Investigation of Solid Dosage Form Components Interaction Using Orthogonal Techniques- Discovery of New Forms of Sodium Stearyl Fumarate.

Calorimetry, Differential Scanning Drug Stability Fumarates Spectroscopy, Fourier Transform Infrared X-Ray Diffraction
Hemi salt Hygroscopicity NMR Polymorphism Relative humidity Sodium stearyl fumarate pH of excipient

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
04 2021
Historique:
received: 28 08 2020
revised: 05 12 2020
accepted: 31 12 2020
pubmed: 20 1 2021
medline: 22 6 2021
entrez: 19 1 2021
Statut: ppublish

Résumé

Physical or chemical interactions between drug product (DP) components can occur during manufacturing and/or upon storage; and may alter DP shelf life and performance. In this work a new Powder X-ray Diffraction (PXRD) peak was observed in DP under accelerated storage conditions. Due to the complex drug product matrix (including API, polymer, fillers, super disintegrant and lubricant), it was challenging to pinpoint the component(s) responsible for the new peak. In addition to PXRD, other orthogonal techniques including Differential Scanning Calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapor sorption (DVS), Solid State Nuclear Magnetic Resonance (SSNMR) and Infrared (IR) spectroscopy were employed in this investigation to understand the root cause mechanistically. Specifically, multi nuclei SSNMR (

Identifiants

DOI: 10.1016/j.xphs.2020.12.040 PMID: 33465337
pubmed: 33465337
pii: S0022-3549(21)00028-9
doi: 10.1016/j.xphs.2020.12.040
pii:
doi:

Substances chimiques

Fumarates 0
sodium stearyl fumarate 7CV7WJK4UI

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1592-1600

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Muna Shrestha (M)

Vertex Pharmaceuticals Incorporated, Boston, MA 02210, USA. Electronic address: muna_shrestha@vrtx.com.

Helen Shi (H)

Vertex Pharmaceuticals Incorporated, Boston, MA 02210, USA.

Mark Strohmeier (M)

Vertex Pharmaceuticals Incorporated, Boston, MA 02210, USA.

Ales Medek (A)

Vertex Pharmaceuticals Incorporated, Boston, MA 02210, USA.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Analyse thermique différentielle › Calorimétrie différentielle à balayage › Investigation of Solid Dosage Form Components...
questionsmedicales.fr › Techniques d'investigation › Stabilité de médicament › Investigation of Solid Dosage Form Components...
questionsmedicales.fr › Composés chimiques organiques › Acides carboxyliques › Acides acycliques › Diacides carboxyliques › Fumarates › Investigation of Solid Dosage Form Components...
questionsmedicales.fr › Techniques d'investigation › Techniques de chimie analytique › Analyse spectrale › Spectrophotométrie › Spectrophotométrie IR › Spectroscopie infrarouge à transformée de Fourier › Investigation of Solid Dosage Form Components...
questionsmedicales.fr › Phénomènes chimiques › Diffraction des rayons X › Investigation of Solid Dosage Form Components...