PMID- 22732267
OWN - NLM
STAT- MEDLINE
DCOM- 20130205
LR  - 20151119
IS  - 1873-3441 (Electronic)
IS  - 0939-6411 (Linking)
VI  - 82
IP  - 1
DP  - 2012 Sep
TI  - Pharmacokinetic and efficacy study of cisplatin and paclitaxel formulated in a 
      new injectable poly(sebacic-co-ricinoleic acid) polymer.
PG  - 85-93
LID - 10.1016/j.ejpb.2012.06.004 [doi]
AB  - Injectable biodegradable polymer poly(sebacic-co-ricinoleic acid), P(SA-RA) is 
      currently under development for intratumoral (IT) delivery of drugs for treating 
      solid tumors. This study presents formulation development, pharmacokinetic and 
      efficacy studies of two anticancer drugs (cisplatin and paclitaxel) formulated 
      with P(SA-RA) polymer. In pharmacokinetic study, systemic exposure and 
      pharmacokinetic parameters of cisplatin/paclitaxel following single intravenous 
      (IV) or subcutaneous (SC) doses of cisplatin/paclitaxel was compared with 
      intramuscular (IM) or SC doses of cisplatin/paclitaxel formulated with P(SA-RA) 
      polymer in male CD rat. Simultaneously, the tumor reduction effect and toxicity 
      for these formulations were evaluated in human FaDu head and neck tumor xenograft 
      subcutaneous nude mouse model. Pharmacokinetic data reflect the lower maximal 
      concentrations and sustained release of polymer-cisplatin/paclitaxel formulations 
      compared to standard cisplatin/paclitaxel administration. Regarding efficacy 
      study, a single IT or near the tumor injection (NT) of polymer-paclitaxel or 
      polymer-cisplatin formulation significantly reduced the tumor size, compared to 
      the standard paclitaxel or cisplatin treatments. No death or toxicity and no 
      effect on body weight as well as macroscopic and/or microscopic changes in or 
      near the injected area were observed, proving biocompatibility and acceptability 
      of polymer-formulations. In conclusion, the developed formulation demonstrated 
      controlled release and significant efficacy in delivering these agents and 
      exhibit potential for further clinical development.
CI  - Copyright (c) 2012 Elsevier B.V. All rights reserved.
FAU - Levy-Nissenbaum, Etgar
AU  - Levy-Nissenbaum E
AD  - BioLineRx Ltd., Jerusalem, Israel.
FAU - Khan, Wahid
AU  - Khan W
FAU - Pawar, Rajendra P
AU  - Pawar RP
FAU - Tabakman, Rinat
AU  - Tabakman R
FAU - Naftali, Esmira
AU  - Naftali E
FAU - Winkler, Ilan
AU  - Winkler I
FAU - Kaufman, Olga
AU  - Kaufman O
FAU - Klapper, Leah
AU  - Klapper L
FAU - Domb, Abraham J
AU  - Domb AJ
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20120623
PL  - Netherlands
TA  - Eur J Pharm Biopharm
JT  - European journal of pharmaceutics and biopharmaceutics : official journal of 
      Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V
JID - 9109778
RN  - 0 (Decanoic Acids)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Poly(sebacic acid-co-ricinoleic acid))
RN  - 0 (Polymers)
RN  - 0 (Ricinoleic Acids)
RN  - P88XT4IS4D (Paclitaxel)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
MH  - Animals
MH  - Antineoplastic Combined Chemotherapy Protocols/*administration & 
      dosage/pharmacokinetics/pharmacology
MH  - Cisplatin/administration & dosage
MH  - Decanoic Acids/*chemistry
MH  - Delayed-Action Preparations
MH  - Head and Neck Neoplasms/*drug therapy/pathology
MH  - Humans
MH  - Injections, Intramuscular
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Mice
MH  - Mice, Nude
MH  - Paclitaxel/administration & dosage
MH  - Polymers/*chemistry
MH  - Rats
MH  - Ricinoleic Acids/*chemistry
MH  - Xenograft Model Antitumor Assays
EDAT- 2012/06/27 06:00
MHDA- 2013/02/06 06:00
CRDT- 2012/06/27 06:00
PHST- 2012/03/17 00:00 [received]
PHST- 2012/05/30 00:00 [revised]
PHST- 2012/06/04 00:00 [accepted]
PHST- 2012/06/27 06:00 [entrez]
PHST- 2012/06/27 06:00 [pubmed]
PHST- 2013/02/06 06:00 [medline]
AID - S0939-6411(12)00191-9 [pii]
AID - 10.1016/j.ejpb.2012.06.004 [doi]
PST - ppublish
SO  - Eur J Pharm Biopharm. 2012 Sep;82(1):85-93. doi: 10.1016/j.ejpb.2012.06.004. Epub 
      2012 Jun 23.