Drugs And Pharmaceutical Sciences Special Indian Reprint

This book reviews the history, regulatory status, pharmacopeial specifications, and harmonization of pharmaceutical excipients in the United States and Europe, and provides a comprehensive understanding of the current scientific basis for safety evaluation and risk assessment.

Examines excipients as a unique class of products and explores new procedures for determining toxicity!

A timely and unique addition to the pharmaceutical literature, containing over 570 citations that support and enhance the text, Excipient Toxicity and Safety

• identifies the differences between excipients (inactive ingredients), food ingredients, and drug products
• evaluates issues of dose administration, species selection, and study design for various routes of exposure
• provides detailed information on the historical uses of excipients in drug formulations
• clarifies the Safety Committee of the International Pharmaceutical Excipients Councils (IPEC) guidelines and technical specifications for conducting tests for each route of exposure
• explains how data generated in toxicity models are applied to identify hazards in drug formulations
• details exposure assessment to link hazard identification with risk
• considers the requirements and importance of purity specifications
• and much more!

Excipient Toxicity and Safety is a blue-ribbon reference ideal for pharmacists; toxicologists; pharmacologists; analytical chemists; quality control, quality assurance, and regulatory compliance managers; and upper-level undergraduate and graduate students in these disciplines.

Contents

1. Introduction to Excipients

    

    
2. Safety Evaluation of Pharmaceutical Excipients

    

    
3. Risk Assessment of Excipients

    

    
4. Future Issues

Whether preparing for regulatory submissions or preapproval, investigator-directed, routin, or foreign inspection, this reference is assured to enhance the facility- and compliance-readiness of any company requiring a strengthened approach to compliance and total quality management.

Providing innovative programs for every key quality system within an FDA environment, this guide evaluates critical compliance and quality challenges within the context of FDA expectations, current industry standards, and emerging global trends.

• Lists the necessary steps for meeting compliance requirements during the drug development process

   

• Presents comprehensive approaches for validating analytical methods for pharmaceutical applications

Contents

1. Regulatory Submissions
2. Compliance Requirements During the Drug Development Process
3. Validation – A New Perspective
4. Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach
5. The Stability Testing Program
6. Computer Validation: A Compliance Focus
7. Compliance Issues Associated with Cleaning in the Pharmaceutical Industry
8. The Batch Record: A Blueprint for Quality and Compliance
9. Change Management: A Far Reaching, Comprehensive, and Integrated System
10. The Vendor Qualification Program
11. Handling Laboratory and Manufacturing Deviations
12. The Internal Audit Program: A Quality Assessment
13. Pre-Approval Inspections: The Critical Compliance Path to Success
14. International Compliance Issues and Trends
15. Strategic Planning for Compliance and Regulatory Defensiveness
16. Unique and Unprecedented Compliance Challenges in the Biologics Area
17. The Impact of Total Quality Performance on Compliance

Index

Dermal Absorption and Toxicity Assessment supplies a state-of-the-art overview of the dermal absorption process.

Features:

• completely revised and updated—expanded to include coverage pertaining to innovative research
• expands on the specific barrier properties of the skin such as its physical structure, biosensor properties, cutaneous metabolism, skin lipid morphology, and dermal blood and lymphatic flow.
• examines both the standard established laboratory techniques, for example, diffusion cell technology, and also covers new techniques like cultured skin equivalents, dermal absorption, and risk assessment

Contents

Introduction

1. Human Skin Morphology and Dermal Absorption
2. Animal Skin Morphology and Dermal Absorption

Skin Barrier Properties and Absorption

1. The Physical Structure of the Skin Barrier
2. Morphology of Epidermal Lipids
3. Stratum Corneum as a Biosensor
4. Cutaneous Metabolism
5. Formulation Issues

1. Interpretation of In Vitro Skin Absorption Studies of Lipophilic Chemicals
2. Use of Skin Equivalents for Dermal Absorption and Toxicity
3. Skin Absorption as Studied by Spectroscopic Methods

Modeling of Dermal Absorption and Risk Assessment

1. Physiologically Based Pharmacokinetics and Pharmacodynamics of Skin
2. Beyond Stratum Corneum
3. Biophysical Models for Skin Transport and Absorption
4. Mathematical Models for Different Exposure Conditions
5. Modelling Skin Permeability in Risk Assessment
6. In Vitro-In Vivo Correlations in Transdermal Drug Delivery
7. Estimation of Subsequent Systemic Exposure - Physiological Models
8. RISKOFDERM - Predictions Based on In Vivo Factors

Skin Toxicity and Prevention

1. Quantitative Structure-Activity Relationships for Skin Corrosivity and Sensitization
2. Allergic Contact Dermatitis
3. Irritancy of Topical Chemicals and Transdermal Drug Delivery Systems
4. Phototosensitivity Induced by Exogenous Agents: Phototoxicity and Photoallergy
5. Systemic Toxicity Caused by Absorption of Drugs and Chemicals Through Skin
6. Solvent and Vehicle Effects on the Skin

Regulatory Issues

1. United States Environmental Protection Agency P3erspectives on Skin Absorption and Exposure
2. Dermal Absorption of Chemicals: Some Australian Regulatory Considerations
3. International Perspectives in Dermal Absorption
4. Structure-Activity Relationships and Prediction of Photoallergic and Phototoxic Potential
5. Potential Regulatory Use of (Q)SARs to Develop Dermal Irritation and Corrosion Assessment Strategies
6. Development of (Q)SARs for Dermal Irritation and Corrosion Assessment Using EU New Chemicals Notification Data
7. Regulatory Assessment of Skin Sensitization
8. Assessment of Topical Bioequivalence Using Microdialysis and Other Techniques
9. An Industry Perspective of Topical Dermal Bioequivalence

Specific Examples of Absorption

1. Dermal Absorption of Chemical Contaminants from Soil
2. Percutaneous Absorption of Pesticides
3. Bathing Water: Percutaneous Absorption of Water Contaminants
4. Percutaneous Absorption of Pro- and Soft- Drugs
5. Skin Penetration of Cosmetic Ingredients and Contaminants
6. Percutaneous Absorption of Hair Dyes
7. Percutaneous Absorption of Fragrance Materials

Index

Contains current American Association of Pharmaceutical Scientists/Food and Drug Administration (AAPS/FDA) guidelines for the experimentation and analysis of in vivo and in vitro percutaneous absorption!

This up-to-the-minute reference provides comprehensive coverage of the latest advances in the development, preparation, and application of topical and transdermal therapeutic systems—exploring the biochemistry and treatment of various skin diseases as well as the structure and function of the skin, adverse dermal responses to drug formulations, mechanisms of drug transport through barrier membranes, and methods for measuring and modulating percutaneous permeation.

Offers contemporary discussions on the bioequivalence of dermatological and transdermal dosage forms!

Dermatological and Transdermal Formulations covers:

• recent modalities for the management of psoriasis, hyperkeratosis, and acne
• the enhancement and retardation of skin penetration and permeation
• formulation strategies
• clinical use of transdermal drug delivery systems for motion sickness, hypertension, angina, postmenopausal therapy, male hypogonadism, pain relief, and smoking cessation
• modern usage of cultured skin membranes for the study of irritation and toxic response to emerging materials
• scale-up of dermatological dosage forms
• the improvement of drug delivery systems with super-saturated solutions, liposomes, and niosomes

With more than 1800 useful references and 350 illustrations, tables, and equations, Dermatological and Transdermal Formulations is an essential source for cosmetic and pharmaceutical scientists, dermatologists, toxicologists, agrochemists, regulatory agency personnel, and upper-level undergraduate and graduate students in these disciplines.

Contents

1. The Structure and Function of Skin
2. Common Skin Disorders and Their Topical Treatment
3. Basic Mathematical Principles in Skin Permeation
4. Skin Transport
5. Methods for Studying Percutaneous Absorption
6. Formulation Strategies for Modulating Skin Permeation
7. Dermatological Formulation and Transdermal Systems
8. Bioavailability and Bioequivalence of Dermatological Formulations
9. Scale-up of Dermatological Dosage Forms: A Case for Multivariate Optimization and Product Homogeneity
10. Safety Considerations for Dermal and Transdermal Formulations
11. Transdermal Delivery and Cutaneous Reactions

Index

Dose Optimization in Drug Development provides a concise overview of the key principles in dose selection and optimization and demonstrates applicability to recent successful new drug applications.

Features:

• Focuses on two key interfaces in new drug development: transition from preclinical to Phase I clinical development and transition from Phase IIA/IIB proof-of-concept to Phase IIB/III pivotal efficacy trials
• Promotes innovative clinical trial designs that may allow for a more optimal strategy for dose selection
• Covers procedures and best practices in biomarker validation and qualification
• Considers the benefits of novel clinical trial designs in clinical pharmacology and experimental medicine
• Analyzes the importance of dose optimization during Phase II/III

Contents

1. Introduction to Dose Optimization in Drug Development
2. Bridging Preclinical and Clinical Development: Disease Progression Modeling in Translational Research
3. Bridging Preclinical and Clinical Development: Biomarker Validation and Qualification
4. Dose Selection for First-In-Human Study: A Regulatory Perspective
5. Novel Clinical Trial Designs in Clinical Pharmacology and Experimental Medicine
6. Biomarkers, Surrogate Endpoints, and Clinical Endpoints in the Development of Cardiovascular Drugs: A Regulatory Perspective
7. Pharmacokinetic and Pharmacodynamic Variability
8. Pharmacogenetics and Dose Response: Dose Individualization
9. Optimal Dose Finding in Drug Development: Approaches and Regulatory Perspectives
10. Optimal Dose Selection in Drug Development: Role of Population Pharmacokinetics in Phase 3
11. Dose Optimization Strategy for Strattera, A CYP2D6 Substrate
12. Pediatric Dose Optimization Using Pharmacokinetics/Pharmacodynamics

Index

Drug Delivery Nanoparticles Formulation and Characterization presents key aspects of nanoparticulate system development for various therapeutic applications and provides advanced methods used to file for regulatory approval.

This comprehensive guide features:

• 100 high quality images
• Process Analytical Techniques (PAT) used in manufacturing Nanoparticulate Drug Delivery Systems (NDDS)
• in-vitro and in-vivo evaluation of NDDS
• applications of novel techniques used in formulation development and characterization, such as microscopic and nonmicroscopic techniques

Contents

1. Recent Developments in Nanoparticulate Drug Delivery Systems
2. Polymeric Nanoparticles for Small-Molecule Drugs: Biodegradation of Polymers and Fabrication of Nanoparticles
3. Formulation of NPDDS for Macromolecules
4. Formulation of NPDDS for Gene Delivery
5. NPDDS for Cancer Treatment: Targeting Nanoparticles, a Novel Approach
6. Design and Formulation of Protein-Based NPDDS
7. Gold Nanoparticles and Surfaces: Nanodevices for Diagnostics and Therapeutics
8. NPDDS for the Treatment of Diabetes
9. Nanosystems for Dermal and Transdermal Drug Delivery
10. In Vitro Evaluation of NPDDS
11. In Vitro Characterization of Nanoparticle Cellular Interaction
12. In Vitro Blood Interaction and Pharmacological and Toxicological Characterization of Nanosystems
13. In Vivo Evaluations of Solid Lipid Nanoparticles and Microemulsions
14. Microscopic and Spectroscopic Characterization of Nanoparticles
15. Introduction to Analytical Scanning Transmission Electron Microscopy and Nanoparticle Characterization
16. Structural Fingerprinting of Nanocrystals in the Transmission Electron Microscope: Utilizing Information on Projected Reciprocal Lattice Geometry, 2D Symmetry, and Structure Factors
17. Mechanical Properties of Nanostructures
18. Fullerene-Based Nanostructures: A Novel High-Performance Platform Technology for Magnetic Resonance Imaging (MRI)
19. Semiconducting Quantum Dots for Bioimaging
20. Application of Near Infrared Fluorescence Bioimaging in Nanosystems

Drug Delivery to the Oral Cavity emphasizes the impact of intraoral drug delivery and its advantages over conventional oral dosage forms.

Features:

• Covers the latest research concerning drug delivery to the oral cavity, and examines the basic structure, function, biochemistry, and permeability of the oral cavity
• Analyzes the unique features and optimization of various intraoral drug delivery systems
• Studies quick, slow, and nondissolving intraoral dosage forms
• Explores practical and applied aspects of pharmaceutical development for new solid-stage dosage forms for intraoral drug delivery
• Highlights dozens of oral mucosal delivery systems targeted at the personal care market including quick dissolving films and dentifrice products containing antibacterial agents, fluoride, and flavoring agents
• Provides a comprehensive appendix of various companies developing intraoral dosage forms and novel delivery system technologies
• Offers a detailed overview of the wide array of currently available intraoral drug products for the treatment of systemic diseases, as well as products for local treatment of halitosis, bacterial infections, periodontal disease, and other conditions of the mouth
• Provides an in-depth discussion of recently commercialized drug products for angina pectoris, moderate to severe pain, and smoking addiction

Contents:

• Oral Mucosal Delivery Systems: An Overview, Current Status and Future Trends
• Preformulation Aspects of Oral Mucosal Drug Delivery Systems
• Preclinical Assessment of Oral Mucosal Drug Delivery Systems
• Clinical Development, Manufacturing, and Testing of Oral Mucosal Delivery Systems
• Rapid Dissolving Immediate Release Oral Transmucosal Delivery System
• Oral Oral Transmucosal Delivery of Nicotine: Smoking Cessation Therapy
• Oral Transmucosal Delivery of Melatonin: Normalization of Circadian Rhythm
• Drug Delivery Systems for Treatment of Periodontal and Dental Diseases
• Tetracycline Micorparticulate Periodontal Delivery System: Formulation Development and Preclinical Assessment
• Local Anesthetic Oral Transmucosal Systems: Dental and Oral Surgical Premeditation
• Regulatory Considerations for Approval of Oral Mucosal Delivery Systems

Index

Rapid advances in the science of granulation, particle engineering and process controls, along with regulatory changes, have prompted key opinion leaders and regulatory authorities to develop the Third Edition of this authoritative, practical reference book.

• STAY UP-TO-DATE—with what’s being introduced and implemented in the industry—such as the concept of design space, process optimization and harmonization of regulations by the global health authorities
• LEARN FROM THE EXPERTS—more than 45 global experts in manufacturing, engineering, pharmaceutical technology, drug delivery, pharmacy, and other sub-specialty areas share their years of experience to develop a trustworthy, comprehensive reference
• ENSURE REGULATORY COMPLIANCE—as regulatory bodies are restructuring and developing a product quality regulatory system which provides a framework for implementing quality by design, continuous improvement, and risk management, it is imperative that scientists continue to adhere to the latest guidelines and protocols
• SAVE VALUABLE TIME AND MONEY—by learning how to achieve and manage the most efficient and thus cost effective product development and manufacturing operation in the current competitive environment
• ENHANCE YOUR RESEARCH—new chapters on key topics such as supercritical fluids, nanoparticulate technology, nutraceuticals, biotechnology, controlled release granulation, process control, and expert systems provide in-depth analyses on key drivers in the field

Contents

1. Introduction
2. Theory of Granulation: An Engineering Perspective
3. Drug Substance and Excipient Characterization
4. Binders in Pharmaceutical Granulation
5. Spray Drying and Pharmaceutical Applications
6. Supercritical Fluid Technology
7. Pharmaceutical Applications of Nanoengineering
8. Roller Compaction Technology
9. Wet Granulation in Low and High Shear Mixers
10. Batch Fluid Bed Granulation
11. Single Pot Processing
12. Extrusion-Spheronization as a Granulation Technique
13. Continuous Granulation
14. Effervescent Granulation
15. Granulation Approaches in Biotech Industry
16. Granulation of Plant Products and Nutraceuticals
17. Granulation Approaches for Modified Release Products
18. Granulation of Poorly Water Soluble Drugs
19. Granulation Approaches for Orally Disintegrating Formulations
20. Melt Granulation
21. Sizing of Granulation
22. Granulation Characterization
23. Bioavailability and Granule Properties
24. Granulation Process Modelling
25. Scale Up Considerations in Granulation
26. Advances in Process controls and End Point Determination
27. Experts Systems and Their Use in Pharmaceutical Applications
28. Regulatory Issues in Granulation: The Pharmaceutical Quality for the 21st Century – A Risk Based Approach

Index

Biotechnology of Antibiotics
Second Edition
edited by William R. Strohl