Pharmaco-Complexity (eBook)

Non-Linear Phenomena and Drug Product Development

Anthony J. Hickey, Hugh D.C. Smyth (Autoren)

eBook Download: PDF

2010 | 2011
VIII, 71 Seiten
Springer US (Verlag)
978-1-4419-7856-1 (ISBN)

Infos

The historical approach to the interpretation of physical, chemical and biological phenomena has been to consider relationships with causative factors that can be reduced to linearity allowing simple and direct interpretation. However, it is increasingly evident that there is often more information in the data than linear interpretations allow. The current capacity for computers to assist in identifying non-linear relationships allows greater interpretation of data which illuminates the phenomena allowing the information to be translated into knowledge that can be used wisely to promote various desirable pharmaceutical outcomes. This short volume is intended to stimulate the reader to contemplate research and development areas in which the data might be more accurately interpreted to allow greater understanding and ultimately control of the pharmaceutically complex phenomena.

Dr. Anthony Hickey is Professor of Molecular Pharmaceutics and Biomedical Engineering at the University of North Carolina at Chapel Hill. He is a fellow of the Institute of Biology, American Association of Pharmaceutical Scientists and the American Association for the Advancement of Science. He has published several edited and authored volumes in the fields of pharmaceutical aerosols, process engineering and particulate science.

Dr. Hugh Smyth is Assistant Professor of Pharmaceutics at the University of Texas, Austin. He is a recipient of the Young Investigator in Pharmaceutics and Pharmaceutical Technology Award of the American Association of Pharmaceutical Scientists and has edited a volume on pulmonary drug delivery. Drs. Hickey and Smyth share a research interest in the delivery of drugs to the lungs for the treatment and prevention of a number of diseases.

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The interpretation of physical, chemical and biological phenomena as linear relationships between variables, or as simple functions of the variables, has been a significant scientific and mathematical strategy to their elucidation for centuries. It is often the case that the nature of linearity is to follow mathematical functions, e.g. power, exponential or logarithmic functions, nevertheless the desire to fit data to simple predictable expressions is imbued in every scientist and engineer. From a philosophical standpoint there is no reason to criticize this approach as it allows us to interpret the natural world and has a lofty heritage going back to the classical world.However, non-linear phenomena have been identified in many fields and interpreted as periodic, catastrophic, chaotic or complex involving a variety of mathematical tools for analysis. Benoit Mandelbrot's now classic book on the fractal geometry of nature and the many subsequent texts, most recently Wolfram's magnum opus "e;A New Kind of Science"e; have raised questions about the nature of reality and the interpretation of observed phenomena. It seems clear that the complexity of dynamic events (on any scale) can rarely be explained by linear interpretations. The rare exceptions are likely to represent a convergence of multiple phenomena giving the appearance of a linear relationship between variables.In fields related to pharmaceutical sciences some texts have been written by pioneers such as Brian Kaye. His eminently readable "e;A random walk through fractal dimensions"e; and "e;Chaos and complexity"e; were seminal volumes for the editors. Tracing the mathematics of complexity back to the nineteenth century and beyond gives a validity to the search for more accurate interpretations of experimental observations that should impact on the pharmaceutical sciences as significantly as other fields of endeavor.The chemistry and physics literature is replete with papers on complexity from such notables as Ilya Prigogine and Murray Gell-Mann. A broad range of biological phenomena, the most complex imaginable from molecular biology to ecology, are now the subject of complexity analysis. Pharmaceutical sciences encompass the biology, chemistry, physics and mathematics associated with drug discovery, delivery, disposition and action. This text describes a range of topics of importance in the pharmaceutical sciences that indicate a need for a non-linear interpretation if they are to be characterized accurately, understood fully and potentially controlled or modulated in the service of improved therapeutic strategies. It is likely that the future will involve increasingly complex interpretations of data related to drug design and delivery, particularly as our knowledge of the human genome leads inexorably to the potential for individualized therapy. We hope that this text will promote discussion of the varied phenomena leading to pharmacological effect and the complex interactions ultimately resulting in improved disease control and health maintenance.

Inhalt

Pharmaco-Complexity 3
Preface 5
Contents 7
Chapter 1: The Nature of Complexity and Relevance to Pharmaceutical Sciences 9
References 12
Chapter 2: Phenomena in Physical and Surface Chemistry 13
Chemical Reactions 13
Surface and Interfacial Chemistry 14
Aggregation 15
Adsorption from Solution 18
Solid Surface Interaction 21
Summary 23
References 23
Chapter 3: Solid State Pharmaceuticals: Solving Complex Problems in Preformulation and Formulation 27
Statics 28
Solubility, Dissolution, and Release 28
Fractal Dimensions and Surface Phenomena 29
Monte Carlo Methods in Modeling Drug Release 30
Surfaces and Particles 32
Complexity of Crystallization 32
Complexity of Particle Shape 34
Dynamics 35
Powder Flow and Mixing 35
Summary 39
References 39
Chapter 4: Considerations in Monitoring and Controlling Pharmaceutical Manufacturing 45
Statistics and Experimental Design 45
Sources of Error 45
Randomized and Latin Square Designs 46
Factorial Design 46
Fractional Factorial Design 47
Central Composite Design 47
Response Surface Maps 47
Process Design and Control 48
Quality by Design 48
Design Space 49
Process Analytical Technology 50
Risk Assessment and Management 51
Summary 52
References 52
Chapter 5: Pharmacokinetics and Pharmacodynamics 54
Pharmacokinetics/Toxicokinetics 54
Compartmental Modeling 55
Fractal Kinetics 56
Physiologically Relevant Modeling 57
Efficacy/Safety 57
Summary 60
References 60
Chapter 6: Impact of Complexity on Population Biology 62
Nature of Disease 62
Potential for Disease Intervention 63
Epidemiological Studies and Adverse Events 64
Summary 65
References 65
Chapter 7: Conclusion 67
References 72
Index 73
About the Authors 76

Produkt-Details

• Erscheint lt. Verlag: 15.12.2010
• Reihe/Serie: Outlines in Pharmaceutical Sciences
• Reihe/Serie: Outlines in Pharmaceutical Sciences
• Zusatzinfo: VIII, 71 p. 9 illus., 2 illus. in color.
• Verlagsort: New York
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitsfachberufe
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Themenwelt: Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie
• Themenwelt: Naturwissenschaften ► Biologie ► Biochemie
• Themenwelt: Technik ► Umwelttechnik / Biotechnologie
• Schlagworte: Complexity • Development • Drug • Hickey • Pharmaco • Phenomena • Product • Smyth
• ISBN-10: 1-4419-7856-9 / 1441978569
• ISBN-13: 978-1-4419-7856-1 / 9781441978561