Are all aciclovir cream formulations bioequivalent?

Trottet, Lionel; Owen, Helen; Holme, Paul; Heylings, Jon R.; Collin, I.P.; Breen, A.P.; Siyad, M.N.; Nandra, R.S.; Davis, Annette

doi:10.1016/j.ijpharm.2005.07.020

Cited by 48 publications

(22 citation statements)

References 18 publications

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“…The occurrence of therapeutic bioinequivalence between generic formulations and the innovator cream has been demonstrated for acyclovir 1.0% creams, for instance [29] , and large differences in the release rates of imiquimod creams have also been identified [30] .…”

Section: Discussionmentioning

confidence: 99%

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

Ortiz¹,

Hansen

Shah

et al. 2010

Skin Pharmacol Physiol

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Aim: To evaluate the bioequivalence of 3 marketed topical metronidazole formulations by simultaneous dermal microdialysis and stratum corneum sampling by the tape stripping methodology, and to compare the techniques as tools for the determination of bioequivalence. Methods: Nine microdialysis probes were inserted in the volar aspect of the left forearm of 14 healthy volunteers and, following application of the 3 metronidazole creams, microdialysis samples were collected for 5 h. On the right forearm, tape strip sampling was performed 30 and 120 min after product application. At the end of the experiment, ultrasound scanning measurements confirmed that all probes were placed inside the dermis. Results: There was no statistical difference in penetration of the 3 topicals as determined by microdialysis. However, their bioequivalence could not be determined due to intersubject variability exceeding the criteria for bioequivalence evaluation. Tape strip sampling established a bioequivalence between 2 of the creams, but rejected any bioequivalence between these 2 formulations and the third. The third formulation was a generic formulation approved despite containing a lower concentration of metronidazole (0.75%) than the innovator formulation (1.0%). The result of the bioequivalence evaluation depends on the methodology employed. Conclusion: Whenever the dermis is the target tissue, microdialysis provides the most relevant information on drug bioavailability.

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Section: Discussionmentioning

confidence: 99%

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

Ortiz¹,

Hansen

Shah

et al. 2010

Skin Pharmacol Physiol

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“…All volumes were scaled down by a factor of 5, as mentioned above. The chromatographic method was based on the procedure described by Trottet et al (2005). As suggested by these authors, a hydrophilic column was tested, i.e.…”

Section: Lc-hesi-ms/msmentioning

confidence: 99%

“…Some published studies describe the use of solid-phase extraction, resulting in extracts that are free of impurities and with high rates of drug recovery (Fernández et al, 2003;Poirier et al, 1999;Svensson et al, 1997;Kishino et al, 2002;Trottet et al, 2005). However, these techniques are rather time-consuming and expensive.…”

Section: Introductionmentioning

confidence: 99%

Determination of acyclovir in horse plasma and body fluids by high‐performance liquid chromatography combined with fluorescence detection and heated electrospray ionization tandem mass spectrometry

Maes

Garré

Desmet

et al. 2008

Biomedical Chromatography

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Two methods are presented for the determination of 'respectively' the plasma protein unbound and total concentration of acyclovir in horse plasma and body fluids: first, a liquid-liquid extraction was performed on plasma, combined with HPLC-fluorescence detection for the total plasma concentration; second a more sensitive method using high-performance liquid chromatography combined with heated electrospray ionization tandem mass spectrometry (LC-HESI-MS/MS) was described for plasma and for body fluids analysis. To obtain the unbound concentration of acyclovir in plasma, a simple deproteinization step using a Microcon filter was performed. Ganciclovir was used as an internal standard. Analysis was carried out on an Inertsil 5 ODS-3 column for the HPLC-fluorescence method. For the LC-HESI-MS/MS method a PLRP-S column was used. The limit of quantification (LOQ) for the total concentration was set at 50 and 2 ng mL(-1) for the HPLC-fluorescence method and the LC-HESI-MS/MS method, respectively. The limit of quantification for the unbound concentration was set at 5 ng mL(-1) and at 2 ng mL(-1) for body fluids. The methods were successfully used to perform pharmacokinetic and clinical studies in horses after intravenous and oral dosage of acyclovir and its prodrug valacyclovir.

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“…Recent studies suggest that not all marketed acyclovir cream preparation is bioequivalent and that the extent of skin permeation is dependent on propylene glycol vehicle content [39].…”

Section: Management Of Recurrent Oro-labial Symptoms Of Hsv Infectionmentioning

confidence: 99%

The diagnosis and management of oral herpes simplex infection

Birek

Ficarra²

2006

Curr Infect Dis Rep

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Acute herpetic gingivostomatitis and recurrent herpes labialis are the most common manifestations of infection with herpes simplex virus type 1 (HSV-1). In primary and recrudescent HSV-associated disease, the symptoms may range from subclinical to debilitating and life-threatening, depending on the host's immune responses or competence level. In this paper, the typical and atypical manifestations, and the current diagnostic and treatment options for localized, non-complicated oro-labial HSV infection are reviewed, with attention to cumulative evidence for the efficacy and safety of systemic antiviral agents. Some recent data on HSV-1 seroprevalence, viremia, and viral shedding are discussed in relation to disease transmission and global importance of herpesvirus disease.

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Are all aciclovir cream formulations bioequivalent?

Cited by 48 publications

References 18 publications

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

Are Marketed Topical Metronidazole Creams Bioequivalent? Evaluation by in vivo Microdialysis Sampling and Tape Stripping Methodology

Determination of acyclovir in horse plasma and body fluids by high‐performance liquid chromatography combined with fluorescence detection and heated electrospray ionization tandem mass spectrometry

The diagnosis and management of oral herpes simplex infection

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