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Şişli, Turkey

Mesut B.,Istanbul University | Ozsoy Y.,Istanbul University | Aksu B.,Santa Farma Pharmaceuticals
Turkish Journal of Pharmaceutical Sciences

Along with the fast developments in the drug production and control technologies, it has been easier to comment on the drug and its production, as well as observing/seeing the defects. These developments have brought within new arrangements in the regulations. Recently added ICH Q8, Q9, Q10 and Q11 guidelines have aimed to make the drug industry to develop rather an information based understanding towards the drug. Within this frame, especially during the drug formulation and active substance development studies, all factors that may affect the quality of the drug should be examined with scientific/statistical methods. For drug development that is compliant with the regulations, proper understanding and interpretation of new concepts explained in the guidelines are initially necessary. Some of these new concepts are Quality by Design (QbD), Critical Quality Attributes (CQA) and Critical Process Parameters (CPP). Each dosage form has its specific Design Space, Critical Quality Attributes and Critical Process Parameters. Correct determination of these parameters and values during the formulation development studies decreases the possible problems related to the drug throughout the drug’s life cycle and help them to be eliminated entirely. Therefore, it contributes to provide the quality that is expected from the drug. © 2015, Turkish Pharmacists Association. All rights reserved. Source

Cevher E.,Istanbul University | Acma A.,Istanbul University | Sinani G.,Istanbul University | Aksu B.,Santa Farma Pharmaceuticals | And 2 more authors.
International Journal of Biological Macromolecules

Itraconazole (ITR) is commonly used in the treatment of Candida infections. It has a nephrotoxic effect and low bioavailability in patients who suffer from renal insufficiency, and its poor solubility in water makes ITR largely unavailable. Cyclodextrins (CyDs) are used to form inclusion complexes with drugs to improve their aqueous solubility and to reduce their side effects. In this study, ITR was complexed with γ-cyclodextrin (γ-CyD), hydroxypropyl-β-cyclodextrin (HP-β-CyD), methyl-β-cyclodextrin (Met-β-CyD) and sulphobutyl ether-β-cyclodextrin (SBE7-β-CyD) to increase its water solubility and to reduce the side effects of the drug without decreasing antifungal activity. Complex formation between ITR and CyDs was evaluated using SEM, 1H NMR and XRD studies. The antifungal activity of the complexes was analyzed on Candida albicans strains, and the susceptibility of the strains was found to be higher for the ITR-SBE7-β-CyD complex than for the complexes that were prepared with other CyDs. Vaginal bioadhesive sustained release tablet formulations were developed using the ITR-SBE7-β-CyD inclusion complex to increase the residence time of ITR in the vagina, thereby boosting the efficacy of the treatment. The swelling, matrix erosion and bioadhesion properties of formulations and the drug release rate of these tablets were analyzed, and the most therapeutically effective vaginal formulation was determined. © 2014 Elsevier B.V. Source

Aksu B.,Santa Farma Pharmaceuticals | Paradkar A.,University of Bradford | De Matas M.,University of Bradford | Ozer O.,Ege University | And 2 more authors.
AAPS PharmSciTech

The publication of the International Conference of Harmonization (ICH) Q8, Q9, and Q10 guidelines paved the way for the standardization of quality after the Food and Drug Administration issued current Good Manufacturing Practices guidelines in 2003. "Quality by Design", mentioned in the ICH Q8 guideline, offers a better scientific understanding of critical process and product qualities using knowledge obtained during the life cycle of a product. In this scope, the "knowledge space" is a summary of all process knowledge obtained during product development, and the "design space" is the area in which a product can be manufactured within acceptable limits. To create the spaces, artificial neural networks (ANNs) can be used to emphasize the multidimensional interactions of input variables and to closely bind these variables to a design space. This helps guide the experimental design process to include interactions among the input variables, along with modeling and optimization of pharmaceutical formulations. The objective of this study was to develop an integrated multivariate approach to obtain a quality product based on an understanding of the cause-effect relationships between formulation ingredients and product properties with ANNs and genetic programming on the ramipril tablets prepared by the direct compression method. In this study, the data are generated through the systematic application of the design of experiments (DoE) principles and optimization studies using artificial neural networks and neurofuzzy logic programs. © 2012 American Association of Pharmaceutical Scientists. Source

Aksu B.,Santa Farma Pharmaceuticals | Aydogan M.,Santa Farma Pharmaceuticals
Research Journal of Pharmaceutical, Biological and Chemical Sciences

Quality by Design (QbD) studies areused in the pharmaceutical industry since 2004. The first step started with the Process Analytical Technologies guideline, which was followed by the International Conference on Harmonisation Q8, Q9, Q10 and Q11 guidelines. During the multi-parameter processes of pharmaceutical production, it is necessary to make different variations in either the formulation or the process. However, these variations cannot be performed without permission of Authorities. Design space is a production space provided by the control of critical parameters that are determined by the formulation and manufacturing process. In addition, working within this Design space is not considered a change. This study is based on the fact that Regulatory authorities do not have to be informed of changes as long as the Quality by Design studies remain within the Design space of the Quality by Design formulations. The objective of this study was to demonstrate the flexibility of post-approval changes on ramipril tablets, which contain components from three different active pharmaceutical ingredient manufacturers, within the scope of the Design space. This information was obtained using artificial neural network programs. The stability of the manufactured tablets was evaluated, the convenience of the Design space was also determined. Source

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