Yazar "Aksu, Buket" seçeneğine göre listele

Listeleniyor 1 - 20 / 24
  • [ X ]
    Öğe
    A survey study in Istanbul on communication between pharmacist and patient
    (University of Ankara, 2019) Aksu, Buket; Yeğen, Gizem; Yeşilada, Akgül
    Objective: Communication which has an undeniable place in our lives is accepted as a quality indicator in health care. Pharmacists interact with many patient groups in different features need to use effective communication tools and methods. Applicable methods and techniques to communicate change in different regions by the factors, mainly culture, demographic structure etc. In this study, determining the shortcomings for the pharmacist-patient-communication; accordingly forming a basis for structuring the pharmacy education was aimed. Material and Method: With the questions prepared as a result of literature reviews face to face interviews with pharmacists and pharmacy outpatients were conducted to evaluate the subjects such as main problems in communication, expectations and opinions of pharmacists and patients. Result and Discussion: As a result, being of a community pharmacist as relevant and solution-oriented and tried to understand the patient meet expectations; however, the most important elements of effective communication, like asking the right questions and feedback, are left under the expectation of the patients. In this concept, revision of pharmacy education and organizing trainings for graduated pharmacists to improve communication skills are required. © 2019 University of Ankara. All rights reserved.
  • [ X ]
    Öğe
    An optimization study on solid lipid nanoparticles using artificial neural network
    (Colegio Farmaceuticos Provincia De Buenos Aires, 2017) Yurdasiper, Aysu; Aksu, Buket; Okur, Neslihan U.; Gökçe, Evren H.
    Common use of supportive programs in finding the best in R&D studies provides positive results and thus ensures benefits to companies in terms of cost and time. The aim of this work was to develop, evaluate and optimize solid lipid nanoparticles (SLNs) formulations by applying the artificial neural network (ANN) programme to achieve the best combination of materials. SLNs have been produced by high-pressure homogenization, and the formulations have been characterized for their mean particle size, polydispersity index and zeta potential. SLN formulations were evaluated with INForm V5.1 program to optimize the best-fit formulation. According to ANN evaluation, S-PT8 formulation including 50% Compritol 888 ATO, 38% Poloxamer 188 and 12% Tween 80 mixture was found to be the most promising formulation in terms of parameters tested. It has been shown that artificial intelligence could be used to improve our understanding of the critical quality parameters that contribute to the overall quality of the drug product.
  • Küçük Resim
    Öğe
    Applying quality by design principles in the development and preparation of a new radiopharmaceutical: Technetium-99m-imatinib mesylate
    (Amer Chemical Soc, 2020) Gündoğdu, Evren; Demir, Emine Selin; Özgenç, Emre; Yeğen, Gizem; Aksu, Buket
    The clinical impact and accessibility of Tc-99m tracers for cancer diagnosis would be greatly enhanced by the availability of a new, simple, and easy labeling process and radiopharmaceuticals. In this study, Technetium-99m-imatinib mesylate ([Tc-99m]TcIMT) was developed and prepared as a new radiopharmaceutical for breast cancer diagnosis. The effect of critical process parameters on the product quality and stability of [Tc-99m]TcIMT was investigated using the quality by design concept of the ICH Q8 (Pharmaceutical Development) guideline. [Tc-99m]TcIMT was subjected to in vitro cell binding studies to determine healthy and cancer cell affinity using HaCaT and MCF-7 cells, respectively. The optimal radiolabeling procedure with 1 mg of IMT, 500 mu g of stannous chloride, 0.1 mg of ascorbic acid, and (1m)Ci Tc-99m radioactivity was obtained for [Tc-99m]TcIMT. The pH of the reaction mixture was adjusted to 10 and allowed to react for 15 min at room temperature. The radiochemical purity of [Tc-99m]TcIMT was found to be higher than 90% at room temperature up to 6 h. Chromatography analysis revealed >85% [Tc-99m]Tc1MT complex formation with promising stability in saline, cell medium, and serum up to 6 h. The radiolabeled complex showed a higher cell-binding ratio to MCF-7 cells (88.90% +/- 3.12) than HaCaT cells (45.64 +/- 4.72) when compared to Tc-99m. Our findings show that the developed preparation method for [Tc-99m]TcIMT falls well within the proven acceptable ranges. Applying quality by design (QbD) principles is feasible and worthwhile for the preparation of [Tc-99m]TcIMT. In conclusion, radiochemical purity, stability, and in vitro cell binding evaluation of the [Tc-99m]TCIMT complex indicate that the agent can be utilized for imaging of breast cancer cells.
  • [ X ]
    Öğe
    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.
  • Küçük Resim
    Öğe
    Design of an orally disintegrating tablet formulation containing metoprolol tartrate in the context of quality by design approach
    (Marmara University Press, 2021) Yeğen, Gizem; Aksu, Buket; Cevher, Erdal
    Orally Disintegrating Tablets (ODTs) are solid dosage forms that rapidly disintegrate or dissolve to release the drug upon contact with saliva in the mouth. As these tablets require special attention during formulation design, it is necessary to use advanced control and formulation design techniques to increase the quality. Quality by Design (QbD) was defined as an approach including better scientific understanding of critical process and product attributes, designing controls and tests based on scientific understanding limits during development stage and used to work in an environment for continuous improvement of information obtained during the product lifecycle. The aim of the study was to develop an ODT formulation containing Metoprolol tartrate with appropriate features via QbD approach with the help of artificial intelligence programs to enlight the multivariate relations between critical parameters and quality attributes of on final product and to obtain an optimum formulation. Physical and chemical tests were conducted on tablets prepared by direct compression according to the designated formulation and process variables. Then, experimental data was evaluated with modeling programs use artificial intelligence technique, FormRules V3.32 to understand the relationship between independent input variables and the critical quality attributes; later with INForm V5.1 for optimization. The optimized formula was prepared and according to test results tablets shows compliance with the pharmacopoeia limits. The adoption of QbD approach and usage of artificial intelligence programs has increased the efficiency of the formulation development process with better understanding of the product and process.
  • [ X ]
    Öğe
    Developing alfuzosin tablet formulation based on quality by design (QbD) approach by using artificial neural network
    (Colegio Farmaceuticos Provincia De Buenos Aires, 2019) Aksu, Buket; Mesut, Burcu; Özsoy, Yıldız
    The purpose of this study was to develop sustained release direct compressible alfuzosin (ALF) hydrochloride (HCl) tablet based on the concept of quality by design (QbD) approach using artificial neural network programs. At the first step of the study, the target product profile (TPP) of the formulation was defined. Subsequently, risk assessment tools were used to determine critical quality attributes (CQAs) and critical formulation parameters (CFPs). In-process control tests, assay and dissolution studies were performed. The test results were transferred to the artificial neural network (ANN) and the program was trained based on these data. The program offered new tablet formulations which have not been studied before and dissolution test results of this formulation was highly similar to the reference product's results than the other formulations. In conclusion, using the ANN programs within the scope of QbD approach for solid dosage formulation developments brings a lot of industry-wide benefits and advantages to ease scaling-up and meet the recent ICH guideline requirements.
  • Küçük Resim
    Öğe
    Evaluation of emulgel formulations contain diclofenac sodium via quality by design approach
    (2022) Kalayi, Mohammed; Yeğen, Gizem; Okur, Neslihan Üstündağ; Aksu, Buket
    Emulgel is considered as emulsions, either oil-in-water or water-in-oil type, that is formed via blending with a gelling agent. Their common usage as pharmaceutical dosage form results from the broad utilization of emulsion systems, particularly for dermatological formulations. Quality by Design (QbD) is a scientific, holistic, risk-based, systematic, and proactive approach that starts with predefined objectives and assertiveness on product quality, procedure understanding, and process control. In this study, the QbD approach was implemented in the production of emulgel containing diclofenac sodium and the goal was to build quality into the product from the inception of formulation development. The hydrogel phase and oil phase of emulgel were prepared separately, then mixed. Emulgels were evaluated for their macroscopic, and microscopic examination, pH, electrical conductivity measurements, and viscosity. The optimum formulation was found by using the ANN Modelling program. According to macroscopic evaluation the optimum emulgel was an opaque white color, and homogeneous with no phase separation or grittiness. The viscosity of the optimum formula is 4600, pH value is 6.7, electrical conductivity is 120 µS-1, and particle diameter was also 0,989 µm. Results showed the optimized formula has the required properties. ANN modeling technique has been used to develop a pharmaceutical formulation via determining multivariate relations between independent parameters and quality properties affected by these parameters. Although artificial intelligence programs are not enough to build and develop formulations by itself, they play a significant role in formulation development.
  • Küçük Resim
    Öğe
    Examining the basic principles of quality by design (QbD) approach in analytical studies
    (2021) Mesut, Burcu; Önal, Cem; Aksu, Buket; Özsoy, Yıldız
    Although the first application of Quality by Design (QbD) concept started for product development studies, the number of studies regarding its application to analytical development has been increased recently. Basically, QbD strategy in both formulation development and analytic studies are identical logically and conceptually, but they have somedifferences in terms of its terminology and application. Essential terminology and approach differences in this concept are; the determination of the analytic target profile, critical method characteristics, critical process parameters, and the determination of the method study area. However, the risk evaluation method which is necessary for the appropriate application of quality by design is also an inseparable part of the analytical quality by design. Despite those terminological differences, developing a quality based method with the analytical design that contributes to research with an appropriately applied risk-based design quality approach and provides multiple advantages that will be noticed each and every time, will be useful both for researchers and authorities who investigate license documentation and changes. Therefore, the terminology which is used for analytic quality by design and appropriate risk evaluation approaches are explained in this study.
  • [ X ]
    Öğe
    Global Regulatory Perspectives on Quality by Design in Pharma Manufacturing
    (Elsevier, 2019) Aksu, Buket; Yeğen, Yegen Gizem
    The legislations have almost frozen the processes used in pharmaceutical manufacturing overtime. Even after the receipt of drugs’ permits/certificates, even a small change in the method of manufacturing of medicines requires examination and approval of health authority, resulting in time and paperwork. The Food and Drug Administration (FDA) is at the forefront of work in the field of “Quality by Design (QbD), " which implements regulatory intelligence to modernize the understanding and control of pharma manufacturing processes. The applications performed within the QbD approach, based on scientific data and with previous knowledge and experiences, are now part of the process for change with the flexibility of real-time release. As a result of these changes, the process is proved to function and the confidence in the system is increased. © 2019 Elsevier Inc. All rights reserved.
  • Küçük Resim
    Öğe
    İlaç formülasyonu geliştirilmesinde deney tasarımı (DoE) seçimi ve kullanımı
    (2017) Demir, Önder; Aksu, Buket; Özsoy, Yıldız
    Son yıllarda ilaç formülasyonu geliştirilmesinde deney tasarımı (DoE) kullanımı artmış olmasına rağmen hala yeterli seviyede değildir. Özellikle katı ve yarı-katı dozaj formları gibi birçok bileşeni olan ve çıktılara etkisi bilinmeyen birçok proses parametresinin bulunduğu formülasyonlarda kullanılmasının ne kadar yararlı olduğu bilinmektedir. Ancak formülasyon geliştirmede deneme-yanılma gibi eski yaklaşımlar yerine DoE kullanılması ne kadar önemli ise, bu DoE’nin doğru kullanımı ve seçimi de bir o kadar önemlidir. Doğru seçilmeyen bir DoE tipi veya uygun olmayacak şekilde yapılan deneme ve ölçümler, sadece boşa kaynak ve zaman harcanması ile sonuçlanmaz, çoğu zaman kafa karıştırıcı veya yanıltıcı veriler de üretir. Bu derlemede DoE, uygun DoE tipinin seçimi, istatiksel eleme ile faktör sayısının düşürülmesi ve yanıt yüzeyi modellemesi (RSM) ile ilaç formülasyonlarının optimizasyonu hakkında özet bilgi verilmesi amaçlanmış olup, bu yöntemlerin ilaç formülasyonu geliştirmedeki uygulamalarından da kısaca bahsedilmiştir. Doğru DoE tipinin seçilerek uygulanması sayesinde; gerçekleştirilen az sayıdaki denemelerden çok fazla kaliteli bilgi (matematiksel modeller) üretilebilir. Bu sayede geliştirme süresi ve maliyeti ciddi oranda azaltılabilir. Ayrıca geliştirilen ürün, değişkenliklere karşı hassas olmayan sağlam bir prosese sahip olabilir.
  • Küçük Resim
    Öğe
    Industry 4.0 elements for pharmaceutical development and manufacture
    (Altınbaş Üniversitesi, 2021) Aksu, Buket; Yeğen, Gizem
    The innovations of the Industry 4.0 revolution in the New World aim at creating a society where we can solve many problems in every sector and social life. As a condition for Industry 4.0, industrial sectors are heading towards digitalization and automation. Pharmaceutical Industry takes its share in this sense and tries to keep up with this pace in the context of Pharma 4.0 which is a hot topic. However, it is a known fact that developing safe and effective new treatments is a long, difficult, and expensive process, so FDA released the Pharmaceutical cGMPs for the 21st-century report and in this report; it specified Quality by Design (QbD) and Process Analytical Technologies (PAT) initiative to bring a solution. The introduction of the new QbD approach, which advocates providing the quality within the product with design instead of testing, brought an increase in the quality of the products manufactured, a decrease in costs and accelerated the market launch of the medicines. Moreover, patient safety is brought to the fore with better quality medicines and the patient accesses the drug in a shorter time.
  • Küçük Resim
    Öğe
    Optimization and evaluation of moisturizing cream containing dexpanthenol
    (Altınbaş Üniversitesi, 2023) Barbar, Arkan; Kalayi, Mohammed; Aksu, Buket
    Background/aim: The main purpose of this work was to prepare and evaluate a moisturizing cream containing dexpanthenol.Materials and methods: In this study, several cream formulations were prepared using the oil-inwater (O/W) emulsion technique to investigate the effect of varying concentrations of the independent variable on the physical appearance, pH, electrical conductivity, viscosity and spreadability. Different formulations were prepared with different combinations of Cera alba and Stearic acid with various excipients. The developed formulations were examined with the QbD approach. A process known as "quality by design" uses statistical, analytical, and risk-management techniques in the planning, development, and production of pharmaceuticals to guarantee the predetermined quality of the product. Results: According to the QbD studies, the Design Space is given for optimum formulae. After establishing the model equations for the main effects and responses, various cream formulations containing stearic acid and cera alba were optimized based on spreadability, viscosity, and electrical conductivity. Conclusion: In conclusion, the outcomes of different formulations obtained in this research study clearly showed that a moisturizing cream containing a certain ratio of Cera alba and Stearic acid have an up-and-coming potential. Therefore, proportions of Cera alba and Stearic acid are included in the moisturizing cream to win its cosmetic benefits.
  • [ X ]
    Öğe
    Optimization of dexketoprofen trometamol tablet formulations utilizing different modeling techniques and the quality by design
    (Colegio Farmaceuticos Provincia De Buenos Aires, 2016) Demir, Önder; Aksu, Buket; Özsoy, Yıldız; Araman, Ahmet
    Dexketoprofen trometamol is a sensitive molecule and consists of a fine, poor flowing, extremely adhesive powder that leaves behind gummed residue on the punch surface of the tablet press machine. The purpose of this study is to determine the optimum formulation utilizing different modeling techniques and the Quality by Design (QbD) approach without sticking problem during production. General full factorial design of experiments (DoE) was formed and the raw experimental data were evaluated using Minitab, artificial neural network (ANN) and gene expression programming (GEP) modules of the INForm. The Minitab, ANN and GEP modeling programs suggested the optimum formulations that should contain 2.03% and 2.50% glyceryl dibehenate by applying slug compression. However, in trial studies, the only lubricant that resolves the sticking problem was sodium stearyl fumarate. Therefore, new optimum formula trials have been performed by employing sodium stearyl fumarate at the same percentages instead of glyceryl dibehenate. All of the optimum formula analysis indicates that quality target product profile (QTPP) was met and the sticking problem was resolved.
  • Küçük Resim
    Öğe
    Preparation and evaluation of Poly(lactic acid)/Poly(vinyl alcohol) nanoparticles using the quality by design approach
    (2022) Ekinci, Meliha; Yeğen, Gizem; Aksu, Buket; İlem-Özdemir, Derya
    The aim of the study was to prepare and evaluate the potential use of poly(lactic acid)/poly(vinyl alcohol) (PLA/ PVA) nanoparticle formulations as a drug delivery system. The nanoparticle formulations were successfully developed by the double emulsification/solvent evaporation method. The developed formulations were optimized using the quality by design approach of the ICH Q8 (Pharmaceutical Development) guideline. In the studies, the effects of emulsifying devices, evaporation technique, centrifugation effect, and polymer concentrations on the physicochemical parameters of the formulations were investigated to obtain the best results. Furthermore, the prepared formulations were evaluated for clarity, particle size, distribution, zeta potential, surface and morphological features, preparation efficiency, and long-term stability. Based on the obtained results, the nanoparticle formulation containing 12.5% PLA, 1% primer, and seconder PVA has a suitable particle size (181.7 ± 2.194 nm) and distribution (0.104 ± 0.049), zeta potential (−0.88 ± 0.45 mV), and high preparation efficiency (65.38%), and nanoparticles were spherical, had a smooth surface, and were stable up to 12 months. In conclusion, this novel formulation can be used as a potential drug delivery system.
  • [ X ]
    Öğe
    QbD based formulation optimization of semi-solid lipid nanoparticles as nano-cosmeceuticals
    (Elsevier, 2021) Amasya, Gulin; Ozturk, Cagla; Aksu, Buket; Tarimci, Nilufer
    Nano-cosmeceuticals are cosmetic formulations containing nano-drug delivery systems to carry cosmetic active molecules to the relevant skin tissues. The purpose of this research is to develop and optimize the semi-solid nanostructured lipid carriers for caffeine delivery to the deeper skin layers. It is also aimed to achieve a novel nanotechnology-based cosmeceutical formulation with predetermined quality. Hence both caffeine and argan oil encapsulated semi-solid NLCs were developed by following QbD steps. An artificial neural network (ANN) program was employed to reach optimized formulation with desired critical quality attributes (CQAs). The optimized formulation suggested by the ANN exhibited a particle size of 186.5 nm with a PDI value of 0.208 and the occlusion factor of the optimized formulation reached 50.25% after 12 h. A high level of similarity was obtained between the CQAs predicted by ANN and experimental results for the optimum formulation. The present study concluded that the novel caffeine-loaded semi-solid NLC formulation which also contains argan oil is a promising candidate for local treatment of cellulite and it may possess the measurable skin effect. Moreover; a high-quality nano-cosmeceutical product was obtained with the help of artificial intelligence by following QbD steps for the first time to the best of our knowledge.
  • [ X ]
    Öğe
    QbD guided early pharmaceutical development study: Production of lipid nanoparticles by high pressure homogenization for skin cancer treatment
    (Elsevier B.V., 2019) Amasya, Gülin; Aksu, Buket; Badilli, U.; Onay-Beşikçi, Arzu; Tarımcı, Nilüfer
    This research attempts to bring together the positive aspects of lipid nanoparticles and Quality by Design (QbD) approach for developing a novel drug delivery system for skin cancers and aktinic keratosis. Lipid nanoparticles which is one of the most efficacious options for topical treatment of skin diseases were prepared due to their ability to overcome the complex structure of skin barrier and to enhance the skin penetration. Since the formulation development contains complex variables of active ingredients, raw materials or production method; all the variables of the product should be elaborated. QbD approach which refers to design and develop formulations and manufacturing processes to maintain the prescribed product quality was also successfully adopted to achieve a time- and cost-saving process ensuring a high-quality product. 5-Fluorouracil (5-FU) loaded lipid nanoparticles, both solid lipid nanoparticles and nanostructured lipid carriers, were developed and characterized by following QbD steps. Optimal lipid nanoparticle formulation with guaranteed quality which was within the design space has been reached through the artificial neural networks. The optimal lipid nanoparticle formulation which is a NLC formulation with a mean particle size of 205,8 ± 9,34 nm, narrow size distribution (0.279 ± 0.01) and negative zeta potantial ?30,20 ± 0,92 was produced by high pressure homogenization method. Cytotoxicity profiles of the optimal NLC was determined by cell culture studies on epidermoid carcinoma cells and human keratinocyte cells. Optimal NLC showed significantly higher anticancer effect on epidermoid carcinoma cells than free 5-FU and also less cytotoxicity towards human keratinocyte cells. Optimal NLC was formulated in hydrogel formulation for ease of application which has suitable occlusive and mechanical properties, viscocity and pH for patient complience. The cumulative amount of 5-FU in dermal tissues of rat skin was found 20.11 ± 2.14 ?g/cm2 and 9.73 ± 0.87 ?g/cm2 after application of NLC enriched hydrogel and 5-FU hydrogel respectively. In conclusion, this study showed that a time and cost saving process ensuring a high-quality product can be obtained by QbD guided formulation development study with the help of artificial neural networks. A novel semisolid dosage form enriched by NLC which is promising for topical treatment of skin cancers was developed. © 2019 Elsevier B.V.
  • [ X ]
    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.
  • Küçük Resim
    Öğe
    Quality by design (QbD) for pharmaceutical area
    (Istanbul Univ, Fac Pharmacy, 2015) Aksu, Buket; Mesut, Burcu
    Recent changes and limited resources for drug development and manufacturing have rendered the conventional pharmaceutical quality assurance approach insufficient and have given rise to new research in these areas. To address these research efforts, the FDA improved and modernized the rules governing pharmaceutical manufacturing and product quality in 2002, thereby realizing a paradigm change in the current Good Manufacturing Practices (cGMP). The Quality by Design (QbD) approach has entered the pharmaceutical industry within the last 10 years after the approval of the ICH Q8 in 2005. QbD is based on an understanding of the target product's quality profile (QTPP) and an assessment of its risks during the design and development of pharmaceutical dosage forms. By determining the critical quality attributes of the drug, including its active ingredient, its excipients, and the processes and design spaces used during the R&D phase, multi-way tracking during the life cycle of the drug can be achieved. This tracking can provide numerous advantages, including flexibility in licensing by decreasing the variation and type modifications in applications of the pharmaceutical product, which result from minimizing the possible issues arising after the release of the product. When all these data are observed, it is clear that the new QbD approach benefits the authorities, the drug manufacturers and the patient. Although QbD has certain challenges during its early stages, it is thought that QbD will benefit pharmaceutical manufacturers.
  • [ X ]
    Öğe
    Quality by design approach for optimizing preparation and characterization of buccal film formulation with different polymers
    (Advanced Scientific Research, 2019) Aksu, Buket; Coşkunmeriç, Nesrin; Yeğen, Gizem; Özalp, Y.; Okur, Neslihan Üstündağ
    Bilayered oromucosal film preparations (buccal films) offer a promising way to enable drug administration via the oral cavity. Polymeric film formulations containing chitosan, sodium alginate or carbopol were evaluated to select a formulation for the development of buccal drug delivery systems. Quality by Design (QbD) is increasingly becoming an important and widely used approach in the pharmaceutical industry. QbD requires producing an understanding of the critical variables affecting the attribues of products. In this study, the principles of QbD have been uniquely applied to 54 different kinds of film formulation contain different excipients as Chitosan, Carbopol, Sodium Alginate, Glycerine, PEG 400, Propylene Glycol to obtain appropriate buccal formulations. Each of the prepared formulations contains different ingredients combination and ingredients’ ratio (% w/v), which appear changes. For this aim, to evaluate the effects of variables to the film formulations, they were characterized as thickness, weight uniformity, swelling and moisture loss. © 2019, Advanced Scientific Research. All rights reserved.
  • [ X ]
    Öğe
    Quality by design case study 1: Design of 5-fluorouracil loaded lipid nanoparticles by the W/O/W double emulsion - Solvent evaporation method
    (Elsevier Science Bv, 2016) Amasya, Gülin; Badilli, Ulya; Aksu, Buket; Tarımcı, Nilufer
    With Quality by Design (QbD), a systematic approach involving design and development of all production processes to achieve the final product with a predetermined quality, you work within a design space that determines the critical formulation and process parameters. Verification of the quality of the final product is no longer necessary. In the current study, the QbD approach was used in the preparation of lipid nanoparticle formulations to improve skin penetration of 5-Fluorouracil, a widely-used compound for treating non-melanoma skin cancer. 5-Fluorouracil-loaded lipid nanoparticles were prepared by the W/O/W double emulsion - solvent evaporation method. Artificial neural network software was used to evaluate the data obtained from the lipid nanoparticle formulations, to establish the design space, and to optimize the formulations. Two different artificial neural network models were developed. The limit values of the design space of the inputs and outputs obtained by both models were found to be within the knowledge space. The optimal formulations recommended by the models were prepared and the critical quality attributes belonging to those formulations were assigned. The experimental results remained within the design space limit values. Consequently, optimal formulations with the critical quality attributes determined to achieve the Quality Target Product Profile were successfully obtained within the design space by following the QbD steps. (C) 2016 Elsevier B.V. All rights reserved.