Handbook of Pharmaceutical Manufacturing Formulations - by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

content material: v. 1. Compressed stable items --
v. 2. Uncompressed stable items --
v. three. Liquid items --
v. four. Semisolid items --
v. five. over the counter items --
v. 6. Sterile products.

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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations - Liquid Products (Volume 3 of 6)

Sample text

Unintended variations in dimensional parameters, if undetected, may affect package permeability, drug delivery performance, or the adequacy of the seal between the container and the closure. Variation in any physical parameter is considered important if it can affect the quality of a dosage form. The chemical composition of the materials of construction may affect the safety of a packaging component. New materials may result in new substances being extracted into the dosage form or in a change in the amount of known extractables.

Elasticity, resistance to solvents, or gas permeability). , using a different mold release agent) or through the use of a new supplier © 2004 by CRC Press LLC Handbook of Pharmaceutical Formulations: Liquid Products of a raw material. A change in the supplier of a polymeric material or a substance of biological origin is more likely to bring with it an unexpected composition change than is a change in the supplier of a pure chemical compound, because polymeric and natural materials are often complex mixtures.

The potential effects of packaging component/dosage form interactions are numerous. Hemolytic effects may result from a decrease in tonicity, and pyrogenic effects © 2004 by CRC Press LLC 23 may result from the presence of impurities. The potency of the drug product or the concentration of the antimicrobial preservatives may decrease because of adsorption or absorption. A cosolvent system essential to the solubilization of a poorly soluble drug can also serve as a potent extractant of plastic additives.

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