Improving Stability Through Science-Led OSD Reformulation

A filed and marketed multivitamin tablet failed within the first month of accelerated stability testing. It held eight vitamins from roughly 0.03% to 46% w/w, so uniformity, quantitation, and degradation control pulled against one another, while the dominant ingredient shaped the moisture, oxygen, and pH conditions around its neighbors.

The Recipharm team took a stability-by-design approach, seeking the smallest scientifically sufficient change by moving from wet granulation to direct compression within a constrained development window. This case study looks at how excipient attributes, particle engineering, light exposure, and packaging barriers were weighed together, and how comparability was planned alongside formulation work. The reformulated tablet remained stable through six months under the same conditions.

Explore the approach to see how the team got there.