Quality by Design (QbD)

In this paper, we have studied Wurster Coating operation for the manufacture of modified release (MR) capsule products submitted to FDA as New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) by using a data-driven approach. We have collected and classified information into…
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This paper describes the specific control strategy of the commercial manufacturing process of an immediate release tablet formulation based on continuous twin-screw wet granulation. This control strategy has been defined by a multidisciplinary team using an enhanced approach, in alignment with the…
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The downstream processing of hot-melt extruded amorphous solid dispersions (ASDs) into tablets is challenging due to the low tabletability of milled ASDs. Typically, the extrudate strand is sized before milling, as the strand cannot be fed directly into the milling system. At the lab scale, the…
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The employment of site-specific administration in colon is a promising technique to improve efficacy and reduce systemic side effects of anticancer medications used in colorectal cancer. However, the physiology of the gastrointestinal tract and colonic environment limit the efficient delivery of…
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Various frameworks and methods, such as quality by design (QbD), real time release test (RTRT), and continuous process verification (CPV), have been introduced to improve drug product quality in the pharmaceutical industry. The methods recognize that an appropriate combination of process controls…
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Design and formulation of an ideal pharmaceutical product is a tedious job for a formulator as it comprises multiple objectives. The traditional method followed for years is not only expensive and time-consuming but also needs a lot of efforts in spite of which they are unfavorable and unpredictable…
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We aimed to develop nafamostat mesylate immediate-release tablets for the treatment of COVID-19 through drug repositioning studies of nafamostat mesylate injection. Nafamostat mesylate is a serine protease inhibitor known to inhibit the activity of the transmembrane protease, serine 2 enzyme that…
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Hesperetin (HT) is a polyphenolic compound with anti-carcinogenic, tumor necrosis, and anti-oxidant properties. The present study reports the fabrication, optimization, and evaluation of HT-loaded nanosponges (HTN)- based gel (HTNG) for sustained anti-inflammatory effect. HTN formulation was…
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The present study describes the formulation, optimization and characterization of quercetin loaded nanosuspension. The formulation was prepared using liquid antisolvent precipitation technique. Optimization of formulation was done using Box Behnken design by varying the concentration of sodium…
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OBJECTIVE CEOLUSTM UF-702 is the most flowable microcrystalline cellulose (MCC). While UF-702 has higher compactibility than standard grade PH-102, it has the lowest repose angle of known commercial grades of MCC. This is because the UF-702 particle has a round shape and has many pores inside its…
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