Placebo Formulation Development

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Placebo Formulation Development

Placebos that look the part

Drug product placebos are made to match the active product physical properties such as colour, shape and size in order to facilitate blinded clinical studies. In other cases, the placebo formulation may be identical to the active formulation with the obvious exception of absence of the active drug.

The placebo, in the case of a tablet, should possess the same shape and color compared to the active product. This presents a challenge to the formulator because many active pharmaceutical ingredients (API’s) are colored.

Active and placebo are often film-coated with a non-functional coating that renders the two tablets virtually indistinguishable to patient and clinician alike.

Another challenge with tablets or powders is taste. Often active dosage forms have a significant taste with many drug substances tasting very bitter or leaving an unpleasant after-taste. Matching these attributes is critical but can be very difficult as any materials used must be approved for use in pharmaceutical products and assessment of such properties can be difficult to determine.

For liquid nasal drug products, the formulation of a placebo should consider factors such as pH, osmolality viscosity which may result in patients noticing a different effect on actuation of the device (e.g., spray characteristics) and in the sensory characteristics experienced after dosing.

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Sterile Manufacturing

Eramol delivers a purpose-built, EU GMP Annex 1–compliant sterile manufacturing service dedicated to Phase I and Phase II clinical trial supply. Our facility is designed for agility, reliability, and regulatory strength by integrating advanced isolator technology, closed-system processing, moist heat terminal sterilisation and a full end-to-end clinical supply chain — ensuring your sterile injectable, cartridges and pre filled syringes reach patients safely, on time and in full regulatory compliance.

Non Sterile Manufacturing

GMP Production of Tablets, Capsules & Oral Liquids for Phase I–III and Commercial Supply Eramol delivers end-to-end non-sterile manufacturing built on a foundation of quality, regulatory expertise, and Qualified Person (QP) leadership. Our Sevenoaks GMP facility, commissioned in November 2021 and operational since August 2022, supports the full product lifecycle—from early-phase clinical development right through to commercial supply.

Labelling Solutions

Our versatile and extensive labelling solutions have been designed to offer flexibility, economy of scale and to meet the demands of last-minute requirements.

Reliable. Proven. Safe. Effective.

Reliable. Proven. Safe. Effective.

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