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Quality by Design (QbD)
Formulating Resveratrol and Melatonin Self-Nanoemulsifying Drug Delivery Systems (SNEDDS) for Ocular…
Recent studies have demonstrated that Sirtuin-1 (SIRT-1)-activating molecules exert a protective role in degenerative ocular diseases. However, these molecules hardly reach the back of the eye due to poor solubility in aqueous environments and low bioavailability after topical application on the…
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A Quality by Design Approach for Developing SNEDDS Loaded with Vemurafenib for Enhanced Oral…
Vemurafenib (VMF) is a practically insoluble (< 0.1 μg/mL) and least bioavailable (1%) drug. To enhance its oral bioavailability and solubility, we formulated a reliable self-nano emulsifying drug delivery system (SNEDDS). A Quality by Design (QbD) approach was used to optimize the ratio of…
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Discriminative Dissolution Method Development Through an aQbD Approach
Using a one-factor-at-a-time approach for dissolution method and discrimination analysis can be time-consuming and may not yield the optimal and discriminative method. To address this, we have developed a two-stage workflow for the dissolution method development followed by demonstration of…
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Quality by Design Galvanized development of resveratrol loaded PLGA nanoparticles: In vitro and Ex…
Melanoma is a lethal form of skin cancer, which progresses with poor prognosis. The melanoma tumors are highly metastatic in nature, which often leads to tumorigenesis in lungs and brain tissues. Invasion and migration are mainly responsible for poor 5-year survival rate of ∼32 % after diagnosis of…
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Quality by design aided self-nano emulsifying drug delivery systems development for the oral…
The primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-by-design (QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the…
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Quality by design (QbD) commended exploration of bosutinib loaded lipid nanocarriers for food effect…
Abstract
Bosutinib (BOS), a BCS class IV drug suffers from poor aqueous solubility and bioavailability along with significant food effect. Lipid nanocarriers (LNC) have the potential to circumvent bioavailability related issues associated with hydrophobic moieties. In this endeavor, we explore the…
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An Integrated Real-time Monitoring and Statistical Process Control Approach for Coating Process and…
Abstract
Purpose
The thickness and other quality aspects of pharmaceutical coatings can be significantly impacted by coating process conditions. Under certain circumstances, they can notably influence the drug product performance such as dissolution profiles. Typically, a target coating…
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Complexities related to the amorphous content of lactose carriers
Abstract
Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and regulatory agencies believe that the levels of amorphous content should be controlled once there is a relationship with the…
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MeltSerts Technology (Brinzolamide ocular inserts via hot-melt extrusion): QbD-steered development,…
The research work aimed to develop a robust sustained release biocompatible brinzolamide (BRZ)-loaded ocular inserts (MeltSerts) using hot-melt extrusion technology with enhanced solubility for glaucoma management. A 32 rotatable central composite design was employed for the optimization of the…
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QbD-driven development of phospholipid-embedded lipidic nanocarriers of raloxifene: extensive in…
Raloxifene (RLX) is popularly indicated in treatment of osteoporosis and prevention of breast cancer. Owing to its poor aqueous solubility, high pre-systemic metabolism, intestinal glucuronidation, and P-glycoprotein (P-gp) efflux, however, it demonstrates low (< 2%) and inconsistent oral…
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