Quality by Design (QbD)

Abstract The hybrid modeling strategy which is based on the integration of mechanistic and data-driven models is proposed and applied on fluidized bed granulation processes. The tight combination of empirical process knowledge by means of a mechanistic model and the multivariate data from PAT…
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The study endeavors the fabrication of extended-release adipic acid (APA) buccal films employing a quality by design (QbD) approach. The films intended for the treatment of xerostomia were developed utilizing hot-melt extrusion technology. The patient-centered quality target product profile was…
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Introduction TYLOPUR® is Hypromellose (HPMC) and a versatile pharmaceutical excipient. TYLOPUR® is manufactured at Tyloshin 2 plant at SE Tylose GmbH & Co. KG in Wiesbaden, Germany. This plant operates under GMP conditions and fulfills the requirements of the pharmaceutical industry. SE Tylose…
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Abstract Parenteral administration is one of the most commonly used drug delivery routes for nanoparticle-based dosage forms, such as lipid-based and polymeric nanoparticles. For the treatment of various diseases, parenteral administration include intravenous, subcutaneous, and intramuscular…
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The MEDELPHARM STYL’One Nano is a compact yet powerful compaction simulator designed for early-stage tablet formulation in research and development settings. It provides researchers with a comprehensive solution for addressing formulation challenges encountered during tablet and oral solid dose…
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To formulate and optimize Ozenoxacin nano-emulsion using Quality by Design (QbD) concept by means of Box–Behnken Design (BBD) and converting it to a gel to form Ozenoxacin nano-emulgel followed by physico-chemical, in-vitro, ex-vivo and in-vivo evaluation. This study demonstrates the application of…
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Abstract Traditional operation modes, such as running the production processes at constant process settings or within a narrow design space, do not fully exploit the advantages of continuous pharmaceutical manufacturing. Integrating Quality by Control (QbC) algorithms as a standard component of…
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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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