Long-term stability of acyclovir in 0.9% NaCl infusion polyolefin bags at 5±3°C after freeze-thaw treatment: A generic product versus the brand name

Dewulf, Joseph; Galanti, Laurence; Godet, Marie; Gillet, Patricia; Jamart, Jacques; Hecq, Jean-Daniel

doi:10.1016/j.pharma.2014.10.003

Cited by 10 publications

(7 citation statements)

References 13 publications

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“…Polyethylene reservoir bags had no stability effect on the remaining drug in the usual administration protocol and the effect of ambient light was ignorable (p value > 0.05). These findings are in accordance with Dewulf et al (17).…”

Section: Hplcsupporting

confidence: 93%

“…According to this study, the drug is stable in sodium chloride and dextrose 5% solutions but a consideration should be done that the diluted solutions must be used within 24 h. In that study, the drug was simply quantified and the stability was concluded when the drug molecule was detected more than 90% of its initial concentration and no attention was paid to any possible degradation product (s). Recent studies and text books are in accordance withthe findings of Gupta et al (15)(16)(17). At the time of writing this report, FDA guidelines updated in November 2003 by GlaxoSmithKline, states that drug should be diluted in Bany appropriate intravenous solution^ (18).…”

Section: Introductionsupporting

confidence: 59%

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Investigation of Possible Maillard Reaction Between Acyclovir and Dextrose upon Dilution Prior to Parenteral Administration

et al. 2016

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Abstract. In this study the stability of parenteral acyclovir (ACV) when diluted in dextrose (DEX) as large volume intravenous fluid preparation (LVIF) was evaluated and the possible Maillard reaction adducts were monitored in the recommended infusion time. Different physicochemical methods were used to evaluate the Maillard reaction of dextrose with ACV to track the reaction in real infusion condition. Other large volume intravenous fluids were checked regarding the diluted drug stability profile. Differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy (FTIR), and mass data proved the reaction of glucose with dextrose. A Maillard-specific high performance liquid chromatography (HPLC) method was used to track the reaction in real infusion condition in vitro. The nucleophilic reaction occurred in diluted parenteral preparations of acyclovir in 5% dextrose solutions. The best diluent solution was also selected as sodium chloride and introduced based on drug stability and also its adsorption onto different infusion sets (PVC or non PVC) to provide an acceptable administration protocol in clinical practices. Although, the Maillard reaction was proved and successfully tracked in diluted solutions, and the level of drug loss when diluted in dextrose was reported to be between 0.27 up to 1.03% of the initial content. There was no drug adsorption to common infusion sets. The best diluent for parenteral acyclovir is sodium chloride large volume intravenous fluid.

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Section: Hplcsupporting

confidence: 93%

Section: Introductionsupporting

confidence: 59%

Investigation of Possible Maillard Reaction Between Acyclovir and Dextrose upon Dilution Prior to Parenteral Administration

et al. 2016

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“…Chemical structures of the studied drugs and IS Several analytical methods have been described for the determination of ACV in pharmaceuticals and biological samples. These methods include spectrophotometric [3][4][5][6][7][8], spectrofluorimetric [9], high performance liquid chromatography (HPLC) [10][11][12][13][14][15], capillary electrophoretic [16][17][18] and electrochemical methods [19][20][21][22][23][24][25]. However, no previous method has been described for the simultaneous determination of ACV and PA.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic interaction study between Acyclovir and Paracetamol using HPLC-UV method

Saleh¹,

Askal²,

Refaat³

et al. 2017

Madridge J Anal Sci Instrum

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Chickenpox is a highly infectious disease caused by the varicella-zoster virus. Acyclovir (ACV) is an antiviral drug that has been concomitantly used with paracetamol (PA) for its analgesic effect in the management of chicken pox infections. However, the simultaneous pharmacokinetic interaction study for ACV and PA has not yet been reported. A simple high-performance liquid chromatography assay was developed and validated for their simultaneous analysis in human urine. The proposed method presents a pharmacokinetic study for ACV with/without co-administration of PA in human urine with high precision, accuracy and sensitivity in a short time not more than 10 minutes.

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“…The stability for a period of 24 hours at least was described for 17 drugs in 8 papers [22,[26][27][28][29]34,41,43,48]. Indeed, only 3 teams have tested the long-term stability after MFTT, the first for ganciclovir after 7 days [51], the second for ceftizoxime after 30 days [36] and the third for 19 drugs after 11 to 70 days described in 18 papers [16,23,31,38,39,46,49,50,[52][53][54]58,60,62,[64][65][66]73].…”

Section: Discussionmentioning

confidence: 99%

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014

Hecq

Godet

Jamart

et al. 2015

Annales Pharmaceutiques Françaises

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Long-term stability of acyclovir in 0.9% NaCl infusion polyolefin bags at 5±3°C after freeze-thaw treatment: A generic product versus the brand name

Cited by 10 publications

References 13 publications

Investigation of Possible Maillard Reaction Between Acyclovir and Dextrose upon Dilution Prior to Parenteral Administration

Investigation of Possible Maillard Reaction Between Acyclovir and Dextrose upon Dilution Prior to Parenteral Administration

Pharmacokinetic interaction study between Acyclovir and Paracetamol using HPLC-UV method

Microwave freeze-thaw technique of injectable drugs. A review from 1980 to 2014

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