Influence of uniformity criteria on the accuracy of quality testing of different dosage forms

Terrmin

HT24

Beskrivning

Background: Uniformity of dose is a fundamental requirement for pharmaceutical preparations and is described in pharmacopeias where procedures for accuracy and/or precision are included in the texts. In the European Pharmacopoeia, the word uniformity is found in both technical procedures and in monographs. Different types of requirements regarding uniformity are needed for different reasons and purposes. However, the underlying rational for which type of requirements that are important for specific dosage forms and/or administration routes is not explicitly described. Thus, suggestions of potential improvement of the requirements are needed.

Aim: The aim of the proposed project is to first study the different requirements for uniformity of dose or uniformity of delivered dose stated in the European Pharmacopeia and describe the methods used and the different statistics behind the methods. The methods should be evaluated and the potential rationales for differences should be analysed, e.g. the use of single-dose or multi-dose containers, manufacturing methods, metering systems etc. In addition, the aim is to perform a systematic literature review and analyse how these requirements are used for various dosage forms and to study this effect on the accuracy of quality assessment of these.

Expected outcome: It is expected that the project will highlight the importance of clear requirements regarding the use of uniformity tests and possible consequences of misuse of terminology and describe any potential improvements.

Note:It is expected that the project report is written in English.

Huvudområde

Farmaceutisk vetenskap

Ämne

Galenisk farmaci

Typ

Litteraturstudie

Företag

RegSmart

Ort/Plats

Uppsala

Handledarens namn

Ann-Sofie Persson (UU) och Agneta Larhed (RegSmart)

Handledarens e-post

ann-sofie.persson@uu.se

Institution

Institutionen för farmaceutisk biovetenskap

Program

Apotekarprogrammet

Kurs

Fördjupningsprojekt i galenisk farmaci med inriktning mot farmaceutisk teknologi 30 hp - 3FB033

Omfattning/hp

30hp

Hur många studenter kan antagas för detta projekt?

1

© 2022 Uppsala universitet | Teknisk support