By Jack Zheng
There are designated demanding situations within the formula, manufacture, analytical chemistry, and regulatory specifications of low-dose medicinal drugs. This ebook offers an summary of this really expert box and combines formula, analytical, and regulatory points of low-dose improvement right into a unmarried reference ebook. It describes analytical methodologies like dissolution trying out, reliable kingdom NMR, Raman microscopy, and LC-MS and offers production strategies akin to granulation, compaction, and compression. entire with case reviews and a dialogue of regulatory standards, it is a center reference for pharmaceutical scientists, regulators, and graduate scholars.
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There are particular demanding situations within the formula, manufacture, analytical chemistry, and regulatory requisites of low-dose medicines. This ebook presents an summary of this really expert box and combines formula, analytical, and regulatory points of low-dose improvement right into a unmarried reference booklet.
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Additional info for Formulation and Analytical Development for Low-Dose Oral Drug Products
Therefore, the quality of excipients in the formulation is vital to ensure quality of the finished dosage form. However, careful characterization and control of excipient quality is often neglected. Over the years, there has been limited progress in developing standard methods for characterizing pharmaceutical excipients and in creating reliable databases and predictive relationships of properties for commonly used excipients. The impact of specific material properties depends on the amount and function of a particular excipient used in the dosage form, as well as a particular manufacturing platform technology.
However, this book covers only oral solid dosage forms for low-dose drug products. Solution and soft-elastic capsule formulation development of low-dose products will be, for sure, the focus and interest of other pharmaceutical scientists. 3 SUMMARY Since the beginning of this decade, research and development of new medicines in today’s pharmaceutical industry have faced increasing challenges. Developing low-dose drug products from candidate selection to market poses a different set of challenges to pharmaceutical scientists in comparison with developing “normal”dose products.
The physical characterization of excipients has received the most attention, as discussed earlier. 21 However, chemical impurity profiles of excipients have not, in general, received similar attention. Excipients, like drug substances, contain process residues, degradation products, or other structural derivatives formed during manufacturing. Lactose is one of the most widely used excipients in solid oral dosage forms. 24 Oxidative degradation is another important pathway for the loss of drug potency over time.