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NICHE AND NOVEL EXCIPIENTS
The definition of an excipient is what they are not. The Latin verb excipere, which means “to except” or “other than,” is the source of the English word excipient. Hence, anything “other than” the active pharmaceutical ingredient in a medicine dosage is referred to as a pharmaceutical excipient. The excipient’s original function as a drug delivery system was to fulfill this role. Excipients can therefore be used as binders, lubricants, coatings, or bulking agents as well as fillers and diluents. They expedite the production of the pharmaceutical product and aid in the drug’s physiological absorption.
What are niche excipients and when are they needed?
What about specialization? When referring to a product, a niche is anything that appeals to a specific market within the sector.The pharmaceutical and biopharmaceutical industries require the discovery and approval of new excipients in order to support the development of innovative drug delivery systems and medications with a biotechnology focus. These excipients are referred to as niche excipients because of their specific and limited applications.
Numerous sizable chemical distributors provide services to various industries. They could provide their high-quality and specialized chemicals for the food, beverage, pulp & paper, and automobile industries. Numerous excipients have multiple uses. It’s feasible that the big chemical distributors will provide the pharmaceutical and biopharmaceutical industries with the same substance used in industrial applications. The chemical ingredient is not fit for use unless it is produced in accordance with GMP guidelines, not only tested to satisfy pharmaceutical standards and labeled as such. The use of a non-GMP excipient in the production of pharmaceutical products may result in the drug being considered adulterated.
When are novel excipients needed?
Major global pharmaceutical and biopharmaceutical firms, who are our clients, frequently need to develop products needing innovative excipients that may currently be on the market as high purity industrial grades but not as GMP made constituents. To solve this issue, they will look for a business similar to A&C that can provide the necessary quantity of products in a timely authentic and certified GMP process.
A&C’s approach to niche and novel excipients
When customers come to A&C, we determine whether or not we can create an appropriate GMP process to produce the specialized excipient they require. After that, A&C will safeguard the supply chain, create a straightforward, reliable procedure, validate it, create purity and stability standards, and decide on a sensible, functional package. There may occasionally already be a Pharmacopoeia monograph available for an excipient. If not, A & C are able to create and verify the relevant test procedures. The customer, who usually audits A&C’s verified and certified GMP systems and paperwork, samples and approves the final product.
The entire procedure is designed to be customer-driven and customized to the demands of the client, with A&C serving as an open collaborator in the creation of the innovative niche excipient. For every product, A&C will also create a comprehensive dossier containing all necessary regulatory documentation. This helps the client achieve seamless regulatory compliance for the designed specialty excipient.
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