diclofenac sodium XR / Generic mfg. - LARVOL DELTA

Rice Bran Wax-Based Matrix Tablets for Sustained Release of Diclofenac Sodium: Effects of Processing and Sintering. (PubMed, Pharmaceutics) - "It met the dissolution limits specified in the USP-NF monograph for Diclofenac Sodium Extended-Release Tablets and showed a dissolution profile that was broadly comparable to that of the commercial reference product based on descriptive profile analysis...The 55MG2 formulation also retained a broadly comparable dissolution profile, although a modest increase in drug release was observed. These findings support the potential of RBW as a natural lipid excipient for controlled oral drug delivery."

Journal

Investigation of the drug release modifying property of Pentadesma butyracea gum in diclofenac sodium matrix tablets. (PubMed, PLoS One) - "A matrix system comprising 15%w/w P. butyracea gum and ≥ 20%w/w xanthan gum effectively extended the release of diclofenac sodium over 24 hours, demonstrating its potential application in extended-release formulations."

Journal • Gene Therapies

Nanonet-nano fiber electrospun mesh of PCL-chitosan for controlled and extended release of diclofenac sodium. (PubMed, Nanoscale) - "DS-NNEMs also enhanced 3T3 cell adhesion, viability, and proliferation in the nanonet-nano fiber network through the controlled release of DS. The presented EN technology-based biodegradable NNEM material is not only limited for the controlled release of hydrophilic anti-inflammatory drugs, but also can be a suitable platform for loading and release of antiviral drugs."

Journal

A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness (clinicaltrials.gov) - P3; N=102; Completed; Sponsor: Novartis; Recruiting -> Completed

Trial completion • Biosimilar • Pain

Application of simplex lattice design for the development of extended release tablets of model drug diclofenac sodium. (PubMed, Ther Deliv) - " The rate of drug release was primarily dictated by the proportion of hydroxypropyl methylcellulose and was also affected by the proportion of dicalcium phosphate and the method of processing (direct compression/wet granulation). Polynomial equations constructed for directly compressed and wet-granulated formulations could successfully predict the extent of drug release at an arbitrary time point of 3 h. Simplex lattice design is a viable tool to predict the drug release patterns of extended release formulations."

Journal

MHRA reviews over-the-counter availability of diclofenac (Pulsetoday) - "The European Medicines Agency recently ruled that systemic diclofenac should no longer be used by people with serious underlying heart or circulatory conditions, such as heart failure and heart disease, after concluding the risk of cardiovascular complications associated with its use outweigh the benefits....Now the UK Medicines and Healthcare Regulatory Agency (MHRA) has announced it will consult doctors and other healthcare professionals on whether oral preparations of diclofenac should stop being classed as pharmacy medicines, or whether they should just have stronger product information warnings and fewer listed indications."

Adverse events • European regulatory