By Sarfaraz K. Niazi
content material: v. 1. Compressed stable items --
v. 2. Uncompressed sturdy items --
v. three. Liquid items --
v. four. Semisolids items --
v. five. over the counter items --
v. 6. Sterile products.
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Extra info for Handbook of Pharmaceutical Manufacturing Formulations - Compressed Solid Products (Volume 1 of 6)
3. Tumbler Common mixers of this type include the twin-shell and double cone. These mixers exert a gentle mixing action. Because of this mild action, lumps of powder will not be broken up and mixed. Powders may also clump due to static charges, and segregation can occur. Low humidity can contribute to this problem. Blending under very dry conditions was found to lead to charge buildup and segregation, while blending of some products under humid conditions led to lumping. More so than with other mixers, powder charge levels should not exceed 60 to 65% of the total volume of the mixer.
B. MOIETIES 1. Parent Drug vs. 24(b)(1)(i)]. This guidance recommends the following approaches for BA and BE studies. ), determination of moieties to be measured in biological fluids should take into account concentration and activity. Concentration refers to the relative quantity of the parent drug or one or more metabolites in a given volume of an accessible biological fluid, such as blood or plasma. Activity refers to 12 Handbook of Pharmaceutical Manufacturing Formulations: Compressed Solid Products the relative contribution of the parent drug and its metabolite in the biological fluids to the clinical safety and efficacy of the drug.
DISINTEGRATION TEST A disintegration test is provided to determine compliance with the limits on disintegration stated in the individual monographs, except where the label states that the tablets or capsules are intended for use as troches, or are to be chewed, or are designed as modified-release dosage forms. Determine the type of units under testing from the labeling and from observation, and apply the appropriate procedure to six or more dosage units. Disintegration does not imply complete solution of the unit or even of its active constituent.