Article Text

PDF
Management of diabetic foot ulcers: a 25% lidocaine topical cream formulation design, physicochemical and microbiological assessments
  1. Hassane Sadou Yayé1,2,
  2. Antoine Faucheron1,
  3. Léa Dupont1,
  4. Fadwa El Kouari1,
  5. Arnaud Fekkar3,
  6. Agnès Bellanger1,
  7. Patrick Tilleul1,4
  1. 1 Département de Pharmacie, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière – Charles Foix, Paris, France
  2. 2 Laboratoire Matériaux et Santé, Université Paris Sud, UFR de Pharmacie, Chatenay-Malabry, France
  3. 3 Département de Parasitologie et de Mycologie, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière – Charles Foix, Paris, France
  4. 4 UFR de Pharmacie, Pharmacie Clinique, Université Paris Descartes, Paris, France
  1. Correspondence to Dr Hassane Sadou Yayé, Laboratoire Matériaux et Santé, Université Paris Sud, UFR de Pharmacie, Chatenay-Malabry 92296, France; hassane.sadou-yaye{at}aphp.fr

Abstract

Background Given the importance of surgical debridement in healing of diabetic foot ulcers, effective local anaesthesia is required to manage the related extreme pain. The pharmaceutical proprietary products currently available have low concentrations and do not exceed 5% w/w local anaesthetic.

Objective Formulation design of a lidocaine cream of 25% and assessment of the intrinsic stability.

Methods A cream pharmaceutical form was chosen for its ability to cross the skin barrier and effectively anaesthetise the skin. The choice of cream formula is based on changes in the size of the emulsions and resistance to physical stress. Stability tests were assessed over a 6-month period in terms of physical (evaluation of oil droplets), microbiological (germ count and identification, and preservative antimicrobial efficacy) and chemical parameters (content and pH).

Results Under the study conditions, the drug product displayed good physicochemical and microbiological stability for 6 months at 20°C and 40°C, and no degradation product was detected. Due to the systemic adverse effects of lidocaine, the pH stability guarantee the drug product tolerance along with very weak systemic passage.

Conclusions Given the good physicochemical and microbiological stability of the drug product over 6-month period, it has been made available to the clinical unit. An average of 250 patients per year benefit from the treatment with an excellent efficacy/tolerability ratio.

  • diabetes
  • drug stability
  • drug analysis
  • validation analytical procedure
  • pain management

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.