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At least 1,405 records · Page 78Linked to original sources
PubMed1992

[Biological availability and pharmacodynamics following single oral administration or three different sustained-release isosorbide-5-mononitrate dosage forms].

The bioavailability of 3 different commercial available isosorbide mononitrate (IS-5-MN; CAS 16051-77-7) 40 mg slow-release preparations (A, B and reference formulation C) was determined after oral application to 18 healthy volunteers in a randomized cross-over study. The AUC after C (26.9 mumol/l x h) was not significantly different from that for A (25.1 mumol/l x h) and B (26.0 mumol/l x h). The corresponding 95% confidence intervals were within the limits of 80-120%. Maximal plasma concentrations (Cmax) for C (1.90 mumol/l), A (1.91 mumol/l), and B (2.05 mumol/l) were obtained at (tmax) 5.72 h, 4.94 h and 4.72 h, respectively. The 95% confidence intervals for Cmax and tmax were within the prescribed limits of 70-130%. Mean residence times (MRT) 10.5 h (C), 10.3 h (A), and 10.1 h (B) and plateau-times (duration over which the plasma concentration greater than 0.524 mumol/l) 17.8 h (C), 17.1 h (A), and 17.0 h (B) were not significantly different. It is concluded that the test preparations A and B are bioequivalent to reference C. Systolic blood pressure and heart rate, easily measurable indeces of the pharmacodynamic effects, showed no significant differences between the 3 preparations. In agreement with recently published data, plasma concentrations above 1.5 mumol/l did not result in a further reduction of systolic blood pressure, but were associated with a further marked elevation in heart rate.

Adult↗
PubMed2005

[Pre-formulation studies of the H1-antihistamine loratadine for a topical dosage form].

The paper focuses on the formulation of the antihistamine loratadine for hydrogels. In the first stage of this study, the evaluated polymer for the preparation of hydrogels was Carbopol 980 of concentrations of 0.5, 0.8, and 1.0%. The paper aimed to determine the optimal concentration of Carbopol 980 in hydrogel formulation on the basis of the evaluation of the rheological properties and biological availability of loratadine from prepared hydrogels. The results of the study show 0.5% hydrogel of Carbopol 980 to be optimal for loratadine from the standpoint of topical administration.

Acrylic Resins↗
PubMedDate not supplied

Validation of a capillary electrophoresis method for analysis of rabeprazole sodium in a pharmaceutical dosage form.

Rabeprazole sodium is an antisecretory agent that inhibits the enzyme H+/K+ ATPase present in the stomach parietal cells. There are few data about its quantitative determinations in laboratorial routines. Capillary electrophoresis is a method being used increasingly for analysis of pharmaceutical compounds, the main advantages of which are the simplicity of instrumentation, low consumption of sample and reagents, and fast analysis. The aim of this study was to develop and validate a capillary electrophoresis method for determination of rabeprazole sodium in coated tablets. The conditions used were a bare fused silica capillary with 48.0 cm length (39.5 cm effective) and 75 microm id; a 10mM, pH 9.0, sodium tetraborate run buffer; a diode array detector set at 291 nm; hydrodynamic injection (50 mbar/5 s); and a voltage of 20 kV. HP Chemstation CE rev. A.06.03 software was used for system control, data acquisition, and analysis. The method was demonstrated to be linear in the concentration range of 5.0-40.0 microg/mL (r = 0.9993), precise (interday relative standard deviation = 0.49), accurate (mean recovery = 103.1%), and specific. The limits of detection and quantitation were 1.29 and 3.91 microg/mL, respectively.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMedDate not supplied

Pharmaceutical development of a parenteral lyophilised dosage form for the novel anticancer agent C1311.

C1311 (5-[[2-(diethylamino)ethyl]amino]-8-hydroxyimidazo [4,5,1-de]-acridin-6-one-dihydrochloride trihydrate) is the lead compound from the group of imidazoacridinones, a novel group of rationally designed anticancer agents. C1311 shows significant cytotoxic activity in vitro and in vivo toward a range of colon tumours. The aim of the present study is to develop a sterile and stable, injectable pharmaceutical product for C1311 to be used in phase I clinical trials. C1311 drug substance was structurally and analytically characterised by chromatographic, spectrometric, and diffraction techniques. C1311 was freely soluble in water, and its stability was investigated in several liquid and lyophilised formulations with or without the use of buffering, tonicity, and bulking agents. The final product, containing 100 mg/vial C1311 (as anhydrous free base), was stable for at least 3 months under accelerated storage conditions and at the designated long-term storage condition of 5 +/- 3 degrees C in the dark. The drug is currently used in phase I clinical trials.

Aged, 80 and over↗
PubMed1988

Spectrophotometric determination of tolmetin sodium in capsule dosage form.

Two different U.V. spectrophotometric modes, zero-order and first derivative, have been applied for the quantitation of tolmetin sodium (Tolectin 200 mg) in bulk form and in its pharmaceutical formulation. Direct U.V.-measurement of aqueous solution of the drug at 325 nm exhibits significant linearity at the concentration range 0.1-1.5 mg% with a coefficient of variation (C.V.) 0.34%. The first derivative (d'A) spectrophotometric measurements at 342 nm yield results with a C.V. 0.29%. Drug assay of the capsule gives percent contents of 100.42 +/- 0.34 and 100.28 +/- 029 by adopting zero-order and d'A spectrophotometry respectively. The reproducibility and accuracy the two proposed methods have been assessed by employing standard additions technique. Accordingly the percent recoveries obtained were 99.60 +/- 0.22 and 100.16 +/- 026 for the zero order and the d'A-spectrophotometry respectively.

Journal Article↗
PubMedDate not supplied

Simultaneous determination of chlorpheniramine maleate and dexamethasone in a tablet dosage form by liquid chromatography.

An accurate, simple, reproducible, and sensible liquid chromatographic method was developed and validated for the determination of chlorpheniramine maleate and dexamethasone in a tablet formulation. The analysis was performed at room temperature on a reversed-phase C18 column with UV detection at 254 nm. The mobile phase consisted of 7.5 mM monobasic potassium phosphate in methanol-water (62.5 + 37.5) at a constant flow rate of 1 mL/min. The method was validated in terms of linearity, precision, accuracy, and specificity by forced decomposition of chlorpheniramine maleate and dexamethasone initiated by using acid, base, water, hydrogen peroxide, heat, and light. The response was linear in the ranges of 0.04-0.12 and 0.006-0.016 mg/mL for chlorpheniramine maleate (r2 = 0.9999) and dexamethasone (r2 = 0.9994), respectively. The relative standard deviation values for intra- and interday precision studies were 2.39 and 2.02, respectively, for chlorpheniramine maleate and 2.39 and 1.25, respectively, for dexamethasone. Recoveries ranged from 95.07 to 101.95% for chlorpheniramine maleate and from 97.75 to 102.10% for dexamethasone.

Chlorpheniramine↗
PubMedDate not supplied

Determination of amlodipine in pharmaceutical dosage forms by liquid chromatography and ultraviolet spectrophotometry.

A liquid chromatography (LC) method and an ultraviolet (UV) spectrophotometric method were developed and validated for quantitative determination of amlodipine in tablets and compounded capsules. The isocratic LC analyses were performed on an RP18 column using a mobile phase composed of 0.1% (v/v) ortho-phosphoric acid (pH 3.0) -acetonitrile (60 + 40, v/v) at a flow rate of 1.0 mL/min. The UV spectrophotometric method was performed at 238 nm. The analytical methods were validated according to International Conference on Harmonization Guidelines. The calibration graphs were linear [correlation coefficient (r) > 0.999] in the studied concentration range of 10-30 microg/mL for LC and 10-35 microg/mL for UV spectrophotometry. The relative standard deviation values for intraday and interday precision studies were less than 2%, and the accuracy was greater than 98% for both methods. The specificity of the LC method was proved using forced degradation. Statistical analyses showed no significant difference between the results obtained by the 2 methods. The proposed methods are precise and accurate and can be applied directly and easily to the oral pharmaceutical preparations of amlodipine.

Amlodipine↗
PubMed2005

[Preclinical investigation and standardization of metronidazole soft dosage forms].

Comparative acute and subacute toxicity of Dentamet gel and Metrovagin suppositories manufactured by ZAO Altaivitaminy was studied with using analogous drugs, i. e. Metrogil Denta, a gel for the gingivae, manufactured by Unique Pharmaceutical Laboratories (India), and Flagil manufactured by Haupt Farma Livron (France) as the reference drugs. It was shown that the drugs induced no changes in the exterior, hair state, body weight and mobility of the experimental animals vs. the control. The pharmacokinetic study of Metrovagin vaginal suppositories vs. the registered analogous drug Flagil showed that Metrovagin was bioequivalent to Flagil. The relative bioavailability of the new drug vs. the control was 103.13%.

Animals↗
PubMed2006

Investigation of colon-specific dosage forms of ondansetron prepared with natural polymers.

The aim of this study was to develop colon-specific delivery systems of ondansetron using natural polymers such as guar gum and sodium alginate. For this purpose colon specific matrix tablets were prepared by a direct compression method. The physical properties of the tablets were tested and in vitro release studies were performed by a flow-through cell apparatus. The amount of polymers affected the in vitro drug release from the matrix tablets. A high amount of polymers provided slow drug release whereas the release of ondansetron from the tablets prepared with low amount of polymers was found to be fast. Ondansetron-alginate and/or guar gum matrix tablet formulations can deliver the drug to the small and large intestine thus these matrix may be a promising system for the reduction of visceral sensitivity and inhibition of motor activity in irritable bowel syndrome (IBS).

Alginates↗
PubMedDate not supplied

UV spectrophotometric determination of bioflavonoids from a semisolid pharmaceutical dosage form containing Trichilia catigua Adr. Juss and Ptychopetalum olacoides Bentham standardized extract: analytical method validation and statistical procedures.

A precise, accurate, and sensitive UV spectrophotometric method was developed and validated for routine quantification of total bioflavonoids, expressed as rutin, from a topical oil-in-water pharmaceutical emulsion containing the extract of Trichilia catigua Adr. Juss and Ptychopetalum olacoides Bentham. The method was validated experimentally, and the data were treated rigorously by statistical analysis. The following analytical parameters were assessed: linearity, specificity, intra- and interrun precision measured as relative standard deviation (RSD, %), intra- and interrun accuracy (E, %), recovery (Rec., %), limit of detection (LOD, microg/mL), and limit of quantification (LOQ, microg/mL). The UV spectrophotometric method was linear (r = 0.9995) for standard rutin over the concentration range of 5.0-15.0 microg/mL with specificity for total bioflavonoids (expressed as rutin) at 361.0 nm with an absence of interferents from the complex matrix; RSD of < or = 1.79%, intrarun (E = 97.88 +/- 1.75 to 99.0 +/- 0.33%) and interrun (E = 98.38 +/- 1.12 to 100.79 +/- 1.30%) accuracy; Rec. = 98.64 +/- 0.42 to 100.74 +/- 0.41%; LOD = 0.20 microg/mL; and LOQ = 0.30 microg/mL.

Administration, Topical↗
PubMed1991

Relative pharmacokinetics of three oral 400 mg ibuprofen dosage forms in healthy volunteers.

The pharmacokinetic properties of two solid form, 400 mg ibuprofen (IP) preparations, a soft gelatin capsule and a film-coated tablet, were compared to those obtained after the administration of liquid prepared from effervescent IP tablets. IP was absorbed rapidly (tmax 0.6-1.9 h). The fastest absorption was observed after the ingestion of the soft gelatin capsule; liquid and film-coated tablet produced 12.2-7.8 times longer absorption half-lives, 50-39% lower peak concentrations of IP in serum and 3.5-3.2 times higher tmax values. Bioavailabilities were close to similar after all products. All products were tolerated without side effects in this single-dose, crossover study on 14 healthy volunteers. The results of this study support the earlier findings that after oral administration, IP is absorbed equally well from solid formulations as from liquid form. Liquid formulations of IP often deliver slower absorption than expected probably due to incomplete dissolution of the active principle. This may have therapeutic significance, and it should be taken into account when studies on the relative bioavailability of IP from pharmaceutical drug products are planned.

Absorption↗
PubMed1991

[The biodisposition of paracetamol. I. The kinetics of disintegration of some dosage forms].

The in vitro properties of twelve brands of paracetamol (nine tablets and three capsules), commercialized in France, are studied. Among the brands tested (tablets), Latepyrine and Gynospasmine are characterized by faster and Panasorb by slower dissolution rate. Total time of dissolution varies between 7 and 60 min. In some brands, paracetamol is liberated from the surface of the disintegrated particles and in others the active principle is released by progressive erosion. The presence of a surface active agent enhances liquid penetration in the case of capsules.

Acetaminophen↗
PubMed1991

[The bioavailability of paracetamol II. The effect of porosity and mechanical properties of the dosage form on solubility].

The authors attempt to explain differences observed in dissolution rate of twelve different brands of paracetamol (nine tablets and three capsules) in terms of pore structure and tensile strength; the pore structure of both tablets and capsules is investigated by mercury porosimetry. Brands (tablets) which liberate paracetamol rapidly are characterized by a higher porosity value. Higher mean pore diameter signifies less t50 and higher porosity. An increase in tensile strength results in an increase in t50 and a decrease in porosity. Porosity alone cannot dictate the dissolution behaviour of capsules.

Acetaminophen↗
PubMed1991

Comparison of oral bioavailability of two dosage-forms of progesterone in women.

For poorly water soluble drugs, the dissolution process in biological fluids the rate limiting step in absorption. However, the utilization of some galenic processes such as solid dispersions (SD) leads to an improvement in quality and intensity of the drug gastro-intestinal absorption. In a previous work, the in vitro studies of the dissolution curves of both the pure micronized progesterone (MP) and the progesterone-PEG 6000 SD revealed marked increases in the progesterone dissolution rates for all the SD investigated compared to the pure MP. The aim of this work was to investigate the in vitro results after oral administration of the two pharmaceutical forms to menopaused volunteer women.

Administration, Oral↗
PubMed1991

[The solubility kinetics of enteric-resistant tablets using riboflavin test tablets. 6. Pharmaceutic-technologic and analytic studies on gastric juice-resistant dosage forms].

To examine the dissolution kinetics of enteric coatings in vivo a test system with riboflavine was developed. This system allows to realize the beginning of disintegration in the small gut because riboflavine is excreted in urine already within 1 h after ingestion, and to locate the area of dissolution of the tablet in vivo, because riboflavine absorption is reduced in the great gut and colon. Thus the test system allows to examine and improve coating compositions in vivo and to demonstrate changes of drug dissolution in vivo conditioned by storage of enteric coated pharmaceuticals.

Chemistry, Pharmaceutical↗
PubMed1991

[Hygienic assessment of protective effects of overalls and individual protective devices used in the production of ampicillin trihydrate and its dosage form, ampicillin sodium salt].

The working clothes and individual protective devices recommended by the industrial Rules for the production of ampicillin trihydrate and its medicinal derivatives such as natrium salt ampicillin, do not provide adequate protection of the skin and respiratory mucous from antibiotic contamination. The use of the overalls in combination with the pressurized helmet (designed and produced at the 'Sintez' enterprise) which provided air supply for breathing and, partially, under the overalls, significantly decreased contamination of the body. At the stages of manual handling of the finished products, adequate protection was attained by using the protective paste produced at the 'Altaivitamine' enterprise.

Air Pollutants, Occupational↗