PMID- 31276685
OWN - NLM
STAT- MEDLINE
DCOM- 20200908
LR  - 20200908
IS  - 1520-6017 (Electronic)
IS  - 0022-3549 (Linking)
VI  - 108
IP  - 11
DP  - 2019 Nov
TI  - Univariate and Multivariate Models for Determination of Prasugrel Base in the 
      Formulation of Prasugrel Hydrochloride Using XRPD Method.
PG  - 3575-3581
LID - S0022-3549(19)30427-7 [pii]
LID - 10.1016/j.xphs.2019.06.024 [doi]
AB  - Prasugrel hydrochloride (PHCl) undergoes salt disproportionation, and the 
      resulting prasugrel free base (PFB) may lead to the poor in vitro and or in vivo 
      performance of the drug product. The aim of the present work was to develop 
      univariate and multivariate models based on X-ray powder diffraction to quantify 
      the salt and base in the powder and tablet formulations. Compositionally 
      identical formulations of PHCl and PFB were prepared and mixed in various 
      proportions to make 0%-30% PFB sample matrices. The formulations consisted of 
      commonly used excipients, which are generally used in commercially available 
      products. X-ray powder diffraction data were collected and subjected to the least 
      square regression and partial least square regression analysis. The model 
      performance parameters such as root mean squared and standard errors were low for 
      univariate models compared to partial least square regression multivariate 
      models. Model predicted values of the independent sample matrices by both methods 
      matched closely with the actual values of PFB and PHCl. However, residual and 
      standard deviation were low in univariate models predicted values. The models 
      developed in this work have been shown to quantitate the PHCl disproportionation 
      to PFB fraction in the drug product and provide a means to control the 
      disproportionation of PHCl.
CI  - Copyright (c) 2019 American Pharmacists Association(R). Published by Elsevier Inc. 
      All rights reserved.
FAU - Dharani, Sathish
AU  - Dharani S
AD  - Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health 
      Science Center, Texas A&M University, College Station, Texas 77843.
FAU - Barakh Ali, Sogra F
AU  - Barakh Ali SF
AD  - Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health 
      Science Center, Texas A&M University, College Station, Texas 77843.
FAU - Afrooz, Hamideh
AU  - Afrooz H
AD  - Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health 
      Science Center, Texas A&M University, College Station, Texas 77843.
FAU - Khan, Mansoor A
AU  - Khan MA
AD  - Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health 
      Science Center, Texas A&M University, College Station, Texas 77843.
FAU - Rahman, Ziyaur
AU  - Rahman Z
AD  - Pharmaceutical Sciences, Irma Lerma Rangel College of Pharmacy, Texas A&M Health 
      Science Center, Texas A&M University, College Station, Texas 77843. Electronic 
      address: rahman@pharmacy.tamhsc.edu.
LA  - eng
PT  - Journal Article
DEP - 20190702
PL  - United States
TA  - J Pharm Sci
JT  - Journal of pharmaceutical sciences
JID - 2985195R
RN  - 0 (Excipients)
RN  - 0 (Powders)
RN  - 0 (Tablets)
RN  - G89JQ59I13 (Prasugrel Hydrochloride)
SB  - IM
MH  - Chemistry, Pharmaceutical/methods
MH  - Excipients/chemistry
MH  - Powder Diffraction/methods
MH  - Powders/chemistry
MH  - Prasugrel Hydrochloride/*chemistry
MH  - Tablets/chemistry
MH  - X-Ray Diffraction/methods
OTO - NOTNLM
OT  - X-ray powder diffraction
OT  - disproportionation
OT  - multivariate models
OT  - prasugrel
OT  - univariate models
EDAT- 2019/07/06 06:00
MHDA- 2020/09/09 06:00
CRDT- 2019/07/06 06:00
PHST- 2019/04/11 00:00 [received]
PHST- 2019/05/28 00:00 [revised]
PHST- 2019/06/26 00:00 [accepted]
PHST- 2019/07/06 06:00 [pubmed]
PHST- 2020/09/09 06:00 [medline]
PHST- 2019/07/06 06:00 [entrez]
AID - S0022-3549(19)30427-7 [pii]
AID - 10.1016/j.xphs.2019.06.024 [doi]
PST - ppublish
SO  - J Pharm Sci. 2019 Nov;108(11):3575-3581. doi: 10.1016/j.xphs.2019.06.024. Epub 
      2019 Jul 2.