Quality by Design (QbD)

Abstract Background: The current research work was aimed to optimize and develop Pulsatile Drug Delivery Systems (PDDS) of esomeprazole so as to control the nocturnal acid breakthrough in ulcer patients. Materials and Methods: Microparticles separately for Delayed Immediate Release (DIR) and…
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Abstract Nanoemulgels require two step formulation, the first one being formulation of nanoemulsion followed by the incorporation of nanoemulsion within a gel matrix. The current investigation aimed to formulate a Clobetasol-17-propionate (CP-17) nanoemulgel using QbD approach as anti-psoriatic for…
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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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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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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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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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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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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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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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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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