PMID- 12711176
OWN - NLM
STAT- MEDLINE
DCOM- 20030529
LR  - 20190910
IS  - 0378-5173 (Print)
IS  - 0378-5173 (Linking)
VI  - 257
IP  - 1-2
DP  - 2003 May 12
TI  - Migration of antioxidant additives from various polyolefinic plastics into 
      oleaginous vehicles.
PG  - 217-25
AB  - The migration of the antioxidant additives pentaerythrityl 
      tetrakis(3,5-di-tert-butyl-4-hydroxyphenyl)propionate (Irganox 1010) and 
      tris(2,4-di-tert-butylphenyl)phosphite (Irgafos 168) from polyolefinic packaging 
      into oily vehicles was investigated. The polyolefins included in the study were 
      from the following classes: isotactic polypropylene homopolymer (PP), 
      ethylene-co-propylene random copolymer (RACO), ethylene-propylene heterophasic 
      copolymer and ethylene-propylene amorphous copolymer blend (EP) and high-density 
      polyethylene (HDPE). Each polymer was additioned with Irganox 1010 (0.15%, w/w) 
      and Irgafos 168 (0.15%, w/w) and processed into blown bottles. To study the 
      antioxidant release process, plastic sheets were cut from the bottles and dipped 
      for various time intervals into a mixture of five oils (caprylic/capric 
      triglyceride, cyclomethicone, dicaprylyl ether, isohexadecane and C(12-15) alkyl 
      benzoate) representative of lipophilic excipients used in pharmaceutical and 
      cosmetic formulations. After exposure to the oil medium, the non-migrated Irganox 
      1010 and Irgafos 168 were recovered from the polymeric matrices using 
      microwave-assisted extraction with ethyl acetate-hexane and assayed by HPLC. The 
      leaching of the two antioxidants varied remarkably depending on the polyolefin 
      crystallinity and structure. The amount of Irganox 1010 transferred into the 
      contact medium at 25 degrees C decreased in the order EP>RACO>PP>HDPE. The same 
      polyolefin ranking was observed in the case of Irgafos 168, except for PP and 
      HDPE which exhibited similar depletion of this additive. Migration of Irgafos 168 
      was greater than that of Irganox 1010 and the release of both antioxidants 
      increased at higher temperature (50 degrees C). The obtained data are useful for 
      the selection of polyolefinic matrices as raw-materials for the production of 
      pharmaceutical and cosmetic containers.
FAU - Marcato, B
AU  - Marcato B
AD  - Basell Polyolefins, G. Natta Research Centre, 44100 Ferrara, Italy.
FAU - Guerra, S
AU  - Guerra S
FAU - Vianello, M
AU  - Vianello M
FAU - Scalia, S
AU  - Scalia S
LA  - eng
PT  - Journal Article
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
RN  - 0 (Antioxidants)
RN  - 0 (Pharmaceutical Vehicles)
RN  - 0 (Phosphites)
RN  - 0 (Plastics)
RN  - 0 (Polyenes)
RN  - 1P9D0Z171K (Butylated Hydroxytoluene)
RN  - 31570-04-4 (tris-(2,4-di-tert-butylphenyl) phosphite)
RN  - 6683-19-8 (Irganox 1010)
RN  - 83136-87-2 (PL 732)
SB  - IM
MH  - Antioxidants/*chemistry
MH  - Butylated Hydroxytoluene/*analogs & derivatives/*chemistry
MH  - *Drug Packaging
MH  - Pharmaceutical Vehicles
MH  - Phosphites/*chemistry
MH  - Plastics/*chemistry
MH  - Polyenes/*chemistry
EDAT- 2003/04/25 05:00
MHDA- 2003/05/30 05:00
CRDT- 2003/04/25 05:00
PHST- 2003/04/25 05:00 [pubmed]
PHST- 2003/05/30 05:00 [medline]
PHST- 2003/04/25 05:00 [entrez]
AID - S0378517303001431 [pii]
AID - 10.1016/s0378-5173(03)00143-1 [doi]
PST - ppublish
SO  - Int J Pharm. 2003 May 12;257(1-2):217-25. doi: 10.1016/s0378-5173(03)00143-1.