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Excipients drug compatibility

The potential for excipients to cause chemical and physical instability in drugs has been recognized for over 30 years. Drug compatibility studies have been used as an... [Pg.896]

Normally, a pharmaceutical development report is written in the United States, which should be available at the time of Pre-Approval Inspection (PAI). The development report contains the choice of excipients, their purpose and levels in the drug product, compatibility with other excipients, drug or package system, and how they may influence the stability and efficacy of the finished producf. [Pg.1638]

The Cadila system [13] has been designed to formulate tablets for drugs based on their physical (solubility, hydroscopicity, etc), chemical (functional groups), and biologically interrelated (dissolution rate) properties. The system first identifies the desirable properties for optimum compatibility with the drug, selects those excipients that have the required properties, and then recommends proportions based on the assumption that all tablet formulations comprise at least one binder, one disintegrant, and one lubricant. Other... [Pg.684]

Incompatibilities have also been observed in solid dosage forms. A typical tablet contain binders, disin-tegrants, lubricants and fillers. Compatibility screening for a new drug should consider two or more excipients from each class. Serajuddin et al. have developed a drug-excipient compatibility screening model to predict interactions of drug substances with excipients [49],... [Pg.151]

It should again be emphasized that at the onset of a new drug program, there are only small amounts of drug substance at hand. One of the first tasks for the preformulation scientist is to establish the framework within which the first clinical batches can be formulated. To this end it is important to know with which common excipients the drug is compatible. Below, the distinction will be made between solid and liquid dosage forms. [Pg.185]

The sample temperature is increased in a linear fashion, while the property in question is evaluated on a continuous basis. These methods are used to characterize compound purity, polymorphism, solvation, degradation, and excipient compatibility [41], Thermal analysis methods are normally used to monitor endothermic processes (melting, boiling, sublimation, vaporization, desolvation, solid-solid phase transitions, and chemical degradation) as well as exothermic processes (crystallization and oxidative decomposition). Thermal methods can be extremely useful in preformulation studies, since the carefully planned studies can be used to indicate the existence of possible drug-excipient interactions in a prototype formulation [7]. [Pg.17]

It was recognized quite some time ago that DTA analysis could be used to deduce the compatibility between a drug substance and its excipients in a formulation. The effect of lubricants on performance was as problematic then as it is now, and DTA proved to be a powerful method in the evaluation of possible incompatibilities. Jacobson and Reier used DTA to study the interaction between various penicillins and stearic acid [17]. For instance, the addition of 5% stearic acid to sodium oxacillin monohydrate completely obliterated the thermal events associated with the antibiotic. Since that time, many workers employed DTA analysis in the study of drug-excipient interactions, although the DTA method has been largely replaced by differential scanning calorimetry technology. [Pg.230]

Serajuddin, A.T.M., Thakur, A.B., Ghoshal, R.N., Fakes, M.G., and Varia, S.A., Selection of solid dosage form composition through drug-excipient compatibility testing, /. Pharm. Sci., 88, 696, 1999. [Pg.48]

The candidate method is used to support drug synthesis, excipient compatibility, and ultimately to evaluate candidate formulations. Such support typically involves analyses of stressed materials to identify degradation trends. These studies are conducted in the solid state by exposing the DS and DP to relative humidity, temperature, light, and oxidizing... [Pg.163]


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