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Predicting stability of lyophilized products.
Dev Biol Stand. 1976 Oct; 36:69-75.DB

Abstract

The usual purpose of freeze-drying is to enhance the stability and thus the marketability of a product. Increasing the length of a product's integrity, however, often requires that the formulator be able to predict the extent of that increased shelf life. Based on the Arrhenius principles, techniques are available that can allow such shelf life estimates with an acceptable degree of confidence. The presentation reviews examples of ongoing studies demonstrating predictive techniques as applied to freeze-dried products. The examples cover the most common situations which call for straight-forward and generally accepted principles of prediction; that is, measuring a specific potency loss at several elevated temperatures and then predicting the time for the same loss at normal storage. Other situations, however, as is the case with many in vitro diagnostic products used in clinical laboratories, require a modification of this technique. In those instances, monitoring of the proper "functioning" of samples of a product subjected to exaggerated temperature conditions with an eye to predicting shelf life is reviewed.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

1030438

Citation

Nicholson, A E.. "Predicting Stability of Lyophilized Products." Developments in Biological Standardization, vol. 36, 1976, pp. 69-75.
Nicholson AE. Predicting stability of lyophilized products. Dev Biol Stand. 1976;36:69-75.
Nicholson, A. E. (1976). Predicting stability of lyophilized products. Developments in Biological Standardization, 36, 69-75.
Nicholson AE. Predicting Stability of Lyophilized Products. Dev Biol Stand. 1976;36:69-75. PubMed PMID: 1030438.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Predicting stability of lyophilized products. A1 - Nicholson,A E, PY - 1976/10/1/pubmed PY - 1976/10/1/medline PY - 1976/10/1/entrez SP - 69 EP - 75 JF - Developments in biological standardization JO - Dev. Biol. Stand. VL - 36 N2 - The usual purpose of freeze-drying is to enhance the stability and thus the marketability of a product. Increasing the length of a product's integrity, however, often requires that the formulator be able to predict the extent of that increased shelf life. Based on the Arrhenius principles, techniques are available that can allow such shelf life estimates with an acceptable degree of confidence. The presentation reviews examples of ongoing studies demonstrating predictive techniques as applied to freeze-dried products. The examples cover the most common situations which call for straight-forward and generally accepted principles of prediction; that is, measuring a specific potency loss at several elevated temperatures and then predicting the time for the same loss at normal storage. Other situations, however, as is the case with many in vitro diagnostic products used in clinical laboratories, require a modification of this technique. In those instances, monitoring of the proper "functioning" of samples of a product subjected to exaggerated temperature conditions with an eye to predicting shelf life is reviewed. SN - 0301-5149 UR - https://www.unboundmedicine.com/medline/citation/1030438/Predicting_stability_of_lyophilized_products_ L2 - https://www.lens.org/lens/search?q=citation_id:1030438 DB - PRIME DP - Unbound Medicine ER -