FARMACEUTISCHE
TOEDININGSVORMEN
Theorie
2024-2025
FARMACEUTISCHE EN BIOLOGISCHE LABORATORIUM TECHNOLOGIE
Lowie Boels
,Lowie Boels Farmaceutische toedieningsvormen: theorie
INLEIDING .................................................................................................................................... 5
DEEL I: APOTHEEKBEREIDINGEN EN KWALITEITSZORG .................................................................. 5
Aannemen en afleveren van het recept ..........................................................................................5
Type bereidingen in een apotheek .................................................................................................................5
Voorschrift voor een apotheekbereiding ........................................................................................................6
Dosering.......................................................................................................................................................6
OEFENINGEN ..........................................................................................................................................7
Kwaliteitszorg in de officina ...........................................................................................................8
Wetten over de apotheek: .............................................................................................................................8
Hoe etiketteren? ...........................................................................................................................................8
SOP ..............................................................................................................................................................9
Goede officina praktijken ..............................................................................................................................9
Kwaliteitseisen voor apotheekbereidingen ..................................................................................................11
DEEL II: BASISBEWERKINGEN IN DE OFFICINA ..............................................................................12
Wegen en volumemeten ............................................................................................................. 12
Wegen ........................................................................................................................................................12
Volumemeten ........................................................................................................................................12
Verkleinen .................................................................................................................................. 12
Zeven ........................................................................................................................................ 13
Mengen ..................................................................................................................................... 14
Voorbeeld...................................................................................................................................................14
Mengtechnieken .........................................................................................................................................14
Mengen op kleine schaal ............................................................................................................................15
Steriliseren en aseptisch werken ................................................................................................. 15
Principes van sterilisatie .............................................................................................................................15
DEEL III: TOEDIENINGSVORMEN ...................................................................................................17
VASTE TOEDIENINGSVORMEN ................................................................................................................ 17
Poeders ..................................................................................................................................... 17
Therapeutische effecten .............................................................................................................................17
Biofarmaceutische aspecten ......................................................................................................................18
Fysisch chemische eigenschappen .............................................................................................................18
Eigenschappen ......................................................................................................................................18
Onderzoek van vloei-eigenschappen ......................................................................................................20
Verbeteren van vloei-eigenschappen ......................................................................................................20
Bestandsdelen van poeders en bereiding ....................................................................................................21
Onverenigbaarheden ..................................................................................................................................21
Onderzoek..................................................................................................................................................21
Gelulen...................................................................................................................................... 22
Therapeutische aspecten ...........................................................................................................................22
Biofarmaceutische aspecten ......................................................................................................................22
Bestandsdelen ...........................................................................................................................................23
Bereiding ....................................................................................................................................................24
Bereiding van een verdunning = trituratie .....................................................................................................25
Oefeningen trituraties en bereidingen van gelulen ...................................................................................25
Enterisch omhullen ................................................................................................................................26
Verpakking en bewaring, etiketten en aflevering ..........................................................................................27
Onderzoek en kwaliteitscontroles ...............................................................................................................27
Tabletten ................................................................................................................................... 28
Therapeutische aspecten ...........................................................................................................................28
Biofarmaceutische aspecten ......................................................................................................................28
Formulatie en bestandsdelen van tabletten ................................................................................................28
Geneesmiddel .......................................................................................................................................28
Hulpstoffen ............................................................................................................................................28
Bereidingsmethoden ..................................................................................................................................29
1
,Lowie Boels Farmaceutische toedieningsvormen: theorie
Droge methoden ....................................................................................................................................31
Gebruikte hulpstoffen bij de bereiding van tabletten ....................................................................................32
Omhullen van tabletten ..............................................................................................................................33
Onderzoek en kwaliteitscontroles ...............................................................................................................33
VLOEIBARE TOEDIENINGSVORMEN .......................................................................................................... 34
Oplossingen ............................................................................................................................... 34
Therapeutische aspecten ...........................................................................................................................34
Biofarmaceutische aspecten ......................................................................................................................34
solventen ...................................................................................................................................................35
Indeling van farmaceutische oplossingen....................................................................................................36
Bestandsdelen van farmaceutische oplossingen .........................................................................................37
Bereiding van farmaceutische oplossingen .................................................................................................37
Conserveren...............................................................................................................................................39
Onverenigbaarheden ..................................................................................................................................41
Aandachtpunten.........................................................................................................................................41
Verpakking en etikettering ...........................................................................................................................42
Onderzoek..................................................................................................................................................42
Oefeningen.................................................................................................................................................42
Solubilisaties ............................................................................................................................. 44
Therapeutische aspecten ...........................................................................................................................44
Biofarmaceutische aspecten ......................................................................................................................44
Micelvorming ..............................................................................................................................................44
Solubilisatie en geensmiddelen stabiliteit ...................................................................................................45
Bereiding van solubilisaties.........................................................................................................................46
Suspensies ................................................................................................................................ 46
Therapeutische aspecten ...........................................................................................................................46
Eigenschappen...........................................................................................................................................46
Fysische stabiliteit van een suspensie .........................................................................................................46
Bestandsdelen van een suspensie ..............................................................................................................50
Bereiden van suspensies ............................................................................................................................53
Verpakking, etikettering en aflevering ..........................................................................................................54
Bewaren van suspensie ..............................................................................................................................55
Onderzoek en kwaliteitscontroles ...............................................................................................................55
Emulsies .................................................................................................................................... 55
Therapeutische aspecten ...........................................................................................................................56
Formulering van emulsies ...........................................................................................................................56
Stabiliteit van emulsies ...............................................................................................................................58
Oorzaken van instabiliteit............................................................................................................................58
Bereiden van emulsies ................................................................................................................................59
Bewaren, etikettering, verpakking en aflevering ...........................................................................................59
Onderzoek en kwaliteitscontrole .................................................................................................................60
Oefeningen.................................................................................................................................................60
DERMATOLOGISCHE PREPARATEN ........................................................................................................... 61
Structuur vd huid ........................................................................................................................ 61
Huidlagen...................................................................................................................................................61
Klinisch resultaat ........................................................................................................................................62
Routes voor het GM ....................................................................................................................................62
Penetratie van GM ...................................................................................................................... 62
Aard en toestand ........................................................................................................................................62
Wijze, duur en frequentie ............................................................................................................................62
Samenstelling ............................................................................................................................................63
Indeling van topische vormen ...................................................................................................... 63
Vaste preparaten ........................................................................................................................................64
Vloeibare preparaten ..................................................................................................................................64
Halfvaste preparaten ..................................................................................................................................64
Lipofiele halfvaste preparaten: ...............................................................................................................64
Hydrofiele halfvaste preparaten ..............................................................................................................65
Behandeling in fucntie van klisch aspect van dermatosen .......................................................................66
2
, Lowie Boels Farmaceutische toedieningsvormen: theorie
Bereiding van dermatologische preparaten .................................................................................. 67
Lipofiele zalven...........................................................................................................................................67
Hydrofiele zalven ........................................................................................................................................67
O/W cremes ...............................................................................................................................................68
W/O cremes ...............................................................................................................................................68
Gels ...........................................................................................................................................................68
Pasta’s .......................................................................................................................................................69
Onderzoek en kwaliteitscontroles................................................................................................ 69
Verpakking, etikettering en aflevering ........................................................................................... 69
RECTALE EN VAGINALE TOEDIENINGSVORMEN ............................................................................................ 71
Definitie en plaatsbepaling .......................................................................................................... 71
Therapeutische aspecten ........................................................................................................... 71
Biofarmaceutische aspecten ...................................................................................................... 72
Fysiologische factoren ................................................................................................................................72
Fysicochemische factoren ..........................................................................................................................72
Bestandsdelen van zetpillen en ovules......................................................................................... 73
GM voor rectaal gebruik ..............................................................................................................................73
GM voor vaginaal gebruik ...........................................................................................................................73
Hulpstoffen ~ zetpil/ovulebasissen .............................................................................................................73
Lipofiele basissen ..................................................................................................................................74
Hydrofiele basissen ................................................................................................................................74
Keuze van de basis .................................................................................................................................75
Bereiden van zetpillen................................................................................................................. 75
Bereiden door gieten in een zetpilvorm = moulding ......................................................................................75
Ijken van zetpilvormen ............................................................................................................................75
De verdringingsfactor .............................................................................................................................75
De berekening van de hoeveelheid af te wegen zetpilmassa ....................................................................76
Bereiden van suspensie zetpillen ............................................................................................................76
Bereiden van oplossingszetpillen ............................................................................................................77
Bereiden van emulsie zetpillen ...............................................................................................................78
Bereiden van zetpillen via compressie .........................................................................................................79
Bereiden van ovules ................................................................................................................... 79
Onderzoek en kwaliteitscontrole ................................................................................................. 79
Verpakking, etikettering, aflevering & bewaring ............................................................................. 79
TRANSDERMALE THERAPEUTISCHE SYSTEMEN ............................................................................................ 80
Type van TTS .............................................................................................................................. 80
Reservoir met sturende membraan systemen .............................................................................................80
Matrix systemen .........................................................................................................................................80
Unilaminaire matrix systemen ................................................................................................................80
Multilaminaire matrix systemen ..............................................................................................................80
Therapeutische aspecten ........................................................................................................... 81
THERAPEUTISCHE AËROSOLS................................................................................................................. 82
Therapeutische aspecten ........................................................................................................... 82
Types van inhalatie therapieën .................................................................................................... 82
Vernevelaars ..............................................................................................................................................82
Doseer aerosols .........................................................................................................................................82
Droogpoeder inhalatoren ............................................................................................................................83
STERIELE PREPARATEN ......................................................................................................................... 84
Parentalia .................................................................................................................................. 84
Algemene kenmerken .................................................................................................................................84
Toedieningswegen ......................................................................................................................................84
Intraveneuze injectie of infusie ...............................................................................................................84
Subcutaan, intramusculair, intracutaan, intra-articulair ..........................................................................84
Intraperitoneaal, intrathecaal, epiduraal, intracisternaal .........................................................................84
Eisen van de farmacopee ............................................................................................................................85
ALGEMENE EISEN ..................................................................................................................................85
3
TOEDININGSVORMEN
Theorie
2024-2025
FARMACEUTISCHE EN BIOLOGISCHE LABORATORIUM TECHNOLOGIE
Lowie Boels
,Lowie Boels Farmaceutische toedieningsvormen: theorie
INLEIDING .................................................................................................................................... 5
DEEL I: APOTHEEKBEREIDINGEN EN KWALITEITSZORG .................................................................. 5
Aannemen en afleveren van het recept ..........................................................................................5
Type bereidingen in een apotheek .................................................................................................................5
Voorschrift voor een apotheekbereiding ........................................................................................................6
Dosering.......................................................................................................................................................6
OEFENINGEN ..........................................................................................................................................7
Kwaliteitszorg in de officina ...........................................................................................................8
Wetten over de apotheek: .............................................................................................................................8
Hoe etiketteren? ...........................................................................................................................................8
SOP ..............................................................................................................................................................9
Goede officina praktijken ..............................................................................................................................9
Kwaliteitseisen voor apotheekbereidingen ..................................................................................................11
DEEL II: BASISBEWERKINGEN IN DE OFFICINA ..............................................................................12
Wegen en volumemeten ............................................................................................................. 12
Wegen ........................................................................................................................................................12
Volumemeten ........................................................................................................................................12
Verkleinen .................................................................................................................................. 12
Zeven ........................................................................................................................................ 13
Mengen ..................................................................................................................................... 14
Voorbeeld...................................................................................................................................................14
Mengtechnieken .........................................................................................................................................14
Mengen op kleine schaal ............................................................................................................................15
Steriliseren en aseptisch werken ................................................................................................. 15
Principes van sterilisatie .............................................................................................................................15
DEEL III: TOEDIENINGSVORMEN ...................................................................................................17
VASTE TOEDIENINGSVORMEN ................................................................................................................ 17
Poeders ..................................................................................................................................... 17
Therapeutische effecten .............................................................................................................................17
Biofarmaceutische aspecten ......................................................................................................................18
Fysisch chemische eigenschappen .............................................................................................................18
Eigenschappen ......................................................................................................................................18
Onderzoek van vloei-eigenschappen ......................................................................................................20
Verbeteren van vloei-eigenschappen ......................................................................................................20
Bestandsdelen van poeders en bereiding ....................................................................................................21
Onverenigbaarheden ..................................................................................................................................21
Onderzoek..................................................................................................................................................21
Gelulen...................................................................................................................................... 22
Therapeutische aspecten ...........................................................................................................................22
Biofarmaceutische aspecten ......................................................................................................................22
Bestandsdelen ...........................................................................................................................................23
Bereiding ....................................................................................................................................................24
Bereiding van een verdunning = trituratie .....................................................................................................25
Oefeningen trituraties en bereidingen van gelulen ...................................................................................25
Enterisch omhullen ................................................................................................................................26
Verpakking en bewaring, etiketten en aflevering ..........................................................................................27
Onderzoek en kwaliteitscontroles ...............................................................................................................27
Tabletten ................................................................................................................................... 28
Therapeutische aspecten ...........................................................................................................................28
Biofarmaceutische aspecten ......................................................................................................................28
Formulatie en bestandsdelen van tabletten ................................................................................................28
Geneesmiddel .......................................................................................................................................28
Hulpstoffen ............................................................................................................................................28
Bereidingsmethoden ..................................................................................................................................29
1
,Lowie Boels Farmaceutische toedieningsvormen: theorie
Droge methoden ....................................................................................................................................31
Gebruikte hulpstoffen bij de bereiding van tabletten ....................................................................................32
Omhullen van tabletten ..............................................................................................................................33
Onderzoek en kwaliteitscontroles ...............................................................................................................33
VLOEIBARE TOEDIENINGSVORMEN .......................................................................................................... 34
Oplossingen ............................................................................................................................... 34
Therapeutische aspecten ...........................................................................................................................34
Biofarmaceutische aspecten ......................................................................................................................34
solventen ...................................................................................................................................................35
Indeling van farmaceutische oplossingen....................................................................................................36
Bestandsdelen van farmaceutische oplossingen .........................................................................................37
Bereiding van farmaceutische oplossingen .................................................................................................37
Conserveren...............................................................................................................................................39
Onverenigbaarheden ..................................................................................................................................41
Aandachtpunten.........................................................................................................................................41
Verpakking en etikettering ...........................................................................................................................42
Onderzoek..................................................................................................................................................42
Oefeningen.................................................................................................................................................42
Solubilisaties ............................................................................................................................. 44
Therapeutische aspecten ...........................................................................................................................44
Biofarmaceutische aspecten ......................................................................................................................44
Micelvorming ..............................................................................................................................................44
Solubilisatie en geensmiddelen stabiliteit ...................................................................................................45
Bereiding van solubilisaties.........................................................................................................................46
Suspensies ................................................................................................................................ 46
Therapeutische aspecten ...........................................................................................................................46
Eigenschappen...........................................................................................................................................46
Fysische stabiliteit van een suspensie .........................................................................................................46
Bestandsdelen van een suspensie ..............................................................................................................50
Bereiden van suspensies ............................................................................................................................53
Verpakking, etikettering en aflevering ..........................................................................................................54
Bewaren van suspensie ..............................................................................................................................55
Onderzoek en kwaliteitscontroles ...............................................................................................................55
Emulsies .................................................................................................................................... 55
Therapeutische aspecten ...........................................................................................................................56
Formulering van emulsies ...........................................................................................................................56
Stabiliteit van emulsies ...............................................................................................................................58
Oorzaken van instabiliteit............................................................................................................................58
Bereiden van emulsies ................................................................................................................................59
Bewaren, etikettering, verpakking en aflevering ...........................................................................................59
Onderzoek en kwaliteitscontrole .................................................................................................................60
Oefeningen.................................................................................................................................................60
DERMATOLOGISCHE PREPARATEN ........................................................................................................... 61
Structuur vd huid ........................................................................................................................ 61
Huidlagen...................................................................................................................................................61
Klinisch resultaat ........................................................................................................................................62
Routes voor het GM ....................................................................................................................................62
Penetratie van GM ...................................................................................................................... 62
Aard en toestand ........................................................................................................................................62
Wijze, duur en frequentie ............................................................................................................................62
Samenstelling ............................................................................................................................................63
Indeling van topische vormen ...................................................................................................... 63
Vaste preparaten ........................................................................................................................................64
Vloeibare preparaten ..................................................................................................................................64
Halfvaste preparaten ..................................................................................................................................64
Lipofiele halfvaste preparaten: ...............................................................................................................64
Hydrofiele halfvaste preparaten ..............................................................................................................65
Behandeling in fucntie van klisch aspect van dermatosen .......................................................................66
2
, Lowie Boels Farmaceutische toedieningsvormen: theorie
Bereiding van dermatologische preparaten .................................................................................. 67
Lipofiele zalven...........................................................................................................................................67
Hydrofiele zalven ........................................................................................................................................67
O/W cremes ...............................................................................................................................................68
W/O cremes ...............................................................................................................................................68
Gels ...........................................................................................................................................................68
Pasta’s .......................................................................................................................................................69
Onderzoek en kwaliteitscontroles................................................................................................ 69
Verpakking, etikettering en aflevering ........................................................................................... 69
RECTALE EN VAGINALE TOEDIENINGSVORMEN ............................................................................................ 71
Definitie en plaatsbepaling .......................................................................................................... 71
Therapeutische aspecten ........................................................................................................... 71
Biofarmaceutische aspecten ...................................................................................................... 72
Fysiologische factoren ................................................................................................................................72
Fysicochemische factoren ..........................................................................................................................72
Bestandsdelen van zetpillen en ovules......................................................................................... 73
GM voor rectaal gebruik ..............................................................................................................................73
GM voor vaginaal gebruik ...........................................................................................................................73
Hulpstoffen ~ zetpil/ovulebasissen .............................................................................................................73
Lipofiele basissen ..................................................................................................................................74
Hydrofiele basissen ................................................................................................................................74
Keuze van de basis .................................................................................................................................75
Bereiden van zetpillen................................................................................................................. 75
Bereiden door gieten in een zetpilvorm = moulding ......................................................................................75
Ijken van zetpilvormen ............................................................................................................................75
De verdringingsfactor .............................................................................................................................75
De berekening van de hoeveelheid af te wegen zetpilmassa ....................................................................76
Bereiden van suspensie zetpillen ............................................................................................................76
Bereiden van oplossingszetpillen ............................................................................................................77
Bereiden van emulsie zetpillen ...............................................................................................................78
Bereiden van zetpillen via compressie .........................................................................................................79
Bereiden van ovules ................................................................................................................... 79
Onderzoek en kwaliteitscontrole ................................................................................................. 79
Verpakking, etikettering, aflevering & bewaring ............................................................................. 79
TRANSDERMALE THERAPEUTISCHE SYSTEMEN ............................................................................................ 80
Type van TTS .............................................................................................................................. 80
Reservoir met sturende membraan systemen .............................................................................................80
Matrix systemen .........................................................................................................................................80
Unilaminaire matrix systemen ................................................................................................................80
Multilaminaire matrix systemen ..............................................................................................................80
Therapeutische aspecten ........................................................................................................... 81
THERAPEUTISCHE AËROSOLS................................................................................................................. 82
Therapeutische aspecten ........................................................................................................... 82
Types van inhalatie therapieën .................................................................................................... 82
Vernevelaars ..............................................................................................................................................82
Doseer aerosols .........................................................................................................................................82
Droogpoeder inhalatoren ............................................................................................................................83
STERIELE PREPARATEN ......................................................................................................................... 84
Parentalia .................................................................................................................................. 84
Algemene kenmerken .................................................................................................................................84
Toedieningswegen ......................................................................................................................................84
Intraveneuze injectie of infusie ...............................................................................................................84
Subcutaan, intramusculair, intracutaan, intra-articulair ..........................................................................84
Intraperitoneaal, intrathecaal, epiduraal, intracisternaal .........................................................................84
Eisen van de farmacopee ............................................................................................................................85
ALGEMENE EISEN ..................................................................................................................................85
3
