TABLE OF CONTENTS. vii

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1 TABLE OF CONTENTS S. No. Description Page No. CHAPTER-I 1.0 Introduction 1 CHAPTER-II 2.0 Literature Review History Formulation Theory Properties of Nanoparticles Existing Technologies To Produce Drug Nanoparticles Bottom up Technologies (Precipitation Methods) Top Down Technologies High Pressure Homogenization Methods Microfluidisation for Production of Drug Nanoparticles Piston gap Technologies Milling Methods Conversion of Nanosuspension in to Solid Intermediate Characterization of Nanoparticles Particle Size and Size Distribution Spectroscopy Microscopy Morphology Differential Scanning Calorimetry (DSC) X-ray Powder Diffraction (XRPD) Interparticular Interactions Drug Candidate Selection Criteria Objective of the Investigation vii

2 2.10 Scope Plan of Work 25 CHAPTER-III 3.0 Experimental Investigations Candesartan cilexetil Drug Profile Pharmacokinetics Mechanism of Action Dose Materials and Methods Materials Instruments and Apparatus Solubility Studies ph solubility Study Preparation of Nanosuspension using In-house Fabricated Equipment Formulation Design Selection of Primary Stabilizer Selection of Secondary Stabilizer Evaluation of Nanosuspension Method Development for Particle Size Analysis by Laser Diffraction Technique Principle and Working of Malvern Mastersizer Method Development for Particle Size Analysis Representative Sampling Use of Dispersant Sample Concentration Solid Particle Measurements Analysis Procedure viii

3 3.8.4 Specifications for Particle Size Measurement in Malvern Mastersizer 3.9 Scale-up of Milling Process using Agitator Bead Mill (Netzsch ) Principle and Working of Netzsch Lab Star Bead Mill Grinding Media Size and Composition Conversion of Nanosuspension in to Solid Intermediates Process Selection Lyophilization Technique Drug Layering Spray Drying Selection of Suitable Carrier Solid State Characterization Differential Scanning Calorimetry (DSC) Powder X-Ray Diffraction (PXRD) Optical Microscopic Examination Scanning Electron Microscopy (SEM) Analytical Methodology Analytical Method Development for Estimation of Candesartan in Formulations Drug Content Estimation by HPLC Chromatographic Conditions Standard Preparation Sample Preparation System Suitability Calculations Saturation Solubility of Nanoparticles Tablet Preparation Selection of Tableting Excipients Preparation of Tablets using Candesartan cilexetil Granules 61 ix 47 56

4 3.16 Evaluation of Blend Physical Properties Angle of Repose Density Carr s Index Hausner Ratio Evaluation of Tablet Physical Properties Average Weight Tablet Thickness Tablet Hardness Friability Disintegration Time Moisture Content Dissolution Studies Apparatus Dissolution Conditions Calculations In-Vivo Pharmacokinetic Study Bioanalysis by LC-MS Chromatographic Conditions Sample Preparation Stability Evaluation Results and Discussion Solubility Studies Preparation of Nanosuspension Using Wet Milling Apparatus Stabilizer Screening for Production of Physically Stable Nanosuspensions Scale-up of Nanosuspension Process using Media Mill x

5 Effect of Process Time Spray Drying Processes for Conversion of Nanosuspension into Solid Intermediate Optical Microscopic Examination Scanning Electron Microscopy (SEM) Solid State Characterization Solubility Studies of Un-milled, Micronized and Drug Nanoparticles Preparation of Tablets Physical Properties of Blend Compression into Tablets Dissolution Rate Evaluation In-Vivo Evaluation Stability Evaluation Camptothecin Analog Camptothecin Analog Drug Profile Mechanism of Action Dose Material and Methods Materials Instruments and Apparatus Solubility Studies ph solubility Study Preparation of Nanosuspension using in-house fabricated equipment Formulation Design Selection of Primary Stabilizer Selection of Secondary Stabilizer Evaluation of Nanosuspension Particle Size Analysis using Malvern Mastersizer 116 xi 82 89

6 Specifications for Particle Size Measurement in Malvern Mastersizer 3.29 Scale-Up of Manufacturing Process using Agitator Bead Mill Preparation of Nanosuspension Conversion of Nanosuspension into Solid Intermediate Process Selection Spray Granulation Process Selection of Suitable Carrier Solid State Characterization Differential Scanning Calorimetry (DSC) Powder X-ray Diffraction (PXRD) Optical Microscopic Examination Scanning Electron Microscopy (SEM) Analytical Methodology Analytical Method for Estimation of Camptothecin analog in Formulations Drug Content Estimation by HPLC 123 xii Chromatographic Conditions Standard Preparation Sample Preparation Preparation of System Suitability Solution Calculations Saturation Solubility of Drug Nanoparticles Tablet Preparation Selection of Tableting Excipients Preparation of Tablets using Processed Camptothecin analog Granules 3.36 Evaluation of Blend Properties Angle of Repose

7 Density Carr s Index Hausner Ratio Evaluation of Tablet Physical Properties Average Weight Tablet Thickness Tablet Hardness Friability Disintegration Time Moisture content Dissolution Studies Apparatus Dissolution Conditions Calculations In-Vivo Pharmacokinetic Study Bioanalysis by HPLC Chromatographic Conditions Sample Preparation Stability Evaluation Results and Discussion Solubility Studies Preparation of Nanosuspension Using Wet Milling Apparatus Stabilizer Screening for Production of Physically Stable Nanosuspensions 3.44 Scale-up of Nanosuspension Process using Media Mill Effect of Process Time Spray Drying Processes for Conversion of Nanosuspension into Solid Intermediate 3.46 Optical Microscopic Examination 150 xiii

8 3.47 Scanning Electron Microscopy (SEM) Solid State Characterization Solubility Studies of Un-milled, Micronized and Drug Nanoparticles Preparation of Tablets Physical Properties of Blend Compression into Tablets Dissolution Rate Evaluation In-Vivo Evaluation Stability Evaluation 163 CHAPTER-IV 4.0 Summary and Conclusions Summary Conclusion 168 CHAPTER-V 5.0 References 170 CHAPTER-VI 6.0 Appendix List of Publications List of Presentations 195 xiv

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