis correlated strongly with percent body fat (r = -.64, P less than .01), but within the average men, thermogenesis was uncorrelated with percent body fat (r = .09) but highly correlated with the glucose response to the meal (r = -.75, P less than .05). Thus, factors other than body fatness, such as insulin sensitivity, may determine thermogenesis within this heterogeneous middle group.(ABSTRACT TRUNCATED AT 250 WORDS)

Effects of exercise mode and intensity on postprandial thermogenesis in lean and obese men.

To characterize further the impact of exercise before a meal on thermogenesis, the effects of exercise intensity and mode and the duration of the effect of exercise on the thermic effect (TEF) of a 720-kcal mixed meal were compared in 10 lean and 10 obese men (16 +/- 1 vs. 34 +/- 2% fat). In study A, TEF (kcal/3 h) was significantly greater for the lean than the obese men during rest and immediately after 1 h of cycling at 50 and 100 W. TEF was significantly greater after both exercise intensities than during rest for the obese men, but exercise had no effect on TEF in the lean men. In study B, TEF was significantly greater for the lean than the obese men during rest and immediately after 1 h of leg cycling at an O2 consumption of 1.09 l/min but only marginally different after 1 h of arm exercise at the same O2 consumption (P = 0.15). For the obese men, TEF was greater after arm than leg cycling and greater after leg cycling than at rest (P less than 0.01), but TEF was not different among the three conditions for the lean men. In study C, TEF was compared at rest and immediately and 24 h after 1 h of cycling at 100 W. TEF was greater for the lean than the obese men under all conditions (P less than 0.05). For the obese but not the lean men, TEF was greater both immediately after and on the day after exercise than at rest (P less than 0.01). Thus, acute exercise improves but does not normalize the blunted TEF in obesity; a minimally intense bout of exercise is needed to improve TEF; exercise mode alters thermogenesis in the obese men, even at a fixed intensity; and TEF in the obese men is enhanced for as long as 24 h after exercise.

Antimicrobial susceptibility of Haemophilus influenzae, Haemophilus parainfluenzae and Moraxella catarrhalis isolated from adult patients with respiratory tract infections in four southern European countries. The ARISE project.

Over a 7-month period in 2000-2001, 1213 Haemophilus influenzae, 112 Haemophilus parainfluenzae and 142 Moraxella catarrhalis isolates were recovered from adult patients with respiratory tract infections. Patients were from four southern European countries (Spain, Italy, Portugal and Greece). The antimicrobial susceptibility of the isolates to 11 antibiotics was determined in a central laboratory. The most active drugs on the basis of MICs were levofloxacin, cefditoren, cefotaxime, cefpodoxime and amoxicillin/clavulanate. MICs > or = 2 mg/l for amoxicillin were found in 19.5, 28.6, and 75.4% of H. influenzae, H. parainfluenzae and M. catarrhalis isolates, respectively. Isolates of H. influenzae and H. parainfluenzae with reduced susceptibility or that were fully resistant to amoxicillin/clavulanate, cefuroxime and clarithromycin were detected (0.2-1.8%) as well as M. catarrhalis resistant to clarithromycin (0.7%). Regular surveys of resistance patterns for antimicrobial agents are necessary.

Human onchocerciasis in the Amazonian area of southern Venezuela: spatial and temporal variations in biting and parity rates of black fly (Diptera: Simuliidae) vectors.

We investigated some entomological factors underlying altitudinal prevalence variation in the Venezuelan Amazonia human onchocerciasis focus. Spatial and temporal variation in relative abundance, daily biting rate, proportion of parous flies, and monthly parous biting rate were studied for the three main simuliid vectors (based on their vectorial competence: Simulium oyapockense s.l. Floch & Abonnenc approximately = S. incrustatum Lutz << S. guianense s.l. Wise). Yanomami villages were selected among sentinel communities of the ivermectin control program, representing hypo- to hyperendemicity conditions of infection. Spatial variation was explored via increasing village altitude on two river systems (A: Ocamo-Putaco and B: Orinoco-Orinoquito). Temporal variation was studied between 1995 and 1999 by sampling the biting population during dry and rainy mouths. Environmental variables included monthly rainfall and maximum river height. Simuliid species composition itself varied along the altitudinal and prevalence gradient. S. oyapockense s.l. prevailed below 150 m. Above this altitude and up to 240 m, S. incrustatum and S. guianense s.l. became more frequently and evenly collected along A but not along B, where S. incrustatum remained absent. The daily biting rate of S. oyapockense s.l. was higher during the dry season along A, whereas the converse took place along B. Daily biting rate of S. incrustatum was lowest during early rains. By contrast, the daily biting rate of S. guianense s.l. was highest during this period. There was a significant negative cross-correlation between proportion of parous of S. oyapockense s.l. and river height (2 and 3 mo lagged), whereas this variable (1 and 2 mo lagged) was positively correlated with the proportion of parous flies for S. incrustatum. Monthly parous biting rate values suggest that the months contributing most to onchocerciasis transmission in the area are likely to be the dry season and the transition periods between seasons.

Antimicrobial resistance among clinical isolates of Streptococcus pneumoniae isolated in four southern European countries (ARISE project) from adult patients: results from the cefditoren surveillance program.

From four southern European countries (Spain, Italy, Portugal, and Greece) 877 Streptococcus pneumoniae isolates were recovered from adult patients with respiratory tract infections between September 2000 and March 2001. The antimicrobial susceptibility to 11 antibiotics was determined in a central laboratory. Penicillin resistance was high in Greece (47.1%) and Spain (25.1%) but much lower in Portugal (7.9%) and Italy (4.8%). On the other hand, erythromycin resistance was high in Italy (38.5%) and Spain (36.2%) with no statistical difference with Greece (29.4%) but reaching significance (p <0.01) with Portugal (15.7%). Resistance to levofloxacin was low (1.5%) but present in Spanish and Italian isolates. Cefditoren, a new cephem antibiotic tested, was the most potent compound (MIC90 = 0.5 microg/ml) followed by levofloxacin and cefotaxime (MIC90 = 1 microg/ml). Given the high rates of penicillin and macrolide resistance reported, there is an evident need for new drugs and continued antimicrobial surveillance of S. pneumoniae.

Clinical pharmacokinetics of ferric natural protein in iron-deficient females.

Although iron therapy is very common, few studies have assessed iron absorption or iron kinetics in general, particularly with Fe(3+). This was the primary objective of this study, with assessment of tolerance as a secondary objective. Eight nonsmoking iron-deficient females without other associated pathologies, with an average age of 21.62 +/- 1.69 years, were studied. The diagnosis of iron deficiency was established by determination of sideraemia (28.7 +/- 13.5 microg/dl), iron binding capacity (380.5 +/- 70.2 microg/dl) and ferritin (5 +/- 1.4 microg/L) on the prestudy visit. The women remained in the Phase I Unit during days 0, 1, 2 and 3 of the study. A serum iron concentration curve was obtained daily from blood samples drawn at 0, 1, 2, 4, 6, 8 and 12 hours postdose. Therapy with ferric natural protein (ferrimannitol ovoalbumin) 40mg twice daily was started on day 1 of the study and continued for 30 days. The following parameters were evaluated: area under the curve (AUC(0-12h)), peak iron concentration (C(max)) and time to reach peak concentration (t(max)). Serum iron concentration-time curves were practically flat on day 0, but showed an increase following ferric therapy (Friedman, p < 0.05), confirming the usefulness of the postabsorption test and good absorption of ferric iron (Fe(3+)). The increase in AUC (314.65 +/- 67.9 to 1174.44 +/- 1071.8 microg/dl.h) and C(max) (49 +/- 24.4 to 146 +/- 101.9 microg/dl) from day 1 and the correlation between both parameters (r(2) > 0.85, p

Bioavailability of the iron formulated as natural ferric protein (TM/FMOA) and natural ferric protein + folic acid (TM/FMOA+FOL).

Numerous oral iron preparations are available for the treatment of iron deficiency anemia but only very few studies have been designed to measure the bioavailability of iron preparations. The aim of this assay is to determine the bioavailability of iron formulated as natural ferric protein (TM/FMOA)(FMOA=Ferrimannitol ovalbumin) and natural ferric protein with folic acid (TM/FMOA+FOL) in healthy and anemic rats. Determination of the bioavailability of iron has been carried out by studying the serum level-time curves after i.v. administration of a single dose of 1 mg iron/kg in the form of ferrous sulfate, and after oral administration of 2 mg of iron/kg in the form of TM/FMOA or TM/FMOA+FOL. The Cmax values obtained after oral administration of TM/FMOA and TM/FMOA+FOL are greater in the case of anemic rats, while the tmax values are similar in both types of animals. The bioavailability (F) is greater for the anemic rats (80% approx), and the presence of folic acid does not appear to influence the bioavailability of the iron. This bioavailability data with TM/FMOA can predict good results in further experiments in human beings with iron deficiencies.