5 / 10
Mass Spectrometry Congress 2019
Journal of Chemical Technology and Applications | Volume 3
Page 18
May 20-21, 2019 | Rome, Italy
MASS SPECTROMETRY,
PROTEOMICS AND POLYMER CHEMISTRY
3
rd
International Conference on
OF EXCELLENCE
IN INTERNATIONAL
MEETINGS
alliedacademies.comYEARS
glass to ensure its suitability for the pH of the product; use COC/COP vial.
Present market demand is syringe barrel and/or plunger coatedwith silicone.
Non-uniform silicone coatings can affect protein stability. The proteins can
absorb into the walls of the container. While silicone can reduce absorp-
tion, excess silicone can form suspended oil-like droplets. Proteins can form
around those droplets and change their natural state. New lubricant coat-
ings, such as inert fluoropolymers, are being introduced to replace silicone.
As a very inert material, fluoropolymer provides smoothness for the syringe
plunger without the irregularities or the issues that have come with silicone.
Other new coating materials are being introduced with new types of pack-
aging related to self-injectors, especially injector pens, patches, transdermal
and wearable devices for self-infusion. Extractable and leachable are most
important for inhalers and catheters. For an extractables from a device com-
ponent the AET (μg/g) can be determined using Equation 1:
Where
Dd- Doses per day
Dt- Total Labelled doses
m- Mass of component
The AET (μg/device) for a drug delivery device (e.g. an MDI) can be determined from Equation 2:
Where
Dd- Doses per day
Dt- Total Labelled doses
Recent Publications
1.
AnupamChanda (2019) Packaging Challenge for Lyophilized Products. Acta Scientific Pharmaceutical Sciences
3.4: 87-91
2.
Anupam Chanda (2018) Packaging Challenge for Biosimilar products. J Bioanal Biomed10: 82