NICHE AND NOVEL EXCIPIENTS
Excipients are defined by what they are not. The word excipient is derived from the Latin excipere, meaning ‘to except’, or ‘other than’. So pharmaceutical excipients are all else in the drug dosage ‘other than’ the active pharmaceutical ingredient. The earliest purpose of the excipient was to serve as the drug delivery vehicle. Thus, excipients may be bulking agents, fillers or diluents but can also serve as binders, lubricants or coatings. They help streamline the manufacture of the drug product and facilitate physiological absorption of the drug.
What are niche excipients and when are they needed?
So how about niche? With reference to a product, niche denotes an item that interests a specialized segment of the industry. The pharmaceutical and biopharmaceutical companies, in order to facilitate development of novel drug delivery systems and biotechnology-oriented drugs, need new excipients to be developed and approved. These excipients are of specialized and narrow application and are defined as niche excipients.
Many large chemical distributors service a range of industries. They may supply their fine and specialty chemicals for use in cosmetics, food, pulp, and paper, or automotive industrial applications. Many excipients are multifunctional. It is possible that the large chemical distributors will sell the same ingredient used for industrial applications also to the pharmaceutical and biopharmaceutical markets. Unless the chemical ingredient is manufactured under GMP compliance, and not just tested to meet the pharmaceutical standards and labeled as such, then it is not fit for purpose. A non-GMP excipient used as an ingredient to manufacture drug products could cause the drug to be deemed adulterated.
When are novel excipients needed?
It is typical for our customers, major international pharmaceutical and biopharmaceutical companies, to develop products requiring novel excipients that may be already available in the industry as high purity industrial grades but not as GMP manufactured ingredients. Their solution to this problem is to find a company like A&C that can manufacture its required amount of material within an authentic and certified GMP process.
A&C’s approach to niche and novel excipients
Customers come to A&C and we assess if it is possible to develop a suitable GMP process to manufacture the niche excipient they need. A&C will then secure the supply chain, develop a simple robust process, validate it, develop the specifications for purity and stability, and select a rational and fit for purpose packaging. Sometimes a Pharmacopoeia monograph for an excipient may already exist. If not, A & C has the capabilities to develop and validate the appropriate test methods. The finished product is sampled and approved by the customer, who typically audit A&C’s validated and certified GMP systems and documentation.
The whole process is built to be tailored to the client’s needs and customer-driven , where A&C acts as a transparent partner in the development of the novel niche excipient. A&C will also develop a complete dossier of regulatory documentation to accompany each product. This supports the customer in achieving smooth regulatory compliance for the niche excipient developed.
At A&C we have developed many niche excipients in partnership with our customers to meet exacting and specialized needs within a fully GMP compliant system. Contact us to work together on your niche excipients