Remington

The Science and Practice of Pharmacy

23rd Edition - October 30, 2020
Editor: Adeboye Adejare
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 2 0 0 0 7 - 0
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 2 2 3 8 9 - 5

The PCP's Bicentennial Edition Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, tra… Read more

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The PCP's Bicentennial Edition

Remington: The Science and Practice of Pharmacy, Twenty Third Edition, offers a trusted, completely updated source of information for education, training, and development of pharmacists. Published for the first time with Elsevier, this edition includes coverage of biologics and biosimilars as uses of those therapeutics have increased substantially since the previous edition. Also discussed are formulations, drug delivery (including prodrugs, salts, polymorphism. With clear, detailed color illustrations, fundamental information on a range of pharmaceutical science areas, and information on new developments in industry, pharmaceutical industry scientists, especially those involved in drug discovery and development will find this edition of Remington an essential reference. Intellectual property professionals will also find this reference helpful to cite in patents and resulting litigations. Additional graduate and postgraduate students in Pharmacy and Pharmaceutical Sciences will refer to this book in courses dealing with medicinal chemistry and pharmaceutics.

Cover image
Title page
Table of Contents
Copyright
Publication history
Dedication
List of contributors
Foreword—Remington 23rd edition
Preface to the first edition
Preface to the 23rd edition
Acknowledgments
Section 1: Introduction
Chapter 1. History of pharmacy
Abstract
1.1 The drug-taking animal
1.2 Prehistoric pharmacy
1.3 Antiquity
1.4 The Middle Ages
1.5 The Renaissance and Early Modern Europe
1.6 American pharmacy
1.7 Antebellum America: Pharmacy finds its niche
1.8 The search for professionalism
1.9 Legislation
1.10 Transition to a modern profession
1.11 The era of Count and Pour
1.12 The emergence of clinical pharmacy
1.13 The conflicting paradigms of pharmaceutical care and managed care
1.14 The promise of a new century
1.15 The future
1.16 History as a discipline
1.17 Bibliographic notes
1.18 A chronology of pharmacy
Chapter 2. Integrated approach to drug nomenclature
Abstract
2.1 Introduction
2.2 The changing face of drug nomenclature
2.3 Principles of drug nomenclature
2.4 Types of drug nomenclature
2.5 Global cooperation on harmonization of drug nomenclature
2.6 The challenges of selecting INN for biologics
2.7 Integrated approach to drug nomenclature
2.8 Conclusion
Acknowledgment
References
Section 2: Natural Products
Chapter 3. Botanical dietary products
Abstract
3.1 Botanical dietary supplements
3.2 Botanicals standardization and quality evaluation
3.3 Quality control and quality assurance of botanicals
3.4 Potential toxicity of botanical dietary supplements
3.5 Kratom (Mitragyna speciosa), a controversial psychoactive plant
3.6 Concluding remarks
References
Chapter 4. Natural products and derivatives as human drugs
Abstract
4.1 Introduction
4.2 Agents against pain
4.3 Antiinfectives (antibacterial, antiparasitic, and antiviral)
4.4 Anticancer agents (Fig. 4.6)
4.5 Conclusion
References
Chapter 5. Medicinal Cannabis: an overview for health-care providers
Abstract
5.1 History of Cannabis use
5.2 Clinical indications
5.3 Cannabis subjective effects
5.4 “Stimulation versus couch lock?”
5.5 Formulations
5.6 Routes of ingestion
5.7 Product labeling
5.8 The endocannabinoid system
5.9 Pharmacology of phytocannabinoids
5.10 Mechanisms of action
5.11 (−)-trans-Δ9-Tetrahydrocannabinol
5.12 Cannabidiol
5.13 Cannabinol
5.14 (−)-trans-Δ8-Tetrahydrocannabinol
5.15 Propyl, butyl, and heptyl phytocannabinoid homologs
5.16 Phytocannabinoid acids
5.17 Terpenes
5.18 Additional small molecule components in Cannabis
5.19 The entourage effect
5.20 Adverse effects
5.21 Pharmaceutical cannabinoid products
5.22 Conclusion
References
Section 3: Pharmaceutical Chemistry
Chapter 6. Pharmaceutical chemistry
Abstract
6.1 Introduction
6.2 Functional groups
6.3 Acids and bases
6.4 Salts
6.5 Structural determinants of drug action
6.6 Intermolecular forces of attraction
6.7 Quantitative structure–activity relationship studies
6.8 Inorganic pharmaceutical chemistry
6.9 Drugs
6.10 Excipients
References and further reading
Chapter 7. Structure–activity relationships and drug design
Abstract
7.1 Introduction
7.2 Analog approach
7.3 Chemical space
7.4 Quantitative structure–activity relationships
7.5 Molecular docking for virtual screening
7.6 In silico prediction of protein–ligand binding affinities by free energy methods
7.7 Machine-learning approaches
References
Chapter 8. Pharmaceutical profiling
Abstract
8.1 Introduction
8.2 Pharmaceutical profiling in drug discovery
8.3 Profiling of active pharmaceutical ingredients and drug products’ degradants
8.4 Pharmaceutical profiling in drug development
8.5 Pharmaceutical profiling in pharmacokinetics and pharmacodynamics
8.6 Pharmaceutical profiling in toxicology and adverse drug reactions
8.7 Methods in pharmaceutical profiling
8.8 Absorption, distribution, metabolism, and excretion prediction models and methodologies
8.9 Methods in toxicity prediction
8.10 Automation in pharmaceutical profiling
8.11 Concluding remarks
References
Chapter 9. Prodrugs
Abstract
9.1 Introduction
9.2 Prodrug approaches based on drug delivery
9.3 Prodrug approaches based on functional groups
9.4 Prodrug approaches for anticancer drugs
9.5 Summary
References
Chapter 10. Fundamentals of medical radionuclides
Abstract
10.1 Applications of radionuclides in medicine and pharmacy
10.2 Radioactivity and radiation
10.3 The atom
10.4 Radioactive decay
10.5 Production of radionuclides
10.6 Radiolabeling of compounds to prepare radiotracers and radiopharmaceuticals
Bibliography
Section 4: Pharmacokinetics/Pharmacodynamics
Chapter 11. The science of pharmacokinetics: an overview and applications
Abstract
11.1 Introduction
11.2 Evolution of pharmacokinetics
11.3 Drug-development concepts
11.4 Clinical application
11.5 Future developments
11.6 Conclusion
References
Chapter 12. Principles of pharmacokinetics and pharmacodynamics
Abstract
12.1 Introduction
12.2 Drug concentration versus time profile
12.3 Rates and orders of reactions
12.4 Intravenous bolus with instantaneous distribution
12.5 Intravenous bolus with noninstantaneous distribution
12.6 Continuous input
12.7 Multiple-dose administration
12.8 Noncompartmental analysis following instantaneous input
12.9 Statistical moments
12.10 Pharmacokinetic parameters derived from statistical moments
12.11 Absorption
12.12 Organ-specific clearance
12.13 Protein binding
12.14 Dose- and time-dependent pharmacokinetics
12.15 Stereochemical considerations
12.16 Kinetics of pharmacologic effect
References
Further reading
Chapter 13. Therapeutic drug monitoring
Abstract
13.1 Rationale for therapeutic drug monitoring
13.2 Practical considerations for therapeutic drug monitoring
13.3 Drugs for which therapeutic drug monitoring is performed
References
Chapter 14. Model-informed drug development and discovery: an overview of current practices
Abstract
14.1 Current drug-development challenges
14.2 Model-informed drug development: virtual reality meets drug discovery and development
14.3 Model-informed drug development tools and approaches
14.4 Applications of model-informed drug development tools in different phases of drug development
Acknowledgments
Disclosures
References
Section 5: Pharmaceutics
Chapter 15. Preformulation
Abstract
15.1 The concept of preformulation
15.2 Physicochemical properties
15.3 Solubility
15.4 Partitioning
15.5 Dissolution rate
15.6 Powder properties
15.7 Compaction
15.8 Summary
References
Chapter 16. Powder characterization
Abstract
16.1 Introduction
16.2 Particle shape
16.3 Particle diameter and particle-size distribution
16.4 Particle size analysis methods
16.5 Powder properties
References
Chapter 17. Salt selection
Abstract
17.1 The need for pharmaceutical salts
17.2 The chemistry of salt formation
17.3 Selection of a salt former
17.4 Salt screening
17.5 Salt solubility
17.6 Solubility of basic salts
17.7 Solubility of acidic salts
17.8 The importance of pHmax
17.9 Dissolution of salts
17.10 Effect of excipients on pHm
17.11 Partitioning of salts
17.12 Summary
References
Chapter 18. Physical form
Abstract
18.1 Introduction
18.2 Particle size and shape
18.3 Crystalline materials
18.4 Amorphous materials
18.5 Characterization
18.6 Summary
References
Chapter 19. Solid oral dosage forms
Abstract
19.1 Introduction
19.2 Tablets
19.3 Types of tablets
19.4 Tablet compression
19.5 Tablet excipients
19.6 Tablet formulation examples
19.7 Tablet characterization
19.8 Capsules
19.9 Capsule characterization
References
Chapter 20. Liquid dosage forms
Abstract
20.1 Introduction
20.2 Monophasic liquids
20.3 Biphasic liquids
20.4 Quality control
20.5 Applications
References
Chapter 21. Medicated topicals
Abstract
21.1 Introduction
21.2 Skin as a site for drug delivery
21.3 Drug delivery to the skin: basic principles
21.4 Topical drug classification system
21.5 Formulation considerations
21.6 Formulation of topical dosage forms
21.7 Semisolids
21.8 Biphasic semisolids
21.9 Packaging and labeling
21.10 Other dosage forms for application to the skin and its appendages
21.11 Rectal, vaginal, and urethral routes of administration
References
Section 6: Biopharmaceutics
Chapter 22. Biotechnology and drugs
Abstract
22.1 Biotechnology
22.2 Biopharmaceuticals
22.3 Biopharmaceutical research and development
22.4 Remarks
References
Chapter 23. Therapeutic antibody discovery
Abstract
23.1 Introduction
23.2 Antibody generation
23.3 Hit and lead generation
23.4 Antibody lead optimization
23.5 Lead selection
23.6 Future directions
Disclosure
References
Chapter 24. Therapeutic antibody development—Remington chapter
Abstract
24.1 Introduction
24.2 Background of therapeutic antibodies
24.3 Nonclinical development of therapeutic antibodies
24.4 Clinical development of therapeutic antibodies
24.5 Conclusion/future direction
Acknowledgments
Disclosure
Abbreviations
References
Chapter 25. Gene and cell therapy
Abstract
25.1 Preface
25.2 Gene therapy
25.3 Cell therapy
25.4 Ethical issues
25.5 Marketing and funding
25.6 Progress and perspective
References
Chapter 26. Protein drug production and formulation
Abstract
26.1 Biologics versus synthetics—basic definitions and history
26.2 Complexity and regulatory considerations
26.3 Biologics manufacturing processes
26.4 Special notes on biosimilars
References
Section 7: Pharmaceutical Materials and Devices/Industrial Pharmacy
Chapter 27. Coating of pharmaceutical dosage forms
Abstract
27.1 Introduction
27.2 Evolution of coating processes
27.3 Pharmaceutical coating processes
27.4 Film coating of oral solid dosage forms
27.5 Coating procedures and equipment
27.6 Coating pans
27.7 Fluidized-bed coating equipment
27.8 Recent trends in film-coating processes
References
Chapter 28. Ophthalmic preparations
Abstract
28.1 Introduction
28.2 Bioavailability
28.3 Types of ophthalmic dosage forms
28.4 Drug administration
28.5 Irrigating solutions
28.6 Intraocular injections
28.7 Intravitreal injections/implants
28.8 Juxtascleral injections
28.9 Intracameral injections
28.10 Iontophoresis
28.11 Subconjunctival injections
28.12 Retrobulbar injections
28.13 Ophthalmic preparation characteristics
28.14 Packaging
28.15 Antimicrobial preservatives
28.16 Summary
References
Chapter 29. Parenteral preparations
Abstract
29.1 Introduction
29.2 Advantages of parenteral route and formulations
29.3 Concerns with parenteral route and formulations
29.4 Considerations for formulation development of parenterals
29.5 Formulation components
29.6 Containers and closures
29.7 Pyrogens (endotoxins) and depyrogenation
29.8 General considerations—production facilities
29.9 Personnel
29.10 Environmental control evaluation
29.11 Process simulation testing by media fill
29.12 Manufacturing of parenteral product
29.13 Quality assurance and control
References
Further reading
Chapter 30. Pulmonary, Nasal, and Topical Aerosol Drug Delivery Systems
Abstract
30.1 Introduction
30.2 Modes of drug delivery to the respiratory tract
30.3 Important considerations in the design of pulmonary aerosol systems
30.4 General aerosol formulation principles
30.5 Aerosol formulation components
30.6 Manufacture of pressurized aerosol products
30.7 Product testing
30.8 Human factors
30.9 Future of aerosols and inhaled drug therapy
Further reading
Chapter 31. Nanotechnology
Abstract
31.1 Introduction toward a definition
31.2 Types of nanomaterials
31.3 Manufacturing technologies
31.4 Characterization of nanoparticles
31.5 Applications of nanoparticles in medicine
31.6 Toxicity of nanoparticles
31.7 Regulatory aspects of nanoparticles
References
Chapter 32. Pharmaceutical excipients
Abstract
32.1 Introduction to excipients
32.2 Solid oral dosage forms
32.3 Liquid oral dosage forms
32.4 Parenteral dosage forms
32.5 Ophthalmic and otic dosage forms
32.6 Nasal
32.7 Inhalation
32.8 Topical
32.9 Rectal and vaginal
32.10 Medical devices
32.11 Conclusion
References
Chapter 33. Hot-melt extrusion: a versatile technology
Abstract
33.1 Introduction
33.2 Hot-melt extrusion processing
33.3 Hot-melt extrusion Instrumentation and other details
33.4 Applications of hot-melt extrusion
33.5 Conclusion
References
Chapter 34. Process validation in pharmaceutical manufacturing
Abstract
34.1 Introduction
34.2 Background
34.3 Approach to process validation
34.4 Documentation
34.5 Conclusion
Disclaimer
References
Section 8: Topics in Translational Research
Chapter 35. Translational research—from basic science to an approved therapeutic—an overview
Abstract
35.1 Introduction to translational research
35.2 Drug discovery—hit to lead to optimized drug candidate
35.3 Drug testing in humans
35.4 Case studies
35.5 Summary
References
Chapter 36. Translation of gene therapies
Abstract
36.1 Introduction
36.2 Mechanisms of action
36.3 Delivery vector
36.4 Adeno-associated virus
36.5 Mode of delivery
36.6 Proof of concept studies
36.7 Preclinical safety evaluation
36.8 Quality and manufacturing considerations
36.9 Clinical trials
36.10 Examples of successful gene therapy translation programs
36.11 Summary
References
Chapter 37. Large-scale molecular profiling approaches facilitating translational medicine: genomics, transcriptomics, proteomics, and metabolomics
Abstract
37.1 The concept of forward and reverse translational medicine studies, and the relevance of OMIC technologies
37.2 Drug development tools (such as biomarkers) can be identified with OMIC technologies
37.3 Translational medicine principles for enhancing drug development probability of success
37.4 A brief introduction to OMIC technologies of the central dogma: DNA→RNA→protein→(metabolite)
37.5 Systems biology: creating context by putting the “OMES” together
37.6 A final word—considerations regarding publicly available OMICS data in silico
37.7 Summary
References
Chapter 38. Neurobiologic correlates of depression: illustration of challenges in bench-to-bedside translation
Abstract
38.1 Introduction
38.2 Defining the patient population
38.3 Cultural impact on defining neuropsychiatric disease
38.4 Hurdles to basic and translational research
38.5 Models of neuropsychiatric disease
38.6 Genomics in depression
38.7 Antidepressant targets beyond serotonin
38.8 Summary
References
Section 9: Pharmacy Practice
Chapter 39. Pharmacy and patient centered care
Abstract
39.1 What is patient centered care?
39.2 Why is patient-centered care needed?
39.3 History of patient centered care
39.4 Future trends in the United States
39.5 Considerations affecting pharmacists provision of patient-centered care
39.6 Barriers and gaps
39.7 Patients, pharmacists, and settings where patient-centered care is practiced
39.8 Education and training
39.9 Conclusion
References
Chapter 40. Medication safety and medication error prevention
Abstract
40.1 State of medication safety and recent advances
40.2 Role of the medication safety leader
40.3 Medication safety analysis
40.4 Error-reduction strategies
40.5 Medication safety practices
40.6 Patient Safety and Medication Safety Organizations
40.7 Conclusion
References
Chapter 41. Substance use disorders
Abstract
41.1 Introduction
41.2 Definitions
41.3 At-risk populations
41.4 Addressing the problem
41.5 Specific substance use
41.6 Pharmacists role
41.7 Conclusion
References
Chapter 42. Global trends in pharmacy practice
Abstract
42.1 Introduction
42.2 Primary care and universal health coverage
42.3 Prevention
42.4 Pharmacists role in disease management
42.5 Pharmacist prescribing
42.6 Collaborating with other health professionals
42.7 Public health roles
42.8 Competency and credentialing to provide services and advance practice
42.9 Advancing community pharmacy globally
References
Further reading
Chapter 43. Value-based payment models involving pharmaceutical services
Abstract
43.1 Introduction
43.2 Approaches toward improving health-care value
43.3 Approaches toward improving health-care value
References
Chapter 44. Role of the pharmacist in research
Abstract
44.1 Introduction
44.2 What constitutes research?
44.3 Roles for pharmacists in research
44.4 Implementation science
44.5 Preparing for careers in research
44.6 Tips for success in pursuing research
44.7 Tips for conducting and assessing outcomes research
44.8 Conclusion
References
Chapter 45. Trends in nutrition practice
Abstract
45.1 Introduction
45.2 Overview
45.3 Nutrition practice models
45.4 Evidence-based medicine
45.5 Factors leading to transformation and innovation
45.6 Oversight by relevant organizations
45.7 Education and training
45.8 Barriers and gaps
45.9 Resources
45.10 Conclusion
References
Chapter 46. Medication disposal
Abstract
46.1 Introduction
46.2 Hazardous waste
46.3 Household disposal of medications
46.4 Minimization of pharmaceutical waste
46.5 Conclusion
References
Further reading
Chapter 47. Pharmacist use of point-of-care testing to improve access to care
Abstract
47.1 Introduction
47.2 Community pharmacy–based CLIA-POCT services
47.3 Pharmacy-based CLIA-POCT testing in the ambulatory care setting
47.4 Cost-effectiveness of pharmacist-provided CLIA-POCT testing
47.5 Future ways pharmacist-provided CLIA-POCT testing can improve access to care
47.6 Summary
References
Chapter 48. Specialty pharmacy services
Abstract
48.1 Practice models and services
48.2 Trends and impact
48.3 Stakeholders
48.4 Technology
48.5 Barriers and challenges
48.6 Organizational oversight
48.7 Education and training
48.8 Resources
48.9 Conclusion
References
Chapter 49. Pharmacy involvement in medical missions
Abstract
49.1 Introduction
49.2 Planning logistics
49.3 Health-care logistics
49.4 Integrating medical missions into pharmacy education
49.5 Conclusion
References
Chapter 50. Pharmacists’ role in infectious pandemics: illustration with COVID-19
Abstract
50.1 Introduction
50.2 Pharmacists’ response to COVID-19
50.3 Pharmacy scope of practice
50.4 Pharmacists’ response in the community
50.5 COVID-19 treatments and medication safety
50.6 Pharmacists’ role in point-of-care testing for COVID-19
50.7 Pharmacists’ response in critical care and healthcare systems
50.8 Pharmacists’ response in long-term care settings
50.10 Conclusion
References
Section 10: Pharmaceutical Outcomes and Policy
Chapter 51. Health policy and pharmacy
Abstract
51.1 Section 1: Introduction to health policy in pharmacy
51.2 Section 2: Pharmacist participation in the policy process—vaccinations and the advancement of the profession
51.3 Section 3: The pharmacists’ role in substance use disorder policy
51.4 Section 4: Opioid use disorder policy levers
51.5 Conclusion
References
Chapter 52. Implementation and evaluation of pharmacy services
Abstract
52.1 Introduction
52.2 Implementation of pharmacy services
52.3 Evaluation of pharmacy services
52.4 Conclusion
References
Chapter 53. Pharmacoepidemiology and pharmacovigilance
Abstract
53.1 Introduction
53.2 Common study types
53.3 Randomized controlled trial
53.4 Cohort studies
53.5 Case–control study
53.6 Cross-sectional and ecological studies
53.7 Measurements
53.8 Bias
53.9 Confounding
53.10 Communicating change
53.11 Summary
References
Additional resources
Chapter 54. Pharmacoeconomics
Abstract
54.1 Overview
54.2 Perspectives
54.3 Designing an economic analysis
54.4 Measuring costs
54.5 Measuring health effects
54.6 Analysis considerations
54.7 Reporting and interpreting results
54.8 Discussion
References
Chapter 55. Laws governing the practice of pharmacy
Abstract
55.1 Relationship between state and federal law
55.2 Definitions
55.3 Rules and regulations
55.4 Entry-level competence: licensing exams
55.5 Transfer of an existing license: “reciprocity”
55.6 Nuclear pharmacy
55.7 Pharmaceutical care
55.8 Remote pharmacy practices
55.9 Prescription drug order
55.10 Transfer of a prescription drug order
55.11 Product selection by the pharmacist
55.12 Hypodermic needles and syringes
55.13 Pharmacy licensing and regulation
55.14 Pharmacy licensing and facilities
55.15 Pharmacy supervision
55.16 Compounding
55.17 Outsourcing facilities
55.18 Federal laws
55.19 Historical background of the act
55.20 Drug approval process
55.21 Liability under the Food, Drug, and Cosmetic Act
55.22 Recordkeeping under the Food, Drug, and Cosmetic Act
55.23 Prescription labeling
55.24 Package inserts/professional product labeling
55.25 Patient package inserts or (“PPI”)
55.26 Unit-dose labeling
55.27 Regulation of dietary supplements
55.28 Drug recalls
55.29 Prescription Drug Marketing Act
55.30 Misbranding and adulteration
55.31 Misbranded drugs
55.32 Poisons
55.33 The Comprehensive Drug Abuse Prevention and Control Act of 1970
55.34 Prescriptions
55.35 Miscellaneous controlled substance issues
55.36 Liability for negligent acts
Further reading
Chapter 56. Drug distribution system
Abstract
56.1 Health-care delivery and third-party payers
56.2 Drug distribution and pharmacy reimbursement
References
Index

Life Sciences

Physical Sciences & Engineering

Social Sciences & Humanities

Health

Remington

The Science and Practice of Pharmacy

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Adeboye Adejare