Pharmacokinetic characterization of controlled-release formulations

Vw, Steinijans

doi:10.1007/bf03190201

Cited by 53 publications

(23 citation statements)

References 17 publications

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“…The controlled release characteristics of the formulations were evaluated by means of the HVD t50%Cmax (halfvalue duration) defined by the period during which the plasma concentration exceeds 50 % of the C max [26,27]. The effect of the formulation on the bioavailability was statistically evaluated by repeated-measures ANOVA (univariate analysis) using SPSS 17 (SPSS, Chicago, USA).…”

Section: Discussionmentioning

confidence: 99%

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Vervaeck

Monteyne

Saerens

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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Section: Discussionmentioning

confidence: 99%

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Vervaeck

Monteyne

Saerens

et al. 2014

European Journal of Pharmaceutics and Biopharmaceutics

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“…All procedures were performed in accordance with the guidelines and after approval by were evaluated by means of the HVD t50%Cmax defined by the period during which the plasma concentration exceeds 50 % of C max [35][36]. The intact tablets, collected in the faeces of the dogs, were analyzed for their remaining MPT concentration.…”

Section: In Vivo Evaluationmentioning

confidence: 99%

Thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding

Claeys

Vervaeck

Hillewaere

et al. 2015

European Journal of Pharmaceutics and Biopharmaceutics

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This study evaluated thermoplastic polyurethanes (TPUR) as matrix excipients for the production of oral solid dosage forms via hot melt extrusion (HME) in combination with injection molding (IM). We demonstrated that TPURs enable the production of solid dispersions -crystalline API in a crystalline carrier -at an extrusion temperature below the drug melting temperature (Tm) with a drug content up to 65% (wt.%). The release of metoprolol tartrate was controlled over 24h, whereas a complete release of diprophylline was only possible in combination with a drug release modifier: polyethylene glycol 4000 (PEG 4000) or Tween 80. No burst release nor a change in tablet size and geometry was detected for any of the formulations after dissolution testing. The total matrix porosity increased gradually upon drug release. Oral administration of TPUR did not affect the GI ecosystem (pH, bacterial count, short chain fatty acids), monitored via the Simulator of the Human Intestinal Microbial Ecosystem (SHIME). The high drug load (65wt.%) in combination with (in-vitro and in-vivo) controlled release capacity of the formulations, is noteworthy in the field of formulations produced via HME/IM.

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“…The sustained release characteristic of a formulation were evaluated by the time span during which the plasma concentrations were at least 50% of the C max value (HVD t 50%Cmax which is the width of the plasma concentration profile at 50% of C max ) (8,9). The HVD t 50% Cmax values were determined from the individual plasma concentrationtime profiles.…”

Section: Pharmacokinetic Analysismentioning

confidence: 99%

Preparation and In-vivo Pharmacokinetic Study of a Novel Extended Release Compression Coated Tablets of Fenoterol Hydrobromide

Elshafeey

Sami

2008

AAPS PharmSciTech

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Abstract. The aim of this study was to formulate extended release compression coated core tablets of fenoterol hydrobromide, a selective β 2 adrenergic receptor agonist, in an attempt to prevent nocturnal asthma. Two hydrophilic polymers viz Kollidon ® SR, Polyox ® WSR 303 and a hydrophobic one (Precirol ® ATO5) were employed. Compression coated tablets were formulated by preparing a core tablet containing 7.5 mg drug and various amounts of polymer and Emcompress ® then compressed coated with the same polymeric materials. For comparison purpose different matrix tablets were also prepared employing the same polymers. In-vitro release studies were carried out at different pH (1.2 and 6.8). Pharmacokinetics of extended release tablets as well as commercially available immediate release tablets (Berotec ® ) were studied after oral administration to beagle dogs using a new developed LC-MS/ MS method with a lower limit of quantification of 1 ng/ml. Fenoterol release from compression coated tablets was significantly lower than matrix tablets. The mechanism of release was changed with the nature and content of polymer. The release pattern of drug from F16 containing 40 mg Kollidon ® SR divided in the core tablet (15 mg) and the rest in the compressed coat (25 mg) showed a typical zero order release kinetic that could extend drug release >10 h and reasonable time for 75% to be released (t 75 ) (8.92 h). When compared to immediate release Berotec ® tablet the MRT was significantly extended from 7.03±0.76 to 10.93±1.25 h (P<0.001) and HVD t 50%Cmax was also significantly extended from 2.71±0.68 to 6.81±0.67 h with expected prevention of nocturnal asthma.

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Pharmacokinetic characterization of controlled-release formulations

Cited by 53 publications

References 17 publications

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Prilling as manufacturing technique for multiparticulate lipid/PEG fixed-dose combinations

Thermoplastic polyurethanes for the manufacturing of highly dosed oral sustained release matrices via hot melt extrusion and injection molding

Preparation and In-vivo Pharmacokinetic Study of a Novel Extended Release Compression Coated Tablets of Fenoterol Hydrobromide

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