Rapid Dissolve Solid Oral Dosage Form

Oral drug delivery system still need advancements because of their some drawbacks related to particular class of patients which include gediatrics, pediatrics, and dysphasics patients associated with many medical conditions as they have difficulty in swallowing or chewing solid oral dosage forms. In the current scenario of novel drug delivery system, much emphasis has been given to effective dosage form in term of producing steady level concentration in plasma for controlled release drug delivery system and rapid release drug for quick effects. In case of allergy, chemotherapeutics side effect treatment, pain medicines and pediatric as well as geriatrics drug delivery prefers rapid response of drug. Numbers of drug from above categories have been formulated in rapid release tablet or film. With the use of natural polymers and superdisintegrants it is feasible to prepare these dosage forms to dissolve within 1min with minimum quantity of water. The aim of present review is to give complete detailed including all formulation aspects and evaluation parameters of rapid dissolve tablet and film. This review also covers patented technology.

Fast Dissolving/Disintegrating Dosage Forms (FDDFs) have been commercially available since the late 1990s. FDDFs were initially available as orodispersible tablets, and later, as orodipsersible films for treating specific populations (pediatrics, geriatrics, and psychiatric patients). Granules, pellets and mini tablets are among latest additions to these dosage forms, which are still in the development pipeline. As drug delivery systems, FDDFs enable quicker onset of action, immediate drug delivery, and sometimes offer bioavailability benefits due to buccal/sublingual absorption. With time, FDDF have evolved to deliver drugs in a sustained and controlled manner. Their current market and application is increasing in demands with advances in age adapted dosage forms for different patients and changing regulatory requirements that warrant mandatory assessments of new drugs and drug products before commercial availability. This book presents detailed information about FDDFs from their inception to recent developments. Readers will learn about the technical details of various FDDF manufacturing methods, formulation aspects, evaluation and methods to conduct clinical studies. The authors also give examples of marketed fast disintegrating/dissolving drug products in US, Europe, Japan, and India. This reference is ideal for pharmacology students at all levels seeking information about this specific form of drug delivery and formulation.

Most commonly employed oral dosage forms are tablets and capsules. Compressed tablets are the most widely used dosage form for a number of reasons like they are convenient, easy to use, less expensive, tamper-proof, easy to pack and ship and more stable than other oral dosage form. Also tablets lend themselves to certain special release profile products such as enteric or delayed release products. products such as enteric or delayed release products.1 Solid dosage forms like tablet and capsule are most popular and preferred drug delivery system because they have high patient compliance, relatively easy to produce, easy to market, accurate dosing, and good physical and chemical stability.Oral drug delivery has been known for decades as the most widely utilized route of administration among all the routes that have been explored for the systemic delivery of drugs via various pharmaceutical products of different dosage forms. The reason that the oral route achieved such popularity may because of its ease of administration as well as the traditional belief that by oral administration the drug is well absorbed as the food stuffs that are ingested daily.

In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

With contributions from recognized authorities in industry, academia, and government, this reference presents the state-of-the-art in the testing, formulation, and clinical evaluation of intraoral drug delivery products-summarizing intraoral dosage forms in various stages of research, as well as products currently on the market.

Oral drug delivery has been known for decades the most widely utilized route for administration among all the route that have been explored for systemic delivery of drugs via various pharmaceutical products of different dosage forms. The reasons that the oral route has achieved such popularity may be in part attributed to its ease of administration as well as the traditional belief that by oral administration the drug is well absorbed as the food stuffs that are ingested daily. In fact, the development of a pharmaceutical product for oral delivery, irrespective of its physical form involves varying extents of optimization of dosage form characteristics within the inherent constraints of GI physiology. Therefore, a fundamental understanding of various disciplines, including GI physiology, pharmacokinetics, pharmacodynamics and formulation design are essential to achieve a systemic approach to successful development of an oral pharmaceutical dosage form. The more sophisticated a delivery system, the greater is the complexity of these various disciplines involved in the design and optimization of the system. In any case, the scientific framework required for the successful development.