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Drugs And Pharmaceutical Sciences Special Indian Reprint

Our product range includes a wide range of excipient toxicity and safety, active pharmaceutical ingredients, biotechnology of antibiotics, 2nd ed., compliance handbook for pharmaceuticals, medical devices, dermal absorption and toxicity assessment 2nd ed and dermatological and transdermal formulations.

Excipient Toxicity and Safety

Excipient Toxicity and Safety
  • Excipient Toxicity and Safety
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Approx. Price: Rs 3,396 / Piece(s)
Excipient Toxicity
and Safety
edited by Myra Weiner
and Lois Kotkoskie

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

 

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Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients
  • Active Pharmaceutical Ingredients
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Approx. Price: Rs 3,145 / Piece(s)
Active Pharmaceutical Ingredients
Development, Manufacturing and Regulations
Second edition

edited by Stanley H. Nusim

 

Active Pharmaceutical Ingredients, Second edition is a comprehensive guide to the development, manufacturing, and regulation of the preparation and use of Active Pharmaceutical Ingredients (APIs) globally.

 

This new edition brings you up-to-date with the quality control regulations for APIs that have been added or amended since the first edition was published in 2005. These updates help ensure that pharmaceutical professionals and drug manufacturers meet the established and required guidelines set forth by the US and international regulatory industries.

New features include:

  • chapters on safety, efficacy, and environmental/regulatory requirements
  • analysis of the recent movement of API manufacturing from the US and Europe to countries such as India and China
  • discussions on both US and international regulatory requirements
  • information about the FDA’s intensified foreign inspection program
  • data on multi-use and flexible design facilities
  • the shift from maintenance scheduling to built-in reliability

Contents

  1. Introduction
  2. Bulk Drugs: The Process Development Task
  3. Bulk Drugs: Process Design, Technology Transfer, and First Manufacture
  4. Design and Construction of API Manufacturing Facilities
  5. Regulatory Affairs: Requirements and Expectations
  6. Regulatory Affairs: Guidelines, Evolving Strategies, and Issues
  7. Validation of Active Pharmaceutical Ingredients
  8. Quality of Active Pharmaceutical Ingredients
  9. Environmental Control
  10. Thermochemical Process Safety—An Introduction
  11. Design and Operating Practices for Safety
  12. Plant Operations
  13. Sterile Bulk Active Pharmaceutical Ingredient Production
  14. Biological Production of Active Pharmaceutical Intermediates
  15. Supply Management
  16. Equipment Maintenance and Reliability

Index

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Biotechnology Of Antibiotics, 2nd Ed.

Biotechnology Of Antibiotics, 2nd Ed.
  • Biotechnology Of Antibiotics, 2nd Ed.
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Approx. Price: Rs 3,396 / Piece(s)

Biotechnology of Antibiotics
Second Edition
edited by William R. Strohl

 

This incomparable Second Edition of a highly regarded reference has been entirely rewritten and enlarged to reflect the explosion of information and technologies that have emerged since the publication of the previous edition.

Strikes the perfect balance between proven traditional approaches and modern methods that promise to yield new products and processes!

Specifically addressing microbially derived commercially important bioactive products that are currently or soon-to-be available, Biotechnology of Antibiotics, Second Edition:

  • analyzes the use of recombinant enzymes to produce biologically active molecules, including a cholesterol-lowering agent, an anti-HIV drug for the treatment of AIDS, and b-lactam antibiotics
  • gives insight into the biochemistry, molecular biology, and production of antibiotics used as therapeutic agents
  • focuses on state-of-the-art techniques for the development of new antibiotics using novel approaches and strategies
  • highlights recent advances in the genetic manipulation of antibiotic biosynthesis genes to create structures from gene combinations for new biological activities
  • describes in detail the development and current status of newly created antibiotics and pharmacologically active natural products
  • and much more!

 

Written by authorities from both industry and academia and containing nearly 4000 bibliographic citations, Biotechnology of Antibiotics, Second Edition is an outstanding resource for pharmaceutical scientists, medicinal chemists and biochemists, molecular biologists and industrial microbiologists, chemical engineers, fermentation bioengineers, bioprocess technologists, and upper-level undergraduate and graduate students in these disciplines.

Contents

  1. Introduction and Approaches for Improvement in Antibiotic Production
  2. Aminoglycosides
  3. Template-Biosynthesized Peptide and b-Lactam Antibiotics

       

       
    • Ribosomally Synthesized Peptide Antibiotics

       

       
    • Polyketide Antibiotics Produced by Type-I Multifunctional Enzymes

       

       
    • Polyketide Antibiotics Produced by Type-II Polyketide Synthase Systems

       

       
    • Peptydil Nucleoside Antibiotics

       

       
    • Recombinant Bioconversions of Bioactive Molecules
    •  

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    Compliance Handbook for Pharmaceuticals, Medical Devices

    Compliance Handbook for Pharmaceuticals, Medical Devices
    • Compliance Handbook for Pharmaceuticals, Medical Devices
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    Approx. Price: Rs 5,096 / Piece(s)
    Compliance Handbook for Pharmaceuticals, Medical Devices
    and Biologics
    edited by Carmen Medina

    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

     

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    Dermal Absorption and Toxicity Assessment 2nd ed

    Dermal Absorption and Toxicity Assessment 2nd ed
    • Dermal Absorption and Toxicity Assessment 2nd ed
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    Approx. Price: Rs 3,396 / Piece(s)
    Dermal Absorption and Toxicity Assessment
    Second edition
    edited by Michael S. Roberts

    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

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    Dermatological and Transdermal Formulations

    Dermatological and Transdermal Formulations
    • Dermatological and Transdermal Formulations
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    Approx. Price: Rs 4,246 / Piece(s)
    Dermatological
    and Transdermal Formulations
    edited by Kenneth A. Walters

    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

     

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    Dose Optimization in Drug Development

    Dose Optimization in Drug Development
    • Dose Optimization in Drug Development
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    Approx. Price: Rs 3,396 / Piece(s)
    Dose Optimization in Drug Development
    edited by Rajesh Krishna

    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

     

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    Drug Delivery Nanoparticles Formulation and Characterization

    Drug Delivery Nanoparticles Formulation and Characterization
    • Drug Delivery Nanoparticles Formulation and Characterization
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    Approx. Price: Rs 4,246 / Piece(s)
    Drug Delivery Nanoparticles Formulation and Characterization
    Second Edition
    edited by Yashwant Pathak

    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

     

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    Drug Delivery to the Oral Cavity

    Drug Delivery to the Oral Cavity
    • Drug Delivery to the Oral Cavity
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    Approx. Price: Rs 3,396 / Piece(s)
    Drug Delivery to the Oral Cavity
    Edited by Tapash K. Gosh
    and William Pfister

    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
    Drub Delivery to the Oral Cavity presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.

    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

     

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    Drug Targeting Technology Physical,Chemical,Biological Metho

    Drug Targeting Technology Physical,Chemical,Biological Metho
    • Drug Targeting Technology Physical,Chemical,Biological Metho
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    Approx. Price: Rs 5,000 / Piece(s)

    Drug Targeting Technology:
    Physical • Chemical • Biological Methods

    edited by Hans Schreier



    Demonstrates how substitution of a variety of ligands can render albumin a versatile targeting tool for selective drug accumulation in various cell populations of the liver!

     

     

    Drug Targeting Technology discusses physical, chemical, and biological approaches to drug targeting technology, focusing on oral, dispersed system, topical, dermal, transdermal, and inhalation delivery, and the development of original formulations that are matched by innovative device design.

    Considers the efforts in biotechnology and molecular biology to produce intelligent drug delivery devices by exploiting biological pathways!

    Containing over 1100 references to facilitate further study, Drug Targeting Technology:

    • updates recent progress in oral and colonic targeting technology using pH- and enzyme-sensitive coating materials and novel polymer systems
    • shows how the systemic distribution of drugs can be modulated by lipid-based carriers taking alternative routes of transport, particularly lymph flow
    • details soft drugs that are rapidly metabolized to inactive and nontoxic metabolites and removed efficiently from the body
    • includes successful designs of virus-like liposomal delivery systems that offer the advantages of viral carriers
    • supplies examples of how viral delivery systems can be directed to cancer sites
    • and more!

    Suggesting harnessing biological processes as the ultimate approach to the delivery or expression of pharmacologically active agents, Drug Targeting Technology is a top-shelf reference for pharmacists, pharmacologists, and pharmaceutical scientists; analytical, surface, physical, and colloid chemists and biochemists; and upper-level undergraduate and graduate students in these disciplines.

    Contents

    1.  
      • Enteric Targeting Through Enteric Coating
      • New Experimental Coating Material for Colon-Specific Drug Delivery
      • Pharmacokinetic Considerations in the Design of Pulmonary Drug Delivery Systems for Glucocorticoids
      • Lipid-Based Formulations for Oral Administration: Opportunities for Bioavailability Enhancement and Lipoprotein Targeting of Lipophilic Drugs
      • Topical Application of Drugs: Mechanisms Involved in Chemical Enhancement
      • Drug Targeting by Retrometabolic Design: Soft Drugs and Chemical Delivery Systems
      • Neoglyco- and Neopeptide Albumins for Cell-Specific Delivery of Drugs to Chronically Diseased Livers
      • Gene Delivery with Artificial Viral Envelopes
      • Evolution of Viral Liposomes: Improvements and Applications
      • Targeting of Viral Vectors for Cancer Gene Therapy
    2. Physical Targeting Approaches
    3. Chemical Targeting Approaches
    4. Biological Targeting Approaches
    5.  

       

     

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    Handbook of Pharmaceutical Granulation Technology

    Handbook of Pharmaceutical Granulation Technology
    • Handbook of Pharmaceutical Granulation Technology
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    Handbook of Pharmaceutical Granulation Technology
    Third edition
    edited by Dilip M. Parikh

    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

     

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