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Low-dose drugs

Interestingly, exceptions are possible. Stewart et al. [81] reported that the effect of magnesium stearate concentration on the dissolution of a model low-dose drug, riboflavin, from capsules was dependent in some manner on the type of filler. Soluble fillers exhibited the anticipated prolonged times with increasing lubricant levels. However, the trends with insoluble fillers were less predictable. In some cases insoluble fillers were only slightly affected by the concentration of magnesium stearate. For others, such as microcrystalline cellulose, there appeared to be an ideal intermediate concentration of lubricant at which the dissolution rate was maximized. [Pg.366]

AG Stewart, DJW Grant, JM Newton. The release of a model low-dose drug (riboflavine) from hard gelatin capsule formulations. J Pharm Pharmacol 31 1-6,1979. [Pg.381]

Crison and Amidon [47,48] recently used the mass balance approach to study the variability in absorption due to intestinal transit time for water-insoluble drugs. As expected, for low dose drugs, such as digoxin, the variability in absorption sharply decreases with the increase of dissolution number via micronization. For high dose drugs, such as griseofulvin, little effect was observed when the dissolution number was increased by micronization. [Pg.403]

Drug particle size can also be a factor in mixing uniformity. When particles of different sizes are mixed, the smaller particles tend to travel or percolate downward. This tendency is a particular problem with low-dose drugs, where a small amount of drug is to be mixed with large amounts of diluents. In this situation, it is more difficult to achieve uniform mixing, and undesirable... [Pg.180]

Insufficient analytical sensitivity for low-dose drugs, especially at higher media volumes (as illustrated in the USP monograph on digoxin tablets). [Pg.10]

Hepatotoxicity Prolonged use of high doses of androgens has been associated with the development of potentially life-threatening peliosis hepatis, hepatic neoplasms, and hepatocellular carcinoma. Cholestatic hepatitis and jaundice occur with fluoxymesterone and methyltestosterone at relatively low doses. Drug-induced jaundice is reversible when the medication is discontinued. [Pg.237]

Wan LSC, Heng PWS, Muhuri G. Incorporation and distribution of a low-dose drug in granules. Int J Pharmaceutics 1992 88 159-163. [Pg.321]

The development phase for low-dose drug products is similar to any other drug product. At a minimum, the drug product developed should be clinically efficacious, safe, and chemically/physically stable no matter how low the dose strength. Needless to say, scientists who work in chemistry, manufacture, and control (CMC) encounter even more challenges. Therefore, this book focuses on strategies and solutions to the challenges from both theoretical and practical aspects. [Pg.12]

CHALLENGES AND STRATEGIES IN DEVELOPMENT OF LOW-DOSE DRUG PRODUCTS... [Pg.12]

TABLE 1.2 Marketed Oral Solid Low-Dose Drug Products... [Pg.13]

For in vitro dissolution methods, a small volume vessel using 100 mL of medium can also offer a significant sensitivity gain. Nevertheless, equipment modification may be needed to develop analytical methods for low-dose drug products. [Pg.21]

Some excipients contain a certain amount of amorphous form such as spray-dried lactose,27 and others are hygroscopic, such as microcrystalline cellulose.28 These excipients will adsorb water, which causes a change in the micro-environment of the formulation. If the drug substance is moisture-sensitive, degradation may occur quickly. Therefore, consider both drug-excipient compatibility and excipient impurity profile in selecting excipients for low-dose drug products. [Pg.36]

Figure 2.3 Solid oral formulation decision tree for low-dose drug product (<1 mg). Figure 2.3 Solid oral formulation decision tree for low-dose drug product (<1 mg).
Sesi NN. 2005. Low-dose drug products analytical challenges and strategies. Annual Meeting of American Association of Pharmaceutical Scientists, Nashville, TN. [Pg.48]

Komchankul W, Parikh NH, Sakr A. 2000. Effect of process variables on the content uniformity of a low dose drug in a high-shear mixer. Pharm. Ind. 62 305-311. [Pg.48]


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See also in sourсe #XX -- [ Pg.498 ]

See also in sourсe #XX -- [ Pg.8 , Pg.9 , Pg.71 , Pg.242 ]




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