If formulation science is the Cinderella of drug development, then excipients are the Cinderellas of formulation science.

Excipients are those materials included in the final product and/or manufacturing process other than the active drug or prodrug. In some ways they are an anomaly; they do not typically have a pharmacological effect, but without them, the therapeutic revolution of the last 100+ years would not have taken place.

Unformulated, most APIs are not very useful to the patient. It is only when the API is included in a formulation and processed into the final product that we have a medicine suitable for administration to the patient.

There are several important issues with excipients:

Safety
Quality Management Systems/GMP
Alternate sourcing
Regulatory filings
Quality by Design
Validation
Significant change

The onus is on the manufacturer of the medicinal product to ensure that the excipients used in their product are fit for the intended use. Excipients are very often traded as commodity items and there is potential for adulteration to occur (see incidents in Haiti, Nigeria, India (twice), Panama and the US). It is thus vitally important that the user of the excipient understands the origin, composition and limitations of their excipients and the supply chain. There is a FDA Form 483 in existence where a pharmaceutical manufacturer was forced to institute a total product recall and replacement because they had not adequately controlled the supply of a key excipient.

The excipient industry is typically not wholly pharmaceutically oriented. Very often the pharmaceutical business represents less than 20%, and often less than 10%, of the total business. The major users may be from the food or industrial sectors. The methods of manufacture used for excipients are frequently continuous processing on dedicated equipment rather than batch manufacture as used for APIs and medicinal products. The application of over rigid batch oriented GMP to continuous processing is impracticable and unnecessary.

It becomes very difficult to impose pharmaceutical standards on materials and processes that are really intended for other customers. There has been a concerted effort in recent years to address such issues. IPEC-Americas (along with IPEC Europe and JPEC) have been very active in this area.

FinnBrit Consulting has all the necessary knowledge and experience to advise on all aspects of excipients.

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