good stability Featured Excipient: Plasticizers-IJPC

  • good stability Featured Excipient: Plasticizers-IJPC
  • good stability Featured Excipient: Plasticizers-IJPC
  • good stability Featured Excipient: Plasticizers-IJPC
  • When will the IPEC stability guide for pharmaceutical excipients be available?
  • IPEC Federation announces the availability of the updated IPEC Stability Guide for Pharmaceutical Excipients (Version 2, 2022).
  • What is the excipient stability guide?
  • The guide provides excipient manufacturers with strategies for assessing an overall approach to stability and how to set up programs to support regulatory filings, aid in maintaining the quality of the excipient, and to define and substantiate recommended storage conditions and shelf-life claims.
  • What is an example of a stable excipient?
  • For example, while an excipient susceptible to oxidation whose commercial packaging allows exposure to air could be classified as Limited Stability, it may become Very Stable or Stable if packaged under conditions to protect it from exposure to air. For excipients where the stability profile has not been established, stability data is needed.
  • What is an excipient in a pharmaceutical product?
  • Excipients are inactive ingredients added to pharmaceutical preparations for aiding in the manufacturing process, sustaining the product stability, and giving desired colors and tastes.
  • Do excipients protect moisture sensitive drugs?
  • Excipients are a critical entity in formulations to enable drug delivery as well as efficient manufacture of pharmaceutical dosage forms. Yet to this end, there is limited application and understanding of the role of excipients in protecting moisture sensitive drugs.
  • How are excipients selected in formu-Lations containing moisture sensitive drugs?
  • Several key considerations are important for selection of excipients in formu-lations containing moisture sensitive drugs (Fig. 5). As each excipient has its unique interaction with moisture, certain excipients may act as stability enhancers, while others may be degradation promoters.

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