By Myra L. Weiner, Lois A. Kotkoskie
This booklet studies the heritage, regulatory prestige, pharmacopeial requirements, and harmonization of pharmaceutical excipients within the usa and Europe, and gives a complete figuring out of the present clinical foundation for safeguard overview and possibility evaluate. Examines excipients as a special type of goods and explores new tactics for deciding upon toxicity! A well timed and certain addition to the pharmaceutical literature, containing over 570 citations that aid and improve the textual content, Excipient Toxicity and defense ·identifies the variations among excipients (inactive ingredients), nutrition materials, and drug items ·evaluates problems with dose management, species choice, and examine layout for varied routes of publicity ·provides special info at the historic makes use of of excipients in drug formulations ·clarifies the protection Committee of the overseas Pharmaceutical Excipients Council's (IPEC) instructions and technical necessities for carrying out checks for every course of publicity ·explains how facts generated in toxicity versions are utilized to spot risks in drug formulations ·details publicity review to hyperlink probability id with hazard ·considers the necessities and value of purity requirements ·and even more! Excipient Toxicity and defense is a blue-ribbon reference excellent for pharmacists; toxicologists; pharmacologists; analytical chemists; quality controls, caliber insurance, and regulatory compliance managers; and upper-level undergraduate and graduate scholars in those disciplines.
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Additional resources for Excipient Toxicity and Safety (Drugs and the Pharmaceutical Sciences)
Detection and limitation of impurities that can have an adverse effect on stability and efficacy of drugs owing to interaction with the active ingredient or other excipients 4. Differentiation of grades for pharmaceutical and technical application 5. Confirmation of the quantitative composition (in case of mixed substances) 30 Ja¨kel and Keck 6. Characterization and specification of physical properties with technological relevance, to ensure a frictionless, economic manufacture of dosage forms and to guarantee their constant physical–galenical properties, in vitro dissolution rate, and bioavailability From the foregoing criteria items 2–5 are directly associated with the purity of excipients.
2 Purity of Excipients Dankward Ja¨kel and Martin Keck Novartis Pharma AG, Basel, Switzerland I. INTRODUCTION Excipients have long been considered to be inert materials, with no significant adverse effects on the safety and efficacy of pharmaceutical preparations. That excipients can have a significant influence on safety and efficacy of pharmaceutical preparations has been demonstrated in numerous examples, ranging from bioequivalence differences, to stability problems, to transfer of critical impurities.
This is especially true for highly potent active ingredients, where only milligram or even microgram amounts are applied, as for instance, in the example of a corticoid ointment shown in Table 6. From this table one can see that the quantities of excipients in a formulation far exceed the quantity of the active ingredient. In such cases, interaction between the active ingredient and impurities in the excipient can lead to a complete or partial deterioration of the active ingredient (see Sec. 3).