Determination of efficacy and toxicity of diclofenac microemulsion formulation for musculoskeletal pain: an observational study

BMC Res Notes. 2020 Jun 12;13(1):285. doi: 10.1186/s13104-020-05120-3.

Abstract

Objective: Musculoskeletal pain is often caused by injury to the bones, muscles, tendons, ligaments or nerves. Symptoms can be localized or generalized. Mild-moderate symptoms are treated with topical/oral over the counter drugs. Microemulsion delivery formulations are thermodynamically stable, have superior bioavailability and better penetration of lipophilic and hydrophilic drug into the dermis. A prospective observational study in patients: 18 years or older, with mild-moderate musculoskeletal pain; with severe pain without adequate pain control; with severe pain and could not tolerate oral agents; with renal impairment were invited to try diclofenac 2% in microemulsion foam. They were followed up at 2 and 4 weeks. A 50% reduction on a visual analog pain scale was considered success. Adverse events were defined as irritation, gastrointestinal upset/bleed, rectal bleed, and hematemesis. The objective was to determine the efficacy and toxicity of diclofenac 2% in microemulsion foam.

Results: Thirteen consecutive patients with musculoskeletal pain consented to participate. Two patients were lost to follow up. Two of the 11 patients reported minimal improvement, while nine patients reported minimum 50% reduction. No adverse effects were reported. Diclofenac 2% in microemulsion foam is effective in the treatment of mild to moderate musculoskeletal pain and well tolerated.

Keywords: Diclofenac; Microemulsion; Pain; Topical foam; Transdermal formulation.

Publication types

  • Observational Study

MeSH terms

  • Administration, Topical
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / toxicity
  • Diclofenac / administration & dosage*
  • Diclofenac / toxicity
  • Drug Compounding
  • Emulsions
  • Female
  • Humans
  • Male
  • Middle Aged
  • Musculoskeletal Pain / drug therapy*
  • Outcome Assessment, Health Care*
  • Prospective Studies

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Emulsions
  • Diclofenac