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

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Consultation DocumentsWHO Drug Information Vol. 25, No. 2, 2011Disintegration testSugar-coated tablets comply with 5.3 Disintegration test for tablets and capsules.Operate the apparatus for 60 minutes, unless otherwise specified in the individualmonograph, using water, and examine the state of the tablets. If any of the tabletshas not disintegrated, repeat the test on an additional six tablets, using hydrochloricacid (0.1 mol/l) VS.All six tablets must disintegrate.Film-coated tabletsDefinitionA film-coated tablet is covered with a thin layer of resins, polymers, and/or plasticizerscapable of forming a film.Disintegration testFilm-coated tablets comply with 5.3 Disintegration test for tablets and capsules.Operate the apparatus for 30 minutes, and examine the state of the tablets.Modified-release tabletsDefinitionModified-release tablets are coated, uncoated, or matrix tablets containing excipientsor prepared by procedures which, separately or together, are designed tomodify the rate, the place or the time of release of the active ingredient(s) in thegastrointestinal tract.Sustained-release tablets (Extended-/prolonged-release tablets)DefinitionSustained-release tablets are designed to slow the rate of release of the activeingredient(s) in the gastrointestinal tract.All requirements for these specialized dosage forms are given in the individual monographs.Delayed-release tablets (gastro-resistant/enteric-coated tablets)DefinitionDelayed-release tablets are intended to resist gastric fluid but disintegrate in intestinalfluid. This is achieved by using coating substances such as cellacefate (celluloseacetate phthalate) and anionic copolymers of methacrylic acid and its esters. It issometimes necessary to apply more than one layer.Uniformity of massThe test for 5.2 Uniformity of mass for single-dose preparations does not apply todelayed-release tablets.Disintegration testDelayed-release tablets comply with 5.3 Disintegration test for tablets and capsules,using hydrochloric acid (0.1 mol/l) VS as the immersion fluid. Operate the apparatusfor 2 hours, unless otherwise specified in the individual monograph (but in any case146
WHO Drug Information Vol. 25, No. 2, 2011Consultation Documentsfor not less than 1 hour), and examine the state of the tablets. No tablet should showsigns of either disintegration (apart from fragments of coating) or cracks that wouldallow the contents to escape. Replace the acid by phosphate buffer solution, pH 6.8,TS. Operate the apparatus for 60 minutes and examine the state of the tablets.Paediatric retinol oral solutionDraft proposal for The International Pharmacopoeia (February2011). Please address any comments to Quality Assurance andSafety: Medicines, World Health Organization, 1211 Geneva 27,Switzerland. Fax +41227914730 or e-mail to mendyc@who.int. Asubscriber mailing list is now available to speed up consultation.For more information please contact bonnyw@who.int.[Note from the secretariat: Paediatric retinol soft gel capsules in doses of 100 000 IUand 200 000 IU have a unique mode of delivery for use in public health programmesworldwide: unlike other capsules, these preparations are equipped with a nipple to besnipped before use. The dosage form is then squeezed and its content is delivereddirectly into the patient’s mouth.WHO has developed a public standard which could be applicable to oral oily solutionsin multidose dispensers as well as to single doses, each encapsulated in a soft gelatinshell.Feedback is sought in particular about the proposed determination of the retinolcontent per delivered dose for single-dose containers. An alternative would be todetermine the retinol content per single-dose container (capsule). The different approacheswill influence the assay results as investigations have shown that about 10%of the material filled into soft capsules remain inside and is not actually deliveredunder the typical condition of use.]Other name. Paediatric vitamin A oral solution.Category. Vitamin.Storage. Paediatric retinol oral solution should be kept in a tight, light-resistant,container.Labelling. The labelling should state the name of the retinol ester or esters present,the proportion of vitamin A expressed in International Units (IU), and the names andproportions of any stabilizing agents added.Additional information. Strength in the current WHO Model List of Essential Medicinesfor Children:Oral oily solution in multidose dispenser: 100 000 IU/ml.Oral oily solution as single-doses (capsules): 100 000 IU; 200 000 IU.147
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WHO Drug Information Vol. 25, No. 2, 2011

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