The Challenge

“For medicines that make it to market successfully, each six-month delay to launch can mean a loss of almost $100 million in NPV. This number is obviously much higher for top-performing drugs.”

McKinsey perspectives on pharmaceutical R&D, 2010

“80% of new drugs are delayed or abandoned due to formulation or scale-up issues.”

Industry Specialist at a major Pharmaceutical Company

1. Service Forms

Service Forms used in Phase I & II Trials are error-prone. If approved, their random delivery profiles become mandatory for future phases.

2. Bio-equivalency

Achieving tablet formulations bio-equivalent to these profiles is difficult and can delay or kill projects.

3. Scale-up

Scaling up formulations from the lab to production facilities is difficult can delay or kill projects.

Our Solution: F-CAD

A platform for in silico tablet and capsule formulation that helps companies:

Find more blockbusters

Get them approved faster

Get them to market faster

F-CAD is a family of software products designed to speed up time to market in development of pharmaceutical solid dosage forms. F-CAD enables Pharmaceutical Quality/CMC divisions to do fast design space exploration and apply QbD and PAT.

How It Works

The F-CAD software suite consist of the following modules:

1. Tablet Designer

The process of in silico formulation with F-CAD begins with modeling your tablet to deliver the necessary dose using the Tablet Designer. The Tablet Designer makes it possible to rapidly develop any tablet geometry in 3D with all necessary patient and production compliance.

2. Particle Arrangement & Compaction

Next, use the Particle Arrangement & Compaction module to „build“ your tablet in F-CAD. Study granular and particulate arrangement within a tablet during compression to find out formulation and process quality attributes, such as granular size distribution or compressive stress.

3. Dissolution Simulations

Once you have designed and constructed your tablet in silico, the simulation power of F-CAD can be unleashed. The Dissolution Simulation Module produces a release profile from any formulation: tablet or capsue, immediate or sustained release, MUPS or minitabs, coated or non-coated tablet, including USP1, USP2, and USP4 methods.