PMID- 28879628
OWN - NLM
STAT- MEDLINE
DCOM- 20180712
LR  - 20181113
IS  - 1550-7416 (Electronic)
IS  - 1550-7416 (Linking)
VI  - 19
IP  - 6
DP  - 2017 Nov
TI  - In vitro Approaches to Support Bioequivalence and Substitutability of Generic 
      Proton Pump Inhibitors via Nasogastric Tube Administration.
PG  - 1593-1599
LID - 10.1208/s12248-017-0137-x [doi]
AB  - Administration of proton pump inhibitors (PPIs) through nasogastric tubes may 
      present risks. If the PPI drug products are not prepared properly, clogging or 
      obstruction of nasogastric tubes can pose a safety concern. In addition, the 
      integrity of the enteric coating of the drug product may be damaged resulting in 
      reduced bioavailability of the active moiety. From the perspective of 
      administration of generic PPIs when compared to the reference drug product, 
      differences in formulation can potentially result in a greater relative risk for 
      the generic drug product. As part of the assessment of bioequivalence, the Office 
      of Generic Drugs (OGD) has developed a suite of in vitro testing to compare the 
      delivery of the generic and reference products via nasogastric tubes. These in 
      vitro tests assess essential attributes associated with the likelihood of 
      clogging and maintenance of the enteric coating. These in vitro tests include 
      studies evaluating sedimentation, granule size distribution, drug recovery, and 
      acid resistance. One of the challenges is that while the administration of PPIs 
      through nasogastric tubes is common in clinical practice, this issue is not 
      uniformly addressed in the FDA approved label of the reference drug products. 
      This paper discusses the design and rationale for in vitro testing of PPI 
      formulations with respect to bioequivalence via nasogastric tube administration 
      and in addition, it summarizes commonly occurring deficiencies in the in vitro 
      nasogastric tube testing of 14 recent Abbreviated New Drug Applications (ANDA) 
      submitted for five generic PPI drug products.
FAU - Ren, Ping
AU  - Ren P
AD  - Office of Research and Standards, Office of Generic Drugs, Center for Drug 
      Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
FAU - Cui, Minglei
AU  - Cui M
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Anand, Om
AU  - Anand O
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Xia, Li
AU  - Xia L
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Zhao, Zhuojun J
AU  - Zhao ZJ
AD  - Division of Biopharmaceutics, Office of New Drug Products, Office of 
      Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and 
      Drug Administration, Silver Spring, Maryland, 20993, USA.
FAU - Sun, Dajun
AU  - Sun D
AD  - Office of Research and Standards, Office of Generic Drugs, Center for Drug 
      Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
FAU - Sharp, Trueman
AU  - Sharp T
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Conner, Dale P
AU  - Conner DP
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Peters, John
AU  - Peters J
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Jiang, Wenlei
AU  - Jiang W
AD  - Office of Research and Standards, Office of Generic Drugs, Center for Drug 
      Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, 
      Maryland, 20993, USA.
FAU - Stier, Ethan
AU  - Stier E
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA.
FAU - Jiang, Xiaojian
AU  - Jiang X
AD  - Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and 
      Research, U.S. Food and Drug Administration, 10903 New Hampshire, Silver Spring, 
      Maryland, 20993, USA. xiaojian.jiang@fda.hhs.gov.
LA  - eng
PT  - Journal Article
DEP - 20170906
PL  - United States
TA  - AAPS J
JT  - The AAPS journal
JID - 101223209
RN  - 0 (Drugs, Generic)
RN  - 0 (Proton Pump Inhibitors)
SB  - IM
MH  - Drug Compounding
MH  - Drugs, Generic/administration & dosage/*pharmacokinetics
MH  - Humans
MH  - *Intubation, Gastrointestinal
MH  - Proton Pump Inhibitors/administration & dosage/*pharmacokinetics
MH  - Therapeutic Equivalency
OTO - NOTNLM
OT  - abbreviated new drug applications
OT  - deficiency
OT  - formulation design
OT  - generic drug
OT  - nasogastric tube study
OT  - proton pump inhibitors
EDAT- 2017/09/08 06:00
MHDA- 2018/07/13 06:00
CRDT- 2017/09/08 06:00
PHST- 2017/06/21 00:00 [received]
PHST- 2017/08/18 00:00 [accepted]
PHST- 2017/09/08 06:00 [pubmed]
PHST- 2018/07/13 06:00 [medline]
PHST- 2017/09/08 06:00 [entrez]
AID - 10.1208/s12248-017-0137-x [pii]
AID - 10.1208/s12248-017-0137-x [doi]
PST - ppublish
SO  - AAPS J. 2017 Nov;19(6):1593-1599. doi: 10.1208/s12248-017-0137-x. Epub 2017 Sep 
      6.