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  • 1
    Electronic Resource
    Electronic Resource
    Pharmacokinetic criteria for the evaluation of retard formulations (1974)
    Springer
    European journal of clinical pharmacology 7 (1974), S. 429-432 
    Details
    ISSN: 1432-1041
    Keywords: Pharmacokinetics ; retard formulations ; retard quotients ; sustained release ; half-value duration ; dibenzepin hydrochloride
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In vivo criteria are proposed for the assessment of retard formulations. If the pharmacokinetics of the retard formulation tested and of the normal preparation are known, in either plasma or urine, two retard quotients can be defined which define the sustained release. One of the quotients refers to the width (half-value duration) and the other to the height of the plasma concentration time curve of the retard form as compared to the conventional preparation. From these criteria it is possible to draw useful conclusions about thein vivo quality of a retard formulation in an early stage of development of the dosage form. As a practical example the criteria have been applied to Noveril® 240 tablets (dibenzepin hydrochloride), the retard effect of which has made it possible to reduce the frequency of administration from three times daily to once a day.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00560355
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  • 2
    Electronic Resource
    Electronic Resource
    Bioavailability studies with Digoxin-Sandoz® and Lanoxin® (1975)
    Springer
    European journal of clinical pharmacology 8 (1975), S. 371-376 
    Details
    ISSN: 1432-1041
    Keywords: Digoxin ; bioavailability ; plasma levels ; cumulative urinary excretion ; particle size ; man
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Various brands of digoxin tablets, and even different batches of one brand, may differ greatly in bioavailability. Digoxin-Sandoz® tablets have been compared with Lanoxin® manufactured between 1969 and 1972 and after May 1972. Comparisons were also made between and within batches of Digoxin-Sandoz tablets. Three separate cross-over studies were conducted involving a total of 20 volunteers. Digoxin-Sandoz tablets were shown to have a constant bioavailability and to produce plasma concentrations very similar to “new” Lanoxin. Storage for 2 years of one batch of Digoxin-Sandoz did not alter the bioavailability. Particle size was shown to influence bioavailability. Care should be exercised when plasma data alone are interpreted as an index of bioavailability. Measures of bioavailability based on plasma data obtained up to 6 h after administration differed from those based on cumulative urinary excretion data (in this study by a factor of about 2), which can lead to the belief that a difference in bioavailability is much greater than is actually the case. Data from cumulative urinary excretion, collected over a sufficiently long period of time, are likely to be the most reliable method for determining the bioavailability of a substance such as digoxin.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00562665
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  • 3
    Electronic Resource
    Electronic Resource
    A pharmacodynamic and pharmacokinetic comparison of pindolol 20 mg retard and a conventional tablet (1981)
    Springer
    European journal of clinical pharmacology 20 (1981), S. 179-183 
    Details
    ISSN: 1432-1041
    Keywords: pindolol ; beta-blockade ; slow release tablet ; plasma levels ; urinary excretion ; pharmacokinetics ; pharmacodynamics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In 10 healthy volunteers the time course of cardiac beta-adrenoceptor blocking activity, plasma levels and cumulative urinary excretion of pindolol were compared during a 4-day course of pindolol 5 mg (Visken®) t. d. s., and one tablet of pindolol 20 mg retard (Visken® retard) once a day. After oral administration of the 20 mg retard tablet, plasma concentrations of pindolol higher than half the maximum value (1/2 Cp (tmax)) were maintained about 2.5 times as long as after administration of the conventional 5 mg tablet. This is evidence for an important and marked retardation of drug release. During treatment with pindolol 20 mg retard once daily, cardiac beta-adrenoceptor blockade, measured by the reduction in exercise-induced tachycardia and in the exercise-induced rise in systolic blood pressure, at almost all times throughout the 24 h period was at least as great as during treatment with pindolol 5 mg t. d. s. This suggests that patients successfully treated with pindolol 5 mg t. d. s. can be maintained with the same beta-adrenoceptor blockade by a single tablet of pindolol 20 mg retard once daily.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00544595
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  • 4
    Electronic Resource
    Electronic Resource
    Assessment of analgesics in dental surgery outpatients (1980)
    Springer
    European journal of clinical pharmacology 18 (1980), S. 479-482 
    Details
    ISSN: 1432-1041
    Keywords: analgesia ; aspirin ; dental surgery ; analgesia assessment
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The usefulness of the dental outpatient model for evaluating the efficacy of mild analgesics, first described by Cooper and Beaver, is demonstrated in five separate, double-blind, randomised, single-dose, parallel-group studies. Pain intensity and pain relief were recorded at hourly intervals for 3 h following the administration of aspirin 1000 mg and placebo. In all five studies aspirin was significantly more effective than placebo, with relatively small variability of the response between the studies. The method is simple, reliable and sensitive and complements the inpatient studies of postoperative pain hitherto more frequently used.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874659
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  • 5
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of isradipine in patients with chronic liver disease (1990)
    Springer
    European journal of clinical pharmacology 38 (1990), S. 599-603 
    Details
    ISSN: 1432-1041
    Keywords: Isradipine ; cirrhosis ; systemic ; calcium antagonist ; aminopyrine breath test ; serum bile acids ; galactose elimination ; pharmacokinetics ; bioavailability
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The pharmacokinetics of the dihydropyridine calcium antagonist isradipine has been examined in 8 healthy volunteers, 7 patients with non-cirrhotic chronic liver disease (CLD), and 8 patients with biopsy-proven cirrhosis (CIR). Isradipine was simultaneously given orally (12C 5 mg) and i.v. (13C 1 mg). Systemic availability was significantly increased from 17% and 16% in controls and CLD, respectively, to 37% in CIR. The corresponding systemic clearances averaged 1.1, 0.9 and 0.61 · min−1, the reduction in cirrhotics being significant. Both aminopyrine demethylation capcity, a measure of hepatic microsomal function, and indocyanine green disappearance, a measure of hepatic perfusion, were correlated with the reduction in systemic clearance, and the reduction in oral clearance was correlated with the reciprocal of the serum bile acid concentration. The loss of first-pass extraction should be considered when this calcium antagonist is given perorally in patients with hepatic cirrhosis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00278589
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  • 6
    Electronic Resource
    Electronic Resource
    Pharmacokinetic investigation of oral and IV dihydroergotamine in healthy subjects (1991)
    Springer
    European journal of clinical pharmacology 41 (1991), S. 597-602 
    Details
    ISSN: 1432-1041
    Keywords: Dihydroergotamine mesilate ; pharmacokinetics ; urinary excretion ; prolonged half-life ; deep compartment ; RIA ; adverse effects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary A new radioimmunoassay (RIA) for the specific measurement of dihydroergotamine (DHE), sufficiently sensitive for the determination of low plasma concentrations, has been used to investigate the pharmacokinetics of unchanged DHE. In a randomized crossover trial, eight healthy male volunteers received single doses of DHE 5 mg, 10 mg and 20 mg orally and 0.1 mg and 0.5 mg intravenously. It was possible to determine plasma concentrations and urinary excretion of DHE over the following 48 h. A long terminal plasma elimination phase of unchanged DHE (half-life 15 h) was found. A similar terminal elimination half-life was also calculated from urine data. The multi-exponential decline in plasma DHE with a long terminal half-life suggests that distribution into a deep compartment contributes to the long-lasting effect of the drug. Plasma protein binding was 93%. Despite extensive tissue distribution (Vz=33 l/kg) and a high plasma clearance (CLP=2l/min), dose-independent linear pharmacokinetics was observed. The present assay was at least 20-times more specific than the polyvalent RIA used previously and appears suitable to explore the pharmacokinetics of unchanged DHE in patients on low-dose therapy. The long terminal elimination half-life of DHE only reported previously in studies using 3H-labelled drug, and considered to be due to metabolites, was also true for the parent compound. This, in addition to the sustained pharmacological activity of the 8′-hydroxy metabolite already shown, provides a further explanation for the long duration of action of DHE in animals and man.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00314992
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  • 7
    Electronic Resource
    Electronic Resource
    Analgesic activity of propyphenazone in patients with pain following oral surgery (1986)
    Springer
    European journal of clinical pharmacology 31 (1986), S. 127-131 
    Details
    ISSN: 1432-1041
    Keywords: propyphenazone ; acetylsalicylic acid ; analgesic efficacy ; pain following dental surgery ; pain assessment ; placebo response
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The acute analgesic effect of single oral doses of 150 and 300 mg propyphenazone, 1000 mg acetylsalicylic acid (ASA) and placebo was investigated in 210 patients with pain following dental surgery. At most time points over the 3-hour observation period all the active medications had a significantly greater analgesic effect than placebo according to all the methods of pain assessment used. Both doses of propyphenazone reached their peak activity sooner than ASA, and their duration of action tended to be shorter. On a per milligram basis, the relative analgesic potency of propyphenazone was about twice that of ASA. All test substances were well tolerated. Side effects, such as tiredness, nausea, headache, dizziness etc., were reported by less than 20% of the patients. The nature of the adverse reactions was similar for all medications, and as they were recorded most frequently after placebo, they cannot therefore be definitely ascribed to one or the other of the active test substances.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606648
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  • 8
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of oral cyclosporin a (Sandimmun) in healthy subjects (1986)
    Springer
    European journal of clinical pharmacology 31 (1986), S. 211-216 
    Details
    ISSN: 1432-1041
    Keywords: cyclosporin A ; absorption ; pharmacokinetics ; healthy subjects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Extensive pharmacokinetic (PK) profiles after oral dosing of 300 mg cyclosporin A (CsA) were determined in whole blood by radioimmunoassay (RIA) in 14 healthy male volunteers, using two-compartment models with either first order (M1) or zero order (M0) absorption. According to zero order absorption the mean of the following PK parameters was determined: terminal half-life=12.1±5.0 h, apparent volume of distribution at steady-state=5.6 ±2.1 l · kg−1, apparent clearance=0.51±0.11 l · h−1 · kg−1. The time lag between drug ingestion and first blood level was short, 0.38±0.11 h. Drug absorption lasted for 2.8±1.6 h. The end of absorption was indicated in each individual by a sharp drop in blood levels. The observations support the assumption that CsA is absorbed in the upper part of the small intestine with a clear-cut termination (absorption window). This assumption may explain the high degree of variability in the bioavailability of CsA.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00606661
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  • 9
    Electronic Resource
    Electronic Resource
    Pharmacokinetic comparison of pindolol 30 mg retard and 15 mg normal tablets (1982)
    Springer
    European journal of clinical pharmacology 21 (1982), S. 451-455 
    Details
    ISSN: 1432-1041
    Keywords: pindolol ; plasma levels ; pindolol retard ; beta-adrenoceptor blockade
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In a cross-over pharmacokinetic study in 8 healthy volunteers a retard formulation containing pindolol 30 mg was compared with the normal 15 mg pindolol tablet. The pindolol 30 mg retard tablet led to the same maximum plasma level as a single dose of the normal pindolol tablet. A plasma concentration higher than half of the maximum was maintained twice as long after the retard than after the normal 15 mg pindolol tablet. The bioavailability of the two forms was practically identical.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00542037
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  • 10
    Electronic Resource
    Electronic Resource
    Pharmacokinetics of a long-acting bromocriptine preparation (Parlodel LA) and its effect on release of prolactin and growth hormone (1986)
    Springer
    European journal of clinical pharmacology 29 (1986), S. 615-618 
    Details
    ISSN: 1432-1041
    Keywords: bromocriptine ; long-acting formulation ; pharmacokinetics ; prolactin inhibition ; growth hormone secretion
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary The pharmacokinetics and endocrine actions of a long-acting form of bromocriptine (Parlodel) were examined in a controlled study in 10 healthy volunteers receiving a single i.m. injection of 50 mg. Six further subjects took bromocriptine 1.25 mg t.i.d. for 3 days p.o. In the subjects given the slow release preparation, the plasma bromocriptine concentrations increased sharply to a maximum of 1.65 mg/l 2 h after injection. This fast release process was followed by slow clearance with a half-life of 16 days. The substance was still detectable in plasma 35 days postinjection. Plasma prolactin (PRL) fell rapidly from a mean of 5.6 ng/ml to reach significantly lower levels at 60 and 120 min. Inhibition was maintained for up to 35 days, when plasma PRL was still significantly below the values recorded at baseline and in the control group. Plasma GH peaked at 3.6 ng/ml at 120 min and subsequently declined slowly to stabilize between 1.4 and 2.2 ng/ml for about 12 h, falling to below the 1 ng/ml limit for the remainder of the study period. In contrast, individuals receiving oral bromocriptine exhibited a significant elevation following the first dose and an equivalent increment after the morning dose on Day 3. Thus, the results show a prolonged inhibitory effect on PRL of this long-acting bromocriptine preparation in parallel with its slow plasma clearance. The stimulant effect on GH secretion is short lived, presumably due to desensitisation of specific receptors.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00635902
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