WHO Drug Information Vol. 25, No. 2, 2011

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Recent Publications, Information and EventsWHO Drug Information Vol. 25, No. 2, 2011Reference: The World Medicines SituationReport 2011, available at http://www.who.int/medicines/areas/policy/world_medicines_situation/en/index.htmlArtesunate instead of quininesaves livesMédecins sans Frontières (MSF) havereleased a report calling for a change insevere malaria treatment protocols fromcenturies old quinine use to the newer,more effective drug artesunate (1).In its report “Making the Switch”, MSFcalls on African governments to followWorld Health Organization (WHO)guidelines, and switch from the far lesseffective quinine to artesunate whichcould avert nearly 200 000 deaths eachyear.For decades, quinine has been used insevere malaria but it can be both difficultto administer and dangerous. Artesunateis safer, easier and more effective thanquinine. Quinine has to be given threetimes a day in a slow intravenous dripthat takes four hours: a treatment that isburdensome for both patients andhealth staff. Artesunate, in contrast, canbe given in just four minutes as anintravenous or intramuscular injection.A landmark clinical trial in late 2010concluded that the use of artesunateto treat children with severe malariareduces the risk of death by nearly aquarter. The study, carried out in nineAfrican countries, found that for every 41children given artesunate over quinine,one extra life was saved. Because of thecomplexities of administering quinine,children in the trial who were assigned toreceive quinine were almost four timesmore likely to die before even receivingtreatment.MSF participated in the trial through itsresearch affiliate Epicentre, with a researchsite in Uganda. MSF has sincechanged its own treatment protocols andnow plans to work with national healthauthorities to roll out artesunate in itsprojects over the coming months.Reference: Médecins sans Frontières.Making the Switch at http://www.msf.org/msf/articles/2011/04/malaria-making-theswitch.cfm134
WHO Drug Information Vol. 25, No. 2, 2011Consultation DocumentsThe International PharmacopoeiaRevision of monograph on capsulesThis monograph was adopted by the Forty-fourth WHO Expert Committee on Specificationsfor Pharmaceutical Preparations in October 2009 for addition to The InternationalPharmacopoeia.CapsulesThe requirements of this monograph do not necessarily apply to preparations that areintended for use other than by oral administration, such as vaginal or rectal capsulesetc. Such preparations may require a special formulation, method of manufacture, orform of presentation appropriate to their particular use. Starch capsules (often knownas cachets) are not included in this monograph.DefinitionCapsules are solid dosage forms with hard or soft shells. They are of various shapesand sizes and contain a single dose of one or more active ingredients. They areintended for oral administration.Capsule surfaces may bear symbols or other markings.Capsule shells are made of gelatin or other substances, the consistency of which maybe modified by the addition of substances such as glycerol or sorbitol. The shellshould disintegrate in the presence of digestive fluids so that the contents are released.The contents of capsules may be solid, liquid, or of a paste-like consistency.Capsule shells and contents may contain excipients such as diluents, solvents, surface-activesubstances, opaque fillers, antimicrobial agents, sweeteners, colouringmatter authorized by the appropriate national or regional authority, flavouring substances,disintegrating agents, glidants, lubricants, and substances capable of modifyingthe behaviour of the active ingredient(s) in the gastrointestinal tract. The contentsshould not cause deterioration of the shell.When excipients are used, it is necessary to ensure that they do not adversely affectthe stability, dissolution rate, bioavailability, safety, or efficacy of the active ingredient(s);there must be no incompatibility between any of the components of thedosage form.The different categories of capsule include hard capsules, soft capsules, and modifiedreleasecapsules [including delayed-release capsules (gastro-resistant/enteric capsules)and sustained-release capsules (extended-/prolonged-release capsules)].135
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WHO Drug Information Vol. 25, No. 2, 2011

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