SPRAY DRYING FORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES SPRAY DRYING Formulation of solids with adjustable particulate properties [email protected]Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical Course Lecture and Practical Course Lecture and Practical Course Lecture and Practical Course March 2013 TITLE OF LECTURE P. Walzel, Febr, 2013 (1) Bio- und Chemieingenieurwesen Mechanische - VT , MV MV MV MV
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SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
SPRAY DRYING
Formulation of solids with adjustable particulate properties
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Influence of spray parameters and
conditions at state 3' can be obtained from aheat balance. In practice ϑwb lies below the ac-tual surface temperature of moist particleswithin CRP but can be used as an estimated
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
Fakultät Bio- und Chemieingenieurwesen Lehrstuhl Mechanische Verfahrenstechnik
Prof. Dr. techn. Walzel (15.01.13)
Produktdesign
7 Sprühtrocknung
16
Limitierende Faktoren bei der Sprühtrocknung, Verdampfungszeit
Der erste Trocknungsabschnitt kann ermittelt werden, da die Oberflächentemperatur des Partikels im Bereich von ϑwb
liegt. Der folgende Trocknungsabschnitt treibt die Wasserfront, die durch die mit Wasser gefüllten Poren innerhalb der Partikel gebildet wird, zurück. Um ihn zu bestimmen sind experimentelle Untersuchungen nötig. Da die Trocknungsrate selbst von der Struktur und Anordnung der Partikel abhängt, liegt ein gekoppeltes System vor, dass z.T. nur teilweise theoretisch beschreibbar. Zur Einschätzung der Trocknungszeit im ersten Trocknungsabschnitt sind in Tabelle 1 die Verdampfungszeiten für Tropfen reinen Wassers gegeben. Tab.1: Verdampfungszeit von Tropfen an der Luft, ϑG = 200°C, ϑwb 47°C
Durchmesser d [μm] 10 50 100 200 500 1000
Verdampfungszeit τ[s] 0,006 0,15 0,61 2,5 15 61
Beim Gegenstrom wird ein wird eine minimale Sinkgeschwindigkeit benötigt um einen Gasstrom in entgegengesetzte Richtung zu ermöglichen. In Tab. 2 sind einige Sinkgeschwindigkeiten gegeben. Tab. 2: Sinkgeschwindigkeiten von Tropfen an der Luft ρp = 1000kg/m³
Durchmesser d [μm] 10 50 100 200 500 1000
Sinkgeschwindigkeit [s] 0,002 0,06 0,21 0,67 2,2 4,1 In Tabelle 3 sind die Daten der theoretischen Eindringtiefen in Luft gegeben, wenn die Partikel horizontal eingespritzt werden. Partikel in einem kontinuierlichem Strahl haben höhere Eindringtiefen, weil sie von der Luft mitgerissen werden. Tab. 3: Eindringtiefe von Tropfen in Luft v0 = 40m/s
Durchmesser d [μm] 10 50 100 200 500 1000
Eindringtiefe l [m] 0,01 0,253 1,01 3,5 12 40
Fakultät Bio- und Chemieingenieurwesen Lehrstuhl Mechanische Verfahrenstechnik
Prof. Dr. techn. Walzel (15.01.13)
Produktdesign
7 Sprühtrocknung
17
Einfluss des Tropfendurchmessers auf Betriebsbedingungen
Max. Tropfengröße d [μm]
• Tro
cknu
ngsz
eit [
s]
• Sin
kges
chw
indi
gkei
t [m
/s]
• Ver
wei
lzei
t [s]
• Trocknungszeit:
• Sinkgeschwindigkeit:
• Verweilzeit:
• Verzögerungsstrecke:
2dvd s
2~ d
dd
112
2xLx B
Fakultät Bio- und Chemieingenieurwesen Lehrstuhl Mechanische Verfahrenstechnik
breakup pointmoves towardsnozzle with in-creasing pressure- ---> no more at-tenuation possible, influence of κ κ κ κceases
d32 = f (Tu, δδδδ0, Θ, Θ, Θ, Θ, Weδδδδ, , , , gas phase) .. ? sparse information in literature
SHEET WITH AERODYNAMICWAVES AND SUPERIMPOSEDSTOCHASTIC 2D- STRUCTURE
LZ
picture: E. Musemic
picture: D. Feggeler
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
"Product Quality" to a large extend depends on dried materials, however influence on structure and morphology due to drying condition, i. e. the drying course (no agglomertion !)
CRPd >>CRPd<
time
tem
pera
ture
gas or air
small particles
large particles
Systematicanalysis in detailis stilloustanding
assessment ofparticle sizefractions andtheir specificmorphologyquality resp. isrequired
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
Narrow PSD only at low pressures ΔΔΔΔp < 50 bar and with uniform spray patternnarrow PSD only at low pressures Dp < 50 bar and with uniform spray pattern
• large primary particle • high solids content • low drying velocity • large slurry droplets • stabilized suspensionstabilizationstastatus
• dissolved polymers• amorphous preciptiation
• small primary particles• low concentrations• high drying velocity• crystallization of dissolved components
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
Drying of skinforming materials
Walton, D. E. , C. J. Mum-ford (1999b) The morpho-logy of spray-dried particles:The effect of process varia-bles upon the morphologyof spray dried particles.Chem.-Engng. Researchand Design, 77 (5): 442-490.
Spray dried product from ceramic primary particles d = 0.8 µm with different status of stabilization
• highly stabilized (large or very low pH) -> dense shell with ex- tended void in the center • low stabilization -> low but uniform density
according to M. Fries, Diss. TU Freiberg, Germany, 2008: "Produktgestaltung kera-mischer Sprühgranulatefür die uniaxiale Pressver-dichtung zu grossformi-gen Bauteilen"
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
OVERVIEW OF PARTICLE MAKEUP PROCESS OF INHALATES (33)
active carrier
SPRAY DRYER
MIXER
variance of doses PSD by LDS
particle morphology
active fines contentin aerosolaerosol<<<<<<<<<<
INHALER/IMPACTOR
JETMILL
active
d < 5 µm 10 < d < 60 µm
salbutamolsulfate (asthma therapy)
mannitol sol.15 %
1% active fines
Helos/RodosSympatec
Novolizer®,Viatris/ NGI Copley, Sci./HPLC
Hosokawa Alpine, 50AS Niro // TU Dortm.
Novolizer®,Viatris
Turbula T2C, Bachofen,CH
SEM,
weightbalance
Cooperation:Prof. N. Urbanetz
Bio- und Chemieingenieurwesen Mechanische - VT MV MV MV MV
SPRAY DRYINGFORMULATION OF SOLIDS WITH ADJUST.PART. PROPERTIES
Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Pharm / Bio-Engng. Lecture and Practical CourseLecture and Practical CourseLecture and Practical CourseLecture and Practical Course
March 2013 P. Walzel, Febr, 2013
=> primary task of SD is to provide solid particles from liquid feeds
=> fast solube materials can be obtained by very fast solidification (amorphous state) in presence of Polymers as PVA, PVP
=> SD experiments e.g. for Paracetamol formulation suitable for tabletting was sucessful
=> special powders as e.g. PULMOSOL (insuline) can be achieved by SD in combination with emulsification technology
=> even proteins (enzymes) or bacteria can be stabilized by proper excipients, e.g. trehalose as with differnt carbohydrates. Temperature is low and residence time is short (few seconds)