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Pharmaceutical Compositions Having Cytoprotective Properties

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Pharmaceutical Compositions Having Cytoprotective Properties Europaisches Patentamt J European Patent Office Office europden des brevets @ Publication number: 0 220 849 B1 EUROPEAN PATENT SPECIFICATION (45) Date of publication of patent specification : © int CI.5 : A61K 33/08, //(A61K33/08, 27.02.91 Bulletin 91/09 33:00, 31:19) @ Application number : 86307619.6 (§) Date of filing : 02.10.86 (si) Pharmaceutical compositions having cytoprotective properties. The file contains technical information (73) Proprietor: AMERICAN HOME PRODUCTS submitted after the application was filed and CORPORATION not included in this specification 685, Third Avenue New York, New York 10017 (US) (§) Priority: 08.10.85 US 785417 20.02.86 US 831756 (72) Inventor : Borella, Luis Enrique 5 Jacob Drive Lawrenceville New Jersey (US) (43) Date of publication of application : Inventor : Dijoseph, John Francis 06.05.87 Bulletin 87/19 571 Linden Avenue Woodbridge New Jersey (US) Inventor : Mir, Ghulam Nabi (45) Publication of the grant of the patent : P.O. Box 392 27.02.91 Bulletin 91/09 Buckingham Pennsylvania 18912 (US) Inventor: Reuter, Gerald Louis 23 Crescent Drive (84) Designated Contracting States : Pittsburgh New York 12901 (US) AT BE CH DE FR GB IT LI LU NL SE (74) Representative : Porter, Graham Ronald et al @ References cited : C/O John Wyeth & Brother Limited FR-A- 2 103 569 Huntercombe Lane South Taplow CHEMICAL ABSTRACTS, vol. 80, no. 26, 1st Maidenhead Berkshire, SL6 0PH (GB) July 1974, pages 193-194, no. 149115a, Colum- bus, Ohio, US; & JP-A-74 13 319 CHEMICAL ABSTRACTS, vol. 98, no. 17, 25th April 1983, page 47, no. 137460L Columbus, Ohio, US; I. SZELENYI: "Cytoprotection with antacids" CO a oo o CM CM Note : Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. 0- Notice of opposition shall be filed in a written reasoned statement It shall not be deemed to have been UJ filed until the opposition fee has been paid (Art. 99(1) European patent convention). Jouve, 18, rue Saint-Denis, 75001 PARIS EP 0 220 849 B1 Description This invention relates to exogenously acidified antacid compositions having gastric cytoprotective properties. More particularly this invention relates to exogenously acidified aluminium base containing 5 antacid compositions wherein an antacid suspension has been acidified to the point at which the aluminium ion component is solubilized, and then formulated into liquid dosage forms or for example, spray dried and formulated into solid dosage forms. Gastric cytoprotection not involving the inhibition of gastric acid secretion, is a known phenomenon. For example, prostaglandin F2 does not inhibit gastric acid secretion, but the compound does induce gastric 10 cytoprotection. Other prostaglandins induce gastric cytoprotection at much smaller dose levels than those required for the inhibition of gastric acid secretion. See for example, Shriver, U.S.-A-. 4,370,348. Although the mechanism of cytoprotection by antacids is not clearly defined yet, there is a suggestion that it may be partially mediated through the release of gastric mucosal prostglandins, (Hollander et al. Gas- troenterology 86 : 1 1 14, 1984 and Tamowski et al, Gastroenterology 86 : 1276, 1984). Szelenyi et al, (Gas- 15 troenterology 88 : 1 604, 1 985) has suggested non-prostaglandin mediated mechanisms for cytoprotection. Activity in the ethanol induced ulcer model is an indication of cytoprotection, regardless of the antisec- retory characteristics of the drug. Antisecretory agents, such as the H2 receptor antagonist cimetidine and the anticholinergic agent propantheline bromide do not protect this model. See Robert et al, Scand. J. Gas- troenterol. 19 (Suppl. 101) : 69, 72, 1984. 20 The cytoprotective activity of antacids is a recent observation (Hagel et al, Hepato-gastroenterol. 29 : 271-274, 1982. Szelenyi et al, Eur. J. Pharmacol. 88 : 403-406, 1 983. Hollander et al, Gastroenterology 86: 1114, 1984. For example, it has been shown by Szelenyi etal, Gastroenterology 88 : 5 Part 2, 1604 (1985) and Tamowski et al, Gastroenterology 86 : 5, Part 2, 1276 (1985) that AI(OH), MAALOX and MYLANTA have cytoprotective properties. MAALOX and MYLANTA are registered trade markes. 25 We have demonstrated that magaldrate and other commercially available aluminium base containing antacids inhibit ethanol induced ulcers in rats. The activity of acidified magaldrate in this test suggests, there- fore, that it possesses cytoprotective properties as an addition to its acid neutralizing effects. Antacids have long been thought to exert their antiulcer effects primarily by one of the following mechan- isms : 1)acid neutralization, 2) inactivation of pepsin (Piper etal, Am. J. Dig, Dis6(2) : 134-141, 1961) and 30 3) binding to bile salts (Beneyto et al, Arzneim.-Forsch 34(11) : 1 350-1 354, 1 984). The coating of the ulcer crater by antacids has also been considered, but it is not a viable mechanism (Piper, Clinics in Gastro. 2 (2): 361-377, 1973). In order to substantiate the cytoprotective activity of magaldrate, as distinguished from the other mechanisms of antiulcer activity, 6 N HCI was added to magaldrate to negate its acid neutralization capacity. 35 The pH was changed from approximately 9.0, for a commercial magaldrate suspension to pH 2.5, for acidi- fied magaldrate source. At pH 2.5. acidified magaldrate was significantly more potent in preventing etha- nol-induced ulcers in the rat than the commercial magaldrate formula. Therefore, acidified magaldrate fulfills Robert's criteria for a cytoprotective agent, i.e., antiulcer effects at doses which are not antisecretory. Also, the acidified magaldrate was used at low pH (<3.0) in a solubilized form in which antacids are reported not 40 able to inactivate pepsin (Wenger et al, J. Clin. Pharmacol. 12 : 136-141, 1972.) In addition, bile salts are not reported to be involved in ethanol induced ulceration and bile is not visibly present in ethanol treated rat stomachs. Since acid neutralization, pepsin inactivation, and bile binding are not involved in the antiulcer activity of acidified magaldrate in the ethanol model, the contribution of the three viable antiulcer mechan- isms to the antiulcer effects of acidified magaldrate has been eliminated and the antiulcer effect of acidified 45 magaldrate can therefore be attributed to its cytoprotective effects. The above identified article by Wenger et al, J. Clin. Pharmacol. 12 : 136-141, 1972 entitled "Pepsin Adsorption By Commercial Antacid Mixtures. In Vitro Studies" described the adsorption of pepsin by various commercial antacid mixtures independently of their effect on pH. In the experiments, antacid dilutions were prepared by adding 10 grams of certain commercial antacid suspensions to 100 milliliters of distilled water. so Using hydrochloric acid and distilled water, the concentration was further decreased to 5 grams per 100 milliliters. For each mixture four flasks were prepared and the final pH of each was brought to 1.5, 3.0, 5.0 and 6.0. The antacids included Gelusil-M, Delcid, Maalox, Riopan and Amphojel (registered trade marks). The article refers to other authors who have similarly acidified antacid solutions. According to the invention there is provided a cytoprotective pharmaceutical composition characterised 55 in that the composition comprises an exogenously acidified aluminium base containing composition acidi- fied to a pH at which the aluminium base component is solubilized and having a concentration of 50 to 98 grams of precursor aluminium base containing composition prior to acidification per 1 00 milliliters of acidified composition. The aluminium base containing compositions may comprise for example, commercial liquid 2 EP 0 220 849 B1 antacid suspensions containing an aluminium base such as aluminium hydroxide, antacid powders or solids containing an aluminium base such as aluminium hydroxide, or aluminium hydroxide gel, such compositions may include magnesium hydroxide. The end point for the solubilization is ordinarily in the range of pH 2.25 to 3.25 5 In another embodiment of this invention, the exogenously acidified compositions containing solubilized aluminium base are further formulated into liquid dosage forms such as syrups, orfor example, the solutions are spray dried and formulated into solid dosage forms such as powders for encapsulation or compression into tablets. Aluminium hydroxide is aluminium hydrate, aluminium trihydrate or hydrated alumina of formula 10 AI(OH)3. The aluminium hydroxide is described only as a gastric antacid (see the Merck Index, 8th Edition P44). Acidified aluminium hydroxide, according to the present invention, is produced by treating an aqueous gel or suspension of aluminium hydroxide with an acid such as aqueous hydrochloric acid until the suspen- sion becomes solubilized. 15 Magaldrate is a magnesium aluminate hydrate, described in Hallmann et al, U.S.-A-2,923,660. Extra strength magaldrate and rehydratable magaldrate are disclosed and claimed in European Patent Appli- cation 0178895. Magaldrate is a chemical union of aluminium and magnesium hydroxide, corresponding approximately to the formula AI5Mg1o(Ori)31(S04)2xH20 according to the official monograph USP XX, third supplement 20 USP-NF and has a molecular weight of about 1 097. Magaldrate, also sometimes referred to in said mono- graph as aluminium magnesium hydroxide sulfate, contains not less than 29.0 per cent and not more than 40.0 percent of magnesium oxide (MgO) and the equivalent of not less than 18.0 percent and not more than 26.0 percent of aluminium oxide (Al203). The preparation of magaldrate is described in U.S.-A-2,923,660. A commercially suitable procedure is 25 described in said patent, for example, beginning in column 2, line 40. Aluminium sulfate is employed as at column 2, line 58 in order to obtain a magaldrate "all sulfate" material and, to maintain a low sodium content for the final product, the use of potassium oxide (or hydroxide) is preferred over the disclosed sodium oxide.
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