Quality by Design (QbD)

Abstract The development of a robust oral solid dosage form requires knowledge of all the sources of variation that could impact the dosage form’s performance and stability, in line with Quality-by-Design (QbD). This requires a deep understanding of the relationships between raw material…
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Abstract The incorporation of poorly soluble active ingredients, which make up the majority of the molecules in development, into fixed-dose combination (FDC) products can be an efficient method to improve the pharmacokinetic properties of these compounds, as well as reduce the side effects and…
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Abstract Quality by Design (QbD) is a transformative and systematic approach to developing top-tier pharmaceutical products, ushering in a departure from traditional trial-and-error methods toward a more science-based, risk-oriented, and holistic strategy. Central to QbD implementation is the…
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Abstract This research study aimed to develop and evaluate a novel freeze-dried nanocrystals formulation of sotorasib (AMG-510) using Quality by Design (QbD) approach to enhance solubility, dissolution, and oral bioavailability. A QbD framework use for identification, optimization and validation of…
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Abstract Aim The present work was aimed to formulate and optimize fast dissolving thin strips of Desvenlafaxine Hydrochloride using QbD. Materials and Methods The solvent casting method was used to formulate fast dissolving thin strips. The drug (Desvenlafaxine HCl), polymer (pullulan), super…
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Abstract The porosity of a pharmaceutical tablet influences liquid transport, disintegration and dissolution, rendering its monitoring and control crucial for quality by design. Optical porosimetry, a non-destructive process analytical technology (PAT), combines gas in scattering media absorption…
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Abstract Ivermectin (IVM) is a widely used antiparasitic agent and has been repurposed for the treatment of COVID-19. However, its poor water solubility and low bioavailability present significant challenges, often requiring large doses for therapeutic effectiveness. This poses a burden on…
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Abstract The main purpose of this study was to design and develop a solid self-nanoemulsifying drug delivery system (S-SNEDDS) for the oral administration of benidipine (BD) and telmisartan (TEL) using the adsorption method with eucalyptus oil, Transcutol P, and Kolliphor EL via the Box–Behnken…
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Abstract There is a significant deficiency of suitable pediatric medications, attributed to limited market, trial complexities, and strict regulatory requirements. Ensuring appropriate dosing and medication acceptance in this population requires careful consideration of age, weight, and…
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Abstract The current study presents a comprehensive pharmaceutical engineering approach to developing an advanced transdermal drug delivery system for addressing skin hyperpigmentation through innovative nanocomposite gel formulation. Utilizing a systematic Quality-by-Design (QbD) methodology with…
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