Coated pharmaceutical dosage forms: fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials
Saved in:
| Format: | Book |
|---|---|
| Language: | German English |
| Published: |
Stuttgart
Medpharm Scientific Publ.
1998
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Literaturangaben |
| Physical Description: | 280 S. Ill., graph. Darst. |
| ISBN: | 3887630491 |
Staff View
MARC
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| 245 | 1 | 0 | |a Coated pharmaceutical dosage forms |b fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials |c Kurt H. Bauer ... [Transl.: Erdmute Stanienda/Mitzi Morgan. Transl. ed.: Geoffrey Lee] |
| 264 | 1 | |a Stuttgart |b Medpharm Scientific Publ. |c 1998 | |
| 300 | |a 280 S. |b Ill., graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
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Record in the Search Index
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TABLE
OF
CONTENTS
PREFACE
.
5
CONTENTS
.
6
LIST
OF
ABBREVIATIONS
.
9
EXPLANATION
OF
TERMS
.
10
1
INTRODUCTION
.
11
1.1
HISTORY
OF
COATED
PHAR
MACEUTICAL
DOSAGE
FORMS
.
13
1.2
FOCAL
POINTS
AND
TRENDS
IN
MODERN
COATING
TECHNOLOGY
.
13
1.3
PURPOSE
OF
COATING
.
14
1.4
TYPES
OF
COATING
.
15
1.5
ACTIVE
INGREDIENTS
IN
COATINGS
.
16
1.6
MICROBIAL
CONTAMINATION
.
17
2
THE
CORE
OR
SUBSTRATE
.
19
2.1
TYPES,
SHAPES
AND
CHARAC
TERISTICS
OF
CORES
.
21
2.2
CALCULATION
OF
AMOUNT
OF
COATING
MATERIAL
FOR
VARIOUS
TYPES
OF
CORES
.
23
3
SUGAR-COATED
AND
OTHER
NON
FILM-COATED
PRODUCTS
.
29
3.1
SUGAR
COATING
AND
OTHER
NON-FILM
COATING
PROCESSES
.
31
3.1.1
COATINGS
WITH
SUCROSE
.
31
3.1.1.1
FUNDAMENTALS
OF
COATING
WITH
SUCROSE
.
31
3.1.1.2
COATING
PROCEDURE
AND
COAT
ING
LAYERS
.
36
3.1.1.2.1
COATING
PROCEDURE
.
36
3.1.1.2.2
COATING
LAYERS
.
38
3.1.2
COATINGS
OF
OTHER
SUGARS
AND
SUGAR
ALCOHOLS
.
43
3.1.2.1
GLUCOSE
.
43
3.1.2.2
LACTOSE
.
44
3.1.2.3
MALTITOL
.
44
3.1.2.4
MANNITOL
.
45
3.1.2.5
ISOMALT
.
45
3.1.2.6
SORBITOL
.
45
3.1.2.7
XYLITOL
.
46
3.1.2.8
SUGAR
MIXTURES
.
46
3.1.3
HOT
MELTS
.
46
3.1.3.1
CHOCOLATE
COATINGS
.
47
3.1.3.2
POLYETHYLENE
GLYCOL
COATINGS
.
47
3.1.3.3
WAX
COATINGS
.
47
3.2
MANUFACTURE
OF
COATINGS
.
48
3.2.1
PLANNING
.
48
3.2.2
FORMULATIONS
.
52
3.2.2.1
FORMULATIONS
FOR
SUCROSE
COATINGS
.
52
3.2.2.2
FORMULATIONS
WITH
OTHER
SUGARS
AND
SUGAR
ALCOHOLS
.
56
3.2.2.3
COCOA
COATINGS
.
58
3.3
PROBLEMS
.
58
4
FILM
COATINGS
.
63
4.1
INTERACTIONS
BETWEEN
SUB
STRATE
AND
FILM
.
65
4.2
COATING
PROCESSES
.
65
4.2.1
TYPES
OF
COATINGS
.
65
4.2.2
PROCESSING
CONDITIONS
AND
TECHNIQUES
.
70
4.2.3
PROCESSES
WITH
ORGANIC
SOL
VENTS
.
71
4.2.3.1
SOLVENT
SELECTION
.
71
4.2.3.2
FORMULATIONS
FOR
APPLICATION
.
75
4.2.3.3
FILM
FORMATION
.
75
4.2.4
PROCESSES
BASED
ON
AQUEOUS
COATING
SYSTEMS
.
77
4.2.4.1
GENERAL
REMARKS
.
77
4.2.4.2
FILM
FORMERS
IN
AQUEOUS
SOLUTION
.
78
4.2.4.2.1
CELLULOSE
ETHERS
.
78
4.2.4.2.2
OTHER
WATER-SOLUBLE
POLY
MERS
.
80
4.2.4.2.3
SALTS
OF ANIONIC
POLYMERS
.
81
4.2.4.2.4
SALTS
OF
CATIONIC
POLYMERS
.
82
4.2.4.3
AQUEOUS
POLYMER
DISPERSIONS
82
4.2.4.3.1
GENERAL
REMARKS
.
82
4.2.4.3.2
MANUFACTURE
.
84
4.2.4.3.3
MECHANISM
OF
FILM
FORMA
TION
.
86
4.2.4.3.4
SPECIAL
TECHNICAL
ASPECTS
OF
DISPERSIONS
.
90
4.2.4.3.5
PRODUCTS,
PROPERTIES
AND
APPLICATIONS
.
91
4.2.4.4
THERMOGELATION
.
98
4.2.4.5
REDISPERSIBLE
POLYMER
POWDERS
.
100
4.2.4.6
EXAMPLES
OF
DOSAGE
FORMS
PREPARED
BY
AQUEOUS
COATING
.
104
4.3
DEVELOPING
THE
FORMULATION
.
107
4.3.1
PLASTICIZER
EFFECT
.
107
4.3.2
SELECTING
THE
FORMULATION
.
108
4.3.3
COATINGS
ON
GELATIN
CAP
SULES
.
109
4.3.4
RECOMMENDED
FORMULATIONS
.
ILL
4.4
PROBLEMS
.
113
5
BIOPHARMACEUTICAL
ASPECTS
.
121
5.1
OBJECTIVES
OF
CONTROLLED
DRUG
RELEASE
AND
CONTROL
PRIN
CIPLES
.
123
5.1.1
RAPIDLY
DISINTEGRATING
COAT
INGS
FOR
PREVENTION
OF
SIDE
EFFECTS
.
123
5.1.2
SPECIFIC
SITE
RELEASE
IN
THE
DIGESTIVE
TRACT
.
124
5.1.3
CONTROLLED
TIME
RELEASE
AND
INFLUENCE
ON
PHARMACO
KINETICS
.
125
5.2
ENVIRONMENTAL
CONDITIONS
IN
THE
DIGESTIVE
TRACT
AND
THEIR
INFLUENCE
ON
THE
DOSAGE
FORM
.
126
5.3
VARIATIONS
IN
THE
ENVIRONMEN
TAL
CONDITIONS
OF
THE
DIGES
TIVE
TRACT
.
130
5.4
BIOPHARMACEUTICAL
PROBLEMS
AND
LIMITS
OF
THE
EFFECTIVE
NESS
OF
COATINGS
ON
PHAR
MACEUTICAL
DOSAGE
FORMS
.
131
5.4.1
SIMPLE
COATINGS
FOR
DISINTE
GRATION
IN
THE
STOMACH
.
131
5.4.2
ENTERIC
FORMULATIONS
.
132
5.4.3
DOSAGE
FORMS
FOR
DELAYED
DISINTEGRATION
IN
THE
INTESTI
NAL
TRACT
.
132
5.4.4
PROLONGED-ACTION
DOSAGE
FORMS
.
133
5.5
PRACTICAL
CONSEQUENCES
AND
EXAMPLES
.
134
6
COLORING
AND
FLAVORING
OF
COATED
DOSAGE
FORMS
.
141
6.1
COLORING
.
143
6.1.1
COLORING
TECHNIQUES
.
143
6.1.2
PSYCHOLOGICAL
EFFECT
OF
COLORED
DOSAGE
FORMS
.
147
6.1.3
LEGAL
REGULATIONS
.
148
6.2
FLAVORING
.
148
7.
EQUIPMENT
FOR
SUGAR
COATING
AND
FILM
COATING
POCESSES
.
153
7.1
PROCESS
PARAMETERS
.
155
7.1.1
MIXING
AND
TUMBLING
MOTIONS
IN
COATING
EQUIPMENT
.
156
7.1.2
SPRAYING
AND
SPRAY
SYSTEMS
.
158
7.1.3
DRYING
OF
THE
COATINGS
.
160
7.2
CONVENTIONAL
COATING
PANS
AND
BELT
COATERS
.
165
7.3
CONVENTIONAL
COATING
PANS
WITH
IMPROVED
DRYING
EFFI
CIENCY
.
168
7.3.1
IMMERSION
TUBE
PROCESS
.
168
7.3.2
IMMERSION
SWORD
PROCESS
.
168
7.3.3
COATING
PAN
WITH
PERFORATED
EXHAUST
CONES
FOR
DEEP-BED
AIR
EXTRACTION
.
169
7.4
PERFORATED
PANS
ROTATING
ON
HORIZONTAL
AXES
.
170
7.5
FLUIDIZED-BED
OR
AIR-SUSPEN
SION
COATERS
.
172
7.5.1
WURSTER
AND
GLATT-ZELLER
FLUIDIZED-BED
EQUIPMENT
.
173
7.5.2
ROTATING
COATING
SYSTEMS
.
174
7.5.3
THE
HKC
KUGELCOATER
.
175
7.6
VACUUM
COATER
WITH
SOLVENT
RECOVERY
AND
ENERGY
TRANSFER
.
177
7.7
SELECTION
CRITERIA
FOR
COATING
EQUIPMENT
.
178
7.8
PERIPHERAL
EQUIPMENT
.
179
7.8.1
SUPPORT
EQUIPMENT
AND
SAFETY
MEASURES
.
179
7.8.2
SOLVENT
DISPOSAL
.
181
8
TESTING
OF
COATED
DOSAGE
FORMS
.
185
8.1
TESTING
OF
COATING
MATERIALS
.
187
8.1.1
DISSOLUTION
BEHAVIOR
.
187
8.1.2
MECHANICAL
FILM
PROPERTIES
.
188
8.1.3
WETTING
BEHAVIOR
OF
COATING
FORMULATIONS
.
190
8.1.4
GAS
AND
WATER
VAPOR
PERMEABILITY
.
191
8.2
TESTING
OF
COATED
DOSAGE
FORMS
.
194
8.2.1
PHARMACOPEIA
TESTS
.
194
8.2.1.1
APARATUS
ACCORDING
TO
PH.EUR.
2
(AND
USP
23)
.
194
8.2.1.2
PERFORMANCE
OF
THE
TESTS
.
195
8.2.2
OTHER
TESTS
.
198
8.2.2.1
RESISTANCE
TO
DIGESTIVE
FLUIDS
.
198
8.2.2.2
SOLVENT
RESIDUES
.
199
8.2.2.3
ROUGHNESS
.
200
8.2.2.4
FILM
ADHESION
.
200
8.2.2.5
COLOR
TESTS
.
201
9
STABILITY
PROBLEMS
.
205
9.1
STABILITY
OF
SUGARS
AND
SUGAR
SOLUTIONS
.
207
9.2
STABILITY
OF
SUGAR-COATED
PRO
DUCTS
207
9.3
STABILITY
OF
THE
FILM
FORMERS
.
207
9.4
INCOMPATIBILITIES
AND
STABILITY
PROBLEMS
OF
COATING
FORMULA
TIONS
.
210
9.5
STABILITY
OF
FILM-COATED
TABLETS
.
212
10
RAW
MATERIALS
.
215
10.1
SUGARS
AND
SUGAR
ALCOHOLS
.
217
10.2
FILM
FORMERS
.
222
10.2.1
CELLULOSE
ETHERS
.
222
10.2.2
CELLULOSE
ESTERS
.
224
10.2.3
POLYMETHACRYLATES
.
225
10.2.4
POLYVINYL
ACETATE
COPOLY
MERS
.
229
10.2.5
POLYVINYL
PYRROLIDONE
.
230
10.3
PLASTICIZERS
.
231
10.4
COLORANTS
.
235
10.5
OTHER
RAW
MATERIALS
.
246
INDEX
.
262 |
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| id | DE-604.BV011663324 |
| illustrated | Illustrated |
| indexdate | 2024-08-16T01:20:36Z |
| institution | BVB |
| isbn | 3887630491 |
| language | German English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-007863564 |
| oclc_num | 320311295 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM |
| owner_facet | DE-19 DE-BY-UBM |
| physical | 280 S. Ill., graph. Darst. |
| publishDate | 1998 |
| publishDateSearch | 1998 |
| publishDateSort | 1998 |
| publisher | Medpharm Scientific Publ. |
| record_format | marc |
| spelling | Überzogene Arzneiformen Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials Kurt H. Bauer ... [Transl.: Erdmute Stanienda/Mitzi Morgan. Transl. ed.: Geoffrey Lee] Stuttgart Medpharm Scientific Publ. 1998 280 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Literaturangaben Beschichtung (DE-588)4144863-7 gnd rswk-swf Tablette (DE-588)4184308-3 gnd rswk-swf Tablette (DE-588)4184308-3 s Beschichtung (DE-588)4144863-7 s DE-604 Bauer, Kurt H. 1930-2024 Sonstige (DE-588)115859748 oth Stanienda, Erdmute Sonstige oth DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007863564&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials Beschichtung (DE-588)4144863-7 gnd Tablette (DE-588)4184308-3 gnd |
| subject_GND | (DE-588)4144863-7 (DE-588)4184308-3 |
| title | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials |
| title_alt | Überzogene Arzneiformen |
| title_auth | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials |
| title_exact_search | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials |
| title_full | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials Kurt H. Bauer ... [Transl.: Erdmute Stanienda/Mitzi Morgan. Transl. ed.: Geoffrey Lee] |
| title_fullStr | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials Kurt H. Bauer ... [Transl.: Erdmute Stanienda/Mitzi Morgan. Transl. ed.: Geoffrey Lee] |
| title_full_unstemmed | Coated pharmaceutical dosage forms fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials Kurt H. Bauer ... [Transl.: Erdmute Stanienda/Mitzi Morgan. Transl. ed.: Geoffrey Lee] |
| title_short | Coated pharmaceutical dosage forms |
| title_sort | coated pharmaceutical dosage forms fundamentals manufacturing techniques biopharmaceutical aspects test methods and raw materials |
| title_sub | fundamentals, manufacturing techniques, biopharmaceutical aspects, test methods and raw materials |
| topic | Beschichtung (DE-588)4144863-7 gnd Tablette (DE-588)4184308-3 gnd |
| topic_facet | Beschichtung Tablette |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=007863564&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | UT uberzogenearzneiformen AT bauerkurth coatedpharmaceuticaldosageformsfundamentalsmanufacturingtechniquesbiopharmaceuticalaspectstestmethodsandrawmaterials AT staniendaerdmute coatedpharmaceuticaldosageformsfundamentalsmanufacturingtechniquesbiopharmaceuticalaspectstestmethodsandrawmaterials |