https://era.library.ualberta.ca/items/36f7f046-2e47-4138-b69b-00eeac6f5792/view/144407f8-44b6-4b04-9762-b561c587100a/Azarmi-20dissolution-20perspectives.pdf

Current perspectives in dissolution testing of conventional and novel dosage forms

This review summarizes the methods used to study real-time (37°C) drug release from nanoparticulate drug delivery systems and establish an IVIVC. Since no compendial standards exist, drug release is currently assessed using a variety of methods including sample and separate (SS), continuous flow (CF), dialysis membrane (DM) methods, and a combination thereof, as well as novel techniques like voltametry and turbidimetry. This review describes the principle of each method along with their advantages and disadvantages, including challenges with set-up and sampling. The SS method allows direct measurement of drug release with simple set-up requirements, but sampling is cumbersome. With the CF method, sampling is straightforward but the set-up is time consuming. Set-up as well as sampling is easier with the DM, but it may not be suitable for drugs that bind to the membrane. Novel methods offer the possibility of real-time drug release measurement but may be restricted to certain types of drugs. Of these methods, Level A IVIVCs have been obtained with dialysis, alone or in combination with the sample and separate technique. Future efforts should focus on developing mathematical models that describe drug release mechanisms as well as facilitate formulation development of nano-sized dosage forms.

/pdf/a-review-of-in-vitro-drug-release-test-methods-for-nano-2hkq6qa2px.pdf

A Review of In Vitro Drug Release Test Methods for Nano-Sized Dosage Forms

Introduction: Orodispersible films for oral delivery are gaining popularity. Whereas breath-fresheners and over-the-counter products have already become quite common in the US, the first prescription drug films were introduced into the EU and US markets only very recently. Already considered as a unique Rx (prescription drug) dosage form by the FDA (oral soluble film), such products are not substitutable by conventional oral dosage forms. The official term defined by the European Medicines Agency is orodispersible film (ODF). Areas covered: This review gives an overview on the benefits of ODFs, typical excipients and products already available on the market. ODFs are defined and differentiated from other films and dosage forms. Possible manufacturing methods are described. As ODFs are not yet listed in one of the pharmacopoeias, possible methods for characterization and quality control are discussed. Required characteristics, advantages and disadvantages are elaborated. Biopharmaceutical considerations ar...

Advances in orodispersible films for drug delivery.

This work reviews the relevant information about the possibility of producing microparticles with chitosan, by a spray drying process, for industrial applications. The applicability and the advantages of chitosan and modified chitosan in the microencapsulation process are discussed, with special emphasis on relevant operational spray drying conditions, which affect the performance of the final product, namely the efficiency and yield of the microencapsulation process, the particle properties, like size, moisture and stability, and the release time of active compounds. The fundamental equations governing the controlled release of active compounds and the application of controlled release technology in food systems are presented.

Microencapsulation with chitosan by spray drying for industry applications – A review

Chitosan nanoparticles loaded with dorzolamide and pramipexole

Contributors Jean-Marc Aiache, Nobuo Aoyagi, Dennis Bashaw, Cynthia Brown, William Brown, Diane Burgess, John Crison, Patrick DeLuca, Ruzica Djerki, Jennifer Dressman, Thomas Foster, Kirsti Gjellan, Vivian Gray, Ajaz Hussain, Tom Ingallinera, James Klancke, Johannes Kraemer, Henning Kristensen, Kofi Kumi, Christian Leuner, Jobst Limberg, Petra Loos, Lenny Margulis, Patrick Marroum, Helga Moeller, Bernd Mueller, Martin Mueller-Zsigmondy, Ngozi Okafo, Larry Ouderkirk, Shravan Parsi, Saeed Qureshi, Joseph Robinson, Vinod Shah, Martin Siewert, Ramana Uppoor, and Roger Williams. Aventis, Frankfurt, Germany JW Goethe University, Frankfurt, Germany Eli Lilly and Company, Indianapolis, IN Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, MD Universite d'Auvergne, Clermont-Ferrand Cedex, France National Institute of Health Sciences, Division of Drugs, Tokyo, Japan US Pharmacopeia, Rockville, MD University of Connecticut, Storrs Mansfield, CT Pfizer, Inc, La Jolla, CA University of Kentucky, Lexington, KY Novartis Pharma, Basel, Switzerland AstraZeneca, Sodertalje, Sweden V.A. Gray Consulting, Inc, Hockessin, DE AAI International, Charleston, SC CIMA Laboratories, Inc, Minneapolis, MN Laboratory and Quality Services, Eschborn, Germany University of Copenhagen, Denmark Bundesinstitut fur Arzneimittel, Bonn, Germany Aventis Pharmaceuticals, Bridgewater, NJ Pfizer, Groton, CT Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany Kiel University, Kiel, Germany Alza Corporation, Mountain View, CA DPT Laboratories, Ltd, San Antonio, TX Health Protection Branch, Ottawa, Canada University of Wisconsin, WI

/pdf/fip-aaps-guidelines-to-dissolution-in-vitro-release-testing-2cp52c25iq.pdf

Bernd W. Mueller

Papers

FIP/AAPS guidelines to dissolution/in vitro release testing of novel/special dosage forms

Chitosan drug binding by ionic interaction.

Characterization of drug-chitosan interaction by 1H NMR, FTIR and isothermal titration calorimetry.