Search in book...
Toggle Font Controls
Create new playlist

Name your new playlist

Playlist description (optional)
Sign In

Email address

Password

Forgot Password?

or

Continue with Facebook

Continue with Google
Sign Up

Full Name

Email address

Confirm Email Address

Password

or

Continue with Facebook

Continue with Google

Index

Active pharmaceutical ingredients (API), 1, 66, 125, 156, 277, 297, 318
Addition mode
- above surface, 234, 274
- normal/forward, 118, 220, 223–224, 235–240
- programmed, 253–256
- reverse, 118, 220, 224–225
- simultaneous, 118, 226, 235–244, 270, 272, 275–276
- strategy, 226–227
- subsurface, 145–146
Adsorption
- carbon, 335–337
- impurity, 47, 49, 108–109
- isotherm, 47–50
Agglomerate/agglomeration, 2, 4–5, 7, 12, 160, 165–167, 179, 224–225, 256, 262–264
- de‐agglomeration, 131
- drying, 218, 307–308, 314–315
- impurity, 112, 168
- mechanisms, 45–46, 112–113, 302–303
- particle size, 55, 116, 239, 240, 251
- supersaturation, 123
Amorphous, 3, 5, 13, 157
- freeze, 317, 338–342
- phase behavior/diagram, 17, 19, 30–36
- solid dispersion (see Solid dispersion)
- solubility (see Solubility)
- stability, 13, 157, 322
- supersaturation, 165, 263
Anti‐solvent, 223
- concentration/supersaturation profiles, 163, 223–226
- in‐line (see Mill and mixer (inline))
- process design and examples, 229–252
API‐excipient co‐processing, 318

Batch and semibatch operation
- anti‐solvent, 10
- concentration of solvent, 9
- cooling, 7–8, 177–183
Bioavailability, 1, 3, 13, 29–30, 36, 66, 157, 241, 248, 322, 349

Cake
- compressible, 12, 282, 288, 292
- mixing/blending, 309
- wetness, 2, 12, 32, 302–309, 314–315
Cocrystal
- screening, 67, 71–73
- solubility (see Solubility)
Computational fluid dynamic (CFD), 5, 139–140, 190, 321
Continuous and semicontinuous operation
- anti‐solvent, 11
- cooling, 8–9, 183–186
- evaporative/evaporation, 10
- fluidized bed, 113, 186, 195–199
- reactive, 11
Cooling, 7–9, 177
- batch operation (see Batch operation)
- continuous operation (see Continuous operation)
- process design and examples, 187–205
- rate of cooling, 7, 29, 52–53, 121, 162–163, 178–180
- scale‐up, 190
Crystal growth, 4, 95–97, 169–172, 178, 191–193, 262
- impurity, 108–110, 150–151
- mechanisms, 105–112
- mixing, 135–137, 150–151, 259
- rate, 113–114, 121–123
Crystalline
- phase behavior, 30–35
- solid dispersion (see Solid dispersion)
- stability, 13, 157, 322, 326, 353
Crystallizer, 126, 141
- baffle, 142–143
- external recirculation loop, 117, 126, 147–148, 275
- fluidized bed, 148–149, 173, 204–205
- impeller, 143–145, 230
- impinging jet, 11, 229, 241–244, 246–249, 264–268
- stirred vessels, 141–142, 146, 172
Crystal morphology, shape, and aspect ratio, 5, 8, 50–51, 157, 268, 276
- heat/cool/mill cycle, 52–53

Damkoehler number
- crystallization, 136–137
- mixing, 5, 145, 147, 258
- nucleation, 132–134
- reaction, 133
Deliquescence, 47
Design of experiment (DOE), 6
- model‐based, 119–123
- model‐free, 123–124
- multivariable/factorial analysis, 193, 236–237
Differential scanning calorimetry (DSC), 33, 35–37, 44, 80–84, 87–90, 93–94, 339–341, 353
- glass transition temperature, 22, 24
- melting point depression, 35
Downstream operations, 12–13, 277, 297
Dryer, 12, 291–292, 309–311
Drying, 2, 12, 297–298
- agglomerate/agglomeration (see Agglomerate/agglomeration)
- constant and falling rates, 305–307
- freeze, 338
- granule/granulation (see Granule/granulation)
- scale‐up, 309–310
- solvent (see Solvent)

Eutectic, 42, 196, 322, 338, 350, 353
Evaporative/evaporation, 9–10, 207
- change in solvent, 210
- concentration profile, 208–209
- equipment, 212, 214
- liquid‐vapor interface, 9, 10, 211
- process design and examples, 215–221
- scale‐up, 211

Filter
- agitated and centrifugal, 292
- cross‐flow, 198–200
- medium, 279–280
Filtration, 12, 277
- breakthrough, 293
- filtrate concentration profile, 287
- particle size (see Particle size)
- resistance, 237–238, 287–288
- scale‐up, 290–291
- sterile, 91–92 (see also Sterile crystallization)
- two‐filtration, 332–333
Foaming
- evaporative/evaporation, 9, 163, 211
Freeze crystallization, 317, 338–342

Granule/Granulation
- drying, 302–303, 315, 350, 352

Humidity, 2, 5, 12, 49–50, 85–87, 299, 309
Hygroscopicity, 47–50, 86

Impurity, 5, 12, 157, 244, 262–264
- adsorption (see Adsorption)
- agglomerate (see Agglomerate/agglomeration)
- crystal growth (see Crystal growth)
- inclusion and occlusion (see Inclusion and occlusion)
- mixing (see Mixing (impurity rejection))
- oil/oiling (see Oil/oiling)
- polymorph (see Polymorph/polymorphism)
- seed/seeding (see Seed/seeding)
- solubility (see Solubility)
- wash (see Wash)
Inclusion and occlusion
- crystal growth, 107–108
- impurity, residual solvent, 45–47, 168, 211, 274, 308–309
Intrinsic dissolution rate (IDR), 66

Melt crystallization, 317, 335–337
Metastable zone and induction time, 28, 180–181, 259–260
- Damkoehler number (see Damkoehler number (nucleation))
- phase diagram, 26–27
- solid dispersion, 29–30
Microscope, 35, 51
Mill and mixer
- in‐line, 11, 172–173, 228–229, 249–250, 264–267
- mixing elbow, 189–190
- rotor‐stator, 117, 132, 147–148, 249–250
- sonicator/sonication, 195, 203–205, 321, 346–349
- wet, 117–118, 275–276, 320–321
Mixing, 4–5, 8, 10–12, 101, 117–118, 125–126, 138–139
- crystal growth (see Crystal growth)
- Damkoehler number (see Damkoehler number)
- distribution, 130, 139
- impurity rejection, 150–151, 189–190
- intensity, 129–130, 140–141
- micro, meso and macro scale, 127–128, 257–259
- nucleation (see Nucleation)
- scale‐up, 128–130, 134–135, 139–141, 151–153, 172
- time, 127–129
- torque/mixing energy, 302–304, 307–310

Nucleation, 4, 8, 95–97, 167–169, 179, 181, 263
- mixing, 130–132, 152–153
- polymorph (see Polymorph/polymorphism)
- primary and secondary, 97–105
- rate, 102–104, 121–123, 168–169
- scale‐up, 134–135

Oil/Oiling, 3, 5, 164–166, 224–225, 234–236, 263–264
- impurity, 36
- phase diagram, 17, 30–36
- supersaturation, 165–166, 263
Ostwald ripening and rule, 58, 100–101, 116, 118

Particle attrition, breakage, and fracture, 132, 307–308, 346
Particle size
- distribution (PSD), 53–55, 125, 157, 159, 229–230, 266, 269
- drug loading, 55
- filtration, 238, 278
- modeling and simulation, 117–123
- population balance, 95–96, 115–116, 203
Polymorph/polymorphism, 36, 57
- conversion/transformation, 58–60, 118, 182
- crystal growth, 169–170
- decomposition/degradation/impurity, 66, 75, 93–94, 182
- enantiotropy and monotropy, 39, 58–59
- examples, 76–94, 199–201, 219–221, 251–252
- melting point, 58–59
- nucleation, 64–66, 101
- phase diagram and rule, 36–39, 57–58
- prediction, equilibrium and kinetic, 60–66
- screening and selection, 66, 73–75, 174
- solubility (see Solubility)
- solvate and hydrate, 57, 299–300 (see also Solubility)
Powder rheometer, 303, 307
Process analytical technology (PAT), 22, 119, 123, 155, 307

Quality by design (QbD)
- basic properties, 156–157
- bio‐batch, 6, 125
- critical quality attributes (CQAs), 6, 155–156
- mixing, 172–173
- seed, 119, 158–162
- strategies, 174–176
- supersaturation, 119, 162–163

Reaction
- selectivity, 264, 327–334
Reactive, 253–255
- in‐line (see Mill and mixer (inline))
- key issues, 256–264
- process design and examples, 267–276
- scale‐up, 254, 267
Residual solvent
- drying humidity level, 49–50
- inclusion and occlusion (see Inclusion and occlusion)
- nucleation over growth, 273–274
- surface hardening, 311–314
- wash, 293–296

Salt
- screening, 61–73
- solubility (see Solubility)
Scale‐up
- drying (see Drying)
- evaporative/evaporation (see Evaporative/evaporation)
- filtration (see Filtration)
- mixing (see Mixing)
- nucleation (see Nucleation)
- reactive (see Reactive)
Seed/seeding
- generation methods, 116–117
- guidelines, 158–162, 227–228, 260–261
- heel, 159–160, 162, 194–195, 261, 275
- impurity, 160, 189
- in‐situ wet, 4, 8, 117–119, 122–123, 147, 162, 226–228, 249–252, 261–262
Settling rate
- filtration, 290
- fluidized bed, 343–344
Solid compound and solid solution
- solubility (see Solubility)
Solid dispersion
- amorphous and crystalline, 3, 13, 19, 29, 36, 317–318, 321–322
- drug loading, 24, 34, 322, 349–350
- hybrid, 322, 349–353
- metastable, 29–30
- phase behavior, 33–34
- solubility and miscibility prediction, 24
Solid particle
- brittleness, hardness, yield stress, 300–302
Solid state NMR, 59–60
Solubility
- amorphous, 63
- chemical structure, salt and co‐crystal, 20–21
- impurity, 20, 25–26, 42–44, 157, 208–209, 231–233
- in‐silico prediction, 22–24
- phase diagram, 16, 34, 43, 197
- polymer and surfactant, 19
- polymorph, 36–39, 63
- selectivity, 25–26
- solid compound and solid solution, 42–44, 157
- solvate and hydrate, 40–42
- solvent, 18–20, 181–182
- temperature, 17–18
Solvent
- drying, 298
- nucleation and crystal growth rates, 122
- screening and selection, 74, 238–240
- solubility (see Solubility)
- wash, 280
Stability
- amorphous (see Amorphous)
- crystalline (see Crystalline)
- delivered product, 119
- milled vs. jet crystallized, 12–13, 244–245
Stereo/optical isomer
- chiral resolution, 8–10, 30, 45, 195–199, 201–203, 319–320, 342–349
Sterile crystallization, 91–92, 322–326, 338
Supercritical fluid crystallization (SFC), 13, 318
Supersaturation
- amorphous (see Amorphous)
- concentration profile, 169, 208–209, 216, 224–227, 255–256, 260–261
- Damkoehler number (see Damkoehler number (crystallization))
- feedback control, 123–124
- generation, 162–163
- oil/oiling (see Oil/oiling)
- rate processes, 4–12, 96–97
- release, 29–30, 137, 209, 227
- surface area, 243, 247

Wash
- impurity, 280, 282–284, 294
- protocol, 284–287
- residual solvent (see Residual solvent)
- solvent (see Solvent)

X‐ray powder diffraction (XRPD), 35, 37, 59–60

..................Content has been hidden....................

You can't read the all page of ebook, please click here login for view all page.

Table of Contents for Index

Create new playlist

Sign In

Sign Up

Table of Contents for
Index