2023 journal article

Factors Influencing the Selection of Medium for Evaluating Drug Solubility and Dissolution in Bovine Milk

DISSOLUTION TECHNOLOGIES, 30(3), 134–142.

By: M. Martinez*, D. Longstaff*, V. Fellner n & M. Coffey

author keywords: Solubility; complex matrices; bovine milk; bioavailability; dissolution
UN Sustainable Development Goal Categories
2. Zero Hunger (OpenAlex)
Source: Web Of Science
Added: November 27, 2023

Milk or milk-containing beverages can be used as vehicles for drug product administration and as a component of human fed-state simulated gastric fluids.Unprocessed bovine milk is also the matrix within which drugs must be solubilized or released when formulations are administered into the bovine mammary gland.Therefore, an appreciation of factors impacting the effect of milk on drug solubility and product dissolution is necessary.Although an off-the-shelf container of cow milk may be adequate for evaluating drug solubility, the composition of milk varies as a function of fat content (e.g., differences in fat content).Differences can occur between bovine breeds, diet, environment, and suppliers.Importantly, it is unclear how to quantify differences in drug solubility across types of milk products versus when the drug is infused directly into the bovine udder.To address these concerns, a two-tiered approach was employed.The first tier involved comparing drug solubility across a range of milk products, including raw (unprocessed) bovine milk obtained from healthy cattle and an aqueous buffer.The second tier, which is the subject of this review, explores publicly available information on the composition of bovine milk and the potential variability of its constituents.The goal of this work is to provide the basis for inclusion of milk as one of the biologically relevant media described in the United States Pharmacopeia general chapter on solubility testing.