Essentials of Pharmaceutical Preformulation

Simon Gaisford 지음

Wiley-Blackwell 2012년 10월 22일 출간

작품소개

책소개

Essentials of Pharmaceutical Preformulation is a study guide which describes the basic principles of pharmaceutical physicochemical characterisation. Successful preformulation requires knowledge of fundamental molecular concepts (solubility, ionisation, partitioning, hygroscopicity and stability) and macroscopic properties (physical form, such as the crystalline and amorphous states, hydrates, solvates and co-crystals and powder properties), familiarity with the techniques used to measure them and appreciation of their effect on product performance, recognising that often there is a position of compromise to be reached between product stability and bioavailability.This text introduces the basic concepts and discusses their wider implication for pharmaceutical development, with reference to many case examples of current drugs and drug products. Special attention is given to the principles and best-practice of the analytical techniques that underpin preformulation (UV spectrophotometry, TLC, DSC, XRPD and HPLC). The material is presented in the typical order that would be followed when developing a medicine and maps onto the indicative pharmacy syllabus of the Royal Pharmaceutical Society of Great BritainUndergraduate-level pharmacy students and RD / analytical scientists working in the pharmaceutical sector (with or without a pharmaceutical background) will find this text easy to follow with relevant pharmaceutical examples.Essential study guide for pharmacy and pharmaceutical science studentsCovers the pharmaceutical preformulation components of the Royal Pharmaceutical Society of Great Britain's indicative syllabusEasy to follow text highlighted with relevant pharmaceutical examplesSelf-assessment assignments in a variety of formatsWritten by authors with both academic and industrial experienceCompanion website with further information to maximise learning

목차

Preface xiiiList of Abbreviations xv1 Basic Principles of Preformulation Studies 11.1 Introduction 11.2 Assay design 21.2.1 Assay development 31.3 Concentrations 51.3.1 Units of concentration 51.4 UV spectrophotometry 91.4.1 Method development for UV assays 111.5 Thin-layer chromatography (TLC) 141.5.1 TLC method development 151.5.2 High-performance TLC 171.6 High-performance liquid chromatography 191.6.1 Normal- and reverse-phase HPLC 201.6.2 HPLC method development 211.7 Differential scanning calorimetry 221.7.1 Interpreting DSC data 231.7.2 Modulated-temperature DSC 271.7.3 DSC method development 301.8 Dynamic vapour sorption 321.8.1 DVS method development 321.9 Summary 33References 33Answer to study question 34Additional study questions 352 Ionisation Constants 362.1 Introduction 362.2 Ionisation 362.2.1 Percent ionisation 422.3 Buffers 442.4 Determination of pKa 442.4.1 Determination of pKa by potentiometric titration 452.4.2 Determination of pKa in nonaqueous solvents 452.4.3 Other factors affecting measurement of pKa 472.5 Summary 48References 48Answers to study questions 49Additional self-study questions and answers 503 Partition Affinity 523.1 Introduction 523.2 Partitioning 523.2.1 Effect of partitioning 543.2.2 Determination of log P 553.2.3 Effect of salt formation on partitioning 623.3 Summary 63References 63Answers to study questions 644 Solubility 654.1 Introduction 654.2 Intrinsic solubility 674.2.1 Ideal solubility 694.2.2 Solubility as a function of temperature 734.2.3 Solubility and physical form 744.2.4 Measurement of intrinsic solubility 77

작가정보

저자(글) Simon Gaisford