NOVEL EXCIPIENTS AS DIFFERENT POLYMERS: A REVIEW

Abstract

Novel excipient is a new chemical entity, a new innovation that has not been used in any drug approved by regulatory authorities. Market trends suggest that pharma companies are not eager to use novel excipients because they don’t want to add additional risks to product being developed as regulatory authority might not approve drug product because of new excipient. Apart from this, pharma companies are also worried about reliable supply from GMP production facilities while using novel excipients. The US FDA also encourages innovation in excipients to develop new drugs or improve approved therapeutics and IPEC is helping to drive acceptance of these novel products into the market. The objective of the present research is to assess the use of different polymers as novel excipients in the development of suitable pharmaceutical dosage forms. These novel excipients used as surface active agents, keratolytic agents, bioreagents and The identified excipients were also studied for their physical and chemical properties along with their regulatory requirements.