Issue link: https://www.e-digitaleditions.com/i/238663
j-Excipients_38-41_Masters 12/30/13 2:08 PM Page 40 40 January 2014 Tablets & Capsules ents, according to the FDA's Mansoor A. Khan, who spoke in November at the annual meeting of the American Association of Pharmaceutical Scientists. In his presentation, "Patientcentric/pediatric formulations and product development: An FDA perspective," Khan stressed the need for dosage forms and for excipients that are appropriate for children. He noted that excipients in the Inactive Ingredient Database (IID) are geared toward adult dosage forms. He also listed several excipients that the American Association of Pediatrics deemed problematic. During the discussion after the presentation, one attendee noted the difficulties involved in using new excipients and asked whether the FDA might be open to allowing excipient manufacturers to pay a fee to have their products evaluated outside an NDA or ANDA. Khan said he welcomed more discussion of the idea. It does seem worth exploring. Such a framework could have myriad benefits. It would give pharmaceutical manufacturers access to materials that better meet the needs of pediatric, geriatric, and other underserved patient populations. After all, many materials have already been studied closely and are ripe for use as new excipients. Consider chitosan, a material that John McCarty discussed in the September 2013 edition of this column. It is consumed in gram quantities in foods and has a long history of safe use. It even has a Drug Master File, yet it is not approved as an excipient. Clearly, the absence of a mechanism for manufacturers to bring a new excipient to market outside an NDA or ANDA is a barrier to innovation. Excipient companies should not have to resort to formulating generic drug products using new excipients solely to get an ANDA (and thus excipient) approval when they have no intent of marketing the drug product. But that is exactly what some have considered doing. In addition to expanding the IID, a fee-based acceptance framework could spark innovation among excipient manufacturers. Perhaps new companies would be formed or spun off from today's suppliers, enterprises dedicated solely to the pursuit of new excipients. It's likely that these narrowly focused companies would respond better to the needs of drug developers. Today, excipient users are seldom able to acquire samples of materials at the margins of a spe- cification range (e.g., the molecular weight range of a polymer) in order to apply QbD prin ciples because most excipients are made continuously in huge volumes. Excipient manufacturers simply cannot accommodate small "special orders." With a fee-based framework, excipient manufacturers might discover they can make smaller volumes of specialty materials and still turn a profit. In fact, it's possible to imagine that a company with a unique excipient for a particular application could prosper serving just one or a few customers. The guidelines for studying new excipients already exist, and that some companies have used them with no promise of a payoff demonstrates a confidence in their products. It's now up to the FDA, in consultation with all stakeholders, to develop a mechanism that will lead to greater acceptance and use of new excipients. T&C For further reading Find more information about the regulations and guidelines that pertain to excipients in articles listed under "Excipients" in Tablets & Capsules' article index in the November 2013 issue or at T&C's website: www. tabletscapsules.com. We are the Fizz! Tower Labs is the premier effervescent product manufacturer in the U.S.