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Quality by Design Based Development ...

Sipos, Bence.

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Quality by Design Based Development and Investigation of Nasal Polymeric Micelles Loaded with Meloxicam.

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Quality by Design Based Development and Investigation of Nasal Polymeric Micelles Loaded with Meloxicam./
作者:	Sipos, Bence.
出版者:	Ann Arbor : ProQuest Dissertations & Theses, : 2023,
面頁冊數:	130 p.
附註:	Source: Dissertations Abstracts International, Volume: 85-06, Section: B.
Contained By:	Dissertations Abstracts International85-06B.
標題:	Physiology. -
電子資源:	https://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=30763609
ISBN:	9798381078428

Quality by Design Based Development and Investigation of Nasal Polymeric Micelles Loaded with Meloxicam.
Sipos, Bence.

Quality by Design Based Development and Investigation of Nasal Polymeric Micelles Loaded with Meloxicam. - Ann Arbor : ProQuest Dissertations & Theses, 2023 - 130 p.

Source: Dissertations Abstracts International, Volume: 85-06, Section: B.

Thesis (Ph.D.)--Szeged University (Hungary), 2023.

Advanced drug delivery systems are of increased interest based on the requirements of current patient expectations, the poor physicochemical properties of even the commonly applied active substances and the effective implementation of processability via industrial techniques [1,2]. This is especially true in case of nano drug delivery systems, such as polymeric micelles and the pharmaceutical engineering techniques aiming to reach hardly accessible areas and target points in the human body like the central nervous system [3].Regulatory expectations of the marketing authorization process of medicinal products defines the main quality, safety and efficacy criteria of a given formulation in general and in the case of nanocarriers. In the early development stages, a proper knowledge space must be set up, presenting nanocarrier criteria and requirements. Besides this, a structured and well-designed formulation study must be conducted based on risk assessment [4-6]. In order to achieve the desired quality, safety and efficacy of the target product, the Quality by Design (QbD)-driven risk assessment can be a beneficial tool [7]. Since polymeric micelles are one of the non-biological complex drugs, the structural complexity and the reproducibility must be taken into consideration.Challenges regarding the intranasal, as an alternative drug delivery pathway can be tackled with the utilization of polymeric micelles [8,9]. Since they can exert a solubilization effect up to an immense degree sided with permeability enhancement, rapid and burst-like drug release can be achieved. Compared to other carriers, polymeric micelles are also characterized with higher stability, especially the ones with poly(ethylene glycol) side chains [10]. With proper stability and the advantageous effects, the active substance can be transported to the site of action such as the central nervous system.Polymeric micelles can be a solution as therapeutic carrier vehicles for numerous unmet clinical needs. A lot of potentially beneficial active substance also fail the clinical trials due to the incapability of administration to the target site [11]. Thus, specific administration in many cases can be only solved with invasive techniques which does not necessary fulfil the required pharmacological effect. That is why the demand is stated based on current clinical and industrial feedbacks, which is the quality-controlled development of advanced drug delivery systems administered through the correct and therapeutically most efficient delivery route [12].

ISBN: 9798381078428Subjects--Topical Terms:

518431
Physiology.

Quality by Design Based Development and Investigation of Nasal Polymeric Micelles Loaded with Meloxicam.
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