Blinding is an essential ingredient in a randomised controlled trial (RCT), ensuring that the placebo and the Investigational Medicinal Product (IMP) are indistinguishable from each other.

But there’s blinding and then there’s blinding – and at Eramol we not only make it easier for you to adopt a more rigorous and reliable blinding approach, we also look after the logistics of getting the blinded product to first patient, first dose.

What we deliver is pretty much unique in the industry – so here’s some insight into how it works and the benefits it brings to Sponsors and other clinical trial clients compared to the alternatives.

Over-encapsulation: strengths and weaknesses

The use of an active IMP alongside a placebo is considered to be the “gold standard” in clinical trials. Often, the process chosen is over-encapsulation, where an IMP is put into an opaque disguising capsule, either in tablet or powder form, with exactly the same type of capsule being used to encase the placebo.

Theoretically, the real IMP and the placebo are then indistinguishable both to the patient and to the clinical professionals conducting the trial, as they have the same physical properties (size, colour, shape, feel) and the same organoleptic qualities (taste and texture) as each other.

Over-encapsulation certainly has its place in clinical trials, owing to its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness. However, it’s not without its issues. Despite the convincing physical appearance it produces, it can also result in palpable differences in mass owing to differing tablet or powder densities.

Also, capsules can be broken open (even the tamper-proof ones), enabling subjects to visually compare the powder contained in each. Even the “rattle” factor – where the capsules, when shaken, sound different owing to disparities in the density and form of the contents - can “break the blind”.

As all of these issues stem from the use of a capsule, avoiding them necessarily entails a non-capsule approach: and this is where matched placebo tablets come into their own.

Matched placebo, better blinding

Made from a specially formulated powder mix, and capsule-free (so also gelatine-free, TSE- and BSE-free, vegan, and halal-friendly), matched placebo tablets are far less likely to compromise the blinding – but the major challenge is that they must also be manufactured in a way that makes them completely indistinguishable from the real thing, without the convenient disguise of a capsule.

This means getting all the physical and organoleptic properties - including shape, markings, score lines, and so on – absolutely right on each and every tablet, and for this reason clinical manufacturers have tended to steer away from this method in favour of the easier (but less reliable) option of over-encapsulation.

At Eramol, however, we have broken the mould, bringing matched placebo tablet trials within cost-effective reach of clinical trial Sponsors.

So, how does this work?

Artisan, end-to-end, outside the box

At Eramol, our teams think outside the box to deliver better matched placebo tablet blinding options to Sponsors and clients in a process that is truly end-to-end, spanning – as it also does with the active IMPs we produce – every stage from initial advice, manufacture, packaging, and certification, to distribution to trial site.

In many ways, we adopt what you might call an “artisan” approach, making the most of our extensive in-house expertise and investment in state-of-the-art facilities to devise innovative solutions that address clients’ specific challenges on a case-by-case basis.

For example, whatever the colour and shade of the active tablets, we can produce the best colour-match for the placebo tablets by developing a bespoke coating process specific to the project.  Our in-house technicians will painstakingly adjust the coating process to achieve the best colour-match,  using several samples with different base coating ingredients for every colour-matching sample,  covering a range of colour, shading, and texture. 

In addition to colour coating, we can also reproduce the appearance of functional coatings like sugar, as well as enteric coatings.

To replicate the active tablet’s physical dimensions exactly in the sample, we make a 3D laser scan, from which we then produce the placebo.

However, our differentiators don’t stop there! As we’ve been involved in making many placebo tablets for a variety of projects, we have also built up a library of stability data that mitigates the need to conduct new stability studies, thus saving cost and time.

With you through blinding – and before

In short, our team will explore every possible option to take you from initial consultation to effective blinding at the trial site as smoothly and economically as possible, helping your trial to pass through its all-important funding milestones quicker.

At Eramol, we think blinding should be transparent from the start.