AAPS Open
2364-9534
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Development and validation of a headspace GC-MS method to evaluate the interconversion of impurities and the product quality of liquid hand sanitizers
Tập 8 Số 1 - 2022
AbstractThe COVID-19 pandemic has led to increased usage of hand sanitizer
products by the public to prevent the spread of COVID-19 and decrease the
likelihood of acquiring the disease. The increase in demand has also led to an
increase in the number of manufacturers. This work describes the FDA’s Center
for Drug Evaluation and Research (CDER) laboratories efforts to develop tests to
assess the qu...
Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach
Tập 7 Số 1
AbstractSkin cancer is fifth most diagnosed disease in human population due to
ultraviolet radiation (UV) exposure. Gamma oryzanol (OZ) is a natural
antioxidant, and it also has skin anti-aging properties. OZ is naturally found
in rice bran oil. The main aim of the present work was to optimize OZ niosomal
formulation using quality by design approach including one variable at a time
and full factor...
Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT)
- 2021
Abstract We previously developed a triazole modified tetraiodothyroacetic acid
(TAT) conjugated to a polyethylene glycol (PEG)-based thyrointegrin αvβ3
antagonist targeted compound, called P-bi-TAT. It exhibited potent
anti-angiogenic and anticancer activities in vivo. The objective of the current
study is to develop a quantitative bioanalytical method for P-bi-TAT using
liquid chromatography-tand...
Understanding the implication of Kawakita model parameters using in-die force-displacement curve analysis for compacted and non-compacted API powders
Tập 8 Số 1 - 2022
AbstractThe aim of this study was to investigate powder mechanics upon
compression using data obtained from force-displacement (F-D) curves. The
Kawakita model of powder compression analysis was adopted in order to compare
the pressure-volume reduction relationship of the drug powders in relation to
the F-D curves. Experiments were carried out on six model drugs (metronidazole,
metformin, secnidaz...
Customer-centric product presentations for monoclonal antibodies
AbstractDelivering customer-centric product presentations for biotherapeutics,
such as monoclonal antibodies (mAbs), represents a long-standing and paramount
area of engagement for pharmaceutical scientists. Activities include improving
experience with the dosing procedure, reducing drug administration-related
expenditures, and ultimately shifting parenteral treatments outside of a
controlled heal...
Strategies to stabilize dalbavancin in aqueous solutions: Section 4—identification of heat degradation products in 2-hydroxypropyl-β-cyclodextrin and divalent metal ion solutions at pH 4.5 and 7.0
AbstractHeat stress studies have been conducted in support of developing a
heat-stable liquid solution of dalbavancin. The degradation products that form
in heat-stressed buffered dalbavancin solutions have been identified, including
the known major degradation product, mannosyl aglycone (MAG), and four
previously uncharacterized compounds. Liquid chromatography-mass
spectrometry/mass spectrometry...
Nano-formulations composed of cell membrane-specific cellular lipid extracts derived from target cells: physicochemical characterization and in vitro evaluation using cellular models of breast carcinoma
Tập 4 - Trang 1-9 - 2018
Highly selective drug targeting is an important goal in the development of
cancer nanotechnologies. In an effort to improve tumor targeting a method was
developed to formulate cell membrane lipid-extracted nanoliposomes (CLENs). The
main ingredients were extracted directly from the membrane of cancer cells. For
this study we used three different breast cancer cell lines (4 T1, BT-20, and
SK-BR-3)....