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Aksu B.,Santa Farma Pharmaceuticals | Aydogan M.,Santa Farma Pharmaceuticals
Research Journal of Pharmaceutical, Biological and Chemical Sciences | Year: 2013

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.


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 | Year: 2014

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.


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 | Year: 2012

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.


Mesut B.,Istanbul University | Ozsoy Y.,Istanbul University | Aksu B.,Santa Farma Pharmaceuticals
Turkish Journal of Pharmaceutical Sciences | Year: 2015

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.


PubMed | Santa Farma Pharmaceuticals
Type: Journal Article | Journal: Pharmaceutical development and technology | Year: 2012

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.


PubMed | Santa Farma Pharmaceuticals
Type: Journal Article | Journal: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences | Year: 2012

Substantial changes in Pharmaceutical R&D strategy are required to address existing issues of low productivity, imminent patent expirations and pressures on pricing. Moves towards personalized healthcare and increasing diversity in the nature of portfolios including the rise of biopharmaceuticals however have the potential to provide considerable challenges to the establishment of cost effective and robust supply chains. To guarantee product quality and surety of supply for essential medicines it is necessary that manufacturing science keeps pace with advances in pharmaceutical R&D. In this position paper, the EUFEPS QbD and PAT Sciences network make recommendations that European industry, academia and health agencies focus attention on delivering step changes in science and technology in a number of key themes. These subject areas, all underpinned by the sciences allied to QbD and PAT, include product design and development for personalized healthcare, continuous-processing in pharmaceutical product manufacture, quantitative quality risk assessment for pharmaceutical development including life cycle management and the downstream processing of biopharmaceutical products. Plans are being established to gain commitment for inclusion of these themes into future funding priorities for the Innovative Medicines Initiative (IMI).


PubMed | Santa Farma Pharmaceuticals
Type: Journal Article | Journal: AAPS PharmSciTech | Year: 2012

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.

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