Pharmaceutical product shelf-life

Understanding and Predicting Pharmaceutical Product Shelf-Life. .115 Kenneth C. Waterman... 

Understanding and Predicting Pharmaceutical Product Shelf-Life... 

Waterman, K. C. Understanding and predicting pharmaceutical product shelf-life. In Handbook of Stability Testing in Pharmaceutical Development Regulations, Methodologies, and Best Practices (K. Huyn-Ba, ed.). New York, NY, pp. 115-138, 2009. 

Pharmaceutical packaging is the means of providing protection, presentation, identification and information, containment, and convenience to encourage compliance with a course of therapy. The period from product manufacture to ultimate use or administration lies within the product shelf life interval. Criteria for selecting a satisfactory packaging system for pharmaceutical products are established by addressing a checklist of basic considerations ... 

Change of product shelf life Major Stability data to support the new shelf life. Please refer to the Guidelines to Stability Testing of Pharmaceutical Products (Annex B of Guide to Product Licence) C22(i)... 

Estimation of product shelf life is done by two methods—estimation from data obtained under the same conditions as those that the final product is expected to withstand and estimation from tests conducted under accelerated conditions. This section describes these two methods for estimating the shelf life of pharmaceuticals when chemical degradation is the major contributor to the degradation process and the degradation can be adequately described by a rate expression. 

The lyophilization process minimizes the potential for interactions between the glass and the drug product. In some circumstances, a pharmaceutical manufacturer may decide that lyophilization is the best alternative for extended product shelf-life because a compatible glass container for the liquid product cannot be found. An example of this may be a strongly alkaline solution. For this reason, this chapter will briefly explain the concepts of leaching and dissolution as they relate to the glass vial there will be more focus on the potential of the rubber closures to have extractables that may leach into the lyophilized drug product since this process is more likely to occur. 

Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored, distributed and subsequently handled so that quality is maintained throughout their shelf life. 

Non-specific absolute assay methods, e.g. volumetric titration, can be applied to avoid the establishment of a reference substance. This is only appropriate, however, when the monograph describes a separation test for related substances. This approach is certainly valid for the determination of the content of pharmaceutical raw materials but less acceptable for the assay of content of pharmaceutical preparations where the employment of specific assay methods is recommended (ICH Guideline 1994) to take account of decomposition of the active ingredient during the shelf life of the product and to avoid possible interference from excipients. 

Topical preparations, like all other dosage forms, must be formulated, manufactured, and packaged in a manner that assures that they meet general standards of bioavailability, physical (physical system) stability, chemical (ingredient) stability, freedom from contamination, and elegance. Like all other pharmaceuticals, these factors must remain essentially invariant over the stated shelf life of the product and they must be reproducible from batch to batch. 

Various drugs are known to exist in different polymorphic forms (e.g., cortisone and prednisolone). The rate of conversion from a metastable into the stable form is an important criteria to be considered with respect to the shelf life of a pharmaceutical product. Polymorphic changes have also been observed during the manufacture of steroid suspensions. When steroid powders are subjected to dry heat sterilization, subsequent rehydration of anhydrous steroid in the presence of an aqueous vehicle results in the formation of large, needle-like crystals. A similar effect may be... 

According to current PDA guidelines, an acceptable pharmaceutical product should exhibit less than 10% deterioration after 2 years.5 Protein biopharmaceuticals usually have to be stored under refrigerated conditions or freeze dried to achieve an acceptable shelf life. EL IS As for aggregates and product variants as discussed previously would be applicable for determining shelf life. 

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