Postmarketing pharmacokinetic and pharmacodynamic equivalence of generic and brand atenolol in Egypt

Concerns have raised regarding the postmarketing quality of generic drugs. This study assessed the pharmacokinetic and pharmacodynamic equivalence of generic and brand atenolol tablets in 24 healthy male volunteers in a single-dose, open, randomized, two-period crossover study under fasting conditions. Blood samples were collected for 24 h post dosing and assayed for atenolol using HPLC. Blood pressure and heart rate were measured at baseline and throughout blood sampling. The mean plasma concentration-time curves for both products were similar. Pharmacokinetic and statistical analysis indicated bioequivalence based on the mean ratios of log-transformed Cmax and AUC values. Both products had similar time courses of pharmacodynamic activity with a significant fall in blood pressure and heart rate [maximum after 5 h] followed by a gradual increase towards baseline. Both products were well tolerated. Both atenolol products were bioequivalent in the postmarketing setting and can be used interchangeably in clinical practice

Bioequivalence study of erythromycin tablets in man

The bioavailability of some br and s of film-coated erythromycin stearate tablets marketed in Egypt; br and A [250 mg], br and B [250 mg] and br and B' [500 mg] and one br and of enteric-coated erythromycin tablets, was tested in order to assess their bioequivalence. The results of a single dose [500 mg] were studied in healthy subjects indicated wide variability in erythromycin absorption between the subjects and tablet br and s with absorption failure in some cases. The relative bioavailability of erythromycin stearate tablet br and s was 40, 70 and 97% for br and s A, B and B', respectively, using br and C as a st and ard preparation. Judging by AUC values, calculated from mean erythromycin serum levels higher than the MEC [0.6 mug/ml], the products appear obviously inequivalent, product A being presumably inefficient and product B of marginal efficacy. The results suggested that enteric-coated erythromycin base tablets can be considered as a suitable dosage form of orally administered erythromycin

new HPLC method for the determination of ketoprofen in plasma and its application in bioavailability and pharmacokinetic studies

A simple, rapid, sensitive and specific high performance liquid chromatographic method has been developed for the determination of Retoprofen in plasma using dectofenac sodium as the internal standard. Plasma proteins were precipitated with acetonitrile and an aliquot of the clear supernatant was directly injected into the column. The drug and i.s. were eluted from a 10 micro m C-8 reversed phase column with a mobile phase consisting of acetonitrile-water [1:1 v/v] adjusted to pH 4.0 with glacial acetic acid and 1N sodium hydroxide, at a flow rate of 2.5 ml/min. U[V] detector was set at 264 nm. Each analysis required no longer than 6 min. Detection limit for ketoprofen in plasma is 0.05 micro g/ml. The method was applied for determination of the biovailability and pharmacokinetic parameters of ketoprofen after its administration, by two routes, to a healthy male volunteer

Phytochemical and pharmacological studies on achillea santolina I plant

Preliminary phytochemical screening of Achillea santolina L. plant revealed the presence of an alkaloid, saponins, tannins, resins, sterols, flavenoids, carbohydrates and volatile oils. Paper chromatographic studies and microanalysis showed the presence of one alkaloid which amounts 0.1806% of the dry plant. The separated alkaloid possesses cardioinhibitory and intestinal antispasmodic effects on the isolated rabbit heart and intestine, respectively. It also relaxes the contractions of isolated rat uterus and the histamine-induced spasm of tracheal strips of guinea pigs. The alkaloid decreased the blood pressure of normal dogs and had no anti-inflammatory effect against formalin-induced oedema in rat paws. LD[50] of the alkaloid after subcutaneous injection in mice was 22.25 mg/100 g. b. wt. Its acute toxicity is characterised by shallow, rapid respiration, paralysis of the hind limbs and stretching of the tail