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  2364-9534

 

 

 

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ANVISA: an introduction to a new regulatory agency with many challenges
- 2018
Kim Huynh‐Ba, Alexandra B. Sassi
Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach
Tập 7 Số 1
Harsh Shah, Ankit Gotecha, Dolly Jetha, Amarjitsing Rajput, Aditi Bariya, Shital S. Panchal, Shital Butani
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 v...... hiện toàn bộ
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
Nicolas Abrigo, Connie Ruzicka, Patrick J. Faustino, Neil Stiber, Agnes NguyenPho, Thomas O’Connor, Diaá M. Shakleya
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 ...... hiện toàn bộ
Development and evaluation of taste masked dry syrup formulation of potassium chloride
- 2019
Madhur Kulkarni, Brijesh Vishwakarma, Siddhartha Sen, Sandhya Anupuram, Abhijit A. Date
Pharmacokinetics and biodistribution of a novel anticancer thyrointegrin αvβ3 antagonist: triazole modified tetraiodothyroacetic acid conjugated to polyethylene glycol (P-bi-TAT)
- 2021
Kazutoshi Fujioka, Kavitha Godugu, Shaker A. Mousa
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 qua...... hiện toàn bộ
Customer-centric product presentations for monoclonal antibodies
Beate Bittner
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 treatm...... hiện toàn bộ
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
Iyad Rashid, Rula Raji Haddadin, Ashaar Abdulsalam Alkafaween, Rawan Al-Karaki, Rehan Mohammad Alkasasbeh
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 (m...... hiện toàn bộ
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
Sardar M. Jakaria, David E. Budil, James Murtagh
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-ma...... hiện toàn bộ
Oral nanoemulsions of candesartan cilexetil: formulation, characterization and in vitro drug release studies
Tập 3 - Trang 1-16 - 2017
Halah Hussein Ali, Ahmed Abbas Hussein
Nanoemulsion is considered to be a new and exciting field of research that seeks to exploit the attractive properties of components to improve oral delivery of drugs like candesartan cilexetil used in the management of chronic diseases. Candesartan cilexetil is a lipophilic acidic drug with a half-life of about (5–10) hour and absolute bioavailability of (14–40%). For this reason, the study target...... hiện toàn bộ