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(12) Patent Application Publication (10) Pub. No.: US 2006/0193914 A1 Ashworth Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2006/0193914 A1 Ashworth Et Al US 2006O193914A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0193914 A1 Ashworth et al. (43) Pub. Date: Aug. 31, 2006 (54) CRUSH RESISTANT DELAYED-RELEASE Publication Classification DOSAGE FORMS (51) Int. Cl. (76) Inventors: Judy Ashworth, Wermelskirchen (DE); A6IR 9/26 (2006.01) Elisabeth Arkenau Maric, Koln (DE); (52) U.S. Cl. .............................................................. 424/469 Johannes Bartholomaus, Aachen (DE) Correspondence Address: (57) ABSTRACT PERMAN & GREEN The invention relates to a dosage form comprising a physi 425 POST ROAD ologically effective amount of a physiologically active Sub FAIRFIELD, CT 06824 (US) stance (A), a synthetic, semi-synthetic or natural polymer (C), optionally one or more physiologically acceptable aux (21) Appl. No.: 11/348,295 iliary Substances (B) and optionally a synthetic, semi-syn (22) Filed: Feb. 6, 2006 thetic or natural wax (D), wherein the dosage form exhibits a resistance to crushing of at least 400 N and wherein under (30) Foreign Application Priority Data physiological conditions the release of the physiologically active Substances (A) from the dosage form is at least Feb. 4, 2005 (DE).......................... 10 2005 OO5 446.3 partially delayed. Patent Application Publication Aug. 31, 2006 Sheet 1 of 5 US 2006/0193914 A1 Figure 1 M Patent Application Publication Aug. 31, 2006 Sheet 2 of 5 US 2006/0193914 A1 Figure 2 NSSWey V Patent Application Publication Aug. 31, 2006 Sheet 3 of 5 US 2006/0193914 A1 13 A1 Figure 3 Figure 4 Patent Application Publication Aug. 31, 2006 Sheet 4 of 5 US 2006/0193914 A1 Figure 5A Figure 5B 81 82 82 84a 84b. 84b. 83 Patent Application Publication Aug. 31, 2006 Sheet 5 of 5 US 2006/0193914 A1 Figure 6, Figure 7 1 O US 2006/01939 14 A1 Aug. 31, 2006 CRUSH RESISTANT DELAYED-RELEASE the people being cared for not as tablets etc. but rather as DOSAGE FORMS powder, for example to get round the difficulties involved in Swallowing tablets. CROSS-REFERENCE TO RELATED APPLICATIONS 0008 However, the comminution of dosage forms with Such apparatuses is problematic if the dosage forms are 0001. This application claims priority from German delayed-release formulations. As a rule, comminution then Patent Application No. 10 2005 005 446.3, filed on Feb. 4, results in destruction of the inner structure of the dosage 2005 and U.S. patent application Ser. No. 10/718,112 filed form, which is responsible for the delayed release, so doing on Nov. 20, 2003. away with the delayed-release action. As a result of com BACKGROUND OF THE INVENTION minution, the diffusion paths of the physiologically active substances contained therein are shortened and/or the dif 0002 The present invention relates to a dosage form for fusion barriers are removed. For instance, a delayed-release administering a physiologically active Substance (A), formulation in which delayed release is achieved by means wherein the dosage form is mechanically stabilised, Such of a film coating exhibits the film coating over only a small that it cannot be comminuted by conventional methods. Such percentage of its Solid Surface after comminution. Conse as pounding, crushing, grinding in a mortar etc., or at least quently, after administration, frequently all the physiologi comminuted only with very great difficulty. The substance cally active Substance originally contained in the dosage (A) is released from the dosage form according to the form is released in a relatively short time, whereby a invention under physiological conditions with an at least comparatively very high plasma concentration of the Sub partially delayed release profile. stance is abruptly reached for a relatively short period. In 0003) Numerous physiologically active substances, such this way, the original delayed-release formulations become as nutritional Supplements, pharmaceutical Substances etc., “immediate release' formulations. are provided as delayed-release formulations, i.e., in contrast to conventional formulations (for example “immediate 0009. Depending on the physiological activity of the release' formulations), release of the substances from these Substance, this may cause considerable side-effects however, formulations into the body is delayed for a comparatively and in extreme cases may even lead to the death of the long period, which often amounts to several hours. Release patient. Examples of Substances with Such a hazard potential of the substance from the dosage form, on the one hand, and are antiparkinson drugs, antiepileptics, antidiabetics, anti metabolisation or excretion by the organism; on the other hypertensives, antiarrhythmics, etc. hand, ensure a relatively uniform blood plasma level for the 0010. As a rule, the people who comminute the dosage administered substance. As a consequence thereof, the num forms for themselves or for others are not aware of these ber of dosage units which need to be taken per day by risks. Cases are known in which patients have died probably patients can frequently be reduced, intake often being as a result of pulverisation of delayed-release formulations required only once or twice a day. by nurses or carers. For further details, reference may be 0004. In certain cases, delayed-release formulations may made for example to J. E. Mitchell, Oral Dosage Forms That also reduce the extent of side-effects caused by the sub Should Not Be Crushed: 2000 Update, Hospital Pharmacy, stance. Thus, for example, some pharmaceutical Substances 2000; H. Miller et al., To Crush or Not to Crush, Nursing produce intensified side-effects if a given limit concentration 2000; R. Griffith et al., Tablet Crushing and the law: the of the pharmaceutical Substance in the blood plasma is implications for nursing: Prof. Nurse 2003; J. G. Schier et al. exceeded at least transiently. Such pharmaceutical Sub Fatality from administration of labetalol and crushed stances are therefore generally unsuitable for “immediate extended-release nifedipine, Ann. Pharmacotherapy 2003: release' formulations, in particular if it is desired to admin A. James, The legal and clinical implications of crushing ister said formulations only two or three times daily. Such tablet medication, Nurse Times 2005, 100(50), 28-9; and P. pharmaceutical Substances are therefore conventionally Cornish, "Avoid the Crush': hazards of medication admin administered as delayed-release formulations, whereby con istration in patients with dysphagia or a feeding tube, CMAJ. tinuous release of the active ingredient is ensured and 2005, 172(7), 871-2. short-term occurrence of elevated concentrations is pre 0011 Delayed-release formulations may also cause prob vented. lems for small children. For instance, children frequently 0005. In delayed-release formulations, the physiologi cannot distinguish Solid dosage forms from Sweets. If chil cally active substance is conventionally either embedded in dren find Such dosage forms, for example because their a matrix controlling release and/or the dosage form is coated parents have carelessly left them lying around in the home, with a film which controls release. there is a risk that the children may think that the dosage forms are Sweets and put them in their mouths and chew 0006. However, older patients in particular frequently them. If said dosage forms are delayed-release formulations, have difficulties in taking Solid dosage forms. Such as tablets, which contain a pharmaceutical Substance in a dosage gelatine capsules, etc. They choke on them and sometimes intended for adults, the child may in Such a case already be develop pronounced aversion to Such dosage forms. at risk of overdose due to the relatively large amount of 0007 To counter this problem, various apparatuses have pharmaceutical Substance contained therein. By chewing the been developed by means of which solid dosage forms may dosage form and thus cancelling out the delayed-release be comminuted or pulverised (“tablet crushers'). Such appa action, this risk is increased still further, however, since the ratuses are used, for example, by the care staff in old excessively high dose already contained therein is addition people's homes. The dosage forms are then administered to ally released over a greatly reduced period of time, a US 2006/01939 14 A1 Aug. 31, 2006 situation which would be very hazardous even for an adult may be deformed as a result of external mechanical action, and which may have all the more drastic consequences for for example using a hammer, but does not crumble into a a child. number of fragments. Comminution is not even Successful 0012. The chewing of delayed-release formulations may when the dosage form is initially chilled to increase its also lead to an overdose of the Substance contained therein brittleness, for example to temperatures below -25° C. in adults. Sometimes adults chew the dosage forms delib below -40°C. or indeed in liquid nitrogen. erately, though often in ignorance of the type and purpose of 0023. As a consequence of the resistance to crushing, a delayed-release formulation, because they hope for a delayed release is maintained and an overdose due to quicker effect. improper handling of the dosage form is effectively pre 0013 A known way of reducing the risks involved in vented. comminuting delayed-release formulations consists in add 0024. The advantageous properties of the dosage form ing to the dosage form antagonists, i.e. antidotes, or com according to the invention, in particular also its mechanical pounds which produce defensive reactions, wherein
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