STP1113: The Determination of Moisture Stability of a Dynamic System Under Different Environmental Conditions

    Marsh, KS
    President and research director, Kenneth S. Marsh & Associates, Ltd., Woodstock, IL

    Ambrosio, T
    Developmental fellow, Package Development, Kenilworth, NJ

    Guazzo, DM
    Senior scientist, R. W. Johnson, PRI, Raritan, NJ

    Pages: 5    Published: Jan 1991


    Abstract

    Effervescent tablets defy standard analysis for moisture sensitivity. High humidity conditions cause effervescence with corresponding changes in the tablet composition. However, the time necessary to perform traditional shelf life testing on a product which requires a two-year shelf life was considered too lengthy. An accelerated testing protocol was therefore desirable.

    Novel analytical techniques were developed to determine the product's response to humidity changes. Computer modeling was then employed to define product response to two isothermal storage conditions and three dynamic distribution environments in a nonfoil blister package. The results predicted that the two-year shelf life would be achieved.

    The product's two-year shelf life was established in three months of research time. The product, Fibre Trim effervescent tablets, became the first effervescent tablet to be introduced in a nonfoil package worldwide.

    The computer estimates have since been confirmed with storage studies.

    Keywords:

    computer modeling, modeling, isotherm, accelerated testing, moisture, distribution, effervescent, shelf life


    Paper ID: STP14838S

    Committee/Subcommittee: F02.40

    DOI: 10.1520/STP14838S


    CrossRef ASTM International is a member of CrossRef.