Current Advances in Drug Delivery Through Fast Dissolving/Disintegrating Dosage Forms


by

Vikas Anand Saharan

DOI: 10.2174/97816810845961170101
eISBN: 978-1-68108-459-6, 2017
ISBN: 978-1-68108-460-2



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Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have been commercially available since the late 1990s. FDDFs were initially availa...[view complete introduction]

Table of Contents

Foreword

- Pp. i-ii (2)

Sanjay Garg

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Preface

- Pp. iii-iv (2)

Vikas A. Saharan

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List of Contributors

- Pp. v

Vikas A. Saharan

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Fast Dissolving/Disintegrating Dosage Forms: Introducing through Development, Market, Pharmacopoeial and Regulatory Status

- Pp. 3-18 (16)

Vikas A. Saharan, Anupama Singh and Vandana Kharb

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Freeze Drying Technologies for Developing Fast Dissolving/Disintegrating Tablets

- Pp. 19-40 (22)

Vikas A. Saharan

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Modifications in Conventional Tablet Compaction Technologies for Developing Fast Dissolving/ Disintegrating Tablets

- Pp. 41-98 (58)

Vikas A. Saharan

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Moulding, Extrusion, Floss and Three Dimensional Printing Technologies for Developing Fast Dissolving/Disintegrating Tablets

- Pp. 99-118 (20)

Vikas A. Saharan

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Patent Innovations in Fast Dissolving/ Disintegrating Dosage Forms

- Pp. 119-174 (56)

Kalpana Nagpal, Shailendra K. Singh and D. N. Mishra

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Excipients for Fast Dissolving /Disintegrating Tablets

- Pp. 175-212 (38)

Vikas A. Saharan

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Taste Masking in Fast Dissolving/Disintegrating Dosage Forms

- Pp. 213-251 (39)

Vikas A. Saharan, Vandana Kharb and Anupama Singh

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Quality Assurance and Evaluation of Fast Dissolving/Disintegrating Dosage Forms

- Pp. 252-285 (34)

Vikas A. Saharan

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Clinical Studies on Fast Dissolving/Disintegrating Dosage Forms

- Pp. 286-317 (32)

Prashant Mathur, Arpita Jindal, Sokindra Kumar and Vikas A. Saharan

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Fast Dissolving Oral Films

- Pp. 318-356 (39)

Mahaveer Singh and Hemant R. Jadhav

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Novel Fast Dissolving/Disintegrating Dosage Forms

- Pp. 357-377 (21)

Vikas A. Saharan

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Approved and Marketed Fast Dissolving/ Disintegrating Drug Products

- Pp. 378-430 (53)

Vikas A. Saharan, Anupama Singh and Vandana Kharb

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Subject Index

- Pp. 431-436 (6)

Vikas A. Saharan

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Foreword

The major challenge that I have experienced as a pharmaceutical science professional is to keep abreast of the ever-evolving developments in the field and translating the innovations to ensure better quality of life to human and animals. The history of pharmaceuticals is loaded with a concern for the development of new chemical entities. Only in recent years, the importance of dosage form design has been recognized as a vital component of safe and effective clinical outcomes.

Despite tremendous innovations in drug delivery, the oral drug delivery continues to be a step ahead as a preferred route of administration for therapeutic agents. Some obvious advantages include accurate dosage, low cost, self-medication, non-invasive and easy administration. At the same time, an important drawback with oral dosage forms is “dysphagia” or difficulty in swallowing in paediatric and geriatric populations, leading to noncompliance and ineffective therapy.

Recent advances in novel delivery systems aim to enhance the safety of drug molecules while maintaining the therapeutic efficacy with an overall aim of better patient compliance. To achieve this objective, the concept of Fast Dissolving/Disintegrating Dosage Forms (FDDF) was introduced. FDDF is a perfect example of patient-oriented pharmaceutical approach, which has emerged from the need to provide a convenient way to administer medicines. Solid dosage forms that disintegrate, dissolve, or get suspended in the saliva in the mouth rapidly (in seconds) without chewing or use of water, provide an excellent alternative to swallowing the solid dosage form. This technique facilitates easy swallowing providing significant benefits to the relevant patient population.

In addition to patient compliance, extending the pharmaceutical product life cycle is another reason for the increasing popularity of the FDDFs. As a drug entity reaches the end of its patent life, it is common for manufacturers to develop it in a new and improved dosage form that allows extension of market exclusivity, while offering its patient population a more convenient dosage form. It also leads to increased revenue for the company, while targeting underserved and undertreated patient populations. Generally, the additional cost of manufacturing these specialized dosage forms is only marginally higher, which is easily compensated by additional benefits to patients.

The book covers relevant topics in different chapters, e.g. basic introduction with advantages and key concepts, patented technologies, taste masking approaches, general ingredients for developing formulation, quality control parameters, and critical review of clinical trials, which will be useful for a wide range of readers. The book has also included application of FDDFs to achieve controlled and targeted release which is expected to be of considerable interest to experts as well as new researchers. I strongly feel that this addition to literature will be especially useful to undergraduate pharmacy and post-graduate pharmaceutical science students. The book will serve as a sound source of systematic information for FDDFs. Students and researchers who consider dysphagia or pharmaceutical marketing during innovative product development will find it as a welcoming tool. A single textbook that brings together inputs from experts in all of these subjects is certainly an invaluable asset to pharmaceutical industry.

I wish to congratulate the editor, team of authors and Bentham publisher for excellent work and contribution to the pharmaceutical sciences. It is especially pleasing to note that a small Master’s project undertaken by Dr Vikas Anand in his early years motivated him to continue working in the field and led to this wonderful compilation.

Sanjay Garg
School of Pharmacy and Medical Sciences
University of South Australia, City East Campus
Adelaide, SA
Australia


Preface

The solid dosage forms that dissolve or disintegrate quickly in the oral cavity, resulting in solution or suspension, eliminating the need of water for swallowing, are known as fast dissolving/disintegrating dosage forms (FDDFs). Over the last 20 years, the field of FDDFs has expanded considerably to address not only concerns of immediate release dosage forms but additionally played an important role in controlled/modified release drug delivery. This is still an exciting and growing area of pharmaceutical research and education. Ironically, to date no single book provides detailed and specific information on FDDFs. Therefore, I decided to write a book comprising of chapters that collectively address this void and provide an insight into the various technologies and methodologies currently adopted to formulate, prepare and evaluate FDDFs. The idea for this book on the topic has been in mind since my first research project during M.S.(Pharm.) at NIPER, Mohali. Since, then it gradually strengthened when I was Assistant Professor at Seth GL Bihani SD College, Sri Ganganagar and Professor/Associate Professor at Sardar Bhagwan Singh Post Graduate Institute (SBSPGI) of Biomedical Sciences & Research, Dehradun. My teaching and research in relevant and related fields continuously helped me in understanding and developing deeper interests towards FDDFs.

The present book is an attempt to provide comprehensive information to the readers interested in FDDFs. The specific emphasis in this book has been given to various technologies of making FDDFs, formulation development, evaluation, clinical studies, and marketed FDDFs products. This book intends to serve as a source of reference work and some chapters may be used for classroom teaching in graduate/postgraduate programmes. The authors do feel that graduate/postgraduate programmes in pharmaceutical sciences often neglect to adequately address FDDFs as novel drug delivery systems. Research fellows and experience scientists also feel paucity to find few resources outside the primary literature for FDDFs.

Due to its organization into different chapters, the book can be read at different levels and a reader can start as per the sequence of chapters or may opt to go directly onto the desired chapter. Thus, this book could be useful for graduate, postgraduate and PhD students belonging to the pharmaceutical sciences. Nevertheless, we do hope that this book is also useful to expert as well as new researchers, who may find information and new ideas for novel advancements in the field of FDDFs.

I hope that all those who consult this book find it useful as an easy-to-understand text for FDDFs. Constructive comments/suggestions are also invited from readers for further refinements in this book.

CONFLICT OF INTEREST

The authors confirm that they have no conflict of interest to declare for this publication.

ACKNOWLEDGEMENTS

I am grateful and highly indebted to my M.S.(Pharm.) supervisor and teacher Prof.(Dr.) Sanjay Garg for teaching the concepts of research in pharmaceutics and extending his support to this book by writing a foreword to this book. I greatly acknowledge continuous motivation and support of my Ph.D. supervisor Prof.(Dr.) P.K. Choudhury for all my efforts to do the best in the field of pharmaceutical sciences.

I am extremely grateful to the management of SBSPGI, especially Sh. S. P. Singh (Chairman, SBSPGI) and Dr. Gauravdeep Singh (Managing Secretary, SBSPGI) for all round support during my entire tenure at SBSPGI. I am highly privileged to have some of my good teachers, like Dr. Luvkush (academic advisor, SBSPGI), Prof. Veerma Ram and Ms. Urmi Chaurasia, as a constant and continuous source of inspiration and motivation.

Without the support of my mother, father and wife, it was really impossible to complete this arduous task. They have sacrificed a lot of my personal time while I was working on this book. I also missed my son, Inesh, when I was working on this book and he was not beside me.

I would like to thank all the chapter authors for their hard work, valuable contributions and their patience in various phases of publication of this book. I am extremely thankful to Bentham for providing a platform from where this book can reach to it’s readers.

Vikas A. Saharan
Department of Pharmaceutics
School of Pharmaceutical Sciences
Sardar Bhagwan Singh Post Graduate Institute
of Biomedical Sciences & Research (SBSPGI)
Balawala, Dehradun
India

List of Contributors

Editor(s):
Vikas Anand Saharan




Contributor(s):
Anupama Singh
Department of Pharmacognosy, School of Pharmaceutical Sciences
Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences & Research (SBSPGI), Balawala, Dehradun 248161
India


Arpita Jindal
Department of Clinical Pharmacy, Division of Pharmaceutical Sciences
Shri Guru Ram Rai Institute of Technology and Science, Dehradun 248001, Uttarakhand
India


D. N. Mishra
Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar 125001, Haryana
India


Hemant Jadhav
Department of Pharmacy
Birla Institute of Technology and Science, Pilani Campus, Vidya Vihar, Pilani 333031, Jhunjhunu, Rajasthan
India


Kalpana Nagpal
Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh 201303
India


Mahaveer Singh
Department of Pharmacy
Birla Institute of Technology and Science, Pilani Campus, Vidya Vihar, Pilani 333031, Jhunjhunu, Rajasthan
India


Prashant Mathur
Department of Clinical Pharmacy, Division of Pharmaceutical Sciences
Shri Guru Ram Rai Institute of Technology and Science, Dehradun 248001, Uttarakhand
India


Shailendra K. Singh
Department of Pharmaceutical Sciences, Guru Jambheshwar University of Science and Technology, Hisar 125001, Haryana
India


Sokindra Kumar
RV Northland Institute of Pharmacy
Greater Noida 203207, Uttar Pradesh
India


Vandana Kharb
Sachdeva College of Pharmacy, Chandigarh-Ludhiana National Highway, Gharuan 140413, Punjab
India


Vikas A. Saharan
Department of Pharmaceutics, School of Pharmaceutical Sciences
Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences & Research (SBSPGI), Balawala, Dehradun 248161
India




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