Table of Contents
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FOREWORD I
PREFACE
DEDICATION
List of Contributors
Controlled Drug Delivery Systems: Concepts and Rationale
Abstract
INTRODUCTION
Historical Overview
Rationale Behind CDDS
Classification of Controlled Release Drug Delivery Systems (CRDDS)
Based on Route of Administration
Transdermal Drug Delivery Systems (TDDSs)
Inhalation DDSs
Injectable DDSs
Based on Release Mechanism
Swelling-CDDSs
Osmotic Drug Delivery Systems
Dissolution-CDDSs
Diffusion-CDDSs
Reservoir Systems
Based on Design
Trigger-based Design
Polymer-based Design
Supramolecular Design
Hydrogel-based Design
Based on Matrix Type
Diffusion-based Matrix System
Dissolution-based Matrix System
Erosion-based Matrix System
Combination of Diffusion/dissolution-based Designs
Based on Stimulus Responsive Systems
Light-responsive Drug Delivery Systems
pH-responsive Drug Delivery Systems
Temperature-responsive Drug Delivery Systems
Enzyme-responsive Drug Delivery Systems
Magnetic-responsive drug delivery systems
DESIGN AND FORMULATION OF CDDS
Selection of Drug Candidates
Physicochemical Properties
Therapeutic Response
Pharmacokinetics
Pharmacodynamics
Safety and Tolerability
Patient Population
Regulatory Considerations
Polymer Selection and Drug-Polymer Compatibility
Biocompatibility
Degradability
Drug Loading and Release
Mechanical Properties
Drug Stability
Drug Solubility
Manufacturability
Manufacturing Techniques
Regulatory Considerations
PRINCIPLE OF CONTROLLED DRUG RELEASE
Mechanisms of Drug Release
Diffusion-based Release
Erosion-based Release
Osmosis-based Release
Mathematical Modelling of Drug Release
THERAPEUTIC APPLICATIONS OF CONTROLLED DRUG DELIVERY
Chronic Pain Management
Cancer Treatment
Diabetes Management
Other Therapeutic Areas
FUTURE TRENDS AND EMERGING TECHNOLOGIES
Nanotechnology in Drug Delivery
Personalized Medicine and Drug Delivery
Advancements in Drug Delivery Devices
Microneedles for Drug Delivery
CHALLENGES WHILE DEVELOPING CDDS
CONCLUSION
REFERENCES
Pharmacokinetic Considerations for Controlled-release Dosage Forms
Abstract
INTRODUCTION
EXAMPLES OF CDDS
Transdermal Patches
Microspheres and Nanoparticles
Implants
Osmotic Pumps
ADVANTAGES OF CONTROLLED DRUG DELIVERY SYSTEMS
Enhanced Therapeutic Efficacy
Minimized Systemic Side Effects
Increased Drug Bioavailability
Improved Patient Compliance
Reduced Drug Resistance
Personalized Medicine
Combination Therapy Optimization
Prolonged Drug Release
ROUTES OF ADMINISTRATION FOR CDDS
Oral Route
Transdermal Route
Intravenous (IV) Route
Intramuscular (IM) and Subcutaneous (SC) Routes
Implants and Depots
DESIRED BIOPHARMACEUTICAL CHARACTERISTICS OF DRUG TO QUALIFY FOR CDDS
Molecular Weight or Size
Solubility
Apparent partition coefficient (APC)
Low Toxicity and Side Effects
Therapeutic Index
Sufficient Half-Life
General absorption mechanism
Basic Pharmacokinetic Parameters
Biological Half-life (t½)
Minimum Effective Concentration (MEC)
Dose Size and Extent Of Duration
Total Clearance (CL)
The Terminal Disposition Rate Constant (Ke or λz)
Apparent Volume of Distribution (Vz)
Absolute Bioavailability (F)
Intrinsic Absorption Rate Constant (Ka)
Therapeutic concentration (Css)
Drug Absorption
Factors Affecting Absorption
Permeability Through Membranes
Solubility of Drug
Drug Ionization
Site Specific Conditions
Hepatic Metabolism
Interaction with Transporters
Interactions Between Food and Drug
Size of Particle in Formulation
Enzyme Activity
Rapid Onset of Action
Short Duration of Action
Fluctuating Drug Levels
Delay in Action Onset
Long Action Duration
Steady-state Drug Levels
Reduced Peak Concentrations
Drug Distribution
Tissue Penetration
Rapid Equilibration
Potential for Elevated Peak Concentrations
Short Duration of High Concentrations
Prolonged Exposure
Gradual Equilibration
Reduced Peak Concentrations
Selective Targeting
Drug Efficacy
Safety
Dosage Regimen
Combination Therapy
Disease Characteristics
Drug Metabolism
Phase I Reactions
Phase II Reactions
Bioavailability
Prodrugs
Drug Elimination
Half-Life
Drug-Drug Interactions
Toxicity and Adverse Effects
Cytochrome P450 (CYP) Enzymes
Uridine Diphosphate-glucuronosyltransferases, or UGTs
Sulfotransferases (SULTs)
Flavin-Containing Monooxygenases (FMOs)
Drug Elimination
Renal Excretion
Hepatic Clearance
Other Clearance Mechanisms
Pulmonary Excretion
Salivary Excretion
Sweat and Tears
Breast Milk Excretion
Dosing Frequency
Steady-State Concentrations
Withdrawal
Dose Adjustments
Minimizing Fluctuations
Duration of Action
INFLUENCE OF ENZYMES ON PHARMACOKINETICS OF CDDS
Bioavailability Modification
Drug-Drug Interactions
Impact on Pharmacokinetics
Prodrug Activation
BIOAVAILABILITY OF CONTROLLED DRUG DELIVERY SYSTEM
Methods for Determining Bioavailability in CDDS
Pharmacokinetic Studies
Relative Bioavailability Studies
Steady-State Analysis
Bioequivalence Studies
Imaging Techniques
CHALLENGES AND CONSIDERATIONS IN THE BIOAVAILABILITY ASSESSMENT OF CDDS
Release Mechanism
Targeted Delivery
Variability
Sample Collection
Regulatory Considerations
IMPACT OF DRUG-DRUG INTERACTIONS ON PHARMACOKINETICS OF CDDS
Absorption Interactions
pH-Dependent Drug Delivery Systems and Acid-Suppressing Medications
Interactions Affecting Gastric Emptying Time
Complexation or Chelation Interactions
Alterations in Intestinal Permeability
Distribution Interactions
Protein Binding Interactions
Drug-Drug Interactions Affecting Tissue Penetration
pH-dependent Tissue Accumulation
Efflux Transporter Interactions
Changes in Blood Flow
Metabolism Interactions
Cytochrome P450 (CYP) Enzyme Interactions
Inhibition
Induction
Prodrug Activation
Herb-Drug Interactions
Genetic Variations in Metabolizing Enzymes
Poor Metabolizers
Ultrarapid Metabolizers
Competition for Metabolic Pathways
Elimination Interactions
Renal Clearance Interactions
Competition for Renal Clearance
Renal Impairment
Hepatic Clearance Interactions
Drug-Induced Liver Injury (DILI)
Competition for Hepatic Clearance
Gastrointestinal Interactions
Bile Acid Sequestrants
Changes in pH and Drug Elimination
Drug-Drug Interactions Affecting Elimination
PHARMACOKINETICS OF NANO-BASED DRUG DELIVERY SYSTEMS
Absorption
Distribution
Metabolism
Excretion
PHARMACOKINETICS OF MICRONEEDLE
PHARMACOKINETIC MODELING OF CDDS
Compartmental Models
Non-Compartmental Models
Physiologically Based Pharmacokinetic (PBPK) Models
Monte Carlo Simulation
STEPS IN PHARMACOKINETIC MODELING FOR CDDS
Formulation Characterization
Input Data Collection
Model Selection and Development
Parameter Estimation
Model Validation and Prediction
STATISTICAL METHODS FOR DETERMINING PHARMACOKINETIC PARAMETERS
Exploratory Data Analysis Methods
Multivariate Approach (MANOVA)
Model Dependent Methods
Linear or First-order Regression Model
Nonlinear Regression Models
Quadratic Model or Second-order Regression Model
CONSTRAINTS ASSOCIATED WITH EXCLUSIVELY EMPLOYING PHARMACOKINETICS FOR THE DEVELOPMENT OF CONTROLLED-RELEASE DELIVERY SYSTEMS
CONCLUSION
REFERENCES
Polymers: Backbone of Controlled Drug Delivery
Abstract
INTRODUCTION
TYPES OF POLYMERS
Classifications Based on Source of Origin
Natural Polymers
Semi-synthetic Polymers
Synthetic Fibres
Classifications Based on the Structure
Linear Polymers
Branching Polymers
Network or Cross-Linked Polymers
Classifications Based on Polymerization Process
Addition Polymers
Condensation Polymers
Classifications Based on Molecular Forces
Elastomer
Fibers
Thermoplastic Polymers
Thermosetting Polymers
Classifications Based on the Homogeneity of Polymers
Classifications Based on Development Polymerization
Chain Expansion Polymerization
Step Growth Polymerization
Classification Based on Biostability
Biodegradable
Non-biodegradable
PROPERTIES OF POLYMERS
Chemical Properties
Thermal Properties
Mechanical Properties
Viscoelastic Properties
Drug Release Mechanism from Polymer
Diffusion
Degradation
Swelling
Advantages of Polymers
CONTROLLED DRUG DELIVERY SYSTEM WITH POLYMERS
Natural Polymers
Protein-Based Polymers
Albumin
Collagen
Gelatin
Carbohydrate-Based Polymers
Cyclodextrin
Alginates
Chitosan
Hyaluronic Acid (HA)
Dextran
Agarose
Cellulose
Cellulose Ether Derivatives
Cellulose Ester Derivatives
Synthetic Polymers
Polyhydroxy Butyrate
Polylactic Acid
Poly(e-Caprolactone)
Polyglutamic Acid
Polyamide
Poly (2-Hydroxyethyl Methacrylate)
Poly (Vinyl Alcohol)
Poly (N-Vinyl Pyrrolidone)
Poly (methylmethacrylate)
Poly (Acrylic Acid)
Poly (Ethylene Glycol)
Polyanhydrides
Diblock Copolymer
Triblock Copolymer
RECENT ADVANCES IN POLYMERIC DRUG DELIVERY SYSTEMS
Enteract Hpmcas Polymers
AFFINISOL Solubility Enhancing Polymers
Amberlite and Duolite Ion Exchange Resins
Ethocel
Polyox Water-soluble Resins
POLYMERIC MICRONEEDLE-BASED DRUG DELIVERY SYSTEM
Design Strategies of Long-acting Polymeric Microneedles
FACTORS AFFECTING BIODEGRADATION OF POLYMERS
Chemical Structure
Chemical Composition
Repeat Unit Distribution
Presence of Ionic Groups
Unexpected Units or Chain Defects
Configuration Structure
Molecular Weight
Molecular-Weight Distribution
Morphology
Low-Molecular-Weight Compounds
Processing Conditions
Annealing
Sterilization Process
Storage History
Shape of the Polymer
Site of Implantation
Adsorbed and Absorbed Compounds (Water, Lipids, Ions, etc.)
Physicochemical Factors (Ion Exchange, Ionic Strength, pH)
POLYMERS FOR RESPONSE-BASED RELEASE
Temperature-based Polymers
pH-sensitive Polymers
pH-responsive Acidic Polymer
pH-responsive Basic Polymer
pH-responsive Natural Polymer
Based on Redox Potential Polymers
Polymers that Respond to Glucose
Ionic Potency
Species of Chemical
Enzyme-Substrate
Magnetic Field Responsive Polymers
Ultrasound Irradiation
CONCLUSION
REFERENCES
Microencapsulation as a Tool for Controlled Drug Delivery
Abstract
INTRODUCTION
Reasons for Microencapsulation
FORMULATION CONSIDERATION
Core Material
Coating Materials
Classification of Coating Material
Types of Microcapsules
MICROENCAPSULATION TECHNIQUES
Mechanical Processes
Chemical Processes
Physico-chemical Processes
Air Suspension
Pan Coating
Spray Drying and Spray Congealing
Multi-orifice-centrifugal Process
Solvent Evaporation/Solvent Extraction
Suspension Cross-linking
Extrusion through a Nozzle
Vibrational Jet/Electrostatic Extrusion
Freeze-drying
Supercritical Fluid (SCF) Process
Coacervation-phase Separation
Step 1: Creation of Three Immiscible Chemical Phases
Step 2: Deposition of the Liquid Polymer Coating onto the Surface of the Core Material.
Step 3: Rigidization of the Coating
Step 4: Coacervation Phase
DRUG RELEASE MECHANISM
Diffusion
Swelling and Dissolution
Erosion and Degradation
Osmosis
POLYMERS USED IN CONTROLLED-RELEASE MICROCAPSULES
Natural Polymers
Chitosan
Alginate
Gelatin
Cellulose
Pectin
Synthetic Polymers
Poly(L-lactic Acid) (PLA) and Poly(Lactic-coglycolic Acid) (PLGA)
Poly(ɛ-caprolactone) (PCL)
Polyvinyl Alcohol (PVA)
Poly(methyl Methacrylate) (PMMA)
CHARACTERIZATION AND EVALUATION OF MICROCAPSULES
Particle Size Analysis
Particle Morphology
Drug Loading Efficiency, Encapsulation Efficiency and % Yield
Fourier Transform Infra-Red (FTIR) Spectral Analysis
Differential Scanning Calorimetry (DSC) Analysis
Thermogravimetric Analysis (TGA)
X-ray Diffraction (XRD)
Raman Spectroscopy
Rheological Properties
Angle of Repose
Compressibility Index
Hausner’s Ratio
Swelling Studies
In vitro Drug Release Studies
Drug Release Kinetic Analysis
Zero Order
First Order
Higuchi
Hixon-Crowell Cube Root Law
Korsmeyer-Peppas Model
Kopcha Model
In vivo drug release study
CHALLENGES OF DRUG MICROENCAPSULATION
COMMERCIALLY AVAILABLE MICROENCAPSULATED PHARMACEUTICAL PRODUCTS
CONCLUSION
REFERENCES
Comprehensive Insights into Mucoadhesive Drug Delivery Systems
Abstract
INTRODUCTION
Category I
Category II
Category III
Advantages of Mucoadhesive Drug Delivery System
Mucus Membrane
Mucus Structure, Composition, and Function
Central Protein Core
Terminal Peptide Segments
MECHANISM OF MUCOADHESION
Contact Stage
Consolidation Stage
Theories of Mucoadhesion
The Electrostatic Theory
The Wettability Theory
The Diffusion Interpenetration Theory
The Adsorption Theory
The Fracture Theory
FACTORS AFFECTING MUCOADHESION
Polymer-Related Factors
Molecular Weight
The Concentration of Polymer
Flexibility of Polymer Chains
Spatial Confirmation
Swelling or Hydration
Hydrogen Bonding Capacity
Cross-linking Density
Charge
Environment-Related Factors
Polymer-substrate Interface pH
Initial Contact Time
Moistening
Physiological Factors
Mucin Turnover
Disease State
Concomitant Illnesses
Tissue Movement
SITES FOR MUCOADHESION
Buccal Cavity
Vagina
Nasal Cavity
Eye
GI Tract
Esophagus
MUCOADHESIVE DRUG DELIVERY SYSTEMS
Tablets
Film
Patches
Gels and Ointments
MUCOADHESIVE POLYMERS
Ideal Characteristics of Mucoadhesive Polymers
First-Generation Mucoadhesive Polymers
Second Generation Mucoadhesive Materials
Synthetic Polymers
Natural Polymers
Thiolated Polymers
Lectin-based Polymers
MUCOADHESIVE POLYMER EVALUATION TECHNIQUES
In vitro Methods
Shear Stress Method
Detachment Force Measurement
Unique Flow Chamber Technique
Wilhelmy Plate Technique
Tensiometer Method
Dual Tensiometer Method
Everted Sac Technique
Falling Liquid Film Technique
The Colloidal Gold Staining Method
Fluorescent Probe Method
Thumb Test Method
Modified USP Disintegration Apparatus
Flow Channel Method
Wash-off Test Method
Rheological Measurement Method
Modified Balance Apparatus
In vivo Methods
Gamma Scintigraphy Technique
GI transit using Radio-opaque Technique
Radioisotopes and Fluorescent Labeling Techniques
Surface Characterization Technique
ADVANCEMENTS IN MUCOADHESIVE DRUG DELIVERY SYSTEMS
Nanotechnology Approach
Enhanced Drug Bioavailability
Targeted Drug Delivery
Improved Stability and Protection
Versatile Formulation Options
Recent Innovations and Applications
Microneedle-based Drug Delivery Systems
Oral Mucosal Applications
Transdermal Applications
Innovations in Microneedle Design
CONCLUSION
REFERENCES
Gastroretentive Drug Delivery Systems
Abstract
INTRODUCTION
PHYSIOLOGY
NEED OF GRDDS
Suitable Drug Candidates for GRDDS
Advantages and Disadvantages Associated with GRDDS
MECHANISM OF GASTRIC RETENTION
Bio-adhesive and Mucoadhesive Systems
Swelling and Expandable Systems
Magnetic Systems
High-density Systems
Superporous Hydrogels
Ion-exchange Resin Systems
Floating Systems
Effervescent systems
Non Effervescent Systems
GASTRORETENTIVE DRUG DELIVERY SYSTEMS
Mucoadhesive System
Magnetic Tablet
Superporous Hydrogel
Floating System
Effervescent Floating Tablet
Gas-generating Effervescent Floating System
The Volatile Oil Containing Effervescent Floating System
Non-Effervescent Floating System
Hydrodynamically Balance System (HBS)
Matrix Bilayer Tablet
Microballoons
Floating Beads
High-Density System
Ion-exchange Resin System
Swellable System
Raft Forming System
Expandable System
3D Printing Technology in GRDDS
ADVANCED NANOMATERIALS FOR GRDDS
POLYMERS USED IN GRDDS
Polymers used in Floating Systems
Polymers used in Mucoadhesive/Bioadhesive systems
Polymers used in Swelling/Expanding Systems
Polymers Used in Superporous Hydrogels
EVALUATION OF GRDDS
In Vivo Assessment
Gastroscopy
Scintigraphy
Radiology/x ray Technique
Magnetic Resonance Imagining (MRI)
Ultrasonography
In Vitro Assessment
In Vitro Techniques for Expanding Dosage Forms
LIMITATIONS OF GRDDS
PATENT SCENARIO OF GRDDS [151, 195]
CONCLUSION
REFERENCES
Novel Drug Delivery System
(Part 1)
Edited by
Atish S. Mundada
Department of Pharmaceutics
SNJBs SSDJ College of Pharmacy
Chandwad, Nashik, Maharashtra, India
&
Alap Chaudhari
Teva Pharmaceutical
United States
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FOREWORD I
I extend my heartful gratitude to all the authors who gave their valuable input in finalizing this book and to the editor for completing a monumental task. This book covers a detailed review of different drug delivery systems. The authors provide valuable insights into many delivery systems in a clear and concise manner. I found each and every article to be worth reading. The topics covered in this volume show elementary to current developments in drug delivery systems. This book contains more than enough references, to both primary and secondary sources, for those wanting to learn more about drug delivery systems. In my opinion, this book is a thought-provoking book that would be of interest to students, professors, and industry personnel. It can be used as supplementary material for teaching drug delivery systems at an undergraduate or postgraduate level and can be a great read for undergraduate and postgraduate students of pharmacy.
P. R. Vavia
Department of Pharmaceutics
Institute of Chemical Technology
Mumbai, India
FOREWORD II
The field of drug delivery systems has witnessed remarkable advancements over the past few decades, driven by the need for more effective, targeted, and patient-friendly therapeutic options. “Novel Drug Delivery Systems (NDDS)” is a comprehensive compilation of the latest innovations and research in this dynamic field, offering valuable insights into the development and application of advanced drug delivery technologies.
This book, meticulously curated by experts in the field, represents a comprehensive exploration of various controlled-release technologies that are reshaping the way medications are developed and delivered for patient compliance.
This book, meticulously curated by experts in the field, represents a comprehensive exploration of various controlled-release technologies that are reshaping the way medications are developed and delivered for patient compliance.
Microencapsulation is elucidated as a powerful tool augmenting controlled drug release mechanisms. Similarly, muco-adhesive, gastro-retentive, and naso-pulmonary drug delivery systems are meticulously explored, highlighting their specialized mechanisms and therapeutic advantages in treating diverse medical conditions.
The chapters dedicated to transdermal and ocular drug delivery systems underscore the innovative strides made in enhancing patient compliance and therapeutic outcomes through non-invasive delivery routes. Nanotechnology, a rapidly advancing frontier, is explored for its potential to revolutionize drug delivery precision and efficacy
Furthermore, the development of implantable and controlled-release injectables is detailed, underscoring their role in sustained delivery and personalized medicine approaches. Each chapter is authored by leading experts, ensuring the content is not only authoritative but also at the forefront of current research and application.
"Novel Drug Delivery Systems (NDDS)" serves as an indispensable resource for researchers, academicians, and pharmaceutical professionals navigating the dynamic landscape of drug delivery. Each chapter is meticulously crafted to offer comprehensive coverage and depth, making this book an essential addition to the library of anyone involved in pharmaceutical sciences.
I commend the editors and contributors for their scholarly contributions and dedication, which have culminated in this authoritative reference. I trust this book will inspire further research and innovation in the field of drug delivery systems.
Warm regards,
Sandip Tiwari
Head of Technical Services
Pharma Solutions BASF Corporation, 500 White Plains Road
Tarrytown, NY 10591
PREFACE
We are delighted to present the first edition of our book, which focuses on Controlled Drug Delivery Systems (CDDS). In the rapidly advancing realm of pharmaceutical sciences, CDDS has emerged as a crucial innovation that enhances therapeutic efficacy and patient care. This book, crafted with the international readership in mind, seeks to provide a comprehensive understanding of the fundamental and practical aspects of controlled drug delivery systems.
This edition includes six carefully selected chapters, each authored by experts in the field. The book begins with Chapter 1, "Controlled Drug Delivery Systems: Concepts and Rationale," which lays the foundation for understanding the principles behind CDDS. It provides the necessary context and insight into why controlled release systems have become integral in modern therapy.
In Chapter 2, "Pharmacokinetic Considerations for Controlled Release Dosage Forms," the focus shifts to the essential pharmacokinetic aspects that influence the design and performance of controlled release systems. This chapter bridges the gap between theoretical knowledge and clinical application, ensuring readers grasp the critical factors affecting drug release and absorption.
Chapter 3, "Polymers: Backbone of Controlled Drug Delivery," delves into the world of polymers, emphasizing their indispensable role as the building blocks of many drug delivery systems. This chapter explores the design, development, and applications of various polymers in achieving desired drug release profiles.
Microencapsulation is the focus of Chapter 4, "Microencapsulation as a Tool for Controlled Drug Delivery." This chapter introduces readers to the concept and utility of microencapsulation technology in protecting drugs, controlling release rates, and improving stability, offering an in-depth look at a critical tool in the formulation of controlled release dosage forms.
Chapter 5, "Comprehensive Insights into Muco-Adhesive Drug Delivery Systems," addresses the specific niche of muco-adhesive systems, providing insight into their potential to enhance drug absorption and prolong residence time at the target site. The application of this technology offers promising solutions to various therapeutic challenges.
Finally, Chapter 6, "Gastroretentive Drug Delivery Systems," rounds off the book with a thorough exploration of gastroretentive technologies. This chapter presents innovative strategies to improve drug retention in the gastrointestinal tract, ensuring optimal drug delivery to the site of action.
Our goal with this book is to provide a robust resource for students, researchers, and professionals in the pharmaceutical sciences. By offering both theoretical foundations and practical insights, we hope to foster a deeper understanding of controlled drug delivery systems and inspire further innovation in this important field.
We extend our heartfelt thanks to the contributing authors, whose expertise and dedication have made this book possible. We are confident that the knowledge shared within these pages will serve as a valuable tool in the continued advancement of pharmaceutical sciences on a global scale.
Atish S. Mundada
Department of Pharmaceutics
SNJBs SSDJ College of Pharmacy
Chandwad, Nashik, Maharashtra, India
&Alap Chaudhari
Teva Pharmaceutical
United States
DEDICATION
I would like to dedicate this bookToMy Late Grandfather,Whose love and Teachings have been guiding light throughout my lifeToMy family Members
Atish Mundada
I would like to dedicate this bookToMy family and Friends
Alap Chaudhari
List of Contributors
Atish S. MundadaDepartment of Pharmaceutics, SNJBs SSDJ College of Pharmacy, Chandwad, Nashik, Maharashtra, IndiaAvinash K. KudhekarDepartment of Pharmaceutics, Srinath College of Pharmacy, Aurangabad, Maharashtra, IndiaChaitali S. ShirsatheDepartment of Pharmaceutics, Srinath College of Pharmacy, Aurangabad, Maharashtra, IndiaDeepak A. KulkarniDepartment of Pharmaceutics, Srinath College of Pharmacy, Aurangabad, Maharashtra, IndiaDeepak S. KhobragadeDatta Meghe College of Pharmacy, Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, IndiaHitesh V. ShahareDepartment of Pharmaceutical Chemistry, SNJBs SSDJ College of Pharmacy, Chandwad, Nashik, Maharashtra, IndiaKavita SutharDepartment of Pharmaceutical Quality Assurance, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, IndiaMrunali S. PotbhareSwami Samarth College of Pharmacy, Dhamangaon, Wardha, Maharashtra, IndiaMoreshwar P. PatilDepartment of Pharmaceutics, METs Institute of Pharmacy, Bhujbal Knowledge City, Nashik, IndiaNayana S. BasteDepartment of Pharmaceutics, SNJBs SSDJ College of Pharmacy, Chandwad, Nashik, Maharashtra, IndiaNayana S. BasteDepartment of Pharmaceutics, SNJBs SSDJ College of Pharmacy, Chandwad, Nashik, Maharashtra, IndiaPrincy ShrivastavDepartment of Pharmaceutical Chemistry, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, IndiaRajendra T. MogalDepartment of Pharmaceutics, METs Institute of Pharmacy, Bhujbal Knowledge City, Nashik, IndiaRushikesh S. SherkarDepartment of Pharmaceutics, Srinath College of Pharmacy, Aurangabad, Maharashtra, IndiaShweta H. ShahareKalyani R.G. Sapkal Institute of Pharmacy, Anjaneri, Nashik, Maharashtra, IndiaSurendra S. AgrawalDatta Meghe College of Pharmacy, Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, IndiaSwaroop R. LahotiDepartment of Pharmaceutics, Y. B. Chavan College of Pharmacy, Aurangabad, Maharashtra, IndiaVipul D. PrajapatiDepartment of Pharmaceutics, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, India
Controlled Drug Delivery Systems: Concepts and Rationale
Vipul D. Prajapati1,*,Princy Shrivastav2,Kavita Suthar3
1 Department of Pharmaceutics, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, India
2 Department of Pharmaceutical Chemistry, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, India
3 Department of Pharmaceutical Quality Assurance, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, India
Abstract
Modern pharmaceutical research and development has evolved to rely heavily on controlled drug delivery systems because they provide creative ways to improve therapeutic results while reducing side effects. The underlying ideas and justification for controlled drug delivery systems are covered in detail in this chapter. Beginning with a discussion of the drawbacks of conventional drug delivery techniques and the benefits of controlled release, the chapter explains the need for controlled drug delivery systems in modern medicine. The requirements for the design and formulation of controlled drug delivery systems have also been discussed in the chapter. The concepts of controlled drug release, which cover a variety of mechanisms, including diffusion, erosion, and osmosis, take up a sizeable section of the chapter. Additionally, emphasis is put on the function that mathematical modeling plays in predicting and optimizing drug release characteristics. It examines the wide spectrum of therapeutic uses for controlled drug administration, such as the treatment of chronic pain, cancer, diabetes, and other chronic disorders. The chapter also illuminates the future trends of such drug delivery systems like nanotechnology, personalized medicines, and advancements in medical devices. It also explores regulatory aspects and challenges involved in the design and commercialization of these systems, placing emphasis on the necessity of stringent quality control and safety evaluations. In conclusion, this chapter is a useful resource for researchers, scientists, and medical experts who want to understand underlying ideas and justifications of controlled drug delivery systems.
Keywords: Controlled drug delivery, Digital health, Drug release kinetics, Implantable devices, Nanoparticle-based delivery, Personalized medicine, Transdermal drug delivery.
*Corresponding author Vipul D. Prajapati: Department of Pharmaceutics, SSR College of Pharmacy (Permanently Affiliated to Savitribai Phule Pune University), Sayli-Silvassa Road, Sayli, Silvassa-396230, Union Territory of Dadra Nagar Haveli & Daman Diu, India; E-mail:
[email protected]
