The pharmacopeial evolution of intralipid injectable emulsion in plastic containers: from a coarse to a fine dispersion.

The pharmacopeial evolution of intralipid injectable emulsion in plastic containers: from a coarse to a fine dispersion.

Driscoll, David F;
International journal of pharmaceutics 2009 Vol. 368 pp. 193-8
198
driscoll2009theinternational

Abstract

On December 1, 2007, the United States Pharmacopeia (USP) adopted Chapter 729 entitled Globule Size Distribution in Lipid Injectable Emulsions that contains two globule sizing methods and criteria to measure the mean droplet diameter (MDD) and the large-diameter tail of the globule size distribution to meet pharmacopeial specifications. The first of these measures, as the intensity-weighted MDD expressed in nanometers, must be less than 500 nm. The second measure, as the volume-weighted percentage of fat greater than 5 microm or PFAT(5), must be less than 0.05%. These limits were first suggested in 2001 based on an analysis of 16 lipid injectable emulsions available worldwide. In 2004, the packaging of the innovator lipid emulsion product Intralipid was changed from conventional glass bottles to plastic containers in the U.S. A subsequent analysis of the emulsion in its new container showed it to be more coarse than its previous glass counterpart and now failed the PFAT(5) limit. In 2007, it was announced that Intralipid in plastic containers was reformulated to meet the pharmacopeial limits. To track the time course of its transition from a coarse to a fine dispersion, 31 lots of Intralipid with expiration dates spanning five years were investigated.

Citation

ID: 66857
Ref Key: driscoll2009theinternational
Use this key to autocite in SciMatic or Thesis Manager

References

Blockchain Verification

Account:
NFT Contract Address:
0x95644003c57E6F55A65596E3D9Eac6813e3566dA
Article ID:
66857
Unique Identifier:
10.1016/j.ijpharm.2008.09.059
Network:
Scimatic Chain (ID: 481)
Loading...
Blockchain Readiness Checklist
Authors
Abstract
Journal Name
Year
Title
5/5
Creates 1,000,000 NFT tokens for this article
Token Features:
  • ERC-1155 Standard NFT
  • 1 Million Supply per Article
  • Transferable via MetaMask
  • Permanent Blockchain Record
Blockchain QR Code
Scan with Saymatik Web3.0 Wallet

Saymatik Web3.0 Wallet