Pharmacokinetics of Omeprazole in Healthy Adults and in Children with Gastroesophageal Reflux Disease

Marier, Jean‐François; Dubuc, Marie-Claude; Drouin, Éric; Alvarez, Fernando; Ducharme, Murray P.; Brazier, J. L.

doi:10.1097/00007691-200402000-00003

Cited by 23 publications

(17 citation statements)

References 15 publications

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“…Several methods have been developed for determination, chiral separation, stability, or pharmacokinetic studies of 2 in bulk form, pharmaceuticals or biological samples, and these methods may include different spectrophotometric methods via formation of metal chelates [14], UV-derivative spectrophotometry [15] and HPLC methods for its determination [16], separation of enantiomers [17], for stability studies [18], or for the study of its pharmacokinetic profile [19].…”

Section: Introductionmentioning

confidence: 99%

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Elokely

Eldawy

Elkersh

et al. 2012

ISRN Analytical Chemistry

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A simple fluorometric method, using N 1 -methylnicotinamide chloride (NMNCl) as a fluorogenic reagent, has been developed, adapted, and validated for the quantitative estimation of drugs containing α-methylene sulfoxide functional groups. The proposed method has been applied successfully to the determination of sulindac (1), omeprazole (2), lansoprazole (3), pantoprazole (4), and rabeprazole (5) in the pure form, laboratory-prepared mixtures, pharmaceutical dosage forms, spiked human plasma samples, and in hospitalized patient's or volunteer's blood. For the standard solutions of 1, 2, 3, 4, and 5, the method showed linearity over concentration ranging between 1-50 μg/mL, 50-1200 ng/mL, 100-1500 ng/mL, 10-1500 ng/mL, and 20-2200 ng/mL, respectively. For the spiked human plasma of 1, 2, 3, 4, and 5, the linearity was shown over concentration ranging between 1-50 μg/mL, 75-1200 ng/mL, 100-1400 ng/mL, 10-1500 ng/mL, and 50-2100 ng/mL, respectively. The method showed good accuracy, specificity, and precision in both laboratory-prepared mixtures and spiked human plasma samples. The proposed method is simple, does not need sophisticated instrumentation, suitable for quality control application, bioavailability, and bioequivalency studies. Besides, the sensitivity and detection limits are comparable to sophisticated chromatographic methods.

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Section: Introductionmentioning

confidence: 99%

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Elokely

Eldawy

Elkersh

et al. 2012

ISRN Analytical Chemistry

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show abstract

“…Gastric emptying and intestinal motility vary with age, affecting rates of drug absorption [15]. Neonates have slower gastric emptying, and lower motility, leading to a greater absorption of drugs in the neonatal age range [16].…”

Section: Gastric Secretion and Motility In Childrenmentioning

confidence: 99%

“…The distribution of PPIs can be different in children as factors such as tissue perfusion, the concentration of plasma proteins, and body composition vary with age [15,17].…”

Section: Distribution Of Ppis In Childrenmentioning

confidence: 99%

“…Protein concentrations vary with age (infants have lower levels and reach adult levels at 10-12 months of age), nutrition, and disease [15]. The significance of protein levels derives from the fact that only the free drug, that is, the non-protein-bound drug, reaches the tissues, binds to the receptor, and induces a response [16].…”

Section: Distribution Of Ppis In Childrenmentioning

confidence: 99%

“…Marier et al compared the pharmacokinetic parameters of oral omeprazole in children with gastro-oesophageal reflux disease (GERD) with those in healthy adults [15]. Those authors found that the clearance and volume of distribution were similar for the two age groups, with a greater delay in drug absorption in adults.…”

Section: Pharmacokinetics Of Omeprazol In Childrenmentioning

confidence: 99%

See 2 more Smart Citations

Pharmacokinetics of intravenous omeprazole in critically ill paediatric patients

Solana

López‐Herce

2009

Eur J Clin Pharmacol

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Developmental Pharmacology and Age‐Related Phenomena

Curry

Whelpton

2010

Drug Disposition and Pharmacokinetics

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There is a saying: 'Children are not just small adults.' However, and paradoxically, this statement is often followed by a discussion of dosing based on weight, such as in mg kg À1 terms, as in classical pharmacology.Interest in both the young and the old as special populations is now well established, especially in phenomena related to pharmacokinetics. Development of hepatic function and renal processes has received intensive study. Studies of drug responses, and of drug concentrations in body fluids, at different ages are commonplace. This reflects a dramatic change since the early days of clinical pharmacology. However, the study of extreme age groups remains hampered by severe limitations. For example, analytical methods suitable for the small blood samples obtainable from children have required specific development, and ethical problems persist for studies in both the very young and very old age groups.A major problem has been dissociating effects of age itself from effects of age-related practices and phenomena, such as smoking, caffeine, alcohol and other drug consumption, and dietary and exercise habits. Also, age-related disease is an inevitable complication. There remains a great need for longitudinal studies in particular individuals, but the time required for such work is an obvious limitation. Any claim for an agerelated observation must be interpreted in this light. Scientific and regulatory environment in regard to younger and older patientsAwareness that there was a growing need to ensure that drug therapies for the paediatric population were studied with the same level of scientific and clinical rigour as adult therapeutic agents developed slowly between 1968 and 1998. In 1968, children were described by Shirkey as 'therapeutic orphans', but it was not until 1998 that the Food and Drug Administration (FDA) issued its 'Final Rule' on requirements for assessing safety and effectiveness in paediatric patients. Companies had been reluctant to study drugs in children because of the complexity, difficulty and expense of clinical trials in children, preferring to leave dosing recommendations to prescribers, who tended to assume that children merely required relatively low doses in order to respond similarly in the way that adults do. The result was empirical use of medicines without prior evidence-based efficacy and safety studies, with a high incidence of off-label or off-licence use of drugs (i.e. use in ways not approved by the relevant authorities). While often satisfactory for drugs for which there was a long history of experience, the outcome with newer drugs could be beneficial or harmful.Legislative initiatives have catalysed a vast improvement in this situation, such that by 2009, the approved prescribing information on over 100 drugs had been brought up-to-date in regard to paediatric populations as

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Pharmacokinetics of Omeprazole in Healthy Adults and in Children with Gastroesophageal Reflux Disease

Cited by 23 publications

References 15 publications

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Fluorometric Determination of Drugs Containing α-Methylene Sulfoxide Functional Groups Using - Methylnicotinamide Chloride as a Fluorogenic Agent

Pharmacokinetics of intravenous omeprazole in critically ill paediatric patients

Developmental Pharmacology and Age‐Related Phenomena

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