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The formulation and evaluation of orally disintegrating tablets - diphenhydramine HC1
Table of Contents
Abstract
Acknowledgements
Table of Contents
List of Tables
List of Figures
Preface
Chapter 1: Orally Disintegrating Tablets (ODTs)
1.1 Introduction
1.2 Pediatric Dosage Forms
1.3 Liquid Dosage Forms
1.4 Solid Dosage Forms
1.5 Orally Disintegrating Tablets
1.5.1 ODT Terminology and Definition
1.5.2 Common Reasons and Conditions for Using ODTs
1.5.3 Manufacturing Methods
1.5.4 Direct Compression
1.5.5 Orally Disintegrating Tablet Characteristics
1.5.6 Bioavailability
1.5.7 Palatability
Chapter 2: Thermal Analysis: Differential Scanning Calorimetry (DSC) and Themogravimetric Analysis (TGA)
2.1 Introduction
2.2 Differential Scanning Calorimetry
2.2.1 Development of modern DSC
2.2.2 DSC characteristics
2.2.3 Sample preparation
2.2.4 DSC applications
2.2.5 Calculations
2.3 Thermogravimetric Analysis
2.3.1 TGA characteristics
2.3.2 Sample preparation
Chapter 3: Fourier Transform Infrared Spectroscopy (FTIR)
3.1 Electromagnetic Spectrum
3.2 Vibrational Spectroscopy
3.3 FTIR Spectrometer
3.3.1 Overview
3.3.2 Sources
3.3.3 Detector
3.4 Advantages
3.5 Sample Preparation
3.6 FTIR Spectra
3.7 Characteristic Frequencies
Chapter 4: Ultraviolet-Visible Spectroscopy
4.1 Introduction
4.2 Instrument Components
4.2.1 Light Source
4.2.2 Wavelength Selector
4.2.3 Sample Holder/Compartment
4.2.4 Detector
4.3 Types of Instruments
4.3.1 Single Beam
4.3.2 Double Beam
4.4 Beer-Lambert Law
4.4.1 Limitations of Beer-Lambert Law
4.5 Application
Chapter 5: Preformulation Considerations
5.1 Introduction
5.2 Maillard Reaction
5.3 Superdisintegrants
5.3.1 Kollidon CL-SF®
5.3.2 Primojel®
5.3.3 Ac-Di-Sol®
5.3.4 Polyplasdone XL®
Chapter 6: Tableting
6.1 Introduction
6.2 Tablet Manufacturing Methods
6.2.1 Wet Granulation
6.2.2 Dry Granulation
6.2.3 Direct Compression
6.3 Ingredients
6.3.1 Diluents
6.3.2 Binders
6.3.3 Glidants and Lubricants
6.3.4 Disintegrating Agents
6.4 Tableting Press
Chapter 7: Tablet Testing
7.1 Introduction
7.2 Weight Variation
7.3 Tablet Dimensions
7.4 Hardness
7.5 Friability
7.6 Disintegration Time
7.7 Wetting Time
Chapter 8: Powder Flow
8.1 Introduction
8.2 Angle of Repose
8.3 Compressibility Index and Hausner Ratio
8.4 Flow Through an Orifice
8.5 Shear Cell
Chapter 9: Dissolution
9.1 Introduction
9.2 Instrumentation
9.2.1 Apparatus 1 (Basket Apparatus)
9.2.2 Apparatus 2 (Paddle Apparatus)
9.3 Procedure
9.4 Release Kinetics
9.4.1 Zero Order Kinetics
9.4.2 First Order Kinetics
9.4.3 Higuchi Model
9.4.4 Hixson-Crowell Model
9.4.5 Korsmeyer-Peppas Model
9.5 Small-Volume Dissolution
Chapter 10: Stability Testing
10.1 Introduction
10.2 Accelerated Stability Testing
10.3 Limitations
10.4 Humidity Testing
10.5 Shelf-Life Determination
Chapter 11: Materials and Methods
11.1 Materials
11.1.1 Diphenhydramine Hydrochloride
11.1.2 Sugars
11.1.3 Superdisintegrants
11.1.4 Lubricant
11.1.5 Simulated Gastric Fluid without Enzymes
11.1.6 Deionized Water
11.1.7 Humidity Testing Salts
11.1.8 Over-the-Counter Diphenhydramine Orally Dissolving Tablets
11.2 Methods
11.2.1 Diphenhydramine HCl Analysis
11.2.2 DSC Analysis of Sugar and Diphenhydramine HCl
11.2.3 FTIR Analysis of Trehalose and Diphenhydramine HCl
11.2.4 UV-Vis Analysis of Trehalose and Diphenhydramine HCl
11.2.5 Preparation of Superdisintegrant Powder Mixtures
11.2.6 Superdisintegrant Tableting
11.2.7 Superdisintegrant Tablet Testing
11.2.8 Powder Properties for the Optimal Choice of Superdisintegrant and its Concentration
11.2.9 Preparation of Diphenhydramine HCl Powder Mixture with Polyplasdone XL®
11.2.10 Diphenhydramine HCl Tableting
11.2.11 Diphenhydramine HCl Tablet Testing
11.2.12 Powder Properties for the Optimal Polyplasdone XL® Concentration with Diphenhydramine HCl
11.2.13 Preparation of the Final Diphenhydramine HCl Tablets with 10% Polyplasdone XL®
11.2.14 Final Diphenhydramine HCl Tablets with 10% Polyplasdone XL® Tableting
11.2.15 Tablet Packaging
11.2.16 Stability Testing
11.2.17 Humidity Testing
11.2.18 Physical and Mechanical Testing of Currently Available Diphenhydramine HCl Orally Dissolving Tablets
Chapter 12: Results and Disscussion
12.1 Diphenhydramine HCl Analysis
12.2 DSC Analysis of Sugar and Diphenhydramine HCl
12.3 FTIR Analysis of Trehalose and Diphenhydramine HCl
12.4 UV-Vis Analysis of Trehalose and Diphenhydramine HCl
12.5 Superdisintegrant Tablet Testing
12.6 Powder Properties for the Optimal Choice of Superdisintegrant and its Concentration
12.7 Diphenhydramine HCl Tablet Testing
12.8 Powder Properties for the Optimal Polyplasdone XL® Concentration with Diphenhydramine HCl
12.9 Stability Testing
12.10 Humidity Testing
12.11 Physical and Mechanical Testing of Currently Available Diphenhydramine HCl Orally Dissolving Tablets
12.12 Future Studies
Chapter 13: Conclusion
ReferencesBài viết liên quan
