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Razvoj metode za vrednotenje sproščanja paracetamola iz granul, napolnjenih v slamice
Minova, Jasmina (Author), Planinšek, Odon (Mentor) More about this mentor... This link opens in a new window

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Abstract
Testi, ki dokazujejo kakovost zdravila, omogočajo pridobitev dovoljenja za trženje. Trenutne konvencionalne zahteve za trdne farmacevtske oblike navajajo test razpadnosti in/oz. test sproščanja kot ključne za vrednotenje kakovosti teh zdravil. Pri večini zdravil so postopki, ki jih moramo uporabljati za dokazovanje zdravila, znani in natančno definirani. Izziv se pojavi pri vrednotenju trdnih farmacevtskih oblik - s specifično sestavo in obliko, pri katerih je implementacija veljavnih navodil in monografij otežena, ter ne odražajo dejanske kakovosti zdravila. Magistrska naloga je usmerjena na razvoj metode za vrednotenje sproščanja paracetamola iz zrnc, napolnjenih v slamice. Pri razvoju smo upoštevali monografije evropske in ameriške farmakopeje. Praktični del je bil razdeljen v tri faze. Prva faza povzema validacijske parametre, definirane v skladu z mednarodno konferenco o harmonizaciji. Vrednotili smo ustreznost analizne metode v smislu specifičnosti, linearnosti in razpona linearnosti, ponovljivosti ter stabilnosti raztopin. Za boljše osnovno razumevanje fizikalno-kemijskih lastnosti paracetamola smo izvedli še preliminarne študije, ki predstavljajo drugo fazo praktičnega dela magistrske naloge. V tej fazi smo vrednotili parametre, kot so topnost zdravilne učinkovine, kompatibilnost filtrov različnih materialov, volumen in sestava medija ter ustreznost aparata USP 1 in aparata USP 2. V zadnji fazi smo razvili postopek izvedbe analize za vrednotenje granul. Izbrali smo parametre: vrsto prezračenosti medija, hitrost vrtenja mešala in vpliv hidrodinamike na pojav učinka stožca; vsi našteti parametri so bili ovrednoteni. Kljub uradnim navodilom je bil izveden še preizkus zmožnosti prekrivanja neprijetnega okusa paracetamola kot parameter za nadzor kakovosti končne farmacevtske oblike.

Language:Slovenian
Keywords:sproščanje, paracetamol, zrnca, aparat USP 1, aparat USP 2, v kislini topni polimer
Work type:Master's thesis/paper (mb22)
Organization:FFA - Faculty of Pharmacy
Year:2020
Views:168
Downloads:77
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Secondary language

Language:English
Title:Development of a method for evaluation of paracetamol dissolution from granules packed in straws
Abstract:
For industrially manufactured pharmaceutical dosage forms, specific types of tests are required to ascertain the quality of the final product, prior to its arrival to the market. Current compendial requirements determine disintegration and/or dissolution tests as a crucial component of the quality control analysis. For the most of the drugs these requrements are well known and precisely defined. However, the challenge arises, when for some of the oral dosage forms - with specific formulation, the implementation of the effective instructions and monographs is difficult and does not reflect the actual quality of the dosage form. The Master’s thesis is focused on the development of a method for evaluation of paracetamol dissolution from granules packed in straws. During the development of the method monographs from European and American pharmacopeia were considered. The practical part of the thesis consists of three main phases. The first phase summarizes only a part of the validation parameters of the analytical method in terms of specificity, linearity and range, repeatability, and stability of solutions (defined in accordance with the international conference on harmonization). In order to obtain a better basic understanding of the physicochemical properties of paracetamol, preliminary studies were performed, which also represent the second phase of the thesis. In this section parameters such as: active pharmaceutical ingredient solubility, filter compatibility, media type, volume media and the adequacy of USP apparatus 1 and USP apparatus 2 were evaluated. Obtained results were important and therefore considered while performing the third phase of the thesis-method development. This section refers to the actual procedure and its final parameters used for the sample analysis. Parameters such as deaeration, agitation, and hydrodynamics and its influence on the coning effect were determined. Despite following the official instructions, an additional test as a part of method development was performed in order to define the taste masking ability of granules, as a quality control parameter of the final dosage form.

Keywords:dissolution, paracetamol, granules, USP apparatus 1, USP apparatus 2, vesla, acid-soluble polymer

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