Biomedical subjects

E Sallam

Publications and source records attributed to E Sallam.

9 recordsLinked to original sources

PubMed1999

The bioequivalence study of folifer-Z: a new formulation of sustained-release iron and zinc.

The bioequivalence of Folifer-Z tablets, a new sustained-release iron and zinc formulation was evaluated and compared to that of Fefol-Z capsules in 30 healthy male subjects. Each subject received a single oral dose of either product according to a randomized two-way crossover design. A washout period of 1 week was allowed after each treatment. Blood samples were obtained over a 24-h period, and iron and zinc concentrations were measured. The pharmacokinetic parameters of Folifer-Z were Cmax (103 +/- 46.2 micrograms/dl), Tmax (5.93 +/- 2.94 h) and AUC0-24 h (1937 +/- 706 micrograms/dl per h), whereas the corresponding Fefol-Z values were Cmax (109 +/- 41.5 micrograms/dl), Tmax (6.64 +/- 2.54) and AUC0-24 h (1865 +/- 699 micrograms/h per dl). Analysis of variance on log-transformed data for Cmax and AUC0-24 h revealed lack of significant differences among the two formulations. The mean relative bioavailability of AUCtest/AUCreference was 1.07 (90% confidence interval range: 99-115%) and for Cmax test/Cmax reference was 0.96 (90% confidence interval range: 88-105%). Regarding the zinc results, the pharmacokinetic parameters of Folifer-Z values were Cmax (101 +/- 20.7 micrograms/dl), Tmax (4.86 +/- 1.53 h) and AUC0-24 h (1944 +/- 202 micrograms/h per dl), while the corresponding Fefol-Z values were Cmax (102 +/- 20.7), Tmax (4.93 +/- 1.51) and AUC0-24 h (1953 +/- 200). Analysis of variance on log-transformed zinc data for Cmax, Tmax and AUC0-24 h revealed lack of significant difference among the two formulations. The mean relative bioavailability of AUCtest/AUCreference was 0.98 (90% confidence interval range; 95-101%) and for Cmax test/Cmax reference was 0.92 (90% confidence interval range: 89-96%). The results also indicate a possible inhibition of zinc absorption by iron content of both formulations. It is concluded that Folifer-Z product is bioequivalent to Fefol-Z product.

Adult↗

PubMed1998

Evaluation of fast disintegrants in terfenadine tablets containing a gas-evolving disintegrant.

Effects of four fast disintegrants on the dissolution of terfenadine tablets containing the gas-evolving disintegrant, CaCO3, were evaluated. In addition, effects of presence of starch along with the fast disintegrants on the dissolution of the tablets were examined. Dissolution data were treated to give dissolution parameters which reflected efficiency of the disintegrant combinations. The four fast disintegrants improved disintegration/dissolution of the original formulation. The relative efficiency of improvement was in the order crospovidone > Ac-Di-Sol > Primojel > low substituted hydroxypropylcellulose. The presence of starch advertently affected the role of the fast disintegrants. Scanning electron microscope studies revealed that starch covered the drug-containing granules and other particles of the tablet. pH changes during dissolution of representative tablets in 0.1 N HCl solutions were determined at specific time intervals. The progressive decrease in rates of acid consumption as a function of the amount of starch, along with the SEM studies, suggested that a barrier existed around the tablet particles. The barrier was generated by the swelled starch grains and was responsible for the loss of the dissolution-improving capacity of the fast disintegrants. Furthermore, the barrier interfered with the diffusion of the hydronium ions and therefore, impaired the function of the disintegrant combination.

Calcium Carbonate↗

PubMed1996

Bioavailability and pharmacokinetic properties of 2 sustained-release formulations of diclofenac sodium, Voltaren vs inflaban: effect of food on inflaban bioavailability.

In this study, in vitro characterization, bioavailability and pharmacokinetics of 2 different sustained-release diclofenac sodium dosage forms were compared, Voltaren (100 mg tablets), manufactured by Ciba-Geigy and Inflaban (100 mg enteric-coated tablets), manufactured by the Arab Pharmaceutical Manufacturing Company. The in vitro results demonstrated a faster rate of dissolution for Inflaban as compared to Voltaren, but both products exhibited a sustained-release pattern. The bioavailability study was conducted on 20 healthy male subjects who received a single oral dose (100 mg) of each product according to a randomized 2-way crossover design. Blood samples were obtained over a 26-hour period, and drug concentrations were determined by an HPLC method. Concentration time profiles revealed a sustained-release pattern for both products. The Tlag for Voltaren was 0.8 +/- 0.2 h, significantly shorter than for Inflaban (1.7 +/- 0.2 h) indicating a faster rate of absorption from the upper gastrointestinal tract. The Cmax obtained with Voltaren was significantly higher than that obtained with Inflaban (1,161 +/- 102 and 799 +/- 83, respectively). With respect to Tmax and AUC0-26h parameters, both products were not found to be statistically different. Tmax for Voltaren and Inflaban was 4.2 +/- 0.5 and 4.5 +/- 0.4 h, respectively, whereas AUC0-26h values for both products were 5,423 +/- 562 and 5,237 +/- 520 ng x h/ml, respectively. It is believed that the observed differences between Voltaren and Inflaban are mainly due to the fact that Inflaban is designed as an enteric-coated tablet form, with a core tablet having different sustained-release behavior. In addition, the effect of food on the bioavailability of Inflaban was evaluated in randomly selected 6 male volunteers. Our results revealed that, following light and heavy meals, the AUC0-30 and Cmax were minimally affected by food whereas a significant increase in Tmax and Tlag as compared to fasting conditions was observed.

Adult↗

PubMed1996

Bioequivalence study of two capsule formulations of omeprazole.

Bioequivalency of Omeraz, a test-product of Arab Pharmaceutical Manufacturing Company (Jordan) and Losec, a reference product by Astra (Sweden), was evaluated by a randomised crossover study on 22 healthy male volunteers. Serum concentrations of omeprazole were measured by an HPLC assay. There were no statistically significant differences between the two products in terms of serum profile and pharmacokinetic parameters including AUC, Cmax, Tlag, Tmax, MRT, Ke and T1/2. The AUC ratios (Omeraz/Losec) for 24 hours and for infinity were respectively 1.02 with a 90% C.L. of 0.88-1.16 and 1.00 with a 90% C.L. of 0.88-1.14. The two products may be considered as bioequivalent in terms of the extent of absorption as indicated by the AUC ratios. However, the confidence limits of Cmax fall outside the FDA accepted range.

Administration, Oral↗

PubMed1993

Analysis and bioequivalency study on two tablet formulations of co-trimoxazole.

This paper describes an analytical procedure for simultaneous quantification of trimethoprim (TMP) and sulphamethoxazole (SMZ) in serum. Serum samples were rendered alkaline with glycine-sodium hydroxide buffer (pH 9.1) and extracted with ethyl acetate. The reconstituted sample was analysed using reversed-phase C-18 column high-performance chromatography. The mobile phase consisted of 75% triethyl ammonium acetate buffer, 20% methanol and 5% acetonitrile. The analytes were monitored at 289 nm and tetroxoprim was used as an internal standard. The maximum values for intra-day coefficients of variation (CV) for TMP-and SMZ were 5.7 and 2.1%, respectively. Interday CV values were 6.4 and 2.2%, respectively. The method was used to compare the bioavailability of two tablet formulations in terms of their pharmacokinetic parameters following oral administration of the tablets to 18 volunteers.

Biological Availability↗

PubMed1992

A bioequivalence study of two products of furosemide tablets.

Twenty healthy male volunteers participated in a balanced crossover comparison of diusemide versus lasix. Each treatment was given as a single 40 mg tablet following an overnight fast. Furosemide concentration in plasma were determined up to 8 h after treatment. Urine output and urinary sodium excretion was also measured. At the 5% confidence level, no significant difference was found between the area under the plasma concentration-time curves of the two products. The Cmax, tmax, cumulative urine volume, cumulative sodium and potassium electrolytes were found not significantly different for both products. Quality control data including assay, content uniformity, disintegration and dissolution indicated that both products passed the pharmacopoeial requirements, U.S.P. XXII and B.P. 1988. In conclusion, diusemide 40 mg is bioequivalent to the brand name lasix.

Adult↗

PubMed1989

A bioequivalence study of two dipyridamole products.

Bioequivalence of Antiplate 75 mg was assessed versus Persantine 75 mg in a two-way crossover study. At the 5% confidence level, no significant difference was found between the area under the plasma concentration-time curves of the two products. The Cmax were comparable for both products. Quality control data including assay, content uniformity, disintegration and dissolution indicated that both products passed the pharmacopoeial requirements, USP XXI and BP 1980, Addendum 1983. It is concluded that Antiplate-75 is bioequivalent to Persantine.

Adult↗

PubMed1979

Histopathological changes in experimental free thyroid transplants.

Free thyroid autotransplants into new receptor sites have been tried in 28 dogs, by two different techniques. Good but irregular histopathological survival of thyroid acini has been found after free autotransplantation of bisected and everted thyroid lobes into the external genitalia of dogs. The results have been very encouraging and the functional assessment of these implants is essential; such work is already in progress in our laboratory. Our findings and their significance have been discussed.

Animals↗

PubMedDate not supplied

Preparation and characterization of a new polymorphic form and a solvate of glibenclamide.

A new crystalline form and a solvate of glibenclamide were prepared and characterized by hot-stage microscopy, DSC, IR, scanning electron microscope, X-ray powder diffraction and dissolution studies. From I, III and the solvate which melt at 174.4, 153.2 and 109.3 degrees C, were obtained by crystallization. Significant differences between the three forms in the X-ray and IR spectra were observed. Polymorphic transformation was observed for the least stable form (III) to the most stable one (form I) upon storage at different temperatures and trituration. The dissolution profiles showed significant differences between the three forms, with form III having the highest dissolution rate.

Calorimetry, Differential Scanning↗