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Zusammenfassung Skript - Grundlagen der Arzneiformenlehre $10.73
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Zusammenfassung Skript - Grundlagen der Arzneiformenlehre

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In diesem Skript werden die Inhalte der Vorlesung "Grundlagen der Arzneiformenlehre" (zweites Fachsemester, Düsseldorf) sowie die Seminare zu dem begleitenden Praktikum "Arzneiformenlehre" (drittes Fachsemester, Düsseldorf) ausführlich behandelt. Beginnend mit der Gesetzeslage (Arzneimittelsgese...

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  • February 18, 2023
  • 67
  • 2022/2023
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SKRIPT: GRUNDLAGEN DER ARZNEIFORMENLEHRE
INHALT
Grundlagen ......................................................................................................................................................................................... 6
Begriffsdefinitionen und Gesetzeslage ......................................................................................................................................... 6
§ 2 Arzneimittelbegriff (Arzneimittelgesetz) ............................................................................................................................. 6
§ 4 Sonstige Begriffsbestimmungen (Arzneimittelgesetz) ...................................................................................................... 7
§ 7 Rezepturarzneimttel (Apothekenbetriebsordnung) ........................................................................................................... 7
§ 8 Defekturarzneimittel (Apothekenbetriebsordnung) .......................................................................................................... 8
Kennzeichnung von Arzneimitteln (§ 14 Apothekenbetriebsordnung) ....................................................................................... 9
Normen für die Herstellung .........................................................................................................................................................10
Haltbarkeit ....................................................................................................................................................................................10
Definitionen ..............................................................................................................................................................................10
Arzneiformen als disperse Systeme ............................................................................................................................................10
Pulver & Puder .................................................................................................................................................................................11
Grundlagen ...................................................................................................................................................................................11
Darreichungsformen ....................................................................................................................................................................11
Monographien: Pulver zum Einnehmen (inklusive Brausepulver) ........................................................................................11
Monographien: Brausepulver ..................................................................................................................................................12
Monographien: Pulver zur kutanen Anwendung ....................................................................................................................13
Eigenschaften von Pulvern ..........................................................................................................................................................14
Teilchengröße: Bestimmungsmethoden .................................................................................................................................14
Oberfläche und Porosität .........................................................................................................................................................15
Fließverhalten von Pulvern (2.9.36) .......................................................................................................................................15
Sorption ....................................................................................................................................................................................16
Pulver- und Pudergrundstoffe .................................................................................................................................................16
Herstellung ...................................................................................................................................................................................18
Überblick über alle Arbeitsschritte ..........................................................................................................................................18
Zerkleinern und Mahlen ..........................................................................................................................................................19
Abteilen und Verpacken...........................................................................................................................................................19
Qualitätskontrolle .........................................................................................................................................................................19
Inprozessprüfungen .................................................................................................................................................................19
Endproduktprüfungen ..............................................................................................................................................................19
Granulate ..........................................................................................................................................................................................20
Grundlagen ...................................................................................................................................................................................20
Darreichungsformen ....................................................................................................................................................................20
Monographien: Granulate (Ph. Eur.) .......................................................................................................................................20
Monographien: Brausegranulate (Ph. Eur.) ............................................................................................................................21
Monographien: Überzogene Granulate (Ph. Eur.) ..................................................................................................................21
Monographien: Magensaftresistente Granulate (Ph. Eur.) ....................................................................................................22
Monographien: Granulate mit veränderter Wirkstofffreisetzung (Ph. Eur.) ..........................................................................22
Eigenschaften von Granulaten ....................................................................................................................................................23

, Vergleich zwischen Pulvern und Granulaten ..........................................................................................................................23
Grund- und Hilfsstoffe..............................................................................................................................................................23
Herstellung ...................................................................................................................................................................................23
Übersicht ..................................................................................................................................................................................23
Aufbauende Granulierung .......................................................................................................................................................24
Abbauende Granulierung.........................................................................................................................................................24
Qualitätskontrolle .........................................................................................................................................................................24
Abgeteilte Granulate ................................................................................................................................................................24
nicht abgeteilte Granulate .......................................................................................................................................................24
Kapseln.............................................................................................................................................................................................25
Grundlagen ...................................................................................................................................................................................25
Darreichungsformen ....................................................................................................................................................................25
Monographien: Kapseln (Ph. Eur.) ..........................................................................................................................................25
Monographien: Hartkapseln (Ph. Eur.) ...................................................................................................................................26
Monographien: Weichkapseln (Ph. Eur.) ................................................................................................................................26
Monographien: Kapseln mit veränderter Wirkstoffreisetzung (Ph. Eur.) ..............................................................................27
Monographien: Magensaftresistente Kapseln (Ph. Eur.) .......................................................................................................27
Monographien: Oblatenkapseln (Ph. Eur.)..............................................................................................................................27
Eigenschaften von Kapseln .........................................................................................................................................................28
Vorteile und Nachteile .............................................................................................................................................................28
Kapselhülle...............................................................................................................................................................................28
Unverträglichkeiten im Zusammenhang mit der Stabilität der Kapsel .................................................................................28
Herstellung ...................................................................................................................................................................................29
Herstellung der Kapselhülle: Tauchverfahren ........................................................................................................................29
Füllgut & Füllstoffe ...................................................................................................................................................................29
Kapselfüllung mit Pulver (NRF I.9.3.1) ...................................................................................................................................29
Qualitätskontrolle .........................................................................................................................................................................32
Kapselzerfall (DAC-Probe 13) ..................................................................................................................................................32
Kapselzerfall (2.9.1) ................................................................................................................................................................32
Lösungen ..........................................................................................................................................................................................33
Grundlagen ...................................................................................................................................................................................33
Größe der dispersen Komponente .........................................................................................................................................33
Aggregatzustand der Dispersen Komponente .......................................................................................................................33
Darreichungsformen ....................................................................................................................................................................33
Darreichungsformen im Ph. Eur. .............................................................................................................................................33
Monographien: Flüssige Zubereitungen zum Einnehmen (Ph. Eur.) .....................................................................................34
Eigenschaften von Lösungen ......................................................................................................................................................35
Löslichkeit ................................................................................................................................................................................35
Herstellung ...................................................................................................................................................................................36
Grundstoffe ..............................................................................................................................................................................36
Lösungsprinzipien ....................................................................................................................................................................36
Abtrennen ungelöster Stoffe ...................................................................................................................................................36
Mischungsberechnung ............................................................................................................................................................36

, Konservierungsmittel ...............................................................................................................................................................37
Sterilisationsverfahren ............................................................................................................................................................37
Isotonieberechnung .................................................................................................................................................................37
Emulsionen .......................................................................................................................................................................................38
Grundlagen ...................................................................................................................................................................................38
Emulsionstypen ........................................................................................................................................................................38
Tenside .........................................................................................................................................................................................38
W/O-Emulgatoren ....................................................................................................................................................................39
O/W-Emulgatoren ....................................................................................................................................................................39
Emulgatorgemische .................................................................................................................................................................39
Emulsionsbildung .........................................................................................................................................................................40
Instabilitäten ............................................................................................................................................................................40
Stabilisation..............................................................................................................................................................................40
Konservierungsmittel ...............................................................................................................................................................40
Herstellung ...................................................................................................................................................................................40
Herstellungsmethoden ............................................................................................................................................................40
Einflussfaktoren auf die Phasenverteilung ............................................................................................................................41
Qualitätskontrolle .........................................................................................................................................................................41
Suspensionen ..................................................................................................................................................................................42
Grundlagen ...................................................................................................................................................................................42
Eigenschaften von Suspensionen ...............................................................................................................................................42
Benetzung ................................................................................................................................................................................42
Instabilitäten ............................................................................................................................................................................42
Sedimentation ..........................................................................................................................................................................42
Flotation ....................................................................................................................................................................................43
Stabilisierung ...........................................................................................................................................................................43
Grund- und Hilfsstoffe..............................................................................................................................................................43
Herstellung ...................................................................................................................................................................................43
Qualitätskontrolle .........................................................................................................................................................................43
Salben, Cremes, Gele und Pasten ..................................................................................................................................................44
Grundlagen ...................................................................................................................................................................................44
Darreichungsformen ....................................................................................................................................................................44
Monographien: Halbfeste Zubereitungen zur kutanen Anwendung (Ph. Eur.) .....................................................................44
Monographien: Salben (Ph. Eur.) ............................................................................................................................................45
Monographien: Cremes (Ph. Eur.) ...........................................................................................................................................45
Monographien: Gele (Ph. Eur.) ................................................................................................................................................46
Monographien: Pasten (Ph. Eur.) ............................................................................................................................................46
Monographien: Umschlagspasten (Ph. Eur.) ..........................................................................................................................46
Klassifikation und Einteilung .......................................................................................................................................................47
Klassifikation der Salben.........................................................................................................................................................47
Klassifikation der Cremes .......................................................................................................................................................47
Klassifikation der Gele .............................................................................................................................................................48
Eigenschaften von Salben, Pasten, Cremes und Gelen ............................................................................................................49

, Verwendete Zusatzsstoffe .......................................................................................................................................................49
Herstellung ...................................................................................................................................................................................49
Cremes (nach DAC-NRF I.6.3.2) ..............................................................................................................................................49
Gele (nach DAC-NRF I.6.3.2) ...................................................................................................................................................49
Salben (nach DAC-NRF I.6.3.2) ...............................................................................................................................................50
Pasten .......................................................................................................................................................................................50
Geräte und Techniken .............................................................................................................................................................50
Qualitätskontrolle .........................................................................................................................................................................50
Beurteilung der Phasenlage ....................................................................................................................................................51
Grenzpartikelbestimmung mittels Grindometer .....................................................................................................................51
Spreitbarkeit mittels Extensometer ........................................................................................................................................51
Biopharmazie ...............................................................................................................................................................................51
Suppositorien ...................................................................................................................................................................................52
Darreichungsformen ....................................................................................................................................................................52
Eigenschaften von Suppositorien ...............................................................................................................................................52
Grundstoffe ..............................................................................................................................................................................52
Hilffstoffe ..................................................................................................................................................................................52
Herstellung (DAC I.12.3) ..............................................................................................................................................................52
Verdrängungsfaktor .................................................................................................................................................................53
Münzel-Methode ......................................................................................................................................................................53
Weitere Herstellungstechniken ...............................................................................................................................................54
Qualitätskontrolle .........................................................................................................................................................................54
Vaginalzäpfchen ...............................................................................................................................................................................55
Darreichungsformen ....................................................................................................................................................................55
Monographien: Vaginalzäpfchen (Ph. Eur.) ............................................................................................................................55
Eigenschaften von Vaginalzäpfchen ...........................................................................................................................................55
Grundmassen ...........................................................................................................................................................................55
Herstellung ...................................................................................................................................................................................56
Qualitätskontrolle .........................................................................................................................................................................56
Biopharmazie ...............................................................................................................................................................................56
Augentropfen ....................................................................................................................................................................................57
Darreichungsformen ....................................................................................................................................................................57
Monographien: Zubereitungen zur Anwendung am Auge (Ph. Eur.) .....................................................................................57
Monographien: Augentropfen (Ph. Eur.) .................................................................................................................................58
Monographien: Augenbäder (Ph. Eur.) ....................................................................................................................................58
Monographien: Pulver zur Herstellung von Augentropfen und Pulver zur Herstellung von Augenbädern .........................59
Monographien: Halbfeste Zubereitung zur Anwendung am Auge .........................................................................................60
Monographien: Augeninserte ..................................................................................................................................................60
Grundlagen ...................................................................................................................................................................................61
Eigenschaften von Augentropfen ................................................................................................................................................61
Hilfsstoffe .................................................................................................................................................................................61
Besonderheiten der Herstellung von Zuebreitungen zur Anwendung am Auge ......................................................................61
Methoden zur Herstellung steriler Zubereitungen (nach Ph. Eur.) .......................................................................................61

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