Pharmaceutical Dosage Form and Technology（药物剂型与工艺）

Chapter 1 Introduction\t1

1．1 Drugs and diseases\t1

1．1．1 Treatment of diseases\t1

1．1．2 Drug substances and medicines\t1

1．1．3 The history of drugs\t2

1．1．4 The drug-target interaction\t3

1．2 About pharmacy\t5

1．2．1 Pharmaceutical sciences\t5

1．2．2 Pharmaceutics\t5

1．2．3 Dosage forms and drug delivery systems\t6

1．2．4 Categories of DDS\t9

1．3 The standardization of medicine\t11

1．3．1 Why medicine needs standard\t11

1．3．2 Pharmacopeia\t12

1．4 Clinical using medicine\t12

1．4．1 Brand medicine and generic medicine\t12

1．4．2 Prescription medicine and over-the-counter medicine\t13

1．4．3 Prescription\t13

1．4．4 Drug-drug interaction\t14

1．4．5 Drug-food interaction\t14

References\t16

Chapter 2 Solid dosage forms I\t17

2．1 Introduction\t17

2．2 Powder\t18

2．3 Granules\t20

2．3．1 Preparation of granules\t22

2．3．2 Granulation methods and equipments\t22

2．3．3 Quality control of granules\t31

References\t33

Chapter 3 Solid dosage forms II\t34

3．1 Capsules\t34

3．1．1 Hard gelatin capsules\t34

3．1．2 Soft capsules\t36

3．2 Tablets\t37

3．2．1 Excipients of tablets\t39

3．2．2　Manufacture of tablets\t40

3．2．3 Film coating\t42

3．2．4 Quality control of tablets\t53

3．2．5 Packaging and storing of tablets\t58

References\t59

Chapter 4 Pulmonary drug delivery system\t60

4．1 Introduction\t60

4．1．1 Anatomy of lungs\t60

4．1．2 Advantages of pulmonary drug delivery\t61

4．1．3 Mechanisms of particle deposition in the lung\t62

4．2 Pulmonary drug delivery devices\t62

4．2．1 Nebulizers\t63

4．2．2 pMDIs\t64

4．2．3 DPIs\t64

4．2．4 Soft mist inhaler\t65

4．3 Factors governing aerosol deposition and targeting in the lung\t66

4．3．1 Aerodynamic diameter and size distribution\t66

4．3．2 Airflow rate\t66

4．3．3 Particle shape\t67

4．3．4 Particle density\t67

4．3．5 Surface roughness\t67

4．4 Clinical application of pulmonary drug delivery systems\t68

4．5 Perspectives of pulmonary drug delivery\t69

References\t70

Chapter 5 Transdermal drug delivery system\t73

5．1 Introduction\t73

5．2 Skin structure and the major obstacles of transdermal permeation\t74

5．3 Major transdermal routes\t75

5．3．1 Appendageal routes\t75

5．3．2 Transcellular routes\t75

5．3．3 Intercellular routes\t75

5．4 Chemical penetration enhancers\t76

5．4．1 Natural chemical penetration enhancers\t76

5．4．2 Synthetic chemical penetration enhancers\t77

5．4．3 Combination of penetration enhancers\t82

5．5 Physical techniques to improve transdermal delivery\t83

5．5．1 Microneedle\t83

5．5．2 Laser\t84

5．5．3 Iontophoresis\t86

5．5．4 Sonophoresis\t87

5．5．5 Electroporation\t89

5．5．6 Magnetophoresis\t90

5．5．7 Microwave\t90

5．6 Transdermal formulations\t91

5．6．1 Liposome\t91

5．6．2 Cubic phase\t91

5．6．3 Microemulsion\t91

5．6．4 Hydrogel\t91

5．6．5 Transfersome\t92

5．7 Device-assisted or wearable transdermal delivery systems\t92

5．7．1 Development stages\t92

5．7．2 Device\t93

5．7．3 Application\t94

5．7．4 Prospect\t94

References\t94

Chapter 6 Liquid dosage forms\t101

6．1　Introductions\t101

6．1．1　Solubilities\t101

6．1．2　Solvents\t102

6．1．3　Enhancements\t103

6．2　Syrups\t103

6．3　Elixirs\t104

6．4　Suspensions\t105

6．4．1　Sedimentation of particles in suspension\t105

6．4．2　Preparation of suspensions\t107

6．4．3　Colloidal dispersions\t108

6．5　Emulsions\t109

6．5．1　Pharmaceutical emulsions\t110

6．5．2　Emulsion formation theory\t111

6．5．3　Emulsion identification\t112

6．5．4　Emulsion preparation\t112

6．5．5　The HLB system\t116

6．5．6　Emulsion stability\t117

6．5．7　Nanoemulsions\t120

6．6　Creams\t121

6．7 Gels and magmas\t122

References\t123

Chapter 7 Sterilized preparations\t124

7．1 Principles of sterilization\t124

7．1．1 Introduction\t124

7．1．2　Sterilization parameters\t124

7．1．3　Principles of sterilization processes\t125

7．1．4　Gaseous sterilization\t127

7．1．5　Radiation sterilization\t128

7．1．6　Filtration sterilization\t129

7．1．7 High-level disinfection\t129

7．2　Parenteral\t130

7．2．1　Introduction\t130

7．2．2　Injections\t130

7．2．3　Large-volume parenterals\t131

7．3　Biologics\t131

7．3．1　Introduction\t131

7．3．2　Types of immunity\t132

7．3．3　Production of biologics\t132

7．4　Ophthalmic solution and suspensions\t133

7．4．1　Introduction\t133

7．4．2　Pharmaceutical requirements\t134

References\t136

Chapter 8 Modified-release oral drug delivery\t138

8．1 Introduction of modified-release oral drug delivery\t138

8．1．1　Sustained-release preparation\t138

8．1．2　Controlled-release preparation\t138

8．1．3　Delayed-release preparation\t138

8．2　Theories of extended-release oral drug delivery\t139

8．2．1　Theory of dissolution-controlled\t139

8．2．2　Theory of diffusion-controlled\t140

8．2．3　Combination of erosion and diffusion theory\t141

8．2．4 Osmotic pressure theory\t142

8．2．5　Ion exchange theory\t143

8．3　Design of extended-release oral drug delivery systems\t144

8．3．1　Properties of drugs\t144

8．3．2　Design requirements\t147

8．4　Quality assessment\t149

8．4．1　In vitro assessment\t149

8．4．2　In vivo assessment\t150

8．4．3　In vitro correlation\t150

8．5 Application of extended-release oral drug delivery systems\t154

8．6　Oral chronopharmacologic and oral site-specific drug delivery system\t160

8．6．1　Overview\t160

8．6．2　Theories\t161

8．6．3　Brief introductions\t163

8．6．4 Applications\t166

References\t171

Chapter 9 Suppositories\t173

9．1　Introduction\t173

9．2 Suppository bases\t174

9．2．1　Fatty or oleaginous bases\t174

9．2．2　Water-soluble or water-miscible bases\t174

9．3 Preparation of suppositories\t175

9．3．1 Manufacturing procedure\t175

9．3．2　Displacement value\t176

9．3．3 Quality control\t177

9．3．4　Examples\t177

9．4　Packing and storage\t178

9．5　Special types of suppositories\t178

References\t179

Chapter 10 Paediatric and geriatric drug developent\t180

10．1 Introduction\t180

10．2　Physiological changes\t180

10．3　Excipient safety\t181

10．4　Taste\t183

10．5　Formulation choices\t184

10．5．1　Tablets\t184

10．5．2　Liquids\t185

10．5．3　Multiparticulates\t186

10．5．4　Dispersible and orally dispersible formulations\t186

10．5．5　Chewable tablets\t187

References\t188

Indexes\t190