For children, elderly patients, or patients who find it difficult to swallow pills, mixing medications with soft foods like apple sauce or liquids like milk is often essential to ensure safe and effective administration.
This seemingly simple practice brings forth a host of complex questions… like, how do you make sure that the drug works exactly the way it should after mixing with the dosing vehicle like apple sauce or milk? Does it stay stable? Does the dosing vehicle impact drug release?
Imagine mixing your drug product with apple sauce or yogurt, only to find its release mechanism behaves unpredictably. The result? Altered drug release, reduced efficacy or worse, safety concerns.
This is why product labelling often specifies the use of particular soft foods or liquids – known as dosing vehicles – for administration. These aren’t random instructions! They’re backed by rigorous in vitro testing to ensure the drug’s performance remains consistent when mixed with the recommended vehicle for over the timeframe specified in the product information.
To help you navigate these complexities, I have put together a cheat sheet focused on dissolution testing for drug product-vehicle compatibility. It covers everything from sample handling approaches, media recommendations to acceptance criteria, making the process clear and easy to follow.
While dissolution test plays a leading role in verifying impact on drug release, other critical tests to evaluate drug product-dosing vehicle compatibility include:
Integrity
Assess impact of the vehicle on the drug substance integrity (e.g., changes in the polymorphic form, loss of bead integrity, particle size distribution) and quality attributes.
Potency (Assay)
To determine the amount of the drug substance in the drug product-vehicle mixture to support the recommended labeled use time.
Stability
Determine physical and chemical stability of the drug product – vehicle mixture over time to support labeling instructions for its preparation and labeled use time
Homogeneity (dose uniformity)
The drug product must be thoroughly mixed with the vehicle (soft foods/ liquids) to ensure a homogenous mixture. Drug product – vehicle mixture should be divided into equal portions (n = 3 or 6) and tested for homogeneity of the mixture.
Read also:
- How to Deal with Difficult to Filter Dissolution Sample
- What is the Role of Antifoaming Agents in Dissolution Testing?
Resource Person: Pearl Pereira Nambiar
