Bottles

Drug product — Tramadol Out-Licensing: oral liquid bottle formulation

Securing pediatric opioid dosing while differentiating your portfolio

Health authorities have identified highly concentrated tramadol drop solutions as a major source of medication errors in children.
The need to count drops — up to 40 per administration depending on body weight — has led to serious overdoses and hospitalizations.

In this context, several markets are moving toward presentations enabling volumetric dosing rather than drop counting.

For pharmaceutical companies, this evolution creates a dual opportunity:

  • secure the use of a sensitive active substance (opioid)
  • modernize a mature molecule through a pediatric-adapted presentation

A lifecycle management opportunity for a widely prescribed molecule

Tramadol remains a reference treatment for moderate to severe pain, however:

  • solid oral forms are difficult to administer in pediatric and geriatric populations
  • drop formulations present an identified medico-legal risk
  • some countries still lack an adapted oral liquid presentation

A safe liquid formulation therefore enables:

  • pediatric indication extension
  • differentiation versus generics
  • safety repositioning
  • product lifecycle renewal

The solution developed by Unither

Unither has developed a low-concentration oral tramadol solution allowing dosing in milliliters using a graduated oral syringe.

Objective: eliminate drop counting and secure administration

 

Key characteristics

  • 5 mg/mL (reduced, safety-oriented concentration)
  • 200 mL bottle with graduated oral syringe
  • Child-resistant closure
  • Cherry-raspberry flavor
  • Paraben-free
  • Shelf life up to 36 months + 6 months after opening

Key benefits of the tramadol oral solution

Simplified administration

Form suitable for pediatric and geriatric populations.

Improved compliance

Superior taste acceptability demonstrated in a comparative bioequivalence study.

Dosage safety

The low concentration combined with a graduated syringe allows for precise dosing based on weight.

Gradual dose adjustment

May be used in withdrawal protocols under medical supervision.

Out-Licensing product portfolio — Bottle

 Table: Out-Licensing product portfolio — Bottle
Pharmaceutical vials Volume Category Status Dossier Country
Ambroxol hydrochloride [sugar-free] 30mg/5mL 150 mL Cough and Cold Medicine MA available DE
Dextromethorphan [preservative-free] 15mg/5 mL 125 mL Cough and Cold Medicine Dossier available Contact us
Paracetamol for children [paraben-free; sugar-free] 2.4% 100 mL Fever, pain Medicine Dossier available Contact us
Tramadol 5 mg/mL, oral solution 200 mL Pain, addictology Medicine Contact us