Pharmaceutical Amorphous Solid Dispersions by Ann Newman
By Ann Newman
Delivering a roadmap from early to past due levels of drug improvement, this publication overviews amorphous reliable dispersion know-how – a number one platform to convey poorly water soluble medicines, an immense hurdle in today’s pharmaceutical industry.
• Helps readers comprehend amorphous good dispersions and observe suggestions to specific pharmaceutical systems
• Covers actual and chemical houses, screening, scale-up, formula, drug product manufacture, highbrow estate, and regulatory considerations
• Has an appendix with constitution and estate info for polymers accepted in drug improvement and with advertised medicines built utilizing the amorphous offered dispersion approach
• Addresses worldwide regulatory concerns together with united states laws, ICH guidelines, and patent issues world wide
Read Online or Download Pharmaceutical Amorphous Solid Dispersions PDF
Best analytic books
This is often the 1st booklet to add interfacial nanochemistry of liquid/liquid interfaces, that is a brand new boundary box among analytical chemistry, colloid and floor chemistry, electrochemistry, laser spectroscopy, separation engineering, and interfacial natural synthesis. The liquid/liquid interface is a truly common topic of curiosity either to natural and business chemists, specially these engaged in examine on solvent extraction of steel ion and natural compounds, interfacial synthesis, and micro-scale research.
This can be the 1st booklet to target the most recent advancements in hyphenated innovations utilizing supercritical fluids. the benefits of SFC in hyphenation with a number of detection modes, resembling FTIR, MS, MPD and ICP and others are basically featured during the publication. unique awareness is paid to coupling of SFE with GC or SFC.
As protein technological know-how keeps to turn into an more and more vital element of educational and advertisement sciences and know-how, the necessity has arisen for a prepared resource of laboratory protocols for the research and assessment of those organic polymers. tools for Protein research provides the equipment so much suitable to the generalist bench scientist operating with proteins.
Die Reihe Chemie Basiswissen stellt den gesamten Wissensstoff für das Bachelorstudium Chemie dar. Studenten mit Chemie im Nebenfach und Studierende des höheren Lehramtes dient sie zur Examensvorbereitung. Der Band II, Organische Chemie, präsentiert den Stoff dieses Gebietes in kurzer und übersichtlicher shape.
- Advanced Excel for Scientific Data Analysis
- Analytic Theory of Continued Fractions II: Proceedings of a Seminar-Workshop held in Pitlochry and Aviemore, Scotland June 13–29, 1985
- Mass Spectrometry for the Novice
- Integrated Approach to Coordination Chemistry: An Inorganic Laboratory Guide
- Non-Unique Factorizations: Algebraic, Combinatorial and Analytic Theory (Chapman & Hall/CRC Pure and Applied Mathematics)
Extra resources for Pharmaceutical Amorphous Solid Dispersions
If the rate of dissolution of the added amorphous API, upon contact with the aqueous medium, is slow relative to solid-state crystallization rates, it is also possible that solid API would undergo crystallization due to the plasticizing effects of the water and not attain signiﬁcant supersaturation because of reduced amounts of amorphous API. As we have already seen, many polymers can form amorphous dispersions with an API and signiﬁcantly inhibit solid-state crystallization by reducing molecular mobility and by direct interaction at nucleation sites.
Various details of the processing of amorphous dispersions and the ingredients used on a practical scale will be discussed throughout this book. Here, we wish to introduce some general concepts and issues that build on the principles discussed above. Depending on the physical and chemical characteristics of the API and polymer, amorphous solid dispersions are primarily prepared by either hot melt extrusion (HME) of a mixture of powdered API and polymer, or by the spray drying of a solution of API and polymer from a suitable volatile solvent.
The most widely used polymers include vinyl-pyrrolidone-based polymers, such as poly(vinyl pyrrolidone) (PVP) and the poly(vinyl pyrrolidone)-poly (vinyl acetate) copolymer (PVP-VA); cellulose-based polymers such as hydroxypropyl methylcellulose (HPMC) and hydroxyl propyl methylcellulose acetate-succinate; and methacrylate-based enteric coating polymer systems such as the Eudragits. The monographs in Chapter 14 and the Appendix A tables list various grades of these and other useful polymers with their corresponding Tg values.