PMID- 30805341
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 6
DP  - 2019
TI  - Heparins Sourced From Bovine and Porcine Mucosa Gain Exclusive Monographs in the 
      Brazilian Pharmacopeia.
PG  - 16
LID - 10.3389/fmed.2019.00016 [doi]
LID - 16
AB  - Most of the unfractionated heparin (UFH) consumed worldwide is manufactured using 
      porcine mucosa as raw material (HPI); however, some countries also employ 
      products sourced from bovine mucosa (HBI) as interchangeable versions of the gold 
      standard HPI. Although accounted as a single UFH, HBI, and HPI have differing 
      anticoagulant activities (~100 and 200 IU mg(-1), respectively) because of their 
      compositional dissimilarities. The concomitant use of HBI and HPI in Brazil had 
      already provoked serious bleeding incidents, which led to the withdrawal of HBI 
      products in 2009. In 2010, the Brazilian Pharmacopeia (BP) formed a special 
      committee to develop two complementary monographs approaching HBI and HPI 
      separately, as distinct active pharmaceutical ingredients (APIs). The committee 
      has rapidly agreed on requirements concerning the composition and presence of 
      contaminants based on nuclear magnetic resonance and anion-exchange 
      chromatography. On the other hand, consensus on the anticoagulant activity of HBI 
      was the subject of long and intense discussions. Nevertheless, the committee has 
      ultimately agreed to recommend minimum anti-FIIa activities of 100 IU mg(-1) for 
      HBI and 180 IU mg(-1) for HPI. Upon the approval by the Brazilian Health 
      Authority (ANVISA), the BP published the new monographs for HPI and HBI APIs in 
      2016 and 2017, respectively. These pioneer monographs represent a pivotal step 
      toward the safest use of HBI and HPI as interchangeable anticoagulants and serve 
      as a valuable template for the reformulation of pharmacopeias of other countries 
      willing to introduce HBI.
FAU - Vilanova, Eduardo
AU  - Vilanova E
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Vairo, Bruno C
AU  - Vairo BC
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Oliveira, Stephan-Nicollas M C G
AU  - Oliveira SMCG
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Glauser, Bianca F
AU  - Glauser BF
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Capille, Nina V
AU  - Capille NV
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Santos, Gustavo R C
AU  - Santos GRC
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Tovar, Ana M F
AU  - Tovar AMF
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Pereira, Mariana S
AU  - Pereira MS
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
FAU - Mourao, Paulo A S
AU  - Mourao PAS
AD  - Laboratorio de Tecido Conjuntivo, Hospital Universitario Clementino Fraga Filho 
      and Instituto de Bioquimica Medica Leopoldo de Meis, Universidade Federal do Rio 
      de Janeiro, Rio de Janeiro, Brazil.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20190205
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC6371698
OTO - NOTNLM
OT  - anticoagulant drugs
OT  - antithrombotic drugs
OT  - bioequivalence
OT  - cardiovascular surgeries
OT  - drug regulation
OT  - extracorporeal circulation
OT  - low molecular weight heparin
OT  - unfractionated heparin
EDAT- 2019/02/26 06:00
MHDA- 2019/02/26 06:01
PMCR- 2019/02/05
CRDT- 2019/02/27 06:00
PHST- 2018/10/22 00:00 [received]
PHST- 2019/01/18 00:00 [accepted]
PHST- 2019/02/27 06:00 [entrez]
PHST- 2019/02/26 06:00 [pubmed]
PHST- 2019/02/26 06:01 [medline]
PHST- 2019/02/05 00:00 [pmc-release]
AID - 10.3389/fmed.2019.00016 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2019 Feb 5;6:16. doi: 10.3389/fmed.2019.00016. eCollection 
      2019.