Stability of drugs and dosage forms:
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York [u.a.]
Kluwer
2000
|
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | X, 268 S. graph. Darst. |
| ISBN: | 0306464047 |
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MARC
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| 650 | 7 | |a Estabilidade dos medicamentos |2 larpcal | |
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| 650 | 4 | |a Dosage Forms |x standards | |
| 650 | 4 | |a Drug Stability | |
| 650 | 4 | |a Drug stability | |
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Record in the Search Index
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| adam_text | STABILITY OF DRUGS AND DOSAGE FORMS SUMIE YOSHIOKA NATIONAL INSTITUTE OF
HEALTH SCIENCES TOKYO, JAPAN AND VALENTINO J. STELLA THE UNIVERSITY OF
KANSAS LAWRENCE, KANSAS T KLUWER ACADEMIC/PLENUM PUBLISHERS NEW YORK,
BOSTON, DORDRECHT, LONDON, MOSCOW CONTENTS 1. INTRODUCTION 1 2. CHEMICAL
STABILITY OF DRUG SUBSTANCES 3 2.1. PATHWAYS OF CHEMICAL DEGRADATION 4
2.1.1. HYDROLYSIS 5 2.1.1.1. ESTERS 5 2.1.1.2. AMIDES 10 2.1.1.3.
BARBITURATES, HYDANTOINS, AND IMIDES 12 2.1.1.4. SCHIFF BASE AND OTHER
REACTIONS INVOLVING CARBON-NITROGEN BOND CLEAVAGE 15 2.1.1.5. OTHER
HYDROLYSIS REACTIONS 17 2.1.2. DEHYDRATION 18 2.1.3. ISOMERIZATION AND
RACEMIZATION 18 2.1.4. DECARBOXYLATION AND ELIMINATION 22 2.1.5.
OXIDATION 24 2.1.6. PHOTODEGRADATION 28 2.1.7. DRUG-EXCIPIENT AND
DRUG-DRUG INTERACTIONS 29 2.1.7.1. REACTIONS OF BISULFITE, AN
ANTIOXIDANT 30 2.1.7.2. REACTION OF AMINES WITH REDUCING SUGARS 30
2.1.7.3. TRANSESTERIFICATION REACTIONS 33 2.2. FACTORS AFFECTING
CHEMICAL STABILITY 34 2.2.1. BASIC KINETIC PRINCIPLES 34 2.2.2. THE ROLE
OF MOLECULAR STRUCTURE 37 2.2.3. RATE EQUATIONS AND KINETIC MODELS 38
2.2.3.1. KINETIC MODELS TO DESCRIBE DRUG DEGRADATION IN SOLUTION 39
2.2.3.2. KINETIC MODELS DESCRIBING CHEMICAL DRUG DEGRADATION IN THE
SOLID STATE 52 2.2.3.3. CALCULATION OF RATE CONSTANTS BY FITTING TO
KINETIC MODELS 61 2.2.4. TEMPERATURE 61 2.2.4.1. GENERAL PRINCIPLES 61
VII VIII CONTENTS 2.2.4.2. QUANTITATION OF THE TEMPERATURE DEPENDENCY OF
DEGRADATION RATE CONSTANTS 62 2.2.4.3. STABILITY IN FROZEN SOLUTIONS 78
2.2.5. PH AND PH-RATE PROFILES 80 2.2.5.1. V-TYPE AND U-TYPE PH-RATE
PROFILES 82 2.2.5.2. PH-RATE PROFILES WITH INFLECTION POINTS DUE TO THE
PRESENCE OF ONE OR MORE IONIZED GROUPS 84 2.2.5.3. BELL-SHAPED PH-RATE
PROFILES DUE TO IONIZATION OF MULTIPLE GROUPS OR CHANGE IN RATE-
DETERMINING STEPS 94 2.2.5.4. MISCELLANEOUS PH-RATE PROFILES 96 2.2.6.
BUFFER, GENERAL ACID-BASE, AND NUCLEOPHILIC-ELECTROPHILIC CATALYSIS 97
2.2.7. IONIC STRENGTH (PRIMARY SALT EFFECTS) 99 2.2.8. DIELECTRIC
CONSTANT OF SOLVENTS 102 2.2.9. OXYGEN 104 2.2.10. LIGHT 106 2.2.11.
CRYSTALLINE STATE AND POLYMORPHISM IN SOLID DRUGS 107 2.2.12. EFFECT OF
MOISTURE AND HUMIDITY ON SOLID AND SEMISOLID DRUGS . . 108 2.2.13.
EXCIPIENTS 113 2.2.13.1. EFFECT OF THE AMOUNT OF MOISTURE PRESENT IN
EXCIPIENTS 113 2.2.13.2. EFFECT OF THE PHYSICAL STATE OF WATER MOLECULES
IN EXCIPIENTS 115 2.2.13.3. EFFECT OF THE MOBILITY OF WATER MOLECULES IN
EXCIPIENTS ON DRUG DEGRADATION 117 2.2.13.4. OTHER PROPERTIES OF
EXCIPIENTS 120 2.2.14. MISCELLANEOUS FACTORS 124 2.3. STABILIZATION OF
DRUG SUBSTANCES AGAINST CHEMICAL DEGRADATION 125 2.3.1. STABILIZATION BY
MODIFICATION OF MOLECULAR STRUCTURE OF DRUG SUBSTANCES 125 2.3.2.
STABILIZATION BY COMPLEX FORMATION 126 2.3.3. STABILIZATION BY THE
FORMATION OF INCLUSION COMPLEXES WITH CYCLODEXTRINS 128 2.3.4.
STABILIZATION BY INCORPORATION INTO LIPOSOMES, MICELLES, OR EMULSIONS
133 2.3.5. ADDITION OF STABILIZERS SUCH AS ANTIOXIDANTS AND
STABILIZATION THROUGH THE USE OF PACKAGING 135 3. PHYSICAL STABILITY OF
DRUG SUBSTANCES 139 3.1. PHYSICAL DEGRADATION 139 3.1.1. CRYSTALLIZATION
OF AMORPHOUS DRUGS 139 3.1.2. TRANSITIONS IN CRYSTALLINE STATES 141
3.1.3. FORMATION AND GROWTH OF CRYSTALS 141 3.1.4. VAPOR-PHASE TRANSFERS
INCLUDING SUBLIMATION 143 CONTENTS 3.1.5. MOISTURE ADSORPTION 143 3.2.
FACTORS AFFECTING PHYSICAL STABILITY 144 3.3. KINETICS OF SOLID-PHASE
TRANSITIONS 145 4. STABILITY OF DOSAGE FORMS 151 4.1. PREFORMULATION AND
FORMULATION STABILITY STUDIES 151 4.1.1. METHODS FOR DETECTING CHEMICAL
AND PHYSICAL DEGRADATION . . . . 151 4.1.1.1. THERMAL ANALYSIS 152
4.1.1.2. DIFFUSE REFLECTANCE SPECTROSCOPY 155 4.1.1.3. MISCELLANEOUS
METHODS 156 4.1.2. FACTORIAL ANALYSIS 157 4.2. FUNCTIONAL CHANGES IN
DOSAGE FORMS WITH TIME 159 4.2.1. CHANGES IN MECHANICAL STRENGTH 159
4.2.2. CHANGES IN DRUG DISSOLUTION FROM TABLETS AND CAPSULES 160 4.2.2.1
EFFECT OF FORMULATION ON CHANGES IN DISSOLUTION . . . . 160 4.2.2.2.
CHANGES IN DRUG RELEASE FROM COATED DOSAGE FORMS . 162 4.2.2.3. CHANGES
IN CAPSULE SHELLS WITH TIME AND STORAGE CONDITIONS 163 4.2.2 A.
PREDICTION OF CHANGES IN DISSOLUTION 165 4.2.3. CHANGES IN MELTING TIME
OF SUPPOSITORIES 167 4.2.4. CHANGES IN DRUG RELEASE RATE FROM POLYMERIC
MATRIX DOSAGE FORMS, INCLUDING MICROSPHERES 168 4.2.5. DRUG LEAKAGE FROM
LIPOSOMES 170 4.2.6. AGGREGATION IN EMULSIONS 172 4.2.7. MOISTURE
ADSORPTION 174 4.2.8. DISCOLORATION 175 4.3. EFFECT OF PACKAGING ON
STABILITY OF DRUG PRODUCTS 175 4.3.1. MOISTURE PENETRATION 175 4.3.2.
ADSORPTION ONTO AND ABSORPTION INTO CONTAINERS AND TRANSFER OF CONTAINER
COMPONENTS INTO PHARMACEUTICALS 176 4.4. ESTIMATION OF THE SHELF LIFE
(EXPIRATION PERIOD) OF DRUG PRODUCTS 178 4.4.1. EXTRAPOLATION FROM
REAL-TIME DATA 179 4.4.2. SHELF-LIFE ESTIMATION FROM
TEMPERATURE-ACCELERATED STUDIES ... 180 4.4.2.1. EXPERIMENTAL DESIGN OF
ACCELERATED TESTING 180 4.4.2.2. ESTIMATION OF SHELF LIFE USING
ACCELERATED-TEST DATA AT A SINGLE LEVEL OF TEMPERATURE 182 4.4.3.
ESTIMATION OF SHELF LIFE UNDER TEMPERATURE-FLUCTUATING CONDITIONS 184 5.
STABILITY OF PEPTIDE AND PROTEIN PHARMACEUTICALS 187 5.1. DEGRADATION OF
PEPTIDE AND PROTEIN PHARMACEUTICALS 187 5.1.1. CHEMICAL DEGRADATION 187
5.1.1.1. DEAMIDATION 188 5.1.1.2. ISOMERIZATION AND RACEMIZATION 189 X
CONTENTS 5.1.1.3. HYDROLYSIS 190 5.1.1.4. CROSS-LINKING THROUGH
DISULFIDE BOND FORMATION AND OTHER COVALENT INTERACTIONS . 190 5.1.1.5.
OXIDATION 192 5.1.2. PHYSICAL DEGRADATION 193 5.1.3. DEGRADATION IN
PEPTIDE AND PROTEIN FORMULATIONS 194 5.2. FACTORS AFFECTING THE
DEGRADATION OF PEPTIDE AND PROTEIN DRUGS 194 5.2.1. MOISTURE CONTENT AND
MOLECULAR MOBILITY 194 5.2.2. THE ROLE OF EXCIPIENTS 196 5.3.
DEGRADATION KINETICS OF PEPTIDE AND PROTEIN PHARMACEUTICALS 197 5.3.1.
QUANTITATIVE DESCRIPTION OF PEPTIDE AND PROTEIN DEGRADATION . . . . 197
5.3.2. TEMPERATURE DEPENDENCE OF THE DEGRADATION RATE OF PEPTIDE AND
PROTEIN DRUGS 199 6. REGULATIONS 205 6.1. ICH HARMONISED TRIPARTITE
GUIDELINE FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS 205
6.2 ICH HARMONISED TRIPARTITE GUIDELINE FOR PHOTOSTABILITY TESTING OF
NEW DRUG SUBSTANCES AND PRODUCTS 217 6.3 MAJOR CONCERNS RAISED BY THE
EU, THE UNITED STATES, AND JAPAN AT THE INTERNATIONAL CONFERENCE ON
HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF
PHARMACEUTICALS FOR HUMAN USE 223 6.3.1. STORAGE CONDITIONS FOR
STABILITY TESTING 223 6.3.2. PHOTOSTABILITY TESTING 223 6.3.3.
BRACKETING AND MATRIXING 224 REFERENCES 227 INDEX 263
|
| any_adam_object | 1 |
| author | Yoshioka, Sumie Stella, Valentino J. |
| author_facet | Yoshioka, Sumie Stella, Valentino J. |
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| dewey-search | 615/.18 |
| dewey-sort | 3615 218 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Book |
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| indexdate | 2024-07-09T18:55:50Z |
| institution | BVB |
| isbn | 0306464047 |
| language | English |
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| oclc_num | 43707147 |
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| owner | DE-20 |
| owner_facet | DE-20 |
| physical | X, 268 S. graph. Darst. |
| publishDate | 2000 |
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| spelling | Yoshioka, Sumie Verfasser aut Stability of drugs and dosage forms Sumie Yoshioka and Valentino J. Stella New York [u.a.] Kluwer 2000 X, 268 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Estabilidade dos medicamentos larpcal Fármacos (preparo) larpcal Dosage Forms standards Drug Stability Drug stability Drugs Dosage forms Arzneimittelstabilität (DE-588)4122835-2 gnd rswk-swf Arzneimittelstabilität (DE-588)4122835-2 s DE-604 Stella, Valentino J. Verfasser aut GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009582579&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Yoshioka, Sumie Stella, Valentino J. Stability of drugs and dosage forms Estabilidade dos medicamentos larpcal Fármacos (preparo) larpcal Dosage Forms standards Drug Stability Drug stability Drugs Dosage forms Arzneimittelstabilität (DE-588)4122835-2 gnd |
| subject_GND | (DE-588)4122835-2 |
| title | Stability of drugs and dosage forms |
| title_auth | Stability of drugs and dosage forms |
| title_exact_search | Stability of drugs and dosage forms |
| title_full | Stability of drugs and dosage forms Sumie Yoshioka and Valentino J. Stella |
| title_fullStr | Stability of drugs and dosage forms Sumie Yoshioka and Valentino J. Stella |
| title_full_unstemmed | Stability of drugs and dosage forms Sumie Yoshioka and Valentino J. Stella |
| title_short | Stability of drugs and dosage forms |
| title_sort | stability of drugs and dosage forms |
| topic | Estabilidade dos medicamentos larpcal Fármacos (preparo) larpcal Dosage Forms standards Drug Stability Drug stability Drugs Dosage forms Arzneimittelstabilität (DE-588)4122835-2 gnd |
| topic_facet | Estabilidade dos medicamentos Fármacos (preparo) Dosage Forms standards Drug Stability Drug stability Drugs Dosage forms Arzneimittelstabilität |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009582579&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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