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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5482_Библиотеки_им_академика_М_И_Перельмана.pdf
315
9. Name one section typically found in the layout of a pharma-
ceutical manufacturing plant and describe its function.
10. How does quality assurance differ from quality control in
pharmaceutical manufacturing?
Unit 7: Novel Drug Delivery Systems
1. Define novel and controlled drug delivery systems.
2. Discuss the various advantages and limitations of novel drug
delivery systems.
3. Classify the various novel drug delivery systems.
4. Define the liposomes and discuss their formulation com-
ponents.
5. What do you mean by solid lipid nanoparticles.
6. Discuss targeted drug delivery systems.
7. Write short note on:
a. Hydrogel
b. Nanoemulsion
c. Transdermal drug delivery systems
d. Microparticles
Index
Absorption bases 195
Acacia 165
Acquired immunity 259
Advantages of novel drug delivery
systems 295
Aerosol containers 31
Agar 166
Air-tight containers 31
Alternative method of preparation
using eggs 266
Alum precipitated toxoid (APT) 269
Analytical method validation 293
Ancillary areas 279
Antibacterial agents 236
Antibacterial sera 274
Antibody-drug conjugates (ADCs)
304
Antiviral sera 274
Approximate percentage sieving
area 67
Attrition 58
Bacterial vaccines 262
Ball mill 58
Bases for pastes 209
Bees wax 196
Binders 117
Bottle method 174
Box 30
British Pharmaceutical Codex (BPC)
26
Bruising or contusion 55
Buccal/sublingual tablets 113
Buffers 236
Calibration 290
Capsules 142
Capsules for packing of ophthalmic
ointments 152
Carbowaxes 170
Carton 29
Characteristics of containers and
closures 30
Chemical modification of the
drug 157
Chemical reaction method 203
Chewable tablets 112
Choice of emulsifying agents 172
Cholera vaccine 263
Cholesterol 170, 196
Chondrus (Irish moss) 167
Clarity test 251
Classification of
emulsifying agents 164
immunological preparations 261
novel drug delivery systems 297
ointments 191
powders 226
powders according to IP 63
Cleaning-in-place (CIP) and
sterilization-in-place (SIP)
validation 294
Cleaning validation 293
Closure 29
CoCl
2
filter paper test 164
Coloured glass 36
Colouring 133
agents of 46, 119
Complexation 157
Compression 57
Compression coating 134
Computer system validation 293
Conductivity test 162
Container 29
Contents uniformity test 154
Convective mixing 69
Co-solvency 156
Cracking 177
Creaming and sedimentation 175
Creams 206
Current good manufacturing
practices 287
Introduction to Pharmaceutics
318
Cutting 57
Cyclone separator 64
Decoction 98
Deliquescent or hygroscopic
powders 146
Dermatological factors 198
Diadennic ointments 192
Diagnostic preparations containing
bacterial toxins 270
Dialysis solutions 245
Differences between QA and QC 288
Difficulties in filling the capsules 146
Diffusive mixing 69
Digestion 99
Diluents 117
Dilution test 162
Diphtheria antitoxin 273
Diphtheria vaccine 269
Direct compression 121
Disintegrating agents 118
Disintegration test 153
Dispensing tablets 112
Dispersing agents 184
Dissolution test 140
Distributing the preparation in final
containers 241
Double cone blender 71
Double impression 130
Drainage system 281
Drug-eluting implants 304
Dry granulation 121
Dry gum method 173
Drying 90
Dry powder for reconstitution 189
Dry powder inhaler 222
Dusting powders 226
Dye-solubility test 163
Ear cones 214
Ear drops 223
Ear preparations 222
Ear spray 224
Effervescent granules 229
Effervescent powders 227
Effervescent tablets 114
Egg yolk 167
Elixirs 159
Emulsification method 205
Emulsifying agents 164
Emulsion bases 196
Emulsions 160
Endodermic ointments 192
Enteric coated
capsules 150
tablets 115
Enteric coating 135
Environmental control 283
Epidermic ointments 191
Equipment qualification 294
Essential qualities of a parenteral
product 234
Eutectic mixtures 147
Evaluation of parenteral
preparations 247
Evaluation of tablets 135
Extraction 95
Extraction processes 97
Extra pharmacopoeia
(martindale) 24
Eye drops 253, 254
Eye ointments 253, 255
Factors affecting size reduction 53
Factors governing selection of an
ideal ointment 197
Filling of hard capsules 143
Film coated tablets 115, 134
Filter aids 82
Filter media 79
Filtration 77
Fixed oils 173
Flaking 37
Flavouring agents 47, 119
Flocculated and non-flocculated
suspensions 181
Flocculating agents 182
Fluidised bed dryer 91
Fluorescence test 164
Forms of vaccines 261
Formulation of parenteral products
234
Formulation of suspensions 182
319
Index
Formulation of tablets 116
Freeze drying 93
Friability 138
Fusion method 202
Gelatin 167
Gels 212
Glass 34
Grading of powders 62
Granulating agents 118
Grinding 56
Haemodialysis 245
Hammer mill 59
Hand operated hard gelatin capsule
filling machine 144
Hard capsules 143
Hardness 137
Hardness variation 130
Hard paraffin 194
Hermetically-sealed containers 31
History of Indian Pharmacopoeia 20
History of pharmacy 1
Hydrocarbon bases 194, 209
Hydrogels 302
Hydrophile-lipophile balance (HLB)
171
Hydrotrophy 157
Hydrous wool fat 195
Hypodermic tablets 111
Immunity 257
Immunological
preparations 261
products 256
Impact 57
Implantable delivery systems 303
Implants 115
Indian Pharmacopoeia 17
Infusion 97
Inorganic emulsifying agents 170
Insufflations 226
Insufflators 222
Intraperitoneal dialysis 246
Intravenous fluids (large volume
parenterals) 242
Irrigation and dialysis solutions 245
Isotonicity factors 237
Jobs 15
Lal test 250
Layered tablets 116
Layout 278
Leaching 40
Leaker test 252
Lecithins 171
Levigation 56
Light resistant containers 31
Limitations or challenges 296
Liniments 214
Lipid-based delivery systems 297
Liposomes 297
Liquid mixing 70
Liquid nasal formulations 221
Liquid oral preparations 154
Liquid paraffin 194
Lotions 216
Lozenge tablets 113
Lubricants 119
Maceration 99
Manufacturing defects in tablets 127
Manufacturing of parenteral
preparations 239
Measles serum 275
Measles vaccine 266
Mechanism of mixing 69
Membrane filters 85, 89
Berkefeld filters 87
millipore filters 89
Seitz filter 85
sintered glass filters 86
Metals 41
Methods of preparation of
nanoemulsions 301
combination methods 302
high-energy/low-energy
combination 302
high-energy methods 301
high-pressure
homogenization 301
microfluidization 301
Introduction to Pharmaceutics
320
low-energy methods 302
phase inversion composition
(PIC) method 302
phase inversion temperature
(PIT) method 302
Methods of
preparation of ointments 200
preparation of pastes 211
preparation of tablets 121
size reduction 54
Methyl cellulose 168
Microemulsions 161
Microneedle-based delivery systems
303
Microneedle patches 303
Microparticles 303
Mixing 67
equipment 71
Mixing of
liquids and insoluble solids 70
liquids and soluble solids 70
two immiscible liquids 70
two miscible liquids 70
Monsanto hardness tester 137
Mottling 129
Multi-dose container 31, 253
Multilayer rotary tablet machines
127
Multi punch machines 126
Nanocarriers 304
Nanoemulsions 301
Nasal
preparations 219
suppositories 214
National Formulary of India 26
National pharmacopoeias 17
Natural emulsifying agents
from animal 167
from vegetable sources 165
Natural immunity 258
Negative mixtures 69
Neutral
glass 36
mixtures 69
Nominal diameter of the wire 67
Nominal size of aperture 66
Non-official compendia 17
Novel drug delivery systems 295
Number of sieves 66
Ocular inserts 304
Official compendia 16
Ointment bases 193
Ointments 190
Oleaginous bases 193
Oral tablets 112
Organoleptic additives 184
Organoleptic agent 46
Other additives in ointments 197
Packaging of parenteral product 252
Parenteral hyperalimentation
(total parenteral nutrition,
TPN) 244
Pastes 207
Pectin 167
Percolation 101
Pertussis vaccine 263
Petrolatum (soft paraffin) 194
Pfizer tablet hardness tester 138
pH adjustments 157
Pharmaceutical
factors 199
industry 4
quality assurance premises—
design and construction 284
Pharmacopoeia 16
Pharmacy as a career 7
academics 10
pharmaceutical industries 7
business development and
licensing 10
corporate affairs and public
relations 10
human resources and talent
development 10
information technology (IT)
and data management 10
manufacturing and
production 8
marketing and market access
10
medical affairs 9
321
Index
medical affairs and scientific
research 9
pharmacovigilance and drug
safety 9
quality assurance and quality
control 8
regulatory affairs 8
regulatory compliance 10
research and development
(R&D) 7, 8
supply chain and logistics 9
pharmaceutical sales and
marketing 14
Pharmacy education 3
Pharmacy organizations 4
The United Province Pharma-
ceutical Association 4
Phase inversion 178
Picking 129
Plague vaccine 263
Plastics 38
Poliomyelitis vaccines 267
Polishing 133
Polymeric delivery systems 302
Polymeric nanoparticles 302
Positive mixtures 68
Powder dosage forms for nasal
administration 222
Powders and granules 224
Preparation of
creams 206
emulsions 172
suspensions 184
tablets 120
Preparations containing antibodies
used to produce passive
immunity 272
Preservation of
emulsions 178
pastes 211
Preservative 49, 184
Press coated tablets 116
Pressurized MDIs (metered-dose
inhalers) 222
Principle areas of premises 279
Process validation 293
Production areas 280, 284
Professional associations 4
Indian Pharmaceutical
Association (IPA) 4
Pharmacy Council of India (PCI)
5
state-level associations 5
Pulverization by intervention 57
Purified toxoid aluminium
phosphate (PTAP) 269
Pyrogen test 249
Pyrogen testing 248
Qualities of good suspension 181
Quality assurance (QA) 286
Quality control and quality
assurance 285
Quality control areas 281
Quality control (QC) in
pharmaceuticals 285
Quality control (QC) laboratory
areas 284
Rabies antiserum 275
Rasping or grating 56
Rate of
disintegration 139
mixing 69
Rectal capsules 152
Rectal suppositories 213
Reserved percolation 105
Rotary tablet machines 126
Routes of administration of
parenteral products 230
Rubber 43
Sanitation 282
Sanitation of sterile areas 282
Saponins 170
Sealing the containers 241
Selection criteria of packaging
material 33
Semi-synthetic polysaccharides 168
Shear mixing 69
Sieves 66
Sieves and standards of sieves 66
Sieving/sifting 61
Silverson mixer-emulsifier 77
Introduction to Pharmaceutics
322
Single dose containers 31, 253
Single punch machines 123
Size reduction 51
Size separation 61
Slicing and cutting 54
Smallpox vaccine 264
Smoothing 133
Sodium carboxymethyl cellulose 168
Soft capsules 148
Solid lipid nanoparticles 299
Solubilising agents 235
Solubility 155
Solubilization 156
Soluble tablets 114
Sorption 40
Soxhlet extraction 106
Stability of emulsions 174
Stabilizers 236
Standardization of capsules 152
Staphylococcus toxoid 270
Starch 167
Sterile formulations 230
Sterility test 247
Sterilization 242
Sticking 129
Storage areas 283
Storage of immunological products
276
Sub-coating 132
Sugar coated tablets 115
Sugar coating 132
Suppositories 212
Suspending agents/thickening
agents 183
Suspensions 180
Suspensions containing diffusible
solids 185
Suspensions containing precipitate-
forming liquids 187
Sustained action tablets 115
Sustained release capsules 151
Sweetening agents 48, 120
Synthetic emulsifying agents 168
Syrups 158
Tablet coating 131
Tablet dosage forms 108
Tablet triturates 110
Targeted delivery systems 304
Tests for identification of emulsion
162
Tetanus toxoid 270
The British Pharmacopoeia (BP) 25
The history of the profession of
pharmacy in India 2
The International Pharmacopoeia 23
The Merck index 28
Theory of filtration 83
Darcy’s equation 84
Kozeny-Carman equation 84
Poiseuille’s equation 83
The United States Pharmacopoeia
(USP) 27
Thickness 136
Tolerance average aperture size 67
Topical preparations: Ointments,
creams, pastes, gels,
liniments lotions,
suppositories, and
pessaries 190
Toxoid antitoxin floccules (TAF) 269
Tragacanth 166
Transdermal delivery systems 305
Transdermal patches 305
Transport validation 294
Triple roller mill 75
Trituration 56
Trituration method 201
Turbine mixers 72, 75
Type I (borosilicate glass) 35
Type II (treated soda-lime glass) 35
Type III (soda lime-glass) 35
Type NP (general purpose glass or
non-parenteral glass) 36
Types of
emulsions 161
immunity 258
parenteral preparations 233
suppositories 213
tablets 109
validation 293
Typhoid (paratyphoid A and B
vaccine) 264
323
Index
Uniformity of weight 136
Urethral suppositories 214
Utilities 278
Vaccines containing
killed rickettsia 264
living viruses 264
toxoids 268
Vaginal suppositories 213
Vaginal tablets (inserts) 114
Validation 292
Vehicles 234
Volatile oils 173
Warehousing areas 279
Water miscible bases 210
Water proofing 132
Water soluble bases 196, 211
Weathering 37
Weight variation 130
Weight variation test 153
Well-closed containers 31
Wet granulation 122
Wet gum method 173
Wetting agents 183
Wetting, suspending and
emulsifying agents 237
Wool alcohol 195
Wool fat (anhydrous lanolin) 168, 195
Yellow fever vaccine 268
