Kerry Bio-Science is a leading company in innovation and application of bio- and pharma ingredients, serving the pharmaceutical, savoury, bakery, beverage, dairy and confectionery markets worldwide. Charles Gayser is the global application director for excipients at Sheffield Pharma Ingredients business group of Kerry Bio-Science.
The role of excipients has changed as customers demand the best quality pharmaceutical products at the lowest possible price. Suppliers must now produce drugs that use fewer materials, but retain all positive characteristics.
By definition, an excipient is an inactive substance used as a carrier for the active ingredient of a medication. Excipients assist in the administration of an 'active' substance that typically may not be easily administered or absorbed by the patient. Pharmaceutical codes require that all ingredients in drugs, as well as their excipients, are identified and guaranteed to be safe. For this reason, excipients are only used when absolutely necessary and in the smallest amounts possible.
To stabilise the active ingredient, excipients are added to the formulation, ensuring that the active ingredient stays active and stable for a sufficiently long period of time so that the shelf-life of the product makes it competitive with other products. Thus, the formulation and blends of excipients in many cases are considered trade secrets.
In an excipient market estimated at over $3.5 billion, all suppliers are experiencing increased demands by customers to deliver products that are purer, tested to increased requirements and scrutinised to levels never attained in the past. It is no wonder that prices of products that used to be seen as 'just a filler' or as bulking agents are rising. The industry has grown from being a supplier of tabletting lubricants, binders, disintegrants, fillers, diluents, glidants, sweeteners and coatings, to become a supplier that must deliver products that offer solutions to the needs of clients.
There has been a number of changes over the past decade in customer expectations. All suppliers must attempt to bring value-added products that deliver these solutions for the client's needs or solves their particular problem. This has created a very close working relationship between excipient suppliers and customers.
Manufacturers are being pressed to use less materials, but retain all the positive results they saw with the higher levels of excipients. All excipients, even those at lower levels, must maintain all their positive characteristics, such as compressibility and dissolution profile.
How do suppliers adjust to this new model? As seen in the pharmacopoeia of the US, Japan and Europe, attempts have been made to harmonise tests and testing procedures for purity, clarity and many other specific characteristics. This has created a need for improvement in testing equipment and developing more definitive or discriminating tests.
Long gone are the days when basic particle size analysis was sufficient. These tests have been replaced by laser diffraction, infra-red scans and demands for smaller batch sizes to insure purity and homogeneity all add to the cost of manufacturing. Many suppliers have upgraded their manufacturing sites with state-of-the-art equipment.
The goal should always be to deliver the optimal product at a reasonable price, and to deliver the highest quality and functionally sound ingredients to the customer. This ensures that the patient is being supplied the optimal product that will deliver the expected result. Value-added components must be supplied that deliver a solution for clients' needs or problems with a particular active pharmaceutical ingredient that eliminates inter-action between non-active and active ingredients. Remember, the patient is the ultimate customer.