Gyógyszerészet 2015. július

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Gygyszet B1 1507Továbbképző közlemények

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[item title=”Pallagi Edina, Paál Tamás, Csóka Ildikó: A Quality by Design (QbD) bemutatása és alkalmazási lehetőségeinek ismertetése a nano-rendszerű gyógyszertechnológiai fejlesztésekben – GYOGAI 59. 387-395. 2015.”]


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3., letöltés ideje: 2015. 04. 16.

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22. Sharmista Chatterjee: Role of Models in the Quality by Design (QbD) Paradigm: Regulatory Perspective, AAPS Annual meeting, 2011, , letöltés ideje: 2015. 04. 01.

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Pallagi, E., Paál, T., Csóka, I.: Presentation of the Quality by Design concept and its application possibilities in the pharmaceutical technological development of nano-systems

This paper outlines the new pharmaceutical quality management method called Quality by Design (QbD). The commonly used, conventional quality technique, the Quality by Testing (QbT) method has also been discussed. According to the QbT process, the quality of the pharmaceutical product is assured only by the testing (raw material and drug substance testing, product manufacturing control and in-process testing, end-product-testing). It is quite a rigid system, with fixed processing methods, less eligible for changes. Every change in the system needs the notification to or approval of the regulatory bodies. As QbT has become outdated for today and this led to turning to the QbD. Even the authorities such as the Food and Drug Administration (FDA) in the USA and the European Medicines Agency (EMA) in Europe prefer and support the application of this new approach.

The philosophy of the QbD concept can be summarized as a systematic, scientific, risk-based, holistic and proactive approach of pharmaceutical development to ensure the predefined quality. In this technique the demands and expectations (industrial, regulatory and from patient/customer) are taken into consideration and built in the process from the design phase. 

The steps of a QbD guided pharmaceutical development are also presented in this article: the determination of the Quality Target Product Profile (QTPP), the selection of the Critical Quality Attributes (CQAs) and the Critical Process Parameters (CPPs), the possibilities and importance of the Risk Assessment (RA) activity, the Design Space development and the planning of the Control Strategy.

On the market, the QbD guided industrial production of a medicinal product can avoid the repeated modification of the license if all modifications are in the Design Space. That is why QbD is strongly requested now by the authorities in licensing new medicinal products and it should be used even from the early development phases. The QbD based experimental design could help to reduce efforts of this early phase of research by the predicting the most influential parameters on the final quality. The QbD based method is resulted in shorter development time, lower cost, spare in human resources and more effective target-orientation. It could be particularly important by such studies that are expensive and complex, like nano-pharmaceutical research. The pharmaceutical technological development of nano-systems is in the focus nowadays. Although it is highly studied, the regulatory background is not complete. The elements of this special nano-regulation and some relevant information about nano-drug containing medicinal product are also collected in this article.


[item title=”Hajdú Mária, Kriston Anita, Antal István: A rektális gyógyszerbevitel újabb lehetőségei – GYOGAI 59. 396-399. 2015.”]


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Hajdú, M., Kriston, A., Antal, I.: New possibilities in rectal drug delivery

In recent years, rectal drug administration has been at the forefront of interest again due to its several advantageous properties.

Currently, suppositories are still the most commonly used form, but the rapid  development of pharmaceutical technology allowed  for the emergence of other rectal drug delivery systems. New options are now available for controlled drug release and for the enhancement bioavailability.

By choosing the suitable form and composition along with the optimal starting materials and excipients, the disadvantages  can be eliminated.

The range of used active ingredients is expanding: new chemical entities are being involved for an increasing number of indications. Today, drugs that previously seemed unimaginable to be administered rectally can be delivered successfully in this way, for example: macromolecules, various polypeptides, antibiotics, etc. To ensure optimal effect, it is advisable to examine several pharmaceutical forms during the pharmaceutical formulation.


[item title=”Benedek Angéla, Gál-Knippel Barbara, Tóth Bernadett: Év Gyógyszere – 2014: az Esmya® (uliprisztál-acetát), mint a myomák gyógyszeres kezelésére szolgáló szájon át szedhető originális készítmény – GYOGAI 59. 400-406. 2015.”]


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Benedek A., Gál-Knippel B., Tóth B.: Esmya® (ulipristal-acetate) as a newly developed treatment option for the oral treatment of uterine fibroids

The 2014 prize of „Medicine of the year” established in 1997 by the Hungarian Society for Experimental and Clinical Pharmacology was awarded to Gedeon Richter’s Esmya. The aim of this prize is to facilitate the use and penetration of the most effective and the most patient-friendly medicines in the standard medical care. 

Uterine fibroids are benign solid tumors which affect 30–70% of women of reproductive age. Symptoms may include excessive uterine bleeding, anemia, pain, either frequent urination or incontinence, and occasional interruption of fertility. According to the current product information, Esmya tablets (5mg ulipristal acetate) manufactured by Gedeon Richter Plc. is the only oral medicine for the repeated intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. Presented clinical data prove that Esmya provides an opportunity to women to benefit from long term medical management of uterine fibroids and potentially avoid surgery.


[item title=”Ferdinandy Csilla, Nardai Gábor: „Amikor a csavar nem elég!” A klinikai táplálás jelentőségének vizsgálata csípőtáji sérültekben – GYOGAI 59. 407-410. 2015.”]


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Ferdinandy Cs., Nardai G.: When screws are not enough. Investigation of importance of clinical nutrition in hip injured patients

General benefits of clinical nutrition its positive effect on patient outcomes as well as pharmacoeconomic advantages have already been widely discussed in the scientific literature. In Hungary, however, the implementation of clinical nutritional practice seems to face some shortcomings that limit the extent of success at managing patients with (mildly) elevated nutritional risk in a timely manner. There are only a few institutes where true progress has been made.

To assess the antropometric and nutritional status of the patients, the ESPEN-NRS Nutritional Risk Screening Tool questionnaire was used. For patients with an overall risk score of 3, personalized nutritional therapies were prescribed based on previous clinical findings. During follow-up visits the nutritional statuses and risks were reassessed as well.


[item title=”Gucsi-Végh Gábor: A nodus haemorrhoidalis és kezelésének gyógyszeres lehetőségei – GYOGAI 59. 411-417. 2015.”]


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11.  Alkalmazási előiratok

12. Gyári készítmények betegtájékoztatói.

Gucsi-Végh G.: The disease and treatment of hemorrhoids


[item title=”Polonkai Kata, Dóczy Veronika, Hankó Balázs: Az egészségműveltség aktualitásai II. – GYOGAI 59. 418-421. 2015.”]


1. [2015. 02. 29.] GYEMSZI Informatikai és Rendszerelemzési Főigazgatóság: A krónikus betegek ellátásának jellemzői Európában.

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Polonkai K., Dóczy V., Hankó B.: Actualities of health literacy II.

The paper is (Part I. and Part II.) a comprehensive summary on health literacy. Which aims to introduce health literacy, its influencing factors, and effects on patient adherence. The summary also highlights the main tools used in health literacy surveys. The impact of health literacy is growing worldwide also in Europe. The inadequate health literacy has negative impact on patient adherence. 


[item title=”Bayer István: Drogproblémák VI. – Drogok és bűnözés – GYOGAI 59. 422-423. 2015.”]

Bayer, I.: Drug problems VI. – Drugs and crime



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[item title=”Bognár Júlia: Gyógyszerészként Afrikában – GYOGAI 59. 424-427. 2015.”]

Bognár, J.: As a pharmacist in Africa




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Pallagi Edina, Paál Tamás, Csóka Ildikó: A Quality by Design (QbD) bemutatása és alkalmazási lehetőségeinek ismertetése a nano-rendszerű gyógyszertechnológiai fejlesztésekben

Gucsi-Végh Gábor: A nodus haemorrhoidalis és kezelésének gyógyszeres lehetőségei