Handbook of Lung Targeted Drug Delivery Systems Recent Trends and Clinical Evidences

Contents

Editors ....................................................................................................... xi

List of Contributors ..................................................................................... xiii

Foreword..................................................................................................... xix

Preface......................................................................................................... xxi

1 Introduction to Lung Physiology from a Drug Delivery Perspective.................................................................................1

Aparoop Das, Manash Pratim Pathak, Pompy Patowary, and Sanghita Das

2 Introduction to Pharmacology of the Lung from a

Drug Delivery Perspective......................................................................................................................................................13

Caline McCarthy and Charles Preuss

3 Mechanism and Ways of Pulmonary Drug

Administration .........................................................................................................................................................................29

Ahmed S. Fahad, Sai H.S. Boddu, and Jerry Nesamony

4 Transepithelial Route of Drug Delivery through the

Pulmonary System...................................................................................................................................................................41

Sakshi Kumar and Swati Gupta

5 Understanding the Pharmacokinetics and

Pharmacodynamics of Lung and Lung Drug Delivery ......................................................................................................53

Seth Kwabena Amponsah

6 Chronic Lung Diseases: Treatment, Challenges, and

Solutions....................................................................................................................................................................................61

Aparoop Das, Riya Saikia, Kalyani Pathak, Urvashee Gogoi, and Surovi Saikia

7 Understanding of Lung Diseases with a Focus on

Applications of Nano-particulate Drug Delivery Systems..................................................................................................73

Shraddha Khairnar, Mudassir Ansari, Ujwala Shinde, Agnivesh Shrivastava, and Kavita Singh

8 Model for Pharmaceutical Aerosol Transport through

Stenosis Airway........................................................................................................................................................................91

Puchanee Larpruenrudee, Mohammad S. Islam, Gunther Paul, Akshoy R. Paul, Y. T. Gu, and

Suvash C. Saha

9 Design of Efficient Dry Powder

Inhalers.................... ...............................................................................................................................................................129

Anurag Tiwari, Akshoy R. Paul, Anuj Jain, and Suvash C. Saha

10 In Vivo Animal Models for Lung Targeted Drug

Delivery Systems....................................................................................................................................................................155

Khushali Vashi, Jasmin Patel, and Yashwant Pathak

11 Advances in In Silico Study of Generic Orally Inhaled

Drug Products........................................................................................................................................................................161

Hao Miao, Renjie Li, Xudong Zhou, Jiaqi Yu, Fen Huang, Haoqin Yang, and Zhenbo Tong

12 Effect of Aerosol Devices and Administration

Techniques on Drug Delivery in a Simulated Spontaneously Breathing Pediatric Tracheostomy Model................171

Amelia Alberts and Charles Preuss

13 Pulmonary Drug Delivery: The Role of Polymeric

Nanoparticles..........................................................................................................................................................................181

Ofosua Adi-Dako, Doris Kumadoh, Esther Eshun Oppong, Christina Osei Asare, and Mary Ann Archer

14 Polymeric Nanoparticle-Based Drug–Gene Delivery

for Lung Cancer ....................................................................................................................................................................193

Keshav Moharir, Vinita Kale, Abhay Ittadwar, and Manash K. Paul

15 Inhalable Polymeric Nano-particulate Powders for

Respiratory Delivery .............................................................................................................................................................209

Anita Patel and Jayvadan Patel

vii

16 Recent Trends in Applications of Nano-Drug Delivery

Systems....................................................................................................................................................................................225

Doris Kumadoh, Ofosua Adi-Dako, Yaa Asantewaa Osei, and Mary Ann Archer

17 Nanocarrier Systems for Lung Drug

Delivery.................... ...............................................................................................................................................................239

Sai HS. Boddu and Jerry Nesamony

18 Nanomedicine for the Management of Pulmonary

Disorders.................................................................................................................................................................................257

Pompy Patowary, Manash Pratim Pathak, Pronobesh Chattopadhyay, and Kamaruz Zaman

19 Recent Approaches in Dendrimer-Based Pulmonary

Drug Delivery.........................................................................................................................................................................273

Rajiv Dahiya and Sunita Dahiya

20 Hybrid Lipid/Polymer Nanoparticles for Pulmonary

Delivery of siRNA: Development and Fate Upon In Vitro Deposition on the Human Epithelial Airway

Barrier ....................................................................................................................................................................................287

Samyak Nag, Shivani Baliyan, and Swati Gupta

21 Solid Lipid Nanoparticle-Based Drug Delivery for

Lung Cancer ..........................................................................................................................................................................303

Deepa U. Warrier, Harita R. Desai, Kavita H. Singh, and Ujwala A. Shinde

22 Lipid-Based Pulmonary Delivery System: A Review

and Future Considerations of Formulation Strategies and Limitations ........................................................................325

Komal Parmar and Jayvadan Patel

23 Respirable Controlled Release Polymeric Colloidal

Nanoparticles..........................................................................................................................................................................337

Nazrul Islam and Abdur Rashid

24 Lung Clearance Kinetics of Liposomes and Solid Lipid

Nanoparticles..........................................................................................................................................................................353

Soumalya Chakraborty, Sudipta Roy, Akash Dey, Sanjoy Kumar Das, Dhananjoy Saha, Subhabrata Ray,

and Bhaskar Mazumder

25 Solid Lipid Nanoparticles for Sustained Pulmonary

Delivery of Herbal Drugs for Lung Delivery: Preparation, Characterization, and In Vivo Evaluation ..................361

Nayanmoni Boruah, Himangshu Sharma, and Hemanta Kumar Sharma

26 Improved Solid Lipid Nano-formulations for

Pulmonary Delivery of Paclitaxel for Lung Cancer Therapy .........................................................................................387

Samson A. Adeyemi, Pradeep Kumar, Viness Pillay, and Yahya E. Choonara

27 Anti-angiogenic Therapy for Lung Cancer: Focus on

Bioassay Development in a Quest for Anti-VEGF Drugs................................................................................................409

Urvashi Bhati, Colin J. Barrow, Jagat R. Kanwar, Arnab Kapat, Venkata Ramana, and Rupinder K. Kanwar

28 Emerging Applications of Nanoparticles for Lung

Cancer Diagnosis and Therapy ...........................................................................................................................................423

Raja Reddy, Bommareddy, Sheshanka Kesani, and Yashwant Pathak

29 Metallic Nanoparticles: Technology Overview and

Drug Delivery Applications in Lung Cancer.....................................................................................................................433

Komal Parmar and Jayvadan Patel

30 Modeling of Pharmaceutical Aerosol Transport in the

Targeted Region of Human Lung Airways Due to External Magnetic Field ...............................................................443

Anusmriti Ghosh, Mohammad S. Islam, Mohammad Rahimi-Gorji, Raj Das, and Suvash C. Saha

31 Phytochemicals and Biogenic Metallic Nanoparticles as

Anti-cancer Agents in Lung Cancer ...................................................................................................................................459

Nana Ama Mireku-Gyimah, Rex Frimpong Anane, and Louis Hamenu

32 Pulmonary Applications and Toxicity of Engineered

Metallic Nanoparticles ..........................................................................................................................................................471

Deepti Kaushalkumar Jani

33 Anti-cancer Activity of Eco-friendly Gold

Nanoparticles against Lung and Liver Cancer Cells........................................................................................................483

Jayvadan Patel and Anita Patel

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34 Sub-chronic Inhalational Toxicity Studies for Gold

Nanoparticles..........................................................................................................................................................................497

Srijan Mishra and Jigna Shah

35 Single-Use Dry Powder Inhalers for Pulmonary Drug

Delivery...................................................................................................................................................................................503

Somchai Sawatdee and Teerapol Srichana

36 Lung Delivery of Nicotine for Smoking

Cessation.................... .............................................................................................................................................................513

Hui Wang and Nazrul Islam

37 Formulation and Characterization of Dry Powder

Inhalers for Pulmonary Drug Delivery ..............................................................................................................................527

Himangshu Sarma, Nayanmoni Boruah, and Hemanta Kumar Sharma

38 Devices for Dry Powder Drug Delivery to the

Lung.................... ....................................................................................................................................................................539

Vimal Patel, Jigar Shah, Hiral Shah, and Jayvadan Patel

39 Numerical Modeling of Agglomeration and

De-agglomeration in Dry Powder Inhalers ........................................................................................................................549

Tan Suwandecha and Teerapol Srichana

40 Oronasal and Tracheostomy Delivery of Soft Mist and

Pressurized Metered-Dose Inhalers with Valved Holding Chamber..............................................................................557

Dasharath M. Patel, Unnati D. Chanpura, and Veer J. Patel

41 Modeling for Biopharmaceutical Performance in Lung

Drug Discovery ......................................................................................................................................................................575

Amy Le, Kianna Samuel, Truong Tran, and Yashwant Pathak

42 Regulatory Consideration for Approval of Generic

Inhalation Drug Products in the US, EU, Brazil, China, and India ..............................................................................579

Urvashi K. Parmar and Jayvadan Patel

43 Regulatory Perspectives and Concerns Related to

Nanoparticle-Based Lung Delivery .....................................................................................................................................591

Johirul Islam, Hemanga Hazarika, Probin Kr Roy, Pompy Patowary Pronobesh Chattopadhyay,

Yashwant V. Pathak, and Kamaruz Zaman

44 Clinical Controversies of Pediatric Aerosol

Therapy...................................................................................................................................................................................611

Jeffrey Cruz and Charles Preuss

45 Drug Delivery Using Aerosols: Challenges and

Advances in Neonatal Pediatric Subgroup ........................................................................................................................623

Surovi Saikia, Aparoop Das, and Yashwant Pathak

46 Safety and Toxicological Concerns Related to

Nanoparticle-Based Lung Delivery .....................................................................................................................................631

Humera Memon, Vandit Shah, Tejal Mehta, and Jigna Shah

47 Nanoparticle-Based Lung Drug Delivery: A Clinical Perspective ..................................................................................643

Vandit Shah and Jigna Shah

48 European Perspective on Orally Inhaled Products: In

Vitro Requirements for a Biowaiver ..................................................................................................................................653

Sunita Chaudhary, Dhaval Patel, Dasharath M. Patel, and Jayvadan K. Patel

Index.................................................................................................................................................................................... 661

Biography

Dr Yashwant Pathak completed a PhD in Pharmaceutical

Technology at Nagpur University, India and EMBA & MS

in Conflict Management from Sullivan University. He is

Professor and Associate Dean for Faculty Affairs at College of

Pharmacy, University of South Florida. Tampa, Florida. With

extensive experience in academia as well as industry, he has more

than 100 publications and 2 patent and 2 patent application,

20 edited books published, including 7 books in Nanotechnology

and 6 in Nutraceuticals and drug delivery systems. Dr Yashwant

Pathak is also a Professor of Global health with College of Public

health at USF, and recently his student completed PhD in Global

health on Homeopathy medicine and its efficacy, a survey of

1274 patients in Pune in India.

Dr. Nazrul Islam completed his PhD at Monash University

(Australia), focusing on the development of dry powder inhaler

(DPI) formulation for deep lung delivery of drugs. He worked at

Mayne Pharma (Australia) as a formulation scientist. Currently, he

is working in the Pharmacy Discipline at the Faculty of Health,

Queensland University of Technology (QUT), Australia. As a

senior lecturer, he is engaged in teaching and research in drug

delivery. Dr. Islam has made key contributions to understanding

the mechanism of micronized drug dispersion from dry powder

agglomerates, which stipulate the formulation strategies to increase

drug delivery efficiency from the formulations. He has published

more than 50 research articles and 2 book chapters. He is a

member of the American Association for the Pharmaceutical

Scientist (AAPS) and the Australian Pharmaceutical Science

Association (APSA). His key research areas are pulmonary drug

delivery, nanotechnology, biodegradable polymer nanoparticles,

DPI formulation, aerosol delivery, drug formulation and delivery,

and stability studies of drug and drug products.