Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems

Boussery, Koen; Smet, Julie; Cock, Pieter De; Velde, Saskia Vande; Mehuys, Els; Paepe, Peter De; Remon, Jean Paul; Bocxlaer, Jan F. P. Van; Winckel, Myriam Van

doi:10.1111/j.1365-2125.2011.04038.x

Cited by 8 publications

(7 citation statements)

References 21 publications

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“…This is in agreement with reported delays in in vivo drug absorption from enteric coated PPI products. Boussery et al showed that the time to reach maximum plasma drug concentration (tmax) was 0.57 ± 0.16 and 2.36 ± 1.74 hours for immediate release omeprazole suspensions and enteric coated omeprazole MUPS tablets respectively in patients with severe neurodevelopmental problems (K. Boussery et al, 2011). In addition, the MUPS tablets showed high inter-individual variation in reaching tmax (ranging from 1 to 6 hours).…”

Section: Discussionmentioning

confidence: 99%

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In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer

Liu

Shokrollahi

2015

International Journal of Pharmaceutics

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Proton-pump inhibitor (PPI) products based on enteric coated multiparticulates are design to meet the needs of patients who cannot swallow tablets such as children and older adults. Enteric coated PPI preparations exhibit delays in in vivo absorption and onset of antisecretory effects, which is not reflected by the rapid in vitro dissolution in compendial pH 6.8 phosphate buffer commonly used for assessment of these products. A more representative and physiological medium, pH 6.8 mHanks bicarbonate buffer, was used in this study to evaluate the in vitro dissolution of enteric coated multiparticulate-based PPI products. Commercially available omeprazole, lansoprazole and esomeprazole products were subject to dissolution tests using USP-II apparatus in pH 4.5 phosphate buffer saline for 45 min (acid stage) followed by pH 6.8 phosphate buffer or pH 6.8 mHanks bicarbonate buffer. In pH 6.8 phosphate buffer, all nine tested products displayed rapid and comparable dissolution profiles meeting the pharmacopeia requirements for delayed release preparations. In pH 6.8 mHanks buffer, drug release was delayed and failed the pharmacopeia requirements from most enteric coated preparations. Despite that the same enteric polymer, methacrylic acid-ethyl acrylate copolymer (1:1), was applied to all commercial multiparticulate-based products, marked differences were observed between dissolution profiles of these preparations. The use of pH 6.8 physiological bicarbonate (mHanks) buffer can serve as a useful tool to provide realistic and discriminative in vitro release assessment of enteric coated PPI preparations and to assist rational formulation development of these products.

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Section: Discussionmentioning

confidence: 99%

“…Iwasaki et al, 2004) and the in vitro t80 values are 0.8-1.0 and 1.5-1.6 hours in pH 6.8 phosphate buffer and mHanks buffer respectively. The reported in vivo tmax values for omeprazole products range from 1.9 to 4.0 hours (K. Boussery et al, 2011;S. Karim et al, 2014;Z.…”

Section: Discussionmentioning

confidence: 99%

In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer

Liu

Shokrollahi

2015

International Journal of Pharmaceutics

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“…This variability might be due to genetic polymorphism of the cytochrome P450 (CYP) isoform CYP2C19. [17][18][19][20] Additionally, demographic data of subjects; age, weight, height and concomitant medication could add to the high inter-individual variability.…”

Section: Discussionmentioning

confidence: 99%

Bioequivalence Studies and Pharmacokinetic Properties of Atorvastatin 40Mg Tablet in Healthy Bengali Subjects

Saha

Khan

Poddar

et al. 2017

MOJBB

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Abbreviations: t max , time to reach the maximum concentration; C max , maximum plasma concentration; t 1/2 , half-life; AUC 0-24 , area under the plasma time curve up to last quantifiable time; AUC 0-∞ , area under the plasma time curve up to time infinity; k el , elimination rate constant; NCDs, non-communicable diseases; DGDA, directorate general of drug administration; TPR, total peripheral resistance IntroductionThere is an emerging importance of bioequivalence and pharmacokinetics analysis of highly prescribed brand drugs to judge their therapeutic effectiveness, toxicity, and quality to ensure therapeutic validity and patient's safety. Statin classes of lipidlowering agents are most commonly used treatment intervention for Non-Communicable Diseases (NCDs) like diabetes, obesity, hypertension, and dyslipidemia.1 Atorvastatin is an FDA approved synthetic lipid reducing agent under statin class. This drug, also known as 2-(4-fluorophenyl) -βR, δR-dihydroxy-5-(1-methyl ethyl)-3-phenyl-4(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid (Figure 1), is a second generation 3-hydroxy-3-methylglutaryl-CoA reductase inhibitor.2 This synthetic HMG-CoA reductase inhibitor significantly lowers total cholesterol, low-density lipoprotein cholesterol, and plasma triglycerides in clinical studies.3 According to IMS Health, Lipitor, the pioneer brand of atorvastatin is the world's one of the biggest selling prescription medicines with cumulative sales in excess of $130 billion, but most of the principal brands are now prescribed worldwide as far cheaper generic medicines. In Bangladesh, about 50 atorvastatin brands with different strengths and dosage forms are available and their average sales volume is nearly 1.17 crore taka monthly in the national local market according to Bangladesh Directorate General of Drug Administration (DGDA). This indicates widespread prescribing of this cholesterol-lowering drug in Bangladesh. However, there is no bioequivalence data for any of existing 50 brands of atorvastatin. Dose-dependent lowering of total cholesterol, LDL cholesterol and triglyceride levels have been noticed after oral administration of atorvastatin to patients with hypercholesterolemia and to patients who have hypertriglyceridemia. 4,5 The usual starting dose is 10mg atorvastatin daily. The dose should be adjusted in accordance with plasma lipid levels and can be increased to up to 80mg daily. AbstractThe present study is aimed to investigate the single-dosing pharmacokinetics of two pharmaceutical formulations of atorvastatin 40mg tablet, test (T) sample (Stacor®) and reference (R) sample (Lipitor®) in Bengali subjects. An open-label, randomizedsequence, two-way, two-period crossover study was designed with 24 healthy Bengali male volunteers. Plasma samples collected before and over 0.5-72.0h after a single oral dose per subject. Samples were analyzed by solid phase extraction method and a validated LCMS/MS method. The non-compartmental pharmacokinetic model was used to measure pharmacokinetic parameters of peak plas...

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“…This tablet formulation is a Multiple Unit Pellets System (MUPS ® ) containing enteric-coated pellets that protect the acid-labile omeprazole against protonation in the stomach [ 31 ]. Boussery et al [ 32 ] showed that a suspension formulation of omeprazole (extemporaneous formulation) seemed to be more favourable with regard to plasma concentration-time profiles compared to the MUPS ® formulation. This highlights the complexity of ensuring the efficacy of proton pump inhibitors when being manipulated.…”

Section: Discussionmentioning

confidence: 99%

Manipulation of Medicinal Products for Oral Administration to Paediatric Patients at a German University Hospital: An Observational Study

Zahn¹,

Hoerning²,

Trollmann³

et al. 2020

Pharmaceutics

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Pharmacotherapy in children requires medicinal products in age-appropriate dosage forms and flexible dose strengths. Healthcare professionals often encounter a lack of licensed and commercially available formulations, which results in the need for manipulation. This study aimed to investigate the nature, frequency and preventability of the manipulation of medicinal products before oral drug administration to paediatric inpatients in Germany. A prospective, direct observational approach was used. Two thousand and three medication preparation processes (MPP) in 193 patients were included in the analysis. Medicines were manipulated in 37% of oral administrations, affecting 57% of the patients. The percentage of manipulations was highest in infants/toddlers (42%) and lowest in adolescents (31%). Antiepileptics were most frequently manipulated (27%), followed by vitamins (20%) and drugs for acid-related disorders (13%). Fifty-six per cent of all manipulations were off-label. In 71% of these, no alternative appropriate medicinal product was commercially available. These results demonstrate that the manipulation of medicinal products before oral administration is common in paediatric wards in Germany. About half of the manipulations were off-label, indicating that no suitable formulation was available. Evidence-based guidelines for manipulations are required, with the overall aim of improving the safety of paediatric drug therapy.

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Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems

Cited by 8 publications

References 21 publications

In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer

In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer

Bioequivalence Studies and Pharmacokinetic Properties of Atorvastatin 40Mg Tablet in Healthy Bengali Subjects

Manipulation of Medicinal Products for Oral Administration to Paediatric Patients at a German University Hospital: An Observational Study

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