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Sept. 13, 1966 S. M. BEEKMAN 3,272,704 \ EXAMPLE 2 Sept. 13, 1966 S. M. BEEKMAN 3,272,704 STABLE ALUMINUM HYDRdXIDE-MAGNESM COMPOUND CODRIED GEL ANTACIDS AND PROCESS OF MAKING THE SAME Filed June 6, 1963 3 Sheets-Sheet l. 90 ?? I T - ?. - ATOMC RATIO A : Mg = 2:1 ?O |-- CODE - EXAMPLE | - y DRY BLEND - —. — O 4O 8O 2O 6O 2OO TIME IN MINUTES -o- 90 ??? ??????, RATIO / \ AI: Mg= |:|| \\ CODE \ EXAMPLE 2. DRY BLEND - - - 30 O O 40 BO 2O 6O 2OO TME IN MINUTES -- Sept. 13, 1966 S. M. BEEKMAN 3,272,704 STABLE ALUMINUM HYDROXIDE-MAGNESIUM COMPOUND CODRIED GEL ANTACIDS AND PROCESS OF MAKING THE SAME Filed June 6, 1963 3 Sheets-Sheet 2 9.O ??T? -T- r -T- --- ?? ATOMIC RATIO / \\ A : Mg = O,5: 70 \\ CODE W EXAMPLE 3 DRY BLEND - - - A/G 3 ? 40 8O 2O SO 2OO TIME IN MINUTES -- 90 - - - - - - - - ----------------- ?-------------------------------------------------------------------????????? ?? ?1? ATOMC RATO Ai : Mg= 2:1 7? ? CODE - | \ CONTRO A | 1-\\ DRY BLEND - - - - O 40 8O 2O 6O 2OO TIME IN MINUTES -o- Sept. 13, 1966 S. M. BEEKMAN 3,272,704 STABLE ALUMINUM HYDROXIDE-MAGNESIUM COMPOUND CODRED GEL ANTACIDS AND PROCESS OF MAKING THE SAME Filed June 6, 1963 3. Sheets-Sheet 5 9.O ?- -- --- -----------------rr- ------------------------ ?????? RATIO ? =AI:Mg ||:| 7? fr\1 \\ CODE CONTROL B t 1 \ DRY BLEND - - - - A/G 5 O 4O 8O 2O SO 2OO TME IN MINUTES --- O 4O 8O 2O 16O. 2OO TIME IN MINUTES -a- 3,272,704 United States Patent Office Patented Sept. 13, 1966 1. 2 pepsin and it also does not significantly lose its antacid 3,272,704 characteristics in aging. However, as Edwards and SABEE ALUMINUM HYDROXIDE-MAGNESIUM. others have pointed out, it may have a mildly constipating COMPOUND CODREED GE, ANTACDS AND effect which many have sought to remedy by combining PROCESS OF MAKING THE SAME it with other ingredients such as magnesium hydroxide or Stewart M. Beekman, Chatham, N.J., assignor, by mesme carbonate. assignments, to Armour Pharmaceutical Company, The advantages of the dried gel are obvious. How Chicago, ii., a corporation of Delaware ever, the obvious material, dried aluminum hydroxide Filed June 6, 1963, Ser. No. 286,040 gel, is actually far from an ideal antacid. It exhibits a 16 Claims. (Cl. 167-55) lag in its rate of reaction with stomach acids. It does 10 not give a prolonged antacid in the optimum pH range This invention relates to antacid compositions, and, and its antacid properties are severely affected by pepsin. more particularly, to antacid compositions comprising Also, its antacid activity is less than that of the liquid aluminum hydroxide and magnesium hydroxide, carbon gel, being decreased by the drying and the reduced activ ate or silicate, mixed as wet gels and codried, and stabil ity decreases further with aging. These disadvantages ized by the addition of a hexitol, and to a process of pre 15 have been noted by Gwilt et al. and other workers in this paring the same. field. Antacid preparations are now quite generally em Rossett and Flexner, Ann. Internal Fed., 21, 1:19 ployed for the treatment of peptic ulcers, gastric hyper (1944) reported that mixtures of milk of magnesia (mag acidity and dyspepsia. Gwilt, Livingstone and Robert nesium hydroxide) with aluminum hydroxide gel were Son in the Journal of Pharmacy and Pharmacology, X, 20 more effective gastric antacids than aluminum hydroxide No. 12,770-775 (1958), describe the characteristics of alone. These conclusions were based on in vivo experi an ideal antacid. They point out that it should show ments on humans, together with extensive clinical experi its maximum neutralizing effect in the shortest possible ence. Rossett and Rice, Gastroenterology, 26,490 time, that it should neutralize an adequate amount of 25 (1954), Morrison, Am. J. Gastroenterology, 21, 301 gastric hydrochloric acid and maintain its action during (1954), and Jankelson, Am. J. Dig. Dis., 14, 11 (1947), the normal period of gastric digestion, that any excess reported that liquid aluminum magnesium hydroxide however great beyond the amount required to neutralize gels were effective for the treatment of peptic ulcer, hy free gastric acid should not cause alkalization, that it peracidity, heartburn, spasticity and gastritis. However, should raise the pH of the gastric contents to a level at simple mixtures of aluminum hydroxide and magnesium which pepsin activity is reduced significantly but not total 30 hydroxide dried gels have the disadvantage that they re ly inhibited, that adequate and repeated doses should be sult in a high undesirable initial rise in pH, and they also palatable to the hyperacid patient, and that its use should show a rapid diminution in antacid activity on aging. not lead to laxative, constipating or other side effects such This property is characteristic also of aluminum hy as gastric irritation. In addition to these factors the droxide dried gels. antacid composition should be inexpensive and it should In accordance with the invention, there is provided an not deteriorate significantly in any respect on aging. antacid composition composed of a codried mixture of These workers summarize the various statements in the aluminum hydroxide and a magnesium compound Se literature as to the pH ranges desirable for the ideal ant lected from the group consisting of magnesium hydroxide, acid, and conclude that a pH within the range from about 40 magnesium carbonate and magnesium trisilicate, together 3.5 to about 4.5 is apparently the optimum to ensure ade with a proportion of a hexitol. Such compositions have quate relief from hyperacidity, particularly if an ulcer a more prolonged antacid activity in the optimum pH site is present, and at the same time permits sufficient range of from 3 to 5 than corresponding dry blends com residual pepsin activity to avoid secondary digestive dis taining the same basic components in the same propor turbances. Edwards, in The Chemist and Druggist, December 14, 45 tions, and they do not display a high undesirable initial 1957, page 647, also discusses the properties of an ideal rise in pH. Furthermore, the compositions of the in antacid, and suggests that the nearest approach to the vention are relatively stable, and retain a very high ant ideal attained as of that date was wet activated alumina acid activity on aging, even after two years of storage. gel. Dr. Edwards' views of the properties of the ideal The aluminum hydroxide-magnesium compound co antacid are in substantial agreement with those expressed 50 dried gels in accordance with the invention approach the by Gwilt et al. theoretical requirements for an ideal antacid in dried Liquid aluminum hydroxide gel closely approaches the form, because they are capable of rapidly increasing the ideal for an antacid but its liquid form makes it incon pH of gastric juice to within the optimum range for very venient to use, especially in the case of ambulatory 55 long periods of time, of the order of two hours and more. patients. The liquid gel is quite rapid in its action and They do not display the initial high pH rise characteristic gives a prolonged antacid effect in the optimum pH range. of the magnesium component. They are nonsystemic, It is not significantly affected in its antacid properties by 3,272,704 3 and do not upset the acid-base balance of the blood. 4 They are not adversely affected by pepsin in antacid finely pulverized, or in the form of an aqueous solution, action. They are non-irritating to the gastrointestinal and thoroughly mixed therewith to ensure uniform dis tract. They have a desirable, mild astringent effect, with tribution throughout the composition. The amount of a minimal constipating or laxative effect. They are hexitol is not critical, but enough is used to give the desired palatable, with very little chalkiness, and rehydrate and effect on stability and pH. The amount can be within the swell in water to provide a gelatinous, positively changed range from 2 to 200% preferably within the range from protective coating for inflamed membranes. Further 15 to 35%, by weight of the hydrous gels, calculated more, they can be prepared at moderate cost, because of without the water content so as to correspond to the final the process of their preparation. codried composition weight. The proportions of aluminum hydroxide and magne O The final composition of the invention is in the form of sium compound in the codried gel are quite critical in a codried gel which in finely divided or powdered form is developing and maintaining a fast antacid action within generally soft, white, smooth, tasteless and odorless, and the pH range of from 3 to 5. The molecular ratio of the which reacts readily with gastric strength acid containing components is expressed herein, for simplicity, as the pepsin. The pH of aqueous suspensions of the stabilized atomic ratio Al:Mg, and this should be within the range 5 gels in accordance with invention is from about 9 to about from 2:1 to 0.25:1. Proportions of aluminum hydroxide 9.6 when aluminum hydroxy carbonate is used as the to give an Al:Mg ratio in excess of 2:1 can be used, with source of aluminum hydroxide. The carbonate content out disadvantageously affecting pH, but with the detri of the final mixture will be within the range from about ment that the composition is greatly slowed in its antacid 5 to about 12%, dependent principally upon the method action, so that the desired pH is not reached until a con 20 of drying. The spray-dried samples have spherically siderable time following administration, which is unde shaped particles and are free-flowing. The tray-dried and sirable. The proportion of magnesium compound can drum-dried compositions tend to be lump or flaky, but can exceed the Al:Mg ratio of 0.25:1, but when it does, the reduced to a powder by pulverizing.
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