By Jens T. Carstensen
FROM THE PREFACE This ebook addresses difficulties and suggestions of formula and preformulation with which i've got involved myself for 34 years. while i used to be hired within the pharmaceutical I labored at services, within the 1960's, which have been the precursors of preformulation, and my early guides handled such issues. within the following a long time advances were made in method and the world of preformulation has grown. thought and how within which difficulties are seen have additionally gone through switch. The textual content offers with the pharmaceutical features of preformulation, no longer the substitute nor the analytical facets. It takes its vantage aspect on the time limit whilst the pharmaceutical preformulator first obtains a pattern of the drug substance, and it explores the actual, chemical and technological elements which are wanted for a whole exploration of the capability merits and downsides of the drug substance. it's only in the course of the knowing of underlying ideas that enough exploration may be performed.
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Additional info for Pharmaceutical Preformulation
23 Production Problems 125 References 127 Chapter 7. 9 Preformulation Tasks 151 References 152 Chapter 8. 6 Preformulation Tasks 161 References 161 Chapter 9. 10 Preformulation Tasks 180 Nomenclature 182 References 183 Chapter 10. 6 Preformulation Tasks 195 References 196 Chapter 11. 5 Preformulation Tasks 212 References 212 Chapter 12. 9 Preformulation Tasks 231 References 232 Chapter 13. 18 Preformulation Tasks 256 References 257 Chapter 14. 7 Preformulation Tasks 274 References 274 Chapter 15.
MacMillan, London, p. 445. , Nagai, T. , (1966), Chem. Pharm. , 14:152. N. , (1964), J. , 54:1334. , Sokoloski, T. , (1996), J. Pharm. , 84: 1236. , Sokoloski, T. , (1996), J. Pharm. , 85: 381. 64. , Zografi, G. , (1980), Int. J. , 5:1. 1 Definition of pH pH is defined as the negative of the logarithm of the hydronium ion activity, but in this text we shall simply substitute concentrations for activities, since they are almost equal in dilute solution. Hence, pH is (Brønsted, 1943a): or Some authors employ activity rather than concentration in the definition of pH.
One being octanol and the other being water, and if then a drug substance is added to the system, then part of the drug will dissolve in the octanol phase and part in the water phase. The concentrations in the respective phases are Cor and C aq. e. Octanol/water partition coefficients are important, since absorption in the body is frequently a function of p. It should be determined at several concentrations to assure that it is indeed a constant. g. dimerization) of the drug substance in one of the phases, then one of the concentrations would have to be raised to a power (n) in order that the ratio remain constant.