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A new paediatric formulation of valaciclovir: development and bioequivalence assessment
  1. Diane E T Bastiaans1,
  2. Carli M Bartels-Wilmer1,2,
  3. Angela P H Colbers1,
  4. Claudia A W Heijens3,4,
  5. Kirsten Velthoven-Graafland1,
  6. Oscar S N M Smeets5,
  7. Nicole Vink1,
  8. Veroniek E M Harbers6,
  9. Adilia Warris7,
  10. David M Burger1
  1. 1Department of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands
  2. 2Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands
  3. 3Department of Pharmacy, Rijnstate Hospital, Arnhem, The Netherlands
  4. 4Zuyderland Medical Center, Heerlen, The Netherlands
  5. 5Laboratory of Dutch Pharmacists (LNA), Royal Dutch Pharmacists Association, The Hague, The Netherlands
  6. 6Clinical Research Center Nijmegen, Radboud University Medical Center, Nijmegen, The Netherlands
  7. 7Infection, Immunity and Inflammation Research Group; Aberdeen Fungal Group, Institute of Medical Sciences, University of Aberdeen, Aberdeen, UK
  1. Correspondence to Diane E T Bastiaans, Department of Pharmacy, Radboudumc University Medical Center, Geert Grooteplein-Zuid 10 (route 864), Nijmegen 6525GA, The Netherlands; Diane.Bastiaans{at}radboudumc.nl

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A paediatric formulation of valaciclovir with acceptable palatability, good pharmaceutical quality and stability, and with the possibility of flexible dosing is currently not available. A preparation of valaciclovir liquid using crushed tablets as described in the US Food and Drug Administration label information was found not to be adequate for use in daily practice.1 The mean relative bioavailability of this liquid compared with the tablets was reported to be 91.1% (SD, 33.1%), but was not investigated following the regulatory guidance for bioequivalence testing.2 Aim of this study was to develop a new paediatric formulation and to assess the bioequivalence of this new formulation compared with the brand named valaciclovir tablets.

An oral liquid was developed because this is generally considered acceptable for use in infants and young children.3 Dosing accuracy, use of non-toxic excipients, palatability and good pharmaceutical stability for an acceptable period of time were taken into account during development. A solution …

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Footnotes

  • Contributors Formulation development was performed by DETB, CMB-W, KV-G, OSNMS and NV. For bioequivalence testing: DMB, APHC, CAWH, AW and DMB designed the study. DETB, APHC, CAWH and VEMH screened and enrolled patients. DETB, CMB-W and APHC oversaw data entry and undertook trial management. DETB, APHC, CMB-W, AW and DMB assisted with verification, analysis and interpretation of the data. DETB and CMB-W drafted the original version of the manuscript. All authors participated in the writing of the manuscript, and read and approved the final version.

  • Funding This study has been performed as part of the VALID (a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children) project, which has been granted by The Netherlands Organisation for Health Research and Development (ZonMW), within the ‘Priority Medicines for Children’ Programme (project number: 113201004).

  • Competing interests None.

  • Ethics approval CMO Arnhem-Nijmegen, The Netherlands.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Stability data, exact composition and preparation method of the new valaciclovir liquid is freely available for everyone. For this, the Royal Dutch Pharmacists Association (Department: Laboratorium Nederlandse Apothekers (LNA Helpdesk)) can be approached (+31 70 373 73 70).

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