Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach

Henríquez, Luis Castillo; Zúñiga, Rolando Vargas; Berrocal, Gustavo Carazo; Redondo, German Madrigal; Guzmán, Briner Calvo; Viales, Eleaneth Baltodano

doi:10.1080/03639045.2019.1652637

Cited by 11 publications

(11 citation statements)

References 16 publications

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“…Currently, most of the drug products available do not address the growing demand for personalized therapies. Many of them face several formulation challenges due to the physicochemical properties of the APIs, which may prevent the development of a suitable pharmaceutical form that exerts an adequate therapeutic effect [133][134][135]. However, the rapid growth of nanotechnology intends to contribute greatly to medical and pharmaceutical sciences, providing innovative treatments that can improve patients' lives.…”

Section: Technological Issues For the Formulation Of Poorly Water-solmentioning

confidence: 99%

Electrospun nanofibers: A nanotechnological approach for drug delivery and dissolution optimization in poorly water-soluble drugs

et al. 2020

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<p class="ADMETabstracttext">Electrospinning is a novel and sophisticated technique for the production of nanofibers with high surface area, extreme porous structure, small pore size, and surface morphologies that make them suitable for biomedical and bioengineering applications, which can provide solutions to current drug delivery issues of poorly water-soluble drugs. Electrospun nanofibers can be obtained through different methods asides from the conventional one, such as coaxial, multi-jet, side by side, emulsion, and melt electrospinning. In general, the application of an electric potential to a polymer solution causes a charged liquid jet that moves downfield to an oppositely charged collector, where the nanofibers are deposited. Plenty of polymers that differ in their origin, degradation character and water affinity are used during the process. Physicochemical properties of the drug, polymer(s), and solvent systems need to be addressed to guarantee successful manufacturing. Therefore, this review summarizes the recent progress in electrospun nanofibers for their use as a nanotechnological tool for dissolution optimization and drug delivery systems for poorly water-soluble drugs.</p>

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Section: Technological Issues For the Formulation Of Poorly Water-solmentioning

confidence: 99%

Electrospun nanofibers: A nanotechnological approach for drug delivery and dissolution optimization in poorly water-soluble drugs

et al. 2020

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“…As the results obtained through the analysis of natural raw materials are influenced in some degree by noise or uncontrolled variables, there must be a strategy for the minimization of the effects caused by them. That's why randomization was employed in this study, because it allows a better statistical distribution of the error attributable to those factors among the results (Castillo-Henríquez et al, 2019a;Mead et al, 2012;Reichert et al, 2019).…”

Section: Output Variablementioning

confidence: 99%

Design of Experiments Assessment for the Determination of Moisture Content in Five Herbal Raw Materials Contained in Tea Products

et al. 2020

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Research interest in natural raw materials is rapidly growing due to the high demand for natural products like herbal teas. Their quality control has a direct impact on safety and efficacy. The aim of this study was to evaluate the impact of sample�s mass and temperature on moisture content in Camellia sinensis (Black tea), Cassia fistula (Senna), Chamaemelum nobile (Chamomille), Lippia alba (Juanilama) and Tilia platyphyllos (Linden) with a gravimetric method developed through a full factorial 32 DoE. A response optimizer was executed in order to establish the test conditions that allow obtaining a response according to a target value from a certified method. DoE�s ANOVA shows reproducibility for Camellia sinensis, Cassia fistula, and Lippia alba. Also, the method�s model is able to explain the response variability for all samples based on the R2 (adj). The composite desirability for the proposed conditions of analysis for the five herbal materials is satisfactory according to each target value. However, the lack of reproducibility in Chamaemelum nobile and Tilia platyphyllos and also, the response prediction problems according to the R2 (pred) for Cassia fistula and Chamaemelum nobile, suggest the execution of further studies for them. Therefore, the present method is considered to be adequate for the analysis of moisture content in Camellia sinensis and Lippia alba raw herbs.

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“…[21] Remarkably, since QbD was accepted and strongly advised by the FDA in 2004, DoE has been widely reported in the literature for screening and optimization applications, from clas-sical dosage forms to nano-enabled medicinal products, to provide a comprehensive understanding of pharmaceutical formulations and their manufacturing process. [20][21][22][23] Various CQAs of NCs prepared by the solvent-antisolvent nanoprecipitation (e.g., size, polydispersity, morphology, stability) are impacted by the materials and the unit operations. Hence, several factors must be optimized during early development.…”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Step‐By‐Step Standardization of the Bottom‐Up Semi‐Automated Nanocrystallization of Pharmaceuticals: A Quality By Design and Design of Experiments Joint Approach

Castillo Henríquez,

Bahloul,

Alhareth

et al. 2024

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Nanosized drug crystals have been reported with enhanced apparent solubility, bioavailability, and therapeutic efficacy compared to microcrystal materials, which are not suitable for parenteral administration. However, nanocrystal design and development by bottom‐up approaches are challenging, especially considering the non‐standardized process parameters in the injection step. This work aims to present a systematic step‐by‐step approach through Quality‐by‐Design (QbD) and Design of Experiments (DoE) for synthesizing drug nanocrystals by a semi‐automated nanoprecipitation method. Curcumin is used as a drug model due to its well‐known poor water solubility (0.6 µg mL−1, 25 °C). Formal and informal risk assessment tools allow identifying the critical factors. A fractional factorial 24−1 screening design evaluates their impact on the average size and polydispersity of nanocrystals. The optimization of significant factors is done by a Central Composite Design. This response surface methodology supports the rational design of the nanocrystals, identifying and exploring the design space. The proposed joint approach leads to a reproducible, robust, and stable nanocrystalline preparation of 316 nm with a PdI of 0.217 in compliance with the quality profile. An orthogonal approach for particle size and polydispersity characterization allows discarding the formation of aggregates. Overall, the synergy between advanced data analysis and semi‐automated standardized nanocrystallization of drugs is highlighted.

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Development of immediate release Rupatadine fumarate 10 mg tablets: A Quality by Design (QbD) approach

Cited by 11 publications

References 16 publications

Electrospun nanofibers: A nanotechnological approach for drug delivery and dissolution optimization in poorly water-soluble drugs

Electrospun nanofibers: A nanotechnological approach for drug delivery and dissolution optimization in poorly water-soluble drugs

Design of Experiments Assessment for the Determination of Moisture Content in Five Herbal Raw Materials Contained in Tea Products

Step‐By‐Step Standardization of the Bottom‐Up Semi‐Automated Nanocrystallization of Pharmaceuticals: A Quality By Design and Design of Experiments Joint Approach

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