Handbook of Pharmaceutical Analysis (Drugs and the by Lena A. Ohannesian, Anthony J. Streeter

By Lena A. Ohannesian, Anthony J. Streeter

Exploring the research of prescribed drugs, together with polymorphic types, this booklet discusses regulatory specifications in pharmaceutical product improvement and pharmaceutical trying out. It covers equipment of drug separation and techniques comparable to capillary electrophoresis for chromatographic separation of molecules. extra subject matters comprise drug formula research utilizing vibrational and magnetic resonance spectroscopy and identity of drug metabolites and decomposition items utilizing such recommendations as mass spectrometry. The booklet presents greater than three hundred tables, equations, drawings, and images, and handy, easy-to-use indices, facilitating easy access to every subject.

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Some drug substances form multiple hydrates, all of which can sometimes be identified from the moisture sorption isotherm. For example, the sugar raffinose exists in several hydrated forms. The stepwise conversion of the trihydrate to the pentahydrate is clear from the sorption isotherm at 30°C (Fig. 40) (55). Information about Copyright 2002 by Marcel Dekker. All Rights Reserved. Fig. 39 XRPD patterns obtained before (left) and after (right) a solid-state phase transition (seen as the endothermic peak at 160°C in the DSC trace above).

A more rational approach to expedite the salt selection process using a tiered methodology was reported (21). The tiers were planned so that the least time-consuming experiments were conducted early and the progressively more time-consuming and labor-intensive experiments were conducted later, when fewer salts were in contention. In this way, many different salt forms could be screened with minimal experimental effort. An expanded version of this process will be described in this section. Copyright 2002 by Marcel Dekker.

The stability of both hydrated and anhydrous forms is also derivable from moisture sorption/desorption analysis. The effects of pressure on a drug substance should be investigated as part of any polymorph screen. Common processing operations, such as milling, can cause solid form transformations. Sometimes grinding can be used to generate amorphous material, as noted above for permethylated β-cyclodextrin (Fig. 32) (44) and ursodeoxycholic acid (Fig. 33) (45). It is also possible to bring about crystalline form changes by grinding, including generation of a metastable form from a stable form in certain cases.

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