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    Critical tools in tableting research: Using compaction simulator and quality by design (QbD) to evaluate lubricants’ effect in direct compressible formulation
    (AAPS PharmSciTech, 2021) Jiwa, Nailla; Özalp, Yıldız; Yeğen, Gizem; Aksu, Buket
    As commonly known, the product development stage is quite complex, requires intensive knowledge, and is time-consuming. The selection of the excipients with the proper functionality and their corresponding levels is critical to drug product performance. The objective of this study was to apply quality by design (QbD) principles for formulation development and to define the desired product quality profile (QTPP) and critical quality attributes (CQA) of a product. QbD is a risk- and science-based holistic approach for upgraded pharmaceutical development. In this study, Ibuprofen DC 85W was used as a model drug, Cellactose® 80 along with MicroceLac® 100 as a filler, and magnesium stearate, stearic acid, and sodium stearyl fumarate as lubricants. By applying different formulation parameters to the filler and lubricants, the QbD approach furthers the understanding of the effect of critical formulation and process parameters on CQAs and the contribution to the overall quality of the drug product. An experimental design study was conducted to determine the changes of the obtained outputs of the formulations, which were evaluated using the Modde Pro 12.1 statistical computer program that enables optimization by modeling complex relationships. The results of the optimum formulation revealed that MicroceLac® 100 was the superior filler, while magnesium stearate at 1% was the optimum lubricant. A design space that indicates the safety operation limits for the process and formulation variables was also created. This study enriches the understanding of the effect of excipients in formulation and assists in enhancing formulation design using experimental design and mathematical modeling methods in the frame of the QbD approach.
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    Design and development of oxyclozanide chewable tablet formulation employing quality by design approach
    (Association of Pharmaceutical Teachers of India, 2023) Özalp, Yıldız; Aboubakr, Adel; Onayo, Motunrayo Mayowa; Kebede, Hassen; Jiwa, Nailla; Aksu, Neşe Buket
    Background: The focus of this research was to identify undiscovered knowledge associated with the production of oxyclozanide tablets utilizing Quality by Design (QbD) in order to develop an ideal formulation that would guarantee constant product quality. The modern approach to formulation design and optimization essentially entails QbD which is a systemic method of pharmaceutical development and comprises of the design and development of formulations as well as manufacturing processes to meet the target product quality. Materials and Methods: Pre-formulation studies on excipient flow properties, compactibility and tabletability profiles, identification of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) were carried out. An experimental design was adopted to investigate the effect of formulation and process variables (compression force, super-disintegrant type and concentration) on the CQAs using Modde Pro 12.1. The obtained results were used to generate a Design Space (DS) based on the study data. Results: Preformulation studies carried out on the core excipients used, gave an understanding to their tabletability and compactibility. Process parameters such a compaction force and formulation variables such as super-disintegrant concentration were studied within the framework of Quality by Design (QbD) and the new optimized formulation derived was tested and confirmed to be within the design space generated. Conclusion: At the end of the study, the aim was achieved; which was to implement pre-formulation studies and QbD to design a formulation containing Oxyclozanide (API) with a combination of excipients.
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    Öğe
    Quality by design (QbD) approach and application of preformulation studies for a poorly water soluble model drug, Nimesulid
    (2023) Özalp, Yıldız; Khamis, Hala; Jiwa, Nailla; Mesut, Burcu; Aksu, Buket
    Formulating poorly water-soluble medications is one of the most crucial challenges encountered in the pharmaceutical industry. Due to this obstacle, the model drug chosen for this research was Nimesulide. The primary goal of this research was to obtain information on the drug's physical and chemical properties, either alone or in combination with excipients, in order design a formulation and create a stable and bioavailable dosage form. Formulations were designed using Flowlac (R) 100 and Avicel (R) 102 as fillers, Kollidon (R) 30 as a binder, Magnesium stearate as a lubricant, and variable concentrations of Kollidon (R) CL and Primojel as superdisintegrants. The tableting process was conducted using a compaction simulator. The Quality by Design (QbD) approach allows formulators to enhance product development with built-in product quality. In this study, to understand the relationship between excipients and compaction force differences on tablet properties, the QbD approach was applied by using a compaction simulator.