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Romania
Citizenship:
Romania
Ph.D. degree award:
2010
Mrs.
Porfire
Alina
Associate Professor
Associate Professor
-
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU"
Researcher | Teaching staff | PhD supervisor
19
years
Personal public profile link.
Curriculum Vitae (22/01/2019)
Expertise & keywords
Pharmaceutical Technology
3D printing
Nanomaterials and nanotechnologies
Drug delivery system
regulatory affairs
Biological methods
Oxidative stress
cancer therapy
Gene therapy
Projects
Publications & Patents
Entrepreneurship
Reviewer section
Expert System based on Artificial Neural Network for 3D-Printability Prediction of Tailored Release Oral Dosage Forms
Call name:
P 4 - Proiecte de cercetare exploratorie - PCE-2021
PN-III-P4-PCE-2021-1119
2022
-
2024
Role in this project:
Key expert
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU"
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Project website:
https://www.expertsystem.3dprinting-drugs.com
Abstract:
This project aims to create an expert system based on artificial intelligence for predicting the printing capacity of active substances, in order to prepare personalized pharmaceutical products by 3D printing (3DP). The expert system relies on a database consisting of the characteristics of active substances from different biopharmaceutical classes, the characteristics of the extruded filaments with different API loads and of the printed products. The polymer chosen for printing is polyvinyl alcohol, as such or in combination with plasticizers. Briefly, the substances selected upon a rigorous molecular and physical-chemical characterization will be used for the hot-melt extrusion of polymeric filaments, and after characterization, the filaments will be subjected to printing by fused deposition modelling, followed by the evaluation of the prints. The Design of Experiments method will be used for the study of filaments and prints, multivariate analysis to create multivariate correlations between input and output variables, followed by modelling of algorithms by artificial neural networks (ANNs) capable of predicting the printing capacity of other drugs based on the obtained models. The ANN trained algorithms further integrated into a user-friendly web interface (the Drug3DPrintExpert) will be validated on new active substances and made available for the scientific community and drug producers interested in preparing pharmaceutical drug products by 3DP.
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Pharmaceutical development of a gastroretentive floating drug delivery system manufactured by 3D printing
Call name:
P 2 - SP 2.1 - Proiect experimental - demonstrativ
PN-III-P2-2.1-PED-2021-3370
2022
-
2024
Role in this project:
Key expert
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU"
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Project website:
https://www.3dp-grfdds.3dprinting-drugs.com
Abstract:
The three dimensional printing (3DP) technology integration into the pharmaceutical field was taken into consideration in the pursuit to improve quality with the concomitant enabling of therapy personalization. The notion of 3DP includes a wide variety of technologies, fused deposition modelling (FDM) constituting a preferred representative of the group, due to its versatility and cost-effectiveness.
The integration of 3DP-FDM in pharmaceutics, up to this point, shows promising results. The technology besides material and process considerations, introduces the notion of design in the overall quality equation. By enabling design modulation, dissolution may be adapted achieving personalization and also production may be simplified for products with special design needs, like low density reliant gastro-retentive drug delivery systems (GRDDS).
The scope of the project will be to produce 3D printed gastroretentive floating drug delivery system (3DP-GRFDDS). Complex products will be aimed that combine the particularities of immediate release (IR) and prolonged release (PR) within the same dosage form by employing two different drug delivery mechanisms. The sustained release profile will be achieved through material and design considerations, by having an IR compartment with rapid disintegration and a PR floating compartment with prolonged gastric retention. Biopharmaceutically challenged active pharmaceutical ingredients (APIs) will be selected, that benefit from both sustained release and gastric retention. Due to the novelty of the methodology, the development will be done based on the quality by design premises, ultimately aiming to explain the combined and individual effects of material, technology and design considerations on 3DP product quality.
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: Increasing the competitiveness of AC HELCOR by implementing the QbD concept and process analytical technology, for the development of new medicinal products
Call name:
P 2 - SP 2.1 - Proiect de transfer la operatorul economic
PN-III-P2-2.1-PTE-2019-0445
2020
-
2022
Role in this project:
Key expert
Coordinating institution:
AC HELCOR SRL
Project partners:
AC HELCOR SRL (RO); UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE "IULIU HATIEGANU" (RO)
Project website:
https://www.achelcor.ro/increasing-competitiveness-ac-helcor-implementing-qbd-concept/
Abstract:
The objective of this project is to implement the concepts of quality by design (QbD) and process analytical technology (PAT) at AC HELCOR Pharmaceutical Company, in order to develop and place to the market a new pharmaceutical product. The application of these two modern concepts in the development of the new product will be possible through the collaboration between the academic environment, UMF Iuliu Hațieganu, and the pharmaceutical company AC HELCOR, by transfering in the economic environment the previous results and the expertise of the UMF group, with an impact on the competitiveness of the company on the pharmaceutical market at national and international level. According to the guidelines published by the regulatory agencies in the field of medicine (European Medicines Agency - EMA, Food and Drug Administration - FDA), the entire process of pharmaceutical development must be carried out based on scientific methods, combining risk assessment / management methods. , statistical experimental plans and methods enabling real-time monitoring of the manufacturing process. All these tools contribute to the development of robust products and processes, ensuring the reduction of failed manufacturing series and the constant production of a product that meets the established quality profile. This is made possible by identifying and controlling all input factors that exert an influence on the critical quality attributes of the product, respectively by real-time monitoring of these properties. The project involves the pharmaceutical development of a product of interest for the economic agent by applying these two concepts, the transposition on the technological manufacturing line followed by bioequivalence studies. The results obtained from these stages will represent a solid scientific support for the elaboration of the documentation necessary to authorize the marketing of the developed drug.
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Implementation the Quality by Design concept in drug manufacture. Knowledge transfer UMF Cluj - Laropharm
Call name:
P 2 - SP 2.1 - Transfer de cunoaștere la agentul economic „Bridge Grant”
PN-III-P2-2.1-BG-2016-0201
2016
-
2018
Role in this project:
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO); LAROPHARM SRL (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Project website:
https://qbdbridgeumfcjlph.wordpress.com/
Abstract:
The objective of the project is knowledge transfer concerning the Quality by Design (QbD) concept to the Laropharm company. Industrial practice showed that the raw materials present small variations in terms of their properties within the accepted pharmacopoeia requirements, and these small variations often lead to a poor quality of finished product, because the process is fixed and inflexible. Given in fact that the input variables (variations in the characteristics of raw materials) are not removable, the only way that the outcome remain fixed (the quality of pharmaceutical product) is to develop a robust process, very well known, in deep understood and flexible to input variables. Basically this means a new approach in drug production that means implementing Process Analytical Technology (PAT) in manufacturing and the development of the manufacturing process according to QbD concept. The project involves development the manufacturing process of a medicinal product of interest for the company, based on the two principles and to implement them on the company production line. Based on the obtained experimental data in both stage, technological and analytical development, but also during the technological transfer on production line the documentation required for the company to obtain the marketing authorization for the medicinal product will be done. The project responds to the current requirements of medical regulatory agencies from US and Europe (Administration Food and Drug Administration - FDA, European Medicines Agency - EMA) regarding to use the science and technology not only at new drugs discovery but also in their manufacturing in order to obtain high quality medicinal products.
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Quality by Design approach and development of Process Analytical Technology for a matrix type sustained–release product.
Call name:
Projects for Young Research Teams - RUTE -2014 call
PN-II-RU-TE-2014-4-1862
2015
-
2017
Role in this project:
Key expert
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Project website:
https://qbdpatmatrixrs.wordpress.com/
Abstract:
The aim of the current proposal is to apply the Quality by Design (QbD) approach in development of the manufacturing technological process of matrix type sustained–release products and to use near infrared spectroscopy (NIRs) in association with chemometry as an adequate tool for Process Analytical Technology (PAT). The main factors affecting the release of drugs from hydrophilic matrix systems are related to drug characteristics (particle size, polymorphism), polymer (type, substituents of the side chain, particle size, intrinsic viscosity, percentage), formulation factors (other excipients, air trapped in the porosity, resistance to breakage) and technological factors (homogeneity of powder blend, compression force). Currently those factors are not monitored during the manufacturing process and variability affects product consistency (drug’s release profile/bioavailability) with consequences on quality of the final product. The project propose a scientific approach to overcome this difficulty by applying QbD order to define the Design Space in granulation, mixing and compression septs and development and validation NIRs methods for on-line monitoring of these steps. Therefore, the proposed project aims to find solutions for overcoming the problems of manufacturing high quality sustained release products by developing the innovative solution of applying enhanced process understanding via QbD in product development and NIRs as PAT tool for continuous process monitoring.
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Co-encapsulated doxorubicin and curcumin long circulating nanoformulations towards increased efficiency of colon cancer therapy
Call name:
Projects for Young Research Teams - RUTE -2014 call
PN-II-RU-TE-2014-4-0220
2015
-
2017
Role in this project:
Project coordinator
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Project website:
https://alinaporfire.wordpress.com/
Abstract:
The current challenges in cancer chemotherapy are the adverse toxicity and resistance associated with the treatment regimen. Therefore, it is mandatory to combine these treatments with more effective and safer drugs or products that are able to increase tumor cytotoxicity of chemotherapeutic and reduce its toxic effects to normal cells. Curcumin, a diphenolic compound extracted from the rhizome of turmeric, has been characterized as having the ability to influence a diverse range of molecular targets within cells and by its lack of toxicity in animals or humans.
The approach of this proposal is based on the finding that the combination of curcumin with some cytotoxic agents leads to improving the therapeutic index of drugs used routinely in the chemotherapy of cancer, either by increasing cell kill in tumors (chemosensitizing properties) or by protecting against oxidative damage induced in normal tissues (chemoprotective action). The therapeutic effect of curcumin in cancer is especially advantageous when administered with a delivery system that enhances bioavailability at the tumor site and promote intracellular availability of the combination drugs upon systemic administration.
In this context, the aim of this proposal is to develop an effective strategy to improve the efficacy of doxorubicin assisted chemotherapy against colon cancer, by the use of co-encapsulated doxorubicin and curcumin in liposomes with long circulating properties.
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Development and preclinical evaluation of nanoparticulate drug delivery systems for targeted antitumor therapy of colorectal cancer
Call name:
Joint Applied Research Projects - PCCA-2011 call, Type 2
PN-II-PT-PCCA-2011-3.2-1060
2012
-
2016
Role in this project:
Key expert
Coordinating institution:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca
Project partners:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO); UNIVERSITATEA BABES BOLYAI (RO); BIOTEHNOS SA (RO); UNIVERSITATEA DE STIINTE AGRICOLE SI MEDICINA VETERINARA CLUJ-NAPOCA (RO)
Affiliation:
UNIVERSITATEA DE MEDICINA SI FARMACIE (U.M.F) Cluj-Napoca (RO)
Project website:
https://pcca1060.wordpress.com/
Abstract:
The colorectal cancer remains a major health problem being the second cause of death by cancer in the world. Chemotherapy as major therapeutic approach for the treatment of cancer involves a high patient risk because of lack of tumor specificity of the cytotoxic drugs. Moreover the inefficiency and side effects of chemotherapy have been primarily associated with the formulation and biodistribution of the drug, toxicity to normal cells and the acquisition of drug resistance in the cancer cells. In order to overcome chemotherapy drawbacks, therapeutic bionanotechnologies based on the drug targeting concept might be a promise approach for cancer treatment.
Recent studies have shown the active involvement of inflammatory cells infiltrating the tumor, in tumor development by stimulating and supporting tumor angiogenesis. Tumor angiogenesis induced by the inflammatory pathways seems to be a central force in tumor growth and expansion. Inflammatory cell-targeting by using nanoparticulate delivery systems for certain drugs with primary or secondary anti-inflammatory effects in combination with nanoparticulate systems to deliver cytotoxic drugs to tumor cells might be a promise for the antitumor therapy.
Based on this approach, the aim of this proposal is to develop a successfull targeting strategy of two key cell players in tumor development, tumor and inflammatory cells. This aim will be accomplished by two main objectives: to develop suitable nanoparticulate drug delivery systems for selected drugs in the classes mentioned above and to assess their antitumor efficacy. The novelty of the proposal is to use a tumor targeting strategy for both processes vital for tumor progression, tumor cell proliferation and tumor-associated inflammation. Taking into account our premises, development of targeted antitumor nanosystems would have a significant impact on future anticancer therapy.
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FILE DESCRIPTION
DOCUMENT
List of research grants as project coordinator or partner team leader
Significant R&D projects for enterprises, as project manager
R&D activities in enterprises
Peer-review activity for international programs/projects
[T: 0.3798, O: 218]