The challenge

A major multinational’s existing product wasn’t under attack for its efficacy. Its effectiveness had been well established, and it had been confidently recommended by HCPs and gratefully accepted by patients. Unfortunately, that same efficacy – and everything else about the product – was being undermined not by outside forces, but from within the product itself. Specifically, a proportion of the capsules were cracking and leaking their 450mg dosages, an issue described in customer complaints as “dusting” and “exploding capsules.” Unsurprisingly, this was degrading both the actual and perceived quality of the product, creating doubt, eroding trust, and destroying brand loyalty.

The existing provider suggested migrating to a larger capsule, but this was something the client wanted to avoid due to the complications and financial ramifications associated with changing production and packaging. So SFI Health was enlisted to find a new solution that would halt the damage, reverse the self-implosion and salvage the brand’s good reputation before it became irretrievable – and ideally without changing the way the dosages were delivered.

 

SFI Health solution

Drawing on our global resources and network of experts, we conducted a thorough review of every aspect of the product’s production chain. This revealed that the capsules were failing because they were essentially being over-filled, not by dosages too large but by dosages not sufficiently compacted. Our answer involved substituting the failing formulation method for a different slugging/milling technique available at one of our own production facilities. It would densify the physical ingredients more effectively without changing the amount of physical material in each capsule or affecting label claims.

 

The outcome

The new manufacturing method densified the contents of the capsules to quality levels that matched both the users’ and prescribers’ high expectations, as well as the existing label claims. The “dusting” and “exploding capsules” complaints ceased. The expense and complexity of transitioning to a larger capsule was avoided. And the entire bounceback was achieved just three weeks after our initial incident discussion. Based on the positive response they’ve received since the product re-entered the market, the client has doubled their sales expectations for 2021.

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