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FA-MA106 Geneesmiddelontwerp Samenvatting leerstof

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

In deze samenvatting van FA-MA106 Geneesmiddelontwerp vind je een uitgebreide uitwerking per behandelde thema (werk- en hoorcolleges). Ik heb de samenvatting opgedeeld in de volgende hoofdstukken: Geneesmiddelbereiding in de apotheek (kwaliteit eisen), Toedieningsvormen niet steriel (oraal, rectaa...

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Document information

  • No
  • Alle hoofdstukken/ paragrafen die gelezen moesten worden in de cursus fa-ma106
  • February 14, 2022
  • 50
  • 2020/2021
  • Summary

Subjects

  • fa ma106
  • 106
  • geneesmiddel
  • ontwerp
  • geneesmiddelontwerp
  • design
  • samenstelling
  • hulpstoffen
  • kwaliteit
  • parenteraal
  • bereiding
  • productzorg

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Written for

  • Universiteit Utrecht (UU)
  • Farmacie
  • FA-MA106 Geneesmiddelontwerp (FAMA106)
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By: ireneluzac • 4 months ago

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Content preview

FA-MA106
Geneesmiddelontwerp
Samenvatting

,Inhoud
Leerdoelen....................................................................................................................................................... 4
Algemene leerdoelen .................................................................................................................................. 4
Specifieke leerdoelen .................................................................................................................................. 4
Geneesmiddelbereiding in de apotheek ......................................................................................................... 5
Kwaliteitseisen ............................................................................................................................................ 5
Ontwerpkwaliteit ........................................................................................................................................ 5
Ketenkwaliteit ......................................................................................................................................... 6
Quality by design ..................................................................................................................................... 6
Drug substance/ farmacon Vs. Drug product/ geneesmiddel ..................................................................... 6
Effectiviteit .................................................................................................................................................. 6
Bereidingsverzoek ....................................................................................................................................... 7
Toedieningsvormen; niet steriel ..................................................................................................................... 8
Oraal ............................................................................................................................................................ 8
BCS-klasse ................................................................................................................................................ 8
Tabletten ............................................................................................................................................... 10
Capsules................................................................................................................................................. 11
Dranken ................................................................................................................................................. 13
Rectaal ....................................................................................................................................................... 14
Zetpillen................................................................................................................................................. 14
Klysma’s ................................................................................................................................................. 16
Dermaal ..................................................................................................................................................... 17
O/W crème ............................................................................................................................................ 17
W/O crème ............................................................................................................................................ 18
Zalf ......................................................................................................................................................... 18
Gel ......................................................................................................................................................... 19
Neus........................................................................................................................................................... 20
Toedieningsvormen; steriel........................................................................................................................... 21
Sterilisatie .................................................................................................................................................. 21
Sterilisatiekinetiek ................................................................................................................................. 21
Overkill-proces ...................................................................................................................................... 22
Bioburden-proces .................................................................................................................................. 22
Stoomsterilisatie.................................................................................................................................... 22
Heteluchtsterilisatie .............................................................................................................................. 22
Stralingssterilisatie ................................................................................................................................ 22
Gassterilisatie ........................................................................................................................................ 22
Membraanfilitratie ................................................................................................................................ 22
Parenteraal ................................................................................................................................................ 23
Injectievloeistoffen ontwerpen ............................................................................................................. 24

, Infusievloeistoffen ontwerpen .............................................................................................................. 24
Isotonie berekenen ............................................................................................................................... 25
Oculair (oogdruppels)................................................................................................................................ 28
Oordruppels .............................................................................................................................................. 29
Stabiliteit van geneesmiddelen ..................................................................................................................... 30
Fysische stabiliteit ..................................................................................................................................... 30
Amorf Vs. Kristallijn ............................................................................................................................... 30
Chemische stabiliteit ................................................................................................................................. 32
Hydrolyse............................................................................................................................................... 33
Oxidatie ................................................................................................................................................. 33
Fysisch-chemische analyse ........................................................................................................................ 34
Differential scanning calorimetry .......................................................................................................... 34
Thermo-gravimetrische analyse ............................................................................................................ 37
Microbiologische stabiliteit ....................................................................................................................... 38
Houdbaarheidsonderzoek ............................................................................................................................. 40
Stabiliteitseisen ......................................................................................................................................... 40
Gehalte .................................................................................................................................................. 40
Rekenvoorbeeld tetracyclinehydrochloridecrème 3% FNA ........................................................................ 41
Ontledingsproducten ............................................................................................................................ 42
Fysische- en microbiologische veranderingen ...................................................................................... 43
Stabiliteitsonderzoek................................................................................................................................. 43
Versneld Stabiliteitsonderzoek.............................................................................................................. 43
Lange termijn stabiliteitsonderzoek ...................................................................................................... 44
Tijdens gebruik stabiliteitsonderzoek ................................................................................................... 44
Doorlopend stabiliteitsonderzoek ......................................................................................................... 44
Reactiekinetiek .......................................................................................................................................... 44
Reactiesnelheid ..................................................................................................................................... 44
Temperatuur ......................................................................................................................................... 45
Rekenvoorbeeld reactiekinetiek ........................................................................................................... 45
Bijlagen .......................................................................................................................................................... 48
Bijlage I: Te kennen pKa’s .......................................................................................................................... 48
Bijlage II: Hulpstoffen overzicht ................................................................................................................ 49

, Leerdoelen

Algemene leerdoelen
Na afronding van de cursus is de student in staat:
Het ontwerp, de samenstelling en de productiemethode van geneesmiddelen te evalueren en te
beoordelen
Te beoordelen of een geneesmiddel aan alle criteria voldoet om het farmacotherapeutisch
gewenste effect te kunnen bewerkstelligen
Te reflecteren op zijn eigen professioneel gedrag

Specifieke leerdoelen
Na afronding van de cursus is de student in staat:
Op basis van probleemstellingen een uitvoerbaar werkplan op te stellen en daarbij de taken te
prioriteren, verdelen en (in teamverband) uit te voeren en te evalueren
Een geneesmiddel, farmaceutisch technologisch en biofarmaceutisch te karakteriseren
Kritische stappen in processen of systemen te herkennen en op basis daarvan protocollen op te
stellen; processen schriftelijk vast te leggen in protocollen
Tot het opstellen van keuringen op bereidingen en handelsproducten
Optimale condities voor transport en opslag van geneesmiddelen te bepalen en vast te leggen

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