The physical stability of pharmaceutical materials (e.g., excipients, active ingredients, intermediates) and drug products is an important property to consider when developing any new medicine, as the following considerations illustrate:
Physical changes have been the cause of some high-profile product recalls and reductions in product shelf-life (1). Recalls have occurred for a drug product from the US marketplace because of the unexpected appearance of a more stable and less soluble crystal form and for a transdermal system after crystals formed unexpectedly and compromised its efficacy.
As recently as the 1980s, the screening of drug substances for polymorphism and for the ability to form salts/co-crystals and hydrates/solvates ("pseudopolymorphs") was not routine at many companies. Hence, there was limited awareness of the risks of physical transformations occurring during the manufacture, storage, and use of pharmaceutical dosage forms (2).
Since the 2000s, there has been a marked increase in the use of amorphous drug substances and intermediates, increasing the probability of physical instability occurring because of recrystallization (3).
There has been an increased understanding of the risks of developing salt forms of weak bases, which can disproportionate in the presence of excipients commonly used to manufacture immediate-release solid oral dosage forms (4).
This general information chapter is focused on changes in those physical attributes that can directly affect the safety, quality, and efficacy of pharmaceutical materials, systems, or products. Further, the scope of this chapter is intended to cover all materials and dosage forms described in the USP–NF, including drug substances, drug product intermediates, excipients, solid/liquid/semi-solid dosage forms, sterile and nonsterile preparations, and diagnostic materials.
Even small changes in the critical physical attributes of an excipient, drug substance, intermediate, or drug product over time can affect the shelf life of a material and any product manufactured from it. Several health authorities have discussed this topic in guidance documents and articles (see Appendix 1). In addition, several national pharmacopeias have mentioned physical stability testing and control topics in their monographs and chapters.
Clearly, certain health authorities and official compendia consider physical properties to be potentially critical quality attributes (CQAs) for excipients, drug substances, drug products, and related materials (e.g., intermediates) for some dosage forms. As a result, demonstration of 1) manufacturing processes capable of producing drug substances and drug products of consistent physical quality at release and 2) the physical stability of those materials during storage is required for successful regulatory filing and approval of marketing applications (e.g., new drug applications and marketing authorization applications).
Source from USP and Please refer to USP for details:
https://online.uspnf.com/uspnf/document/2_GUID-6FDBEC05-E973-4E67-B5AC-27D304F43D9E_10101_en-US
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