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FA-MA106 Geneesmiddelontwerp Productdossier p3

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  • Course
  • FA-MA106 (FAMA106)
  • Institution
  • Universiteit Utrecht (UU)

Dit is het productdossier dat ik heb moeten maken voor FA-MA106. Ik heb deze cursus in collegejaar periode 3 gevolgd. Het kan zijn dat het vak sindsdien is veranderd en daarmee ook de bijbehorende opdracht over het dossier. *Ook in een bundel verkrijgbaar met een uitgebreide samenvatting van FA...

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Document information

  • February 14, 2022
  • 46
  • 2020/2021
  • Essay
  • Unknown
  • 7-8

Subjects

  • geneesmiddel
  • ontwerp
  • design
  • geneesmiddelontwerp
  • fa ma
  • farmacie
  • master
  • productdossier
  • dossier
  • cbv
  • fa ma106

Written for

  • Universiteit Utrecht (UU)
  • Farmacie
  • FA-MA106 (FAMA106)
All documents for this subject (2)

1  review

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By: FarmacieArchief • 5 months ago

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Michelle1802

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FA-MA106
Geneesmiddelontwerp
Dossier
M. de Leeuw
29 mei 2021

,FA-MA106 Geneesmiddelontwerp dossier M. de Leeuw



Inhoud
1.Midazolam infuus 1 mg/ml, 100 ml ............................................................................................................. 5
1.1.Casus 2C ................................................................................................................................................ 5
1.2.Voorstel geneesmiddelontwerp ............................................................................................................ 5
1.2.1.Het product .................................................................................................................................... 5
1.2.2.Toedieningsroute ........................................................................................................................... 5
1.2.3.Verpakking...................................................................................................................................... 5
1.2.4.Kritische ontwerpaspecten ............................................................................................................ 5
1.3.Eigenschappen farmacon ...................................................................................................................... 5
1.3.1.Fysisch-chemische eigenschappen van midazolam ....................................................................... 5
1.3.2.Farmacokinetische eigenschappen van midazolam ....................................................................... 6
1.3.3.Farmacodynamische eigenschappen van midazolam .................................................................... 7
1.4.Doseringscontrole ................................................................................................................................. 7
1.4.1.Dosering ......................................................................................................................................... 7
1.4.2.Infusiesnelheid ............................................................................................................................... 7
1.5.Rationale ............................................................................................................................................... 7
1.6.Formulering ........................................................................................................................................... 8
1.7.Berekeningen ........................................................................................................................................ 8
1.7.1. Hoeveelheid infuus........................................................................................................................ 8
1.7.2. Hoeveelheid midazolam HCl ......................................................................................................... 8
1.7.3. Hoeveelheid NaCl; isotonie berekening ........................................................................................ 8
1.8.Veiligheidsaspecten............................................................................................................................... 9
1.9.Stabiliteit en houdbaarheid................................................................................................................... 9
1.9.1.Chemische stabiliteit ...................................................................................................................... 9
1.9.2.Fysische stabiliteit ........................................................................................................................ 10
1.9.3.Microbiologische stabiliteit .......................................................................................................... 10
1.9.4.Houdbaarheid............................................................................................................................... 10
1.10.Conclusie/voorstel tot wijzigen ......................................................................................................... 10
1.11.CBV .................................................................................................................................................... 11
1.12.CBP .................................................................................................................................................... 12
1.13.Discussie ............................................................................................................................................ 14
2.Spironolacton suspensie 1 mg/ml, 100 ml ................................................................................................. 17
2.1.Casus 3C .............................................................................................................................................. 17
2.2.Voorstel geneesmiddelontwerp .......................................................................................................... 17
2.2.1.Het product .................................................................................................................................. 17
2.2.2.Toedieningsroute ......................................................................................................................... 17
2.2.3.Verpakking.................................................................................................................................... 17

Universiteit Utrecht Pagina 2 van 46

,FA-MA106 Geneesmiddelontwerp dossier M. de Leeuw


2.2.4.Kritische ontwerpaspecten .......................................................................................................... 17
2.3.Eigenschappen farmacon .................................................................................................................... 17
2.3.1.Fysisch-chemische eigenschappen van spironolacton ................................................................. 17
2.3.2.Farmacokinetische eigenschappen van spironolacton ................................................................ 18
2.3.3.Farmacodynamische eigenschappen van spironolacton ............................................................. 19
2.4.Doseringscontrole ............................................................................................................................... 19
2.5.Rationale ............................................................................................................................................. 19
2.6.Formulering ......................................................................................................................................... 20
2.7.Berekeningen ...................................................................................................................................... 20
2.8.Veiligheidsaspecten............................................................................................................................. 21
2.9.Stabiliteit en houdbaarheid................................................................................................................. 21
2.9.1.Chemische stabiliteit .................................................................................................................... 21
2.9.2.Fysische stabiliteit ........................................................................................................................ 21
2.9.3.Microbiologische stabiliteit .......................................................................................................... 22
2.9.4.Houdbaarheid............................................................................................................................... 22
2.10.Conclusie/voorstel tot wijzigen ......................................................................................................... 22
2.11.CBV .................................................................................................................................................... 23
2.12.CBP .................................................................................................................................................... 25
2.13.Discussie ............................................................................................................................................ 27
3.Natamycine ................................................................................................................................................ 29
3.1.Casus 4C .............................................................................................................................................. 29
3.2.Voorstel geneesmiddelontwerp .......................................................................................................... 29
3.2.1.Het product .................................................................................................................................. 29
3.2.2.Toedieningsroute ......................................................................................................................... 29
3.2.3.Verpakking.................................................................................................................................... 29
3.2.4.Kritische ontwerpaspecten .......................................................................................................... 29
3.3.Eigenschappen farmacon .................................................................................................................... 29
3.3.1.Fysisch-chemische eigenschappen van natamycine .................................................................... 29
3.3.2.Farmacokinetische eigenschappen van natamycine .................................................................... 30
3.3.3.Farmacodynamische eigenschappen van natamycine ................................................................. 30
3.4.Doseringscontrole ............................................................................................................................... 30
3.5.Rationale ............................................................................................................................................. 31
3.6.Formulering ......................................................................................................................................... 31
3.7.Berekeningen ...................................................................................................................................... 31
3.8.Veiligheidsaspecten............................................................................................................................. 32
3.9.Stabiliteit en houdbaarheid................................................................................................................. 33
3.9.1.Chemische stabiliteit .................................................................................................................... 33


Universiteit Utrecht Pagina 3 van 46

, FA-MA106 Geneesmiddelontwerp dossier M. de Leeuw


3.9.2.Fysische stabiliteit ........................................................................................................................ 33
3.9.3.Microbiologische stabiliteit .......................................................................................................... 33
3.9.4.Houdbaarheid............................................................................................................................... 34
3.10.Conclusie/voorstel tot wijzigen ......................................................................................................... 34
3.11.CBV .................................................................................................................................................... 35
3.12.CBP .................................................................................................................................................... 37
3.13.Discussie ............................................................................................................................................ 39
4.Bronnen ...................................................................................................................................................... 42
5.Bijlagen ....................................................................................................................................................... 44
5.1.Bijlage I: Origineel CBP midazolam infuus ........................................................................................... 44
5.2.Bijlage II: Origineel CBP spironolacton suspensie ............................................................................... 45
5.3.Bijlage III: Origineel CBP natamycine oogdruppels ............................................................................. 46




Universiteit Utrecht Pagina 4 van 46

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