Drug Stability: Principles and Practices by Jens T. Carstensen

By Jens T. Carstensen

Addressing issues for sufferer welfare whereas conserving manufacturer popularity, and delivering a database for formula of different items, this multiauthored reference blends basic conception and useful suggestion on drug product balance in clinical, technical, and regulatory environments, protecting improvement of indicating assays, computing device use, medical trial fabrics, strategic making plans, and packaging. Describing the documentation required to lessen the adjustments of regulatory citations, the booklet lists brands of photostability checking out chambers, balance process software program, and laboratory details administration platforms for pharmaceutical purposes.

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Pharm. Tech (Tabletting Yearbook) 6-12, 1997. 15. M. D. Dhanaraju, K. Senthil Kumaran, T, Baskaran, M. Sree Rama Moorthy. Drug Develop. Indus. Pharm. 24583-587, 1998. ~ ~ d i s o Wisconsin n, 1. The Order of a Reaction 21 2. The Zero-Order Reaction 24 3. First-Order Reactions 25 4. 1. 2. Parallel reactions 27 27 29 5. 1. Steady-state situations 30 33 6. Pseudo-Zero-Order Reactions 34 7. 2. 3. Eyring plots 37 39 41 42 45 8. 1, Equal initial concentration. 2. Pseudo-first-order reactions 9. Complicated HydrolysisSchemes 46 52 52 53 References 54 lability is not synonymous with chemical kinetics, yet most of the rate-limiting phenomena are either associated with chemical reactions or aredescribable by some equation system that bears a resemblance to those encountered in chemical kinetics.

To be more exacting, a steady-state approach would probably be better. It should be pointed out however, that the steady-state approach is a fundamental approximation, and if it is used, then the reasonableness of the approximation should alwa S be checked. ichaelis- ent ten type Th y-state approach is often used, particularly ,as an example, let usconsider the situat often occurring, that kinetics. many low level decomposition products are encountered. There are different regulatory views on this, one being that no more than 1% of a product may be formed for it to be considered a minor decomposition product.

40 0 25 100 91 83 50 Time (months) Data from Table 5 treated by first-order kinetics. ate constants are, of course, a function of temperature, and the data shown in Table 5 are graphed in Figs. 10A and 10B. If rapid results are desired for a given product, it is at times a practice to store it at elevated temperatures. The purpose of this is to force sufficiently large degrees of decomposition in a short time, so that they may be assessed with accuracy. The data in Table 6 are artificially precise, and with a bit of assay error, the 25°C data would not show a discernible loss after 6 months.

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