Handbook of Lung Targeted Drug Delivery Systems

Dr Yashwant Pathak completed a PhD in PharmaceuticalTechnology at Nagpur University, India and EMBA & MSin Conflict Management from Sullivan University. He isProfessor and Associate Dean for Faculty Affairs at College ofPharmacy, University of South Florida. Tampa, Florida. Withextensive experience in academia as well as industry, he has morethan 100 publications and 2 patent and 2 patent application,20 edited books published, including 7 books in Nanotechnologyand 6 in Nutraceuticals and drug delivery systems. Dr YashwantPathak is also a Professor of Global health with College of Publichealth at USF, and recently his student completed PhD in Globalhealth on Homeopathy medicine and its efficacy, a survey of1274 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 atMayne Pharma (Australia) as a formulation scientist. Currently, heis working in the Pharmacy Discipline at the Faculty of Health,Queensland University of Technology (QUT), Australia. As asenior lecturer, he is engaged in teaching and research in drugdelivery. Dr. Islam has made key contributions to understandingthe mechanism of micronized drug dispersion from dry powderagglomerates, which stipulate the formulation strategies to increasedrug delivery efficiency from the formulations. He has publishedmore than 50 research articles and 2 book chapters. He is amember of the American Association for the PharmaceuticalScientist (AAPS) and the Australian Pharmaceutical ScienceAssociation (APSA). His key research areas are pulmonary drugdelivery, nanotechnology, biodegradable polymer nanoparticles,DPI formulation, aerosol delivery, drug formulation and delivery,and stability studies of drug and drug products.

• ContentsEditors ................................................................................................................ xiList of Contributors ............................................................................................. xiiiForeword............................................................................................................. xixPreface................................................................................................................. xxi1 Introduction to Lung Physiology from a Drug Delivery Perspective.................................................................................1Aparoop Das, Manash Pratim Pathak, Pompy Patowary, and Sanghita Das2 Introduction to Pharmacology of the Lung from aDrug Delivery Perspective......................................................................................................................................................13Caline McCarthy and Charles Preuss3 Mechanism and Ways of Pulmonary DrugAdministration .........................................................................................................................................................................29Ahmed S. Fahad, Sai H.S. Boddu, and Jerry Nesamony4 Transepithelial Route of Drug Delivery through thePulmonary System...................................................................................................................................................................41Sakshi Kumar and Swati Gupta5 Understanding the Pharmacokinetics andPharmacodynamics of Lung and Lung Drug Delivery ......................................................................................................53Seth Kwabena Amponsah6 Chronic Lung Diseases: Treatment, Challenges, andSolutions....................................................................................................................................................................................61Aparoop Das, Riya Saikia, Kalyani Pathak, Urvashee Gogoi, and Surovi Saikia7 Understanding of Lung Diseases with a Focus onApplications of Nano-particulate Drug Delivery Systems..................................................................................................73Shraddha Khairnar, Mudassir Ansari, Ujwala Shinde, Agnivesh Shrivastava, and Kavita Singh8 Model for Pharmaceutical Aerosol Transport throughStenosis Airway........................................................................................................................................................................91Puchanee Larpruenrudee, Mohammad S. Islam, Gunther Paul, Akshoy R. Paul, Y. T. Gu, andSuvash C. Saha9 Design of Efficient Dry PowderInhalers.................... ...............................................................................................................................................................129Anurag Tiwari, Akshoy R. Paul, Anuj Jain, and Suvash C. Saha10 In Vivo Animal Models for Lung Targeted DrugDelivery Systems....................................................................................................................................................................155Khushali Vashi, Jasmin Patel, and Yashwant Pathak11 Advances in In Silico Study of Generic Orally InhaledDrug Products........................................................................................................................................................................161Hao Miao, Renjie Li, Xudong Zhou, Jiaqi Yu, Fen Huang, Haoqin Yang, and Zhenbo Tong12 Effect of Aerosol Devices and AdministrationTechniques on Drug Delivery in a Simulated Spontaneously Breathing Pediatric Tracheostomy Model................171Amelia Alberts and Charles Preuss13 Pulmonary Drug Delivery: The Role of PolymericNanoparticles..........................................................................................................................................................................181Ofosua Adi-Dako, Doris Kumadoh, Esther Eshun Oppong, Christina Osei Asare, and Mary Ann Archer14 Polymeric Nanoparticle-Based Drug–Gene Deliveryfor Lung Cancer ....................................................................................................................................................................193Keshav Moharir, Vinita Kale, Abhay Ittadwar, and Manash K. Paul15 Inhalable Polymeric Nano-particulate Powders forRespiratory Delivery .............................................................................................................................................................209Anita Patel and Jayvadan Patelvii16 Recent Trends in Applications of Nano-Drug DeliverySystems....................................................................................................................................................................................225Doris Kumadoh, Ofosua Adi-Dako, Yaa Asantewaa Osei, and Mary Ann Archer17 Nanocarrier Systems for Lung DrugDelivery.................... ...............................................................................................................................................................239Sai HS. Boddu and Jerry Nesamony18 Nanomedicine for the Management of PulmonaryDisorders.................................................................................................................................................................................257Pompy Patowary, Manash Pratim Pathak, Pronobesh Chattopadhyay, and Kamaruz Zaman19 Recent Approaches in Dendrimer-Based PulmonaryDrug Delivery.........................................................................................................................................................................273Rajiv Dahiya and Sunita Dahiya20 Hybrid Lipid/Polymer Nanoparticles for PulmonaryDelivery of siRNA: Development and Fate Upon In Vitro Deposition on the Human Epithelial AirwayBarrier ....................................................................................................................................................................................287Samyak Nag, Shivani Baliyan, and Swati Gupta21 Solid Lipid Nanoparticle-Based Drug Delivery forLung Cancer ..........................................................................................................................................................................303Deepa U. Warrier, Harita R. Desai, Kavita H. Singh, and Ujwala A. Shinde22 Lipid-Based Pulmonary Delivery System: A Reviewand Future Considerations of Formulation Strategies and Limitations ........................................................................325Komal Parmar and Jayvadan Patel23 Respirable Controlled Release Polymeric ColloidalNanoparticles..........................................................................................................................................................................337Nazrul Islam and Abdur Rashid24 Lung Clearance Kinetics of Liposomes and Solid LipidNanoparticles..........................................................................................................................................................................353Soumalya Chakraborty, Sudipta Roy, Akash Dey, Sanjoy Kumar Das, Dhananjoy Saha, Subhabrata Ray,and Bhaskar Mazumder25 Solid Lipid Nanoparticles for Sustained PulmonaryDelivery of Herbal Drugs for Lung Delivery: Preparation, Characterization, and In Vivo Evaluation ..................361Nayanmoni Boruah, Himangshu Sharma, and Hemanta Kumar Sharma26 Improved Solid Lipid Nano-formulations forPulmonary Delivery of Paclitaxel for Lung Cancer Therapy .........................................................................................387Samson A. Adeyemi, Pradeep Kumar, Viness Pillay, and Yahya E. Choonara27 Anti-angiogenic Therapy for Lung Cancer: Focus onBioassay Development in a Quest for Anti-VEGF Drugs................................................................................................409Urvashi Bhati, Colin J. Barrow, Jagat R. Kanwar, Arnab Kapat, Venkata Ramana, and Rupinder K. Kanwar28 Emerging Applications of Nanoparticles for LungCancer Diagnosis and Therapy ...........................................................................................................................................423Raja Reddy, Bommareddy, Sheshanka Kesani, and Yashwant Pathak29 Metallic Nanoparticles: Technology Overview andDrug Delivery Applications in Lung Cancer.....................................................................................................................433Komal Parmar and Jayvadan Patel30 Modeling of Pharmaceutical Aerosol Transport in theTargeted Region of Human Lung Airways Due to External Magnetic Field ...............................................................443Anusmriti Ghosh, Mohammad S. Islam, Mohammad Rahimi-Gorji, Raj Das, and Suvash C. Saha31 Phytochemicals and Biogenic Metallic Nanoparticles asAnti-cancer Agents in Lung Cancer ...................................................................................................................................459Nana Ama Mireku-Gyimah, Rex Frimpong Anane, and Louis Hamenu32 Pulmonary Applications and Toxicity of EngineeredMetallic Nanoparticles ..........................................................................................................................................................471Deepti Kaushalkumar Jani33 Anti-cancer Activity of Eco-friendly GoldNanoparticles against Lung and Liver Cancer Cells........................................................................................................483Jayvadan Patel and Anita Patelviii Contents34 Sub-chronic Inhalational Toxicity Studies for GoldNanoparticles..........................................................................................................................................................................497Srijan Mishra and Jigna Shah35 Single-Use Dry Powder Inhalers for Pulmonary DrugDelivery...................................................................................................................................................................................503Somchai Sawatdee and Teerapol Srichana36 Lung Delivery of Nicotine for SmokingCessation.................... .............................................................................................................................................................513Hui Wang and Nazrul Islam37 Formulation and Characterization of Dry PowderInhalers for Pulmonary Drug Delivery ..............................................................................................................................527Himangshu Sarma, Nayanmoni Boruah, and Hemanta Kumar Sharma38 Devices for Dry Powder Drug Delivery to theLung.................... ....................................................................................................................................................................539Vimal Patel, Jigar Shah, Hiral Shah, and Jayvadan Patel39 Numerical Modeling of Agglomeration andDe-agglomeration in Dry Powder Inhalers ........................................................................................................................549Tan Suwandecha and Teerapol Srichana40 Oronasal and Tracheostomy Delivery of Soft Mist andPressurized Metered-Dose Inhalers with Valved Holding Chamber..............................................................................557Dasharath M. Patel, Unnati D. Chanpura, and Veer J. Patel41 Modeling for Biopharmaceutical Performance in LungDrug Discovery ......................................................................................................................................................................575Amy Le, Kianna Samuel, Truong Tran, and Yashwant Pathak42 Regulatory Consideration for Approval of GenericInhalation Drug Products in the US, EU, Brazil, China, and India ..............................................................................579Urvashi K. Parmar and Jayvadan Patel43 Regulatory Perspectives and Concerns Related toNanoparticle-Based Lung Delivery .....................................................................................................................................591Johirul Islam, Hemanga Hazarika, Probin Kr Roy, Pompy Patowary Pronobesh Chattopadhyay,Yashwant V. Pathak, and Kamaruz Zaman44 Clinical Controversies of Pediatric AerosolTherapy...................................................................................................................................................................................611Jeffrey Cruz and Charles Preuss45 Drug Delivery Using Aerosols: Challenges andAdvances in Neonatal Pediatric Subgroup ........................................................................................................................623Surovi Saikia, Aparoop Das, and Yashwant Pathak46 Safety and Toxicological Concerns Related toNanoparticle-Based Lung Delivery .....................................................................................................................................631Humera Memon, Vandit Shah, Tejal Mehta, and Jigna Shah47 Nanoparticle-Based Lung Drug Delivery: A Clinical Perspective ..................................................................................643Vandit Shah and Jigna Shah48 European Perspective on Orally Inhaled Products: InVitro Requirements for a Biowaiver ..................................................................................................................................653Sunita Chaudhary, Dhaval Patel, Dasharath M. Patel, and Jayvadan K. PatelIndex.................................................................................................................................................................................... 661