Jaypee Brothers
In Current Chapter
In All Chapters
X
Clear
X
GO
Normal
Sepia
Dark
Default Style
Font Style 1
Font Style 2
Font Style 3
Less
Normal
More
Handbook of Pharmaceutical Technology
Poonam Kushwaha
CHAPTER 1:
Tablets
INTRODUCTION
Advantages
Disadvantages
Desired characteristics of tablet
TYPES AND CLASSES OF TABLETS
I. Oral tablet for ingestion
A. Compressed tablets (Fig. 1.1)
B. Multiple compressed tablets
C. Modified release tablets (Fig. 1.5)
D. Delayed action and enteric coated tablets
E. Film coated tablets
F. Chewable tablets
II. Tablet used in oral cavity
A. Buccal and sublingual tablets
B. Troches and lozenges (Figs 1.6A and B)
C. Dental cones (Fig. 1.7)
III. Tablet administered by other routes
A. Implantation tablets
B. Vaginal tablets
IV. Tablets used to prepare solution
A. Effervescent tablets
B. Soluble tablets
C. Dispensing tablets
D. Hypodermic tablets
E. Tablet triturates
FORMULATION OF TABLETS
I. Active pharmaceutical ingredients (API)
Ideal properties of API for formulating tablets
5. Optimum and uniform particle size distribution
6. Spherical shape
7. Good flowability
8. Optimum moisture content
9. Good compressibility
10. Absence of static charge on surface
11. Good organoleptic properties
II. Excipients
Various excipients used in tablet formulation and their functionalities:
Classification of diluents (Table 1.1)
Types of disintegrants (Table 1.7)
Factors affecting disintegration
GRANULATION
Granulation processes
Mechanism of granule formation (Fig. 1.8)
Granules are formed in three stages:
Factors to be considered in granulation
Ideal characteristics of granules
Evaluation tests for binders/granules
METHOD OF TABLET PREPARATION
1. Direct compression method
Merits
Merits over wet granulation process
Demerits
Steps involved in direct compression
Direct compression excipients
2. Dry granulation method
Advantages
Disadvantages
Steps in dry granulation
Dry granulation process
3. Wet granulation method
Steps involved in the wet granulation
Limitation of wet granulation
Special wet granulation techniques
i. High shear mixture granulation
Advantages
ii. Fluid bed granulation
iii. Extrusion and spheronization
Advantages
iv. Spray drying granulation
Advantages
ADVANCEMENT IN GRANULATIONS
A. Steam granulation
B. Melt granulation/thermoplastic granulation
C. Moisture activated dry granulation (MADG)
D. Moist granulation technique (MGT)
E. Thermal adhesion granulation process (TAGP)
F. Foam granulation
OPERATIONS INVOLVED IN TABLET MANUFACTURING
i. Dispensing
ii. Sizing
iii. Powder blending
iv. Granulation
v. Drying
TABLET COMPRESSION
Parts of tablet compression machines
Types of tablet compression machines
i. Single punch tablet compression machine (Fig. 1.13)
ii. Multipunch tablet compression machine
iii. Multilayed rotary tablet compression machine
iv. Rotary tablet compression machine (Fig. 1.14)
Compression cycle
AUXILIARY EQUIPMENTS
i. Feeding device
ii. Tablet weight monitoring devices
iii. Tablet deduster (Fig. 1.17)
iv. Fette machine
PACKAGING
PROBLEMS IN TABLET MANUFACTURING
The defect related to machine
a. Capping
b. Lamination/laminating
c. Cracking
e. Sticking / filming
f. Picking
g. Chipping
h. Mottling
i. Double impression
TABLET COATING
Purpose of tablet coating
TYPES OF TABLET COATING PROCESS
1. Sugar coating
Advantages
Disadvantages
Processing steps (Fig. 1.18)
Steps involved in sugar coating process are:
C. Grossing/ smoothing
D. Color coating
E. Polishing
F. Printing
Process description
Process details
Basic process requirements for film coating
Development of film coating formulations
Materials used in film coating
i. Film formers
ii. Solvents
iii. Plasticizers
Most commonly used plasticizers
iv. Colorants
v. Opaquant-extenders
vi. Miscellaneous coating solution component
Advantages
Disadvantages
SPECIALIZED COATING
A. Compressed coating
B. Electrostatic coating
C. Dip coating
D. Vacuum film coating
TABLET COATING EQUIPMENTS
Advantages
Advantages
Application
Limitation
PROCESS PARAMETERS
PROBLEMS AND REMEDIES FOR TABLET COATING
IN PROCESS QUALITY CONTROL (IPQC) TESTS FOR TABLETS
Classifications
i. General appearance
ii. Weight variation test
iii. Content uniformity test
iv. Hardness test
v. Friability test
vi. Disintegration time
Pharmacopoieal requirements
vii. Dissolution test
viii. Crushing strength of coated tablet
ix. Adhesion test
x. Stability studies
CHAPTER 2:
Capsules
INTRODUCTION
HARD GELATIN CAPSULES (HGC) (FIG. 2.1)
Advantages of HGC
Disadvantages of HGC
Size and Shapes of HGC (Table 2.1)
Composition of HGC
Physiochemical properties of gelatin
Method of production of empty hard gelatin shells
Steps involved in making empty gelatin capsules are (Fig. 2.4):
Properties of empty capsule
Storage of empty capsules
Materials to be filled
1. Diluents
2. Protective sorbents
3. Glidants
4. Antidusting compounds
Capsule Filling
a. Hand operated hard gelatin capsule filling machines
b. Semiautomatic capsule filling machine (Fig. 2.7)
c. Automatic capsule filling machine (Fig. 2.9)
Finishing
Sorting
Sealing and locking
Storage of filled capsules
SOFT GELATIN CAPSULES (SGC)
Advantages of soft gel capsules
Disadvantages of soft gel capsules
Shape of capsule
Composition of soft gelatin capsules
Materials to be filled
Limitations
Manufacture of soft gelatin capsules
QUALITY CONTROL TESTS FOR CAPSULES
i. Disintegration test
ii. Weight variation test
iii. Content uniformity test
iv. Dissolution test
v. Capsule stability
SPECIAL TYPES OF HARD GELATIN AND SOFT GELATIN CAPSULES
a. Altered release
b. Coating capsules
PACKAGING
CHAPTER 3:
Microencapsulation
INTRODUCTION
Dimensions
Reasons for microencapsulation
CORE MATERIAL
Liquid core materials
Solid core materials
COATING MATERIAL
Ideal characteristics of coating material
TECHNIQUES OF MICROENCAPSULATION
1. Air suspension process
2. Coacervation—Phase separation process
Step I: Formation of three immiscible chemical phases
Step II: Deposition of the coating
Step III: Rigidization of the coating
Methods for phase—Separation
3. Pan coating
4. Solvent evaporation
5. Interfacial polymerization
6. Spray drying and spray congealing
7. Multiorifice centrifugal process
EVALUATION OF MICROCAPSULES
1. Particle size analysis
2. Determination of shape and spherecity
3. Scanning electron microscopy
4. Percentage yield
5. Drug entrapment efficiency
6. Flow properties of microcapsules
7. Determination of swelling properties
8. In vitro drug release study
CHAPTER 4:
Parenteral Products
INTRODUCTION
Advantages
Disadvantages
Routes of administration
FORMULATION REQUIREMENTS
1. Vehicles and solvents for parenteral products
a. Aqueous vehicles
b. Aqueous isotonic vehicles
c. Nonaqueous vehicles
2. Solutes
Desired characteristics
GENERAL MANUFACTURING PROCESS
Components
1. Water for injection (WFI) preparation
2. Storage and distribution
3. Containers and closures (Fig. 4.1)
Production facilities
1. Functional areas
2. Flow plan
3. Clean room classified areas
4. Maintenance of clean rooms
5. Personnel
Production procedures
1. Cleaning containers and equipment
2. Product preparation
3. Filtration
4. Filling
5. Sealing of ampules, vials and bottles
6. Sterilization
FREEZE-DRYING (LYOPHILIZATION)
Applications
Advantages
Disadvantages
Desired characteristics of freeze-dried products
Process
QUALITY CONTROL TESTS FOR PARENTERAL PRODUCTS
1. Sterility tests
a. Direct transfer method
b. Membrane filtration method
2. Clarity test
i. By clarity test apparatus (Fig. 4.10)
ii. By filter paper method
iii. By image analysis devices
iv. Other methods
3. Leaker test (Fig. 4.11)
4. Pyrogen test
a. Rabbit test
b. Limulus amebocyte lysate test (LAL)
PACKAGING
CHAPTER 5:
Novel Drug Delivery Systems
ORAL CONTROLLED RELEASE DRUG DELIVERY SYSTEMS
Introduction
Rationale of controlled drug delivery
Terminology
Theoretical overview
Potential advantages and disadvantages of sustained and controlled release dosage forms
Factors considered in designing of sustained/controlled release dosage forms
Biopharmaceutical factors
Pharmacokinetic factors
Criteria to be met by drug proposed to be formulated in sustained/controlled release dosage forms
Design and formulation of oral controlled release drug delivery system
Matrix systems
Types of matrix
PARENTERAL CONTROLLED DRUG DELIVERY SYSTEMS
Introduction
Advantages
Disadvantages
Polymers used in parenteral controlled drug delivery system
Classification of parenteral controlled drug delivery system
Parenteral depot system (PDS)
Reason for development of PDS
Approaches used in depot formulation:
Classification of depot systems
Characteristics of nanosuspension
Preparation of nanosuspension
Application of nanosuspension as parenteral administration
Application
Advantages
Application of lipid nanoparticles for parenteral drug delivery
Advantages
Advantages
Disadvantages
Polymers used for implants
1. Osmotic pressure activated drug delivery systems (Osmotic pumps)
2. Vapor pressure powered pump (infusaid)
3. Battery powered pump
TARGETED DRUG DELIVERY SYSTEMS
Introduction
Advantages of drug targeting
Disadvantages of drug targeting
Ideal characteristics of targeted drug delivery system
Types of drug targeting
Drug carriers
Properties of ideal drug carriers
Type of drug carriers
Targeting moieties
Drug immobilization techniques
1. Liposomes
2. Monoclonal antibodies and fragments
3. Modified (plasma) proteins
4. Soluble polymers
5. Lipoproteins
6. Microspheres and nanoparticles
7. Polymeric micelles
8. Cellular carriers
NANOPARTICLES
Introduction
Advantages
Applications
Polymeric nanoparticles (PNPs)
Polymers used in nanoparticles
Mechanisms of drug release
Techniques of preparation
A. Methods for preparation of nanoparticles from dispersion of preformed polymer
B. Preparation of nanoparticles by polymerization of a monomer
Types of nanoparticles used for drug delivery
Types of nanoparticles
TRANSDERMAL DRUG DELIVERY SYSTEMS
Introduction
Advantages
Limitations
Percutaneous absorption and kinetics of transdermal permeation
A. Transepidermal absorption
B. Transfollicular (shunt pathway) absorption
Factors affecting transdermal permeability
1. Physicochemical properties of the penetrants
2. Physicochemical properties of drug delivery systems
3. Physiological and pathological conditions of the skin
Basic components of TDDS
Approaches used in development of transdermal drug delivery systems
1. Membrane permeation-controlled systems
2. Adhesive dispersion type systems
3. Matrix diffusion controlled systems
4. Microreservoir type or microsealed dissolution controlled system
Evaluation of transdermal drug delivery systems
A. Physicochemical evaluation
B. Evaluation of adhesive
C. In vitro drug release study
D. In vitro permeation studies
The future of transdermal therapy
A. Molecular absorption enhancement
B. Absorption enhancement by energy input
CHAPTER 6:
Pharmaceutical Packaging
INTRODUCTION
Importance of packaging
Objectives of packaging
Types of packaging (Table 6.1)
PACKAGING AND STABILITY OF PRODUCT
CONTAINERS FOR PHARMACEUTICAL USE
Types of containers
a. Container used as primary packaging for liquid orals
b. For solid dosage forms
c. Containers for semisolid and pressurized products
PHARMACEUTICAL PACKAGING MATERIALS
Properties of packaging materials
Packaging components
Paper and board
Glass
Plastic
Metal
Rubber based components
Closure lines
Pharmacopoeial requirements for rubber closures
Rubber closures for injectable preparations
Tamper resistant packaging
QUALIFICATION AND QUALITY CONTROL OF PACKAGING COMPONENTS
Package inspection
FDA Regulation
Child-resistant packaging
CHAPTER 7:
Surgical Dressings
INTRODUCTION
Function of dressings
CLASSIFICATION OF SURGICAL DRESSINGS
NONOFFICIAL DRESSINGS
Primary wound dressings
Primary/Secondary wound dressings
Secondary wound dressings
Adhesive tapes are divided into two categories:
Protective
OFFICIAL DRESSINGS
CELLULOSIC HEMOSTASIS
Bibliography
INDEX
TOC
Index
×
Chapter Notes
Save
Clear