Design and Manufacture of Pharmaceutical Tablets.

Cover -- Title Page -- Copyright Page -- Dedication -- Contents -- Preface -- Abbreviations -- Chapter One - Introduction -- 1.1 - General considerations -- 1.2 - Particle sizes -- 1.3 - Excipients -- 1.3.1 - Ac-Di-Sol SD-711 -- 1.3.2 - Aerosil 200 -- 1.3.3 - Avicel PH-102 -- 1.3.4 - Compactrol -- 1.3.5 - Corn starch -- 1.3.6 - Di-Tab -- 1.3.7 - Eudragit RS PO -- 1.3.8 - Magnesium stearate 5712 -- 1.3.9 - Mannitol 60 -- 1.3.10 - Methocel K4M Premium -- 1.3.11 - Methocel K100M Premium -- 1.3.12 - Methocel K100LV Premium -- 1.3.13 - Pharmatose 150M -- 1.3.14 - Polyplasdone XL-10 -- 1.3.15 - Povidone -- 1.3.16 - Primojel -- 1.3.17 - Pruv -- 1.3.18 - Sodium bicarbonate -- 1.3.19 - Starch 1500 -- 1.3.20 - Stearic acid 2236 -- 1.3.21 - Sterotex K -- 1.3.22 - Tablettose 80 -- 1.3.23 - Talc -- 1.4 - Equipment -- 1.5 - Mixing of pharmaceutical powders -- 1.6 - Design of experiments -- 1.6.1 - Introduction to statistical design of experiments - the two-level factorial -- 1.6.1.1 - Introduction -- 1.6.1.2 - Designed experiments -- 1.6.1.3 - Basic considerations -- 1.6.1.4 - Two-level factorials -- 1.6.1.5 - Two-level fractional factorials -- 1.6.2 - Response surface methodology (RSM) -- 1.6.2.1 - Introduction -- 1.6.2.2 - RSM and a sieving process variable study -- 1.6.2.3 - RSM investigation of the properties of a three-component tablet formulation -- References -- Chapter two - Conventional-Release (CR) Tablets -- 2.1 - Low-dose tablet by direct compression (DC) -- 2.1.1 - Properties of active pharmaceutical ingredient (API) -- 2.1.2 - Design -- 2.1.3 - Manufacturing method -- 2.1.4 - Remarks -- 2.2 - High-dose tablet by direct compression -- 2.2.1 - Properties of active pharmaceutical ingredient -- 2.2.2 - Design -- 2.2.3 - Manufacturing method -- 2.2.4 - Remarks -- 2.3 - Low-solubility API, low-dose tablet by wet granulation (WG).

2.3.1 - Properties of active pharmaceutical ingredient -- 2.3.2 - Design -- 2.3.3 - Manufacturing method -- 2.3.4 - Remarks -- 2.4 - Soluble API, low-dose tablet by wet granulation -- 2.4.1 - Properties of active pharmaceutical ingredient -- 2.4.2 - Design -- 2.4.3 - Manufacturing method -- 2.4.4 - Remarks -- 2.5 - Low-solubility API, high-dose tablet by wet granulation -- 2.5.1 - Properties of active pharmaceutical ingredient -- 2.5.2 - Design -- 2.5.3 - Manufacturing method -- 2.5.4 - Remarks -- 2.6 - Soluble API, high-dose tablet by wet granulation -- 2.6.1 - Properties of active pharmaceutical ingredient -- 2.6.2 - Design -- 2.6.3 - Manufacturing method -- 2.6.4 - Remarks -- References -- Chapter three - Slow-Release (SR) Tablets -- 3.1 - Slow-release tablet using a lipophilic release control agent -- 3.1.1 - Properties of active pharmaceutical ingredient (API) -- 3.1.2 - Design -- 3.1.3 - Manufacturing method -- 3.1.4 - Remarks -- 3.2 - Slow-release tablet using Eudragit and Methocel as release control agents -- 3.2.1 - Properties of active pharmaceutical ingredient -- 3.2.2 - Design -- 3.2.3 - Manufacturing method -- 3.2.4 - Remarks -- 3.3 - Slow-release tablet using a mixture of Methocels as release control agent -- 3.3.1 - Properties of active pharmaceutical ingredient -- 3.3.2 - Design -- 3.3.3 - Manufacturing method -- 3.3.4 - Remarks -- Reference -- Index.

Design and Manufacture of Pharmaceutical Tablets offers real world solutions and outcomes of formulation and processing challenges of pharmaceutical tablets. This book includes numerous practical examples related to actual formulations that have been validated and marketed and covers important data in the areas of stability, dissolution, bioavailibity and processing. It provides important background and theoretical information on design and manufacturing and includes a full section dedicated to design experimental methodology and statistics. In addition, this book offers a a general discussion of excipients used in proper tablet design along with practical examples related to excipients. Drug development scientists in industry and academia, as well as students in the pharmaceutical sciences will greatly benefit from the practical knowledge and case examples provided throughout this book. Incorporates important mathematical models and computational applications Includes unique content on central composite design and augmented simplex lattice Provides background on important design principles with emphasis on quality-based design (QBD) of pharmaceutical dosage forms.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.