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In preformulation studies

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]

Grunenberg, A., Flenck, J-O., Siesler, FI.W., 1996, Theoretical Derivation and practical Application of Energy / Temperature Diagrams as an Instmment in Preformulation Studies of Polymorphic Drug Substances, International Journal of Pharmaceutics, 129, 147-158. [Pg.81]

In preformulation studies, the stability and potential formulation issues must be considered before the Lnal salt selection is made. [Pg.419]

Grunenberg A, Henck JO, Siesler HW. 1996. Theoretical derivation and practical application of energy/temperature diagrams as an instrument in preformulation studies of polymorphic drug substances. Int. J. Pharm. 129 147-158. [Pg.115]

Product quality can be compromised during manufacture, transport, storage or use. The causes of deterioration can be manifold and product-specific. They include microbial spoilage or chemical transformation of the active or physical changes that alter performance in vivo. Deterioration can compromise safety or make the medication less attractive, which means it may not be used. Excipients can contribute to or cause such changes unless carefully screened for possible interactions in preformulation studies. [Pg.1612]

Preformulation testing of the specific API of interest and key excipients to be used in the product design stage, alone and in combinations with the API, should be included as a preliminary first step in the product and process development sequence. A simple check list of items worth consideration in preformulation studies with APIs and important or critical excipients is provided as follows ... [Pg.3932]

Nebuloni M, Pifferi G, Munna E. Thermal analysis in preformulation studies of a lyophilized form of an antibiotic. Boll Chim Farm 1996 135 94-100. [Pg.50]

Methods for concentrating proteins include membrane filtration, osmotic removal of solvent, and solvent evaporation (reviewed by Shire et al., 2004). Early in preformulation studies when material is limited, small-scale methods... [Pg.342]

For liquid dosage forms of water-insoluble drugs, solubilization is an important tool in preformulation studies for the selection of surfactants. When... [Pg.192]

Over the last 20 years, separation technology for analytical testing in the pharmaceutical industry has undergone great advances. This progress was motivated by the need for better quality products, the desire for improved knowledge in product development, and, in part, regulatory requirements. Separation techniques such as TLC, HPLC, GC, LC, counter current extraction (CCE), and capillary electrophoresis (CE) are extensively employed in preformulation studies. [Pg.220]

Rabel SR, Jona JA, Maurin MB. Applications of modulated differential scanning calorimetry in preformulation studies. J Pharm Biomed Anal 1999 21 339 -345. [Pg.128]

To comply with the concept that in preformulation studies minimal amounts of compound are used, an in situ salt screening technique for basic compounds has been developed by Tong and Whitesell (1998). The steps involved in this process are listed below ... [Pg.50]

Rabel et al. (1999) have investigated the use of MDSC in preformulation studies. Its use in investigating glass transitions was discussed however, this was extended to consider its use... [Pg.68]

These criteria are usually difficult to achieve, and the relationship between the in vitro effect of the drug (potency/concentration needed), therapeutic effect and index (acceptable variation in plasma concentration from safety and efficacy point of view) and the rate and extent of absorption must therefore be evaluated carefully for each project and drug. Furthermore, the physicochemical characteristics (e.g., the ability of the drug to be formulated into a relevant delivery system) of the drug as determined in preformulation studies also guide the selection of a potential drug candidate. [Pg.99]

M. Vrbinc and V. Kmetec Physical stability and compatibility of solid-state substances in preformulation studies of solid dosage forms. Farm. Vestn. (Ljubljana, Slav.), 53, 367-376 (2002). [Pg.99]


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