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Pharmaceutical Dosage Form Design
A Sharma, YS Tanwar
CHAPTER 1:
Introduction to Dosage Forms
ORIGIN OF DOSAGE FORMS
TYPES OF COMMONLY USED DOSAGE FORMS
Solutions, Syrups, and Elixirs
Tablets
Capsules
Emulsions
Suspensions
Ointments
Creams
Gels
Ophthalmic Preparations
Parenteral Preparations (Injectable Preparations)
Aerosol Products
Inserts, Implants, and Devices
PHARMACEUTICAL INGREDIENTS
PRINCIPLES OF DOSAGE FORM DESIGN
Biopharmaceutical Aspects of Dosage Form Design
Drug Factors in Dosage Form Design
Therapeutic Considerations in Dosage Form Design
APPROACHES IN DOSAGE FORM DESIGN
Formulation Approach
Prodrug Approach
Device Approach
Alternative Administration Routes
DRUG DEVELOPMENT AND UNITED STATES FDA
CHAPTER 2:
Pharmaceutical Excipients
INTRODUCTION
DILUENTS
Sugars and Sugar Alcohols
α-Lactose Monohydrate (Hydrous)
Lactose Spray Dried
Lactose Anhydrous
Sucrose or Sugar
Mannitol
Sorbitol
Polysaccharides
Starches
Powdered Cellulose
Microcrystalline Cellulose
Inorganic Diluents
Calcium Phosphates
Co-processed Diluents
SOLVENTS
Aqueous Liquids
Water
Aromatic Waters
Syrup
Mucilages
Hydro-alcoholic Liquids
Alcoholic Liquids
Non-aqueous Vehicles
Oils or Oily Materials
Hydroxylated Compounds
Alcohols
Glycerol
Propylene Glycol
Polyethylene Glycols
SUPPOSITORY BASES
Oil-soluble Bases
Cocoa Butter
Hydrogenated Vegetable Oil Bases
Water Soluble Bases
Glycerogelatin Base
Soap Glycerin
Polyethylene Glycols
OINTMENT BASES
Oleaginous Bases
Petrolatum (Soft Paraffin)
Hard Paraffin
Liquid Paraffin
Absorption Bases
Wool Fat
Hydrous Wool Fat
Wool Alcohol
Beeswax
Emulsion Bases
Water Soluble Bases
SURFACTANTS
Hydrophilic-lipophilic Balance
General Applications of Surfactants
Wetting Agents
Emulsifying Agents
Solubilizing Agents
Foaming And Anti-foaming Agents
VISCOSITY ENHANCERS
Common Gelling Agents
Methylcellulose
Hydroxyethylcellulose
Hydroxypropylcellulose
Hydroxypropylmethylcellulose
Carboxymethylcellulose
SUSPENDING AND THICKENING AGENTS
Natural Polysaccharides
Gum Acacia
Gum Tragacanth
Guar Gum
Sodium Alginate
Xanthan Gum
Carrageenan
Semi-synthetic Polysaccharides
Sodium Carboxymethyl Cellulose
Methylcellulose
Hydroxyethyl Cellulose
Hydroxypropyl Cellulose
Hydroxypropyl Methyl Cellulose
Microcrystalline Cellulose
Clays
Aluminum Magnesium Silicate
Bentonite
Hectorite
Synthetic Agents
Carbomer
Colloidal Silicon Dioxide
EMULSIFYING AGENTS
Natural Emulsifying Agents
From Vegetable Sources
From Animal Source
Semi-synthetic Polysaccharides
Synthetic Emulsifying Agents
Anionic Surfactants
Cationic Surfactants
Non-ionic Surfactants
Ampholytic Surfactants
Finely Divided Solids
WETTING AGENTS
Surfactants
Hydrophilic Polymers
Hydrophilic Liquids
FLOCCULATING AGENTS
Surfactants
Electrolytes
Hydrophilic Polymers
BINDERS
DISINTEGRANTS
Types of Disintegrants
Starch
Pregelatinized Starch
Modified Starch
Cellulose and its Derivatives
Microcrystalline Cellulose (MCC)
Alginates
Ion-exchange Resins
Miscellaneous
Superdisintegrants
LUBRICANTS
Water Insoluble Lubricants
Water Soluble Lubricants
GLIDANTS
ANTIADHERENTS
ANTIOXIDANTS
PRESERVATIVES
COLORANTS
FLAVORING AGENTS
SWEETENING AGENTS
PHARMACEUTICAL-EXCIPIENT INTERACTIONS
Physical Interactions
Chemical Interactions
CHAPTER 3:
Preformulation
INTRODUCTION
PHYSICOCHEMICAL PARAMETERS
pKa Determination
Solubility Analysis
Partition Coefficient
Dissolution
Crystal Morphology
Polymorphism
Melting Point Determination
Particle Size Analysis
DRUG AND PRODUCT STABILITY
Temperature
Influence of pH
Hydrolysis
Oxidation
Photolysis
Hygroscopicity
Solid State Stability
POWDER FLOW PROPERTIES
COMPATIBILITY TESTS
CHAPTER 4:
Quality Management in Pharmaceutical Industry
INTRODUCTION
QUALITY CONTROL AND QUALITY ASSURANCE
Quality Control
Quality Assurance
Quality Assurance versus Quality Control
GOOD MANUFACTURING PRACTICES
Personnel
Building and Facilities
Production Area
Material Management
Production Management
Equipment
Process Controls
Quality Management
Quality Control
Quality Assurance
Documentation
Master Production and Control Records
Batch Production and Control Records
Laboratory Records
Packaging Records
Validation
Control of Components, Product Containers and Closures
Stability Studies
Laboratory Animals
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ISO 900 Family
Implementing ISO often gives the following advantages:
ISO 9000 Versions
Benefits of ISO Standards in Pharmaceutical Industry
TOTAL QUALITY MANAGEMENT
PHARMACEUTICAL PROCESS VALIDATION
What is Validation?
Validation can be of Different Types
Analytical Validation
Equipment Validation
Process Validation
Significance of Validation
Phases in Validation
Phase 1
Phase 2
Phase 3
Process Validation
Pre-requisites for Process Validation
Protocol Development
Pharmaceutical Process Equipment
Approaches to Validation Process
Validation Report
Statistical Methods and Tools for Process Validation
Primer on Statistics and Process Validation
Process Validation of Tablets
Raw Materials
Sifting
Granulation
Drying and Sizing
Milling (Table 4.2)
Blending
Lubrication
Compression (Table 4.3)
Coating (Table 4.4)
Labeling and Packing
Finished Product Analysis and Release
Validation of Sterile Processes
Measuring Efficiency of Sterilization Process
Heating, Ventilation and Air Conditioning (HVAC) of Sterile Facility
Dry Heat Sterilization Validation
Steam Sterilization Validation
Ethylene Dioxide Sterilization Validation
Radiation Sterilization Validation
Revalidation of Sterilization Equipment
EFFLUENT TESTING AND TREATMENT (TABLE 4.8)
Effluent Testing
Physio-chemical Measurements of Effluents
Biological Oxygen Demand (BOD)
Chemical Oxygen Demand (COD)
Determination of Ammonical Nitrogen
Determination of Cyanides
Effluent Treatment
INTELLECTUAL PROPERTY RIGHTS
Intellectual Property Rights in India
Patents—An Overview
Patent System in India
Salient Features of Indian Patent Act
Indian Patent Act, 1970
Patent (Amendment) Act, 2002 and Patent Rules, 2003
Patent (Amendment) Bill, 2005
Patentable Inventions
Novelty
Inventive Step
Industrially Applicable
Non-patentable Inventions
Patent Procedure
Patents-Key Databases
Britain Patents Status Enquiry
DEPATISnet
Esp@cenet
Epoline®
European Patent Database
Patent Abstracts of Japan
Patent Scope
US Patent Full-text and Full-page Image Databases
Australian Patent Information
Canadian Patent Database
Indian Patent Database
Fullerene Patent Database (Table 4.9)
CHAPTER 5:
Dissolution Testing of Dosage Forms
INTRODUCTION
THEORIES OF DISSOLUTION
Diffusion Layer Model
Danckwert's Model (Surface Renewal Theory)
Interfacial Barrier Model (Limited Solvation Theory)
BIOPHARMACEUTICAL CLASSIFICATION SYSTEM
DISSOLUTION TESTING METHODS
SELECTION OF DISSOLUTION MEDIUM
MATHEMATICAL MODELS
DISSOLUTION PROFILE COMPARISON USING SIMILARITY FACTOR, f2
CHAPTER 6:
Bioavailability and Bioequivalence Studies
BIOAVAILABILITY
METHODS OF ASSESSING BIOAVAILABILITY
In Vivo Methods/Direct Methods
Blood Level Studies
Urinary Excretion Data (Figure 6.4)
Indirect Methods
BIOEQUIVALENCE STUDIES
Pharmaceutical Equivalent
Pharmaceutical Alternatives
Therapeutic Equivalent
Bioequivalent Drug Products
TYPES OF BIOEQUIVALENCE STUDIES
Assessment of Bioequivalence
General Concepts of Study Design
Pharmacokinetic Criteria
Statistical Criteria
The Two One-sided Test
Data Analysis Method
METHODS TO ENHANCE SOLUBILITY AND BIOAVAILABILITY OF DRUGS
pH Adjustment
Particle Size Reduction
Polymorphism
Carriers
Microemulsion
Self-emulsifying Drug Delivery Systems
Supercritical Fluid Process
Solid Dispersions (Figures 6.5 to 6.7)
Inclusion Complexes
Miceller Solublization
Hydrotropy
IN VITRO-IN VIVO CORRELATION
Level A Correlation
Level B Correlation
Level C Correlation
Multiple-level C Correlation
Level D Correlation
CHAPTER 7:
Stability Testing of Pharmaceuticals
INTRODUCTION
RATE EQUATIONS
Zero-order Reactions
First-order Reactions
Pseudo First-order Reaction
Second-order Reactions
EFFECT OF TEMPERATURE AND pH ON REACTION KINETICS
Temperature
pH
PATHWAYS OF DRUG DEGRADATION
Hydrolysis
Protection Against Hydrolysis
Oxidation
Protection Against Oxidation
Photolysis
Protection from Light
PREDICTION OF SHELF-LIFE
OBJECTIVES AND DESIGN OF STABILITY TESTING
Design of Stability Studies
Accelerated Stability Testing
High Humidity Studies
Real-time Stability Testing
Photostability Testing
Testing Frequency
STABILITY TESTING OF DOSAGE FORMS
ACCELERATED TESTING AND PREDICTION
Accelerated Tests for Emulsion Stability
Accelerated Tests for Suspension Stability
Accelerated Tests for Semi-solids Stability
Accelerated Tests for Tablet Stability
Accelerated Tests for Capsules Stability
OVERAGES
STABILITY TESTING OF PHARMACEUTICAL PRODUCTS IN GLOBAL ENVIRONMENT
INTERNATIONAL CONFERENCE ON HARMONIZATION GUIDELINES
Stability Testing of New Drug Substances and Products
New Drug Substances
New Drug Products
CHAPTER 8:
Polymers—Synthesis, Properties and Applications
INTRODUCTION
POLYMER SYNTHESIS
Step Growth
Chain Growth
Copolymers
CLASSIFICATION OF POLYMERS
Natural and Synthetic Polymers
Organic and Inorganic Polymers
Thermoplastic and Thermosetting Polymers
Biodegradable and Non-biodegradable Polymers
Soluble Polymers and Hydrogels
PROPERTIES OF POLYMERS
Molecular Shape, Structure and Configuration
Molecular Weight
Crystallinity in Polymers
Glass Transition Temperature
Mechanical Properties
BIODEGRADATION OF POLYMERS
PHARMACEUTICAL APPLICATIONS
Pharmaceutical Excipients
Drug Delivery
Hydrogels
Polymeric Matrices for Growth and Immobilization of Cells
Medical Devices
CHAPTER 9:
Prodrugs—An Overview
INTRODUCTION
CLASSIFICATION OF PRODRUGS
APPLICATIONS OF PRODRUGS
Prodrugs to Improve Membrane Permeability
Esters as Prodrugs
N-methylation
Trojan Horse Approach for Carrier Proteins
Prodrugs to Prolong Drug Activity
Prodrugs to Mask Drug Toxicity and Side Effects
Prodrugs to Lower Solubility in Water
Prodrugs to Improve Solubility in Water
Prodrugs Used in Targeting Systems
Prodrugs to Increase Chemical Stability
Prodrugs for Site-specific Conditions
Prodrugs Activated by External Influence
CHAPTER 10:
Drug Delivery Systems
INTRODUCTION
Advantages of Drug Delivery Systems
Patient Compliance
Reduced ‘See-Saw' Fluctuation
Reduced Total Dose
Improved Efficiency in Treatment
Sustained Release versus Controlled Release
TYPES OF DRUG DELIVERY SYSTEMS
ION-EXCHANGE SYSTEMS
Applications
OSMOTICALLY CONTROLLED SYSTEMS
Principle of Osmotic Drug Delivery
Basic Components of Osmotic Systems
Drug
Osmotic Agent
Semipermeable Membrane
Plasticizers
Classification of Osmotic Systems
Elementary Osmotic Pump (EOP)
Push-pull Osmotic Pump (PPOP)
Controlled Porosity Osmotic Pump (CPOP)
Liquid Oral Osmotic System (L-OROS)
Colon Targeted Oral Osmotic System (CT-OROS)
Sandwiched Osmotic Tablets (SOTS)
Characterization
Osmotic Behavior
Release Rate Study
Porosity of Semipermeable Membrane
Other Parameters
Applications
FLOATING DRUG DELIVERY SYSTEMS
Classification of FDDS
Effervescent Floating Systems
Non-effervescent Floating Systems
Characterization of FDDS
Applications
NANOPARTICLES
Methods of Preparation
Dispersion of Preformed Polymers
Coacervation Method
pH Induced Aggregation
Counter Ion Induced Aggregation
Supercritical Fluid Technology
Aerosol-based Processes
Coating of Nanoparticles
Characterization of Nanoparticles
Applications of Nanoparticles
Detection of Cancer by Nanoparticles
Tumor Targeting using Nanoparticulate Delivery Systems
Nanoparticles for Oral Delivery of Peptides and Proteins
Nanoparticles for Gene Delivery
Nanoparticles for Drug Delivery into Brain
Solid Lipid Nanoparticles (SLNs) for Drug Delivery
RESEALED ERYTHROCYTES
Methods of Drug Loading
Hypotonic Dilution
Hypotonic Dialysis
Isotonic Osmotic Lysis
Electroencapsulation
Entrapment by Endocytosis
Membrane Perturbation
Loading by Lipid Fusion
Characterization of Resealed Erythrocytes
Applications of Resealed Erythrocytes
LIPOSOMES
Composition of Liposomes
Phospholipids
Cholesterol
Other Substances
Method of Preparation of Liposomes
Thin-film Hydration
Freeze-thaw Extrusion Method
Dehydration-rehydration Method
Sonication, or Ultrasonic Irradiation
French Pressure Cell
Reverse-phase Evaporation Method
Ether Vaporization Method
Detergent Removal Method
Lamellar Liquid Crystalline Method
Bubble Method
Characterization of Liposomes
Applications of Liposomes
Liposomes in Medicine
Liposomes in Cosmetics
Liposomes in Agro-food Industry
NIOSOMES
Preparation of Niosomes
Hand Shaking Method
Ether Injection Method
Reverse Phase Evaporation Technique
Transmembrane pH Gradient
Bubble Method
Multiple Membrane Extrusion Method
Formation of Niosomes from Proniosomes
Characterization of Niosomes
Vesicle Diameter
Entrapment Efficiency
In vitro Release
Applications of Niosomes
Carriers for Anti-cancer Drugs
Drug Targeting
Transdermal Drug Delivery Systems Utilizing Niosomes
Delivery of Peptide Drugs
Niosomes as Carriers for Hemoglobin
Leishmaniasis Treatment
Niosomes as Vaccine Adjuvants
Cosmetics
DENDRIMERS
Synthesis of Dendrimers
Types of Dendrimers
PAMAM Dendrimer
PAMAMOS Dendrimer
PPI Dendrimer
Tecto Dendrimer
Multilingual Dendrimers
Chiral Dendrimers
Hybrid Dendrimers Linear Polymers
Amphiphilic Dendrimers
Micellar Dendrimers
Applications of Dendrimers
TRANSDERMAL DRUG DELIVERY SYSTEMS
Basic Components of TDDS
Polymer
Adhesives
Penetration Enhancers
Backing Membrane
Classification of Transdermal Patches
Reservoir Systems
Matrix Systems (Drug-in-adhesive system)
Matrix-dispersion Systems
Microreservoir Systems
Characterization of TDDS
Weight Variation
Thickness
Tensile Strength and Percentage Elongation at Break
Folding Endurance
Swellability
Moisture Vapor Permeability
Surface pH
Drug Content
In vitro Permeation Studies
Primary Skin Irritation Study
Test of Irritancy and Sensitivity
Applications and Recent Advances in Transdermal Drug Delivery
OCULAR DRUG DELIVERY SYSTEMS
Types of Ocular Drug Delivery Systems
In-situ Activated Gel-forming Systems
Mucoadhesive Polymeric Systems
Vesicular/colloidal Systems
Ophthalmic Inserts
Collagen Shields
Applications of Ocular Drug Delivery Systems
NASAL DRUG DELIVERY SYSTEMS
Approaches for Nasal Drug Delivery
Nasal Drops
Nasal Sprays
Nasal Gels
Nasal Powders
Mucoadhesive Polymeric Microspheres
In situ Nasal Gels
Liposomal Nasal Drug Delivery
Characterization of Nasal Formulations
Applications of Nasal Drug Delivery Systems
VAGINAL AND UTERINE SYSTEMS
Inert and Copper-based Devices
Hormonal Intrauterine Devices
PROTEIN AND PEPTIDE DELIVERY
Oral Approaches
Intranasal Delivery
Pulmonary Delivery
Transdermal Delivery
Transmucosal Delivery
Rectal Route
DRUG DELIVERY TO BRAIN
Micelles
Liposomes
Nanoparticles
Solid Lipid Nanoparticles
Nanogels
Prodrug Approach
CHAPTER 11:
Fundamentals of Cosmetics
INTRODUCTION
STRUCTURE OF SKIN
Epidermis
Stratum Corneum
Stratum Lucidum
Stratum Granulosum
Stratum Spinosum
Stratum Basale
Dermis
Papillary Region
Reticular Region
Hypodermis
HAIR BIOLOGY
Hair Follicles
Inner Root Sheath
Outer Root Sheath
Fibrous Root Sheath
Suprabulb Region
Isthmus
Infundibulum
Hair Shaft
NAIL ANATOMY
Nail Root
Nail Bed
Nail Plate
Cuticle
Perionychium
Hyponychium
CREAMS
Cleansing and Cold Creams
Formula-1
Formula-2
Formula-3
Vanishing Creams
Formula-4
Foundation Creams
Formula-5
Hands Cream and Lotions
Formula-6
Formula-7
Night and Massage Creams
Formula-8
All Purpose Creams
Formula-9
SUNSCREENS PREPARATIONS
FACE POWDER
LIPSTICKS
HAIR PREPARATIONS AND TREATMENTS
Hair Tonic
Formula-14
Formula-15
Formula-16
Formula-17 (Pantothenic acid tonic)
Hair Conditioners
Formula-18
Hair Colorants
Temporary Hair Dyes
Formula-19
Semi-permanent Hair Dyes
Formula-20
Permanent Hair Dyes
Formula-21
Formula-22
Hair Grooming Aids
Brilliantines
Formula-23
Formula-24
Formula-25
Hair Oils
Formula-26
Formula-27
Hair Setting Lotions
Formula-28
Hair Creams
Formula-29
Formula-30
Hair Lacquers and Sprays
Formula-31
Hair Removers
Formula-32 (Paste Depilatory)
Hair Texturizer
Hair Wax
Hair Gel
Shampoos
Water
Detergents
Foam Boosters
Thickeners
Conditioning Agents
Preservatives
Modifiers
Antidandruff Agents
Special Additives
Formula-34 (Clear Liquid Shampoo)
Formula-35 (Cream Type Shampoo)
Formula-36 (Antidandruff Shampoo)
NAIL PREPARATIONS
Cuticle Oils, Creams and Lotions
Formula-37
Formula-38
Nail Bleaches
Formula-39
Nail Lacquers
Formula-40
Lacquer Removers
Formula-41
Cuticle Removers
Formula-42
MEN'S TOILETRIES
Shaving Cream
Lather Shaving Cream
Formula-43
Brushless Shave Cream
Formula-44
Aerosol Shaving Foam
Formula-45
After-shave Lotion
Formula-46
ANTIPERSPIRANTS AND DEODORANTS
Active Ingredients
Gelling Agents
Other Ingredients
Formula-47 (Deodorant Powder)
Formula-48 (Liquid Antiperspirant)
EYE MAKE-UP
Eye Shadows
Eye Mascaras
Eye Liners
BABY CARE PRODUCTS
Bath Products
Shampoo
Soap Bars and Syndets
Cleansing Milk
Face/Body Creams and Body Lotions, Powders
DENTIFRICES
Binders
Abrasives
Sudsers
Humectants
Flavors
Sweeteners
Therapeutic Agents
Preservatives
Formula-49 (Tooth Powder)
Formula-50 (Tooth Paste)
QUALITY CONTROL AND EVALUATION OF COSMETICS
Creams
Total Fatty Substance Content
Water Content
pH Determination
Microbiological Count
Rheology
Peroxide Stability in Creams
Determination of Acid and Bases
Determination of Total Fatty Acids
Moisturizing Efficiency
Stability Testing
Skin Testing
Measurement of Sebum and Skin Elasticity
Sunscreen Products
Rheology
Sun Protection Factor (SPF) and Sun-screen Index (SI)
Ultraviolet Filters Determination
Photostability Testing
Skin Testing
Face and Compact Powders
Color Dispersion
Pressure Testing
Breakage Test
Particle Size and Abrasiveness Measurement
Flow Properties
Lipsticks
Melting Point
Breaking Point
Pressure Testing
Oxidative Stability
Stability Study
Shampoos
Determination of pH
Percentage of Solids
Foam Stability
Rheology
Dirt Dispersion
Detergency Ability
Surface Tension Measurement
Determination of Acid and Bases
Determination of Anionic and Cationic Surfactants
Determination of Zinc Pyrithione
Stability Tests
Eye Irritation
Hair Preparations
Determination of Thioglycollic Acid
Rheology
Stability Test
Sensitization Test
Effect on Skin and Eyes
Hair-dye Determination
Nail Lacquers
Color Matching
Non-volatile Content
Drying Time
Gloss
Hardness of Film
Viscosity
Water Resistance
Deodorants and Anti-perspirants
Study of Axillary Odors
Efficacy of Anti-perspirant
Determination of Aluminum and Chloride Ions
Dentifrices
Determination of Anionic Foaming Agent
Determination of Fluoride
Viscosity of Toothpastes and Gels
Spreadibility Tests
Abrasiveness
Particle Size
Cleansing Property
pH
Foaming Character
Flow Properties of Tooth Powder
Stability Studies
Animal Safety Screening
CHAPTER 12:
Packaging of Dosage Forms
INTRODUCTION
Containers
Closures
Liners
Storage Temperature
GLASS
Types of Glasses
Soda-lime Glass
Lead Glass
Borosilicate Glass
Amber Glass
PLASTICS
Types of Plastics
Thermoplastics
Thermosets
Plastics of Importance
Polyethylene
Polystyrene
Polypropylene
Polyvinyl Chloride
Polycarbonate
Cellulosics
Problems with Plastic Packaging Materials
Permeation
Leaching
Sorption
Chemical Reactivity
Alteration of Plastic Properties
METALS
Tin
Aluminium
PAPER AND BOARD
RUBBER
Natural Rubber
Butyl and Halobutyl Rubber
PHARMACEUTICAL PACKAGING TECHNOLOGY
Strip Packaging
Blister Packaging
Polyvinyl Chloride
Polychlorotrifluoro Ethylene
Cyclic Olefin Copolymers
Tamper Resistant Packaging
Child Resistant Packaging
Aerosol Packaging
EVALUATION OF CONTAINER-CLOSURE SYSTEM
Tests for Rubber Closures
Mechanical Testing of Rubber and Elastomers
Chemical Testing of Rubber and Elastomers:
Testing of Rubber Closures:
Container Testing
Plastic Containers Tests
Glass Container Tests
INDEX
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