Drug Stability for Pharmaceutical Scientists

Dedication

Chapter 1. Introduction

Chapter 2. Principles of Drug Degradation

2.1 Zero-Order Reactions

2.2 First-Order Reactions

2.3 Second-Order Reactions

2.4 Third-Order Reactions

2.5 Determination of the Order of a Reaction

2.6 Complex Reactions

2.7 Effect of Temperature

2.8 Specific Acid/Base Catalysis and pH-Rate Profiles

2.9 General Acid/Base Catalysis or Buffer Catalysis

2.10 Effects of Ionic Strength (Salt Effects)

2.11 Solvent Effects

2.12 Disperse Colloidal Systems (Micelle Effect)

2.13 Effect of Complexation

2.14 Effect of Light (Photodegradation) and Oxygen

References

Chapter 3. Degradation Pathways

3.1 Hydrolysis

3.2 Oxidation

3.3 Isomerization

3.4 Photochemical Degradation

3.5 Decarboxylation

3.6 Dehydration

3.7 Polymerization

References

Chapter 4. Drug Degradation in Semisolid Dosage Forms

4.1 Tretinoin

4.2 Betamethasone 17-valerate

References

Chapter 5. Stability of Peptides and Proteins

5.1 Physical Degradation

5.2 Chemical Degradation

5.3 Insulin

References

Chapter 6. Drug Degradation in Solid State

6.1 Chloramphenicol Palmitate

6.2 Nitroglycerin

6.3 Chemical Degradation

References

Chapter 7. Stability Testing

7.1 Guidelines for Stability Testing

7.2 Dorzolamide Eye Drops

References

Chapter 8. Problems

8.1 Racemization of (R)-Oxazepam

8.2 Consecutive Degradation of Prostaglandin

8.3 Effect of Buffer Salts on Lomustine Degradation

8.4 pH-rate Profile for Amoxicillin

8.5 Effect of Glucose on Amoxicillin Degradation

8.6 pH-rate Profile and Specific Acid/Base Catalysis

8.7 Aztreonam Polymerization

8.8 Aqueous Drug Suspension

8.9 Racemization of Ropivacaine

8.10 Degradation of Scopolamine

8.11 Primary Salt Effect

8.12 Leaving Groups

8.13 The Shelf-Life of Tetracycline Under Acidic Conditions

8.14 Parenteral Formulation Containing β-Lactam Antibiotic

References

Appendix

Answers to Learning Questions and Problems

Answers to Problems in Chapter 8:

References