Formulation and Analytical Development for Low-Dose Oral by Jack Zheng

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.

Show description

Read or Download Formulation and Analytical Development for Low-Dose Oral Drug Products PDF

Best pharmacy books

Formulation and Analytical Development for Low-Dose Oral Drug Products

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.

Biologie für Mediziner

Um in die Medizin einsteigen zu können, sind die biologischen Grundlagen unerlässlich. Im Buselmaier werden diese sehr effizient vermittelt: leicht verständliche Abbildungen, mehr als a hundred Übersichten mit Lernfakten, Zusammenfassungen am Kapitelende, ein umfangreiches Glossar mit mehr als 800 Begriffen und zahlreiche klinische Beispiele.

Tapping molecular wilderness : drugs from chemistry--biology--biodiversity interface

This ebook is for readers with a few history in technological know-how, in regards to the look for medicinal drugs, ranging from molecular variety in nature or molecular desolate tract. Drug molecules can be utilized as such, or as beginning issues for more advantageous medicines received from the interface of chemistry and biology. every so often, the basic molecular good points for drug houses from common molecules could be pointed out and changed to greater ones.

Ensuring Patient Access to Affordable Cancer Drugs: Workshop Summary

In recent times, sufferers' out-of-pocket bills for melanoma care were emerging swiftly. those expenses contain medical insurance deductibles, coinsurance, and copayments for coated providers, in addition to companies that aren't lined through assurance. Many melanoma sufferers are in particular susceptible financially simply because their disease and/or therapy impedes their skill to paintings, with a few sufferers wasting employment altogether.

Additional info for Formulation and Analytical Development for Low-Dose Oral Drug Products

Sample text

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.

Download PDF sample

Rated 4.46 of 5 – based on 12 votes