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The Mysteries of R&D, Part II: Why Do They Always Say “Not Ready Yet”?

By: Art Rich, PhD
Posted: November 5, 2010, from the November 2010 issue of GCI Magazine.

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Package Compatibility for Cosmetics: Essential to assure that product is not adversely affected by the package components and vice versa, these tests can be run at the same time as the stability program. The difference is that the evaluations are done in the package rather than in lab glass. Again, the testing runs from one to three months. The testing is done in such a manner as to make certain all parts of the package (pump springs, cap liner, etc.) are in contact with the product. Evaluations are done on both the product and the package to determine if there are changes in either or both.

Comparisons can be made with the product in glass to see if there are product changes due to package contact.

In addition, the product is placed in contact with the label to determine if the printing will remain unaffected.

Stability and Compatibility for OTC Drugs: For new formula OTC products, there are tests required by the FDA before going to market. It is important to remember that an OTC formula must contain only the active ingredients specified in the FDA’s monograph for the particular OTC.

Here the testing is much more extensive. The product can be marketed after three months of OTC prescribed testing (analysis of multiple batches at required temperatures, use of the commercial package, etc.). However, additional, long-term testing must be done at room/ambient temperature. In addition, chemical analysis of the active must be conducted at each testing period in addition to the physical examination. It is required that during the three-month accelerated testing program that potency of the active ingredient(s) does not fall below 90% of the labeled concentration.