Effect of concomitant colestipol hydrochloride administration on the bioavailability of diltiazem from immediate‐ and sustained‐release formulations

Turner, Scott W.; Jungbluth, Gail L.; Knuth, Dean W.

doi:10.1002/bdd.330

Cited by 3 publications

(1 citation statement)

References 21 publications

(22 reference statements)

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“…Compared with the PK parameters obtained from the same oral dose of tablets, the main PK parameters of t max , C max , AUC t and t 1/2 of diltiazem hydrochloride delayedonset sustained-release pellet capsules in three single oral dose groups were much higher in the present study than the corresponding PK parameters reported in the previous literatures (Murata et al, 1989;Turner, 2002).…”

Section: Discussioncontrasting

confidence: 73%

Pharmacokinetics of diltiazem hydrochloride delay-onset sustained-release pellet capsules in healthy volunteers

Yan

Chen

Wang

et al. 2013

Braz. J. Pharm. Sci.

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The pharmacokinetics (PK) of ordinary tablets and sustained release capsules of diltiazem hydrochloride in human clinical trials had been studied. The PK of diltiazem hydrochloride delay-onset sustained-release pellet capsules, a new dosage form, has not been reported, although it is very important to clinical use. In this paper, we investigated the PK of diltiazem hydrochloride delay-onset sustained-release pellet capsules and the food influence in Chinese healthy volunteers. The PK parameters indicated that the diltiazem hydrochloride delay-onset sustained-release pellet capsules appeared marked characteristics of delayed and controlled release. An opened-label, randomized and parallel clinical trial was conducted in 36 Chinese healthy volunteers with single oral dose (90 mg, 180 mg or 270 mg) and a multiple oral dose (90 mg dThe effect of food on the PK of one single oral dose (360 mg) was investigated in 24 healthy Chinese volunteers. Plasma diltiazem concentration was determined by reversed-phase high-performance liquid chromatography (RP-HPLC) and the main pharmacokinetic parameters were analyzed by PKSolver (Ver 2.0). All clinical studies were conducted in the Clinical Pharmacological Center (No. JDX1999064) of Xiangya Hospital Affiliated Central South University, China. The PK parameters suggested that the new formulation had marked characteristics of delayed and controlled release of diltiazem, and food intake did not alter significantly diltiazem pharmacokinetic parameters.Uniterms: Diltiazem hydrochloride/delay-onset sustained-release pellet capsules/pharmacokinetics. Food/ingestion/effect in pharmacokinetic profile. High-performance liquid chromatography/quantitative analysis. Embora a farmacocinética (PK) do cloridrato de diltiazem nas formas de comprimidos de liberação imediata e cápsulas de liberação modificada em ensaios clínicos já tenha sido relatada, a pesquisa da PK do cloridrato de diltiazem na forma de cápsulas com peletes de liberação retardada e sustentada ainda é muito importante. Neste trabalho, propusemos avaliar a farmacocinética do cloridrato de diltiazem administrado através desta nova forma farmacêutica em voluntários chineses sadios, assim como a influência da ingestão de alimentos neste perfil farmacocinético. Foi realizado um ensaio clínico aberto, randomizado e paralelo em 36 voluntários, que receberam dose oral única de 90 mg, 180 mg ou 270 mg e dose múltiplas (90 mg/d × 6 d) pela mesma via de administração. Para avaliar o efeito da ingestão de alimentos sobre a PK do diltiazem foi realizada a administração de dose única (360 mg) em 24 voluntários chineses sadios. A concentração plasmática do diltiazem foi determinada por Cromatografia Liquida de Alta Eficiência em fase reversa (CLAE-FR) e os principais parâmetros farmacocinéticos foram analisados através do emprego do software PKSolver (Ver 2.0). O ensaio de farmacocinética clínica foi conduzido na clínica Pharmacological Center (No.JDX1999064) do Hospital de Xiangya, Central South University, China. Os parâmetros PK obtidos ...

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Section: Discussioncontrasting

confidence: 73%

Pharmacokinetics of diltiazem hydrochloride delay-onset sustained-release pellet capsules in healthy volunteers

Yan

Chen

Wang

et al. 2013

Braz. J. Pharm. Sci.

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Reducing shell egg cholesterol content. II. Review of approaches utilizing non-nutritive dietary factors or pharmacological agents and an examination of emerging strategies

Elkin

2007

World's Poultry Science Journal

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Colesevelam: Potential Uses for the Newest Bile Resin

Steinmetz

Schonder

2005

Cardiovascular Drug Reviews

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Colesevelam is the newest bile resin with a unique chemical structure. It binds to bile acids with higher affinity than traditional bile acid sequestrants and has fewer gastrointestinal side effects and drug interactions. Colesevelam is safe and efficacious alone or in combination with HMG-CoA reductase inhibitors (statins) in reducing low-density lipoprotein cholesterol (LDL-C) levels. Despite this, the role of colesevelam in the treatment of hyperlipidemia remains limited, particularly in the face of new lipid lowering agents. As guidelines for cholesterol control become more stringent, the need to maximize therapeutic benefit through combination therapy will become increasingly more important. Colesevelam has a dose-sparing effect on statin therapy, potentially decreasing the risk of unwanted side effects or drug-drug interactions associated with statin use. This makes colesevelam a viable option for addition to a statin regimen when goal LDL-C levels cannot be achieved with a statin alone. Additionally, anecdotal reports indicate that colesevelam may have potential benefits in certain patient populations that cannot tolerate other lipid lowering therapies, including organ transplant recipients, cholestatic liver disesase, and end-stage renal disease. By recognizing the potential utility of colesevelam, clinicians can better manage those patients who are not able to tolerate first-line therapies.

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Effect of concomitant colestipol hydrochloride administration on the bioavailability of diltiazem from immediate‐ and sustained‐release formulations

Cited by 3 publications

References 21 publications

Pharmacokinetics of diltiazem hydrochloride delay-onset sustained-release pellet capsules in healthy volunteers

Pharmacokinetics of diltiazem hydrochloride delay-onset sustained-release pellet capsules in healthy volunteers

Reducing shell egg cholesterol content. II. Review of approaches utilizing non-nutritive dietary factors or pharmacological agents and an examination of emerging strategies

Colesevelam: Potential Uses for the Newest Bile Resin

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