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Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.

Abstract Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40?C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title aaps pharmscitech
Publication Year Start
%A Koo, Otilia M. Y.; Fiske, John D.; Yang, Haitao; Nikfar, Faranak; Thakur, Ajit; Scheer, Barry; Adams, Monica L.
%T Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.
%J AAPS PharmSciTech, vol. 12, no. 2, pp. 746-754
%D 06/2011
%V 12
%N 2
%M eng
%B Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40?C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.
%K Chemistry, Pharmaceutical, Crystallization, Differential Thermal Analysis, Drug Stability, Excipients, Polyvinyl Alcohol, Solubility
%P 746
%L 754
%Y 10.1208/s12249-011-9630-1
%W PHY
%G AUTHOR
%R 2011.......12..746K

@Article{Koo2011,
author="Koo, Otilia M. Y.
and Fiske, John D.
and Yang, Haitao
and Nikfar, Faranak
and Thakur, Ajit
and Scheer, Barry
and Adams, Monica L.",
title="Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.",
journal="AAPS PharmSciTech",
year="2011",
month="Jun",
day="07",
volume="12",
number="2",
pages="746--754",
keywords="Chemistry, Pharmaceutical",
keywords="Crystallization",
keywords="Differential Thermal Analysis",
keywords="Drug Stability",
keywords="Excipients",
keywords="Polyvinyl Alcohol",
keywords="Solubility",
abstract="Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40{\textdegree}C/75\% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.",
issn="1530-9932",
doi="10.1208/s12249-011-9630-1",
url="http://www.ncbi.nlm.nih.gov/pubmed/21647800",
language="eng"
}

%0 Journal Article
%T Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.
%A Koo, Otilia M. Y.
%A Fiske, John D.
%A Yang, Haitao
%A Nikfar, Faranak
%A Thakur, Ajit
%A Scheer, Barry
%A Adams, Monica L.
%J AAPS PharmSciTech
%D 2011
%8 Jun 07
%V 12
%N 2
%@ 1530-9932
%G eng
%F Koo2011
%X Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40?C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.
%K Chemistry, Pharmaceutical
%K Crystallization
%K Differential Thermal Analysis
%K Drug Stability
%K Excipients
%K Polyvinyl Alcohol
%K Solubility
%U http://dx.doi.org/10.1208/s12249-011-9630-1
%U http://www.ncbi.nlm.nih.gov/pubmed/21647800
%P 746-754

PT Journal
AU Koo, OMY
   Fiske, JD
   Yang, H
   Nikfar, F
   Thakur, A
   Scheer, B
   Adams, ML
TI Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.
SO AAPS PharmSciTech
PD Jun
PY 2011
BP 746
EP 754
VL 12
IS 2
DI 10.1208/s12249-011-9630-1
LA eng
DE Chemistry, Pharmaceutical; Crystallization; Differential Thermal Analysis; Drug Stability; Excipients; Polyvinyl Alcohol; Solubility
AB Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40?C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.
ER

PMID- 21647800
OWN - NLM
STAT- MEDLINE
DA  - 20110713
DCOM- 20120516
LR  - 20150204
IS  - 1530-9932 (Electronic)
IS  - 1530-9932 (Linking)
VI  - 12
IP  - 2
DP  - 2011 Jun
TI  - Investigation into stability of poly(vinyl alcohol)-based Opadry(R) II films.
PG  - 746-54
LID - 10.1208/s12249-011-9630-1 [doi]
AB  - Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet
      coating with numerous advantages. Our objective is to study the stability of
      PVA-based coating films in the presence of acidic additives, alkaline additives, 
      and various common impurities typically found in tablet formulations. Opadry(R)
      II 85F was used as the model PVA-based coating formulation. The additives and
      impurities were incorporated into the polymer suspension prior to film casting.
      Control and test films were analyzed before and after exposure to 40 degrees
      C/75% relative humidity. Tests included film disintegration, size-exclusion
      chromatography, thermal analysis, and microscopy. Under stressed conditions,
      acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4)))
      negatively impacted Opadry(R) II 85F film disintegration while NaOH,
      formaldehyde, and peroxide did not. Absence of PVA species from the
      disintegration media corresponded to an increase in crystallinity of PVA for
      reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of
      reactivity and less elevation in melting temperature with no clear change in
      melting enthalpy. Acidic additives posed greater risk of compromise in
      disintegration of PVA-based coatings than alkaline or common impurities. The
      mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs.
      NH(4)HSO(4)) may be different.
FAU - Koo, Otilia M Y
AU  - Koo OM
AD  - Drug Product Science and Technology, Bristol-Myers Squibb Company, New Brunswick,
      New Jersey 08903, USA. [email protected]
FAU - Fiske, John D
AU  - Fiske JD
FAU - Yang, Haitao
AU  - Yang H
FAU - Nikfar, Faranak
AU  - Nikfar F
FAU - Thakur, Ajit
AU  - Thakur A
FAU - Scheer, Barry
AU  - Scheer B
FAU - Adams, Monica L
AU  - Adams ML
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110607
PL  - United States
TA  - AAPS PharmSciTech
JT  - AAPS PharmSciTech
JID - 100960111
RN  - 0 (Excipients)
RN  - 9002-89-5 (Polyvinyl Alcohol)
SB  - IM
MH  - Chemistry, Pharmaceutical/*methods/standards
MH  - Crystallization/standards
MH  - Differential Thermal Analysis/standards
MH  - Drug Stability
MH  - Excipients/*chemistry/standards
MH  - Polyvinyl Alcohol/*chemistry/standards
MH  - Solubility
PMC - PMC3134661
OID - NLM: PMC3134661
EDAT- 2011/06/08 06:00
MHDA- 2012/05/17 06:00
CRDT- 2011/06/08 06:00
PHST- 2011/01/11 [received]
PHST- 2011/05/02 [accepted]
PHST- 2011/06/07 [aheadofprint]
AID - 10.1208/s12249-011-9630-1 [doi]
PST - ppublish
SO  - AAPS PharmSciTech. 2011 Jun;12(2):746-54. doi: 10.1208/s12249-011-9630-1. Epub
      2011 Jun 7.
TY  - JOUR
AU  - Koo, Otilia M. Y.
AU  - Fiske, John D.
AU  - Yang, Haitao
AU  - Nikfar, Faranak
AU  - Thakur, Ajit
AU  - Scheer, Barry
AU  - Adams, Monica L.
PY  - 2011/Jun/07
TI  - Investigation into stability of poly(vinyl alcohol)-based Opadry? II films.
JO  - AAPS PharmSciTech
SP  - 746
EP  - 754
VL  - 12
IS  - 2
KW  - Chemistry, Pharmaceutical
KW  - Crystallization
KW  - Differential Thermal Analysis
KW  - Drug Stability
KW  - Excipients
KW  - Polyvinyl Alcohol
KW  - Solubility
N2  - Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry? II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40?C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH(4)HSO(4))) negatively impacted Opadry? II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH(4)HSO(4) exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH(4)HSO(4)) may be different.
SN  - 1530-9932
UR  - http://dx.doi.org/10.1208/s12249-011-9630-1
UR  - http://www.ncbi.nlm.nih.gov/pubmed/21647800
ID  - Koo2011
ER  - 
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