Formulations for treating acid reflux comprising sodium alginate and vitamin b5

Abstract

The disclosure provides for compositions comprising an alginate salt, optionally sodium alginate, sodium bicarbonate, D-calcium pantothenate, cane sugar, citric acid, and potassium, bicarbonate for the treatment of an acid reflux disease.

Description

FORMULATIONS FOR TREATING ACID REFLUX COMPRISING SODIUM ALGINATE AND VITAMIN B5CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

[0001] This International Patent Application claims priority to U.S. Provisional Patent Application No. 63 / 585,675, filed September 27, 2023 and U.S. Provisional Patent Application No. 63 / 597,961, filed November 10, 2023, the disclosures of each of which are herein incorporated their entirety.FIELD

[0002] The disclosure provides for compositions, optionally pharmaceutical compositions, comprising an alginate salt, bicarbonate, vitamin B, sugar, and citric acid. Methods of using compositions described herein are further provided.BACKGROUND

[0003] Approximately one-quarter of the Western population exhibit symptoms of gastroesophageal reflux disease (or “GERD”) on at least a weekly basis. In fact, GERD is among the most frequent reasons for outpatient gastroenterology consultation.

[0004] GERD is a digestive disorder that affects the lower esophageal sphincter, the ring of muscle between the esophagus and stomach. GERD is characterized by the return of the stomach’s contents back up into the esophagus. In normal digestion, the lower esophageal sphincter opens, allowing food to pass into the stomach, and closes to prevent food and acidic stomach contents from flowing up and into the esophagus. GERD occurs when the lower esophageal sphincter is weak or relaxes inappropriately, thereby allowing the stomach’s contents to flow upward and into the esophagus.

[0005] Individuals with GERD commonly suffer from heartburn caused by the acidic stomach contents. More than 60 million Americans suffer from heartburn at least monthly, and more than 15 million adults suffer from heartburn on a daily basis.

[0006] Laryngopharyngeal reflux (or “LPR”) is another common reflux disease, which is characterized by stomach acid backing up into the back of the pharynx or larynx, or even into the back of the nasal airway. This reflux of acid can cause inflammation in areas not protected against gastric acid exposure. Unlike GERD, heartburn is not typically associated with LPR, and thus LPR is commonly referred to as “silent reflux.”

[0007] Stomach acid that accumulates and pools in the throat and larynx can cause long-term irritation and damage. Without treatment, such damage can be severe. In infants and children, irritation and damage caused by LPR can result in narrowing of the area below the vocal cord, contact ulcers, recurrent ear infections caused by problems with eustachian tube function, and lasting buildup of middle ear fluid. In adults, silent reflux can scar the pharynx and larynx and can increase risk of cancer in the area, affect the lungs, and may aggravate conditions such as asthma, emphysema, or bronchitis.

[0008] Moreover, chronic acid reflux, whether caused by GERD or LPR, can lead to a condition known as erosive esophagitis, in which the lining of the esophagus is inflamed and eroded away.

[0009] There is a need in the art for compositions for the treatment acid reflux diseases including, but not limited to, GERD, LPR and erosive esophagitis.SUMMARY

[0010] In an embodiment, a composition comprises (a) an alginate salt in an amount from about 250 mg to about 1,000 mg, (b) sodium bicarbonate in an amount from about 1 mg to about 250 mg, (c) D-calcium pantothenate (Vitamin B5) in an amount from about 1 mg to 250 mg, (d) citric acid in an amount from about 100 mg to 1,000 mg; (e) potassium bicarbonate in an amount from about 1 mg to about 500 mg. The composition can be a pharmaceutical composition.

[0011] In an embodiment, a pharmaceutical composition comprises (a) an alginate salt in an amount from about 250 mg to about 1,000 mg, (b) sodium bicarbonate in an amount from about 1 mg to about 250 mg, (c) D-calcium pantothenate (Vitamin B5) in an amount from about 1 mg to 250 mg, (d) citric acid in an amount from about 100 mg to 1,000 mg; (e) potassium bicarbonate in an amount from about 1 mg to about 500 mg.

[0012] In an embodiment, the alginate salt comprises sodium alginate. The alginate salt, optionally sodium alginate, can be in an amount from about 250 mg to about 1,000 mg, from about 300 mg to about 900 mg, from about 400 to about 600 mg, from about 300 to about 500 mg, from about 700 mg to about 900 mg, or from about 400 mg to about 600 mg. The alginate salt, optionally sodium alginate, can be in an amount 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411,412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430,431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449,450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620, 630,640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or 1,000 mg. The alginate salt, optionally sodium alginate, can be in an amount of about 425 mg.

[0013] In an embodiment, the sodium bicarbonate is in an amount from about 10 mg to about 200 mg, from about 20 mg to about 180 mg, from about 30 to about 170 mg, or from about 50 to about 150 mg. The sodium bicarbonate can be in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10,I I, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36,37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62,63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88,89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110,I I I, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, or 250 mg. The sodium bicarbonate can be in an amount of about 100 mg.

[0014] In an embodiment, the D-calcium pantothenate is in an amount from about 10 mg to about 200 mg, from about 20 mg to about 180 mg, from about 30 to about 170 mg, or from about 50 to about 150 mg. The D-calcium pantothenate can be in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59,60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85,86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108,109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140, 150, 160, 170, 180, 190,200, 210, 220, 230, 240, or 250 mg. The D-calcium pantothenate can be in an amount of about 100 mg.

[0015] In an embodiment, the citric acid is in an amount from about 100 mg to about 800 mg, from about 200 mg to about 600 mg, from about 300 to about 700 mg, or from about 450 to about 550 mg. The citric acid can be in an amount of about 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140, 150, 160, 170,180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295, 300, 310, 320, 330, 340, 350,360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414,415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433,434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 451, 452,453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 471,472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487, 488, 489, 490,491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 501, 502, 503, 504, 505, 506, 507, 508, 509,510, 511, 512, 513, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523, 524, 525, 526, 527, 528,529, 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547,548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 563, 564, 565, 566,567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579, 580, 581, 582, 583, 584, 585,586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, 610, 620, 630, 640,650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810, 820, 830,840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or 1,000 mg. The citric acid can be in an amount of about 500 mg.

[0016] In an embodiment, the potassium bicarbonate is in an amount from about 200 mg to about 500 mg, from about 200 mg to about 400 mg, from about 100 to about 300 mg, or from about 150 to about 350 mg. The potassium bicarbonate can be in an amount of about 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120,130, 140, 150, 160, 170, 180, 190, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211,212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227, 228, 229, 230,231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246, 247, 248, 249,250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 270, 280, 290, 300, 310, 320, 330, 340,350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413,414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432,433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 451,452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470,471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487, 488, 489,490, 491, 492, 493, 494, 495, 496, 497, 498, 499, or 500 mg. The potassium bicarbonate can be in an amount of about 250 mg.

[0017] In an embodiment, the composition, optionally a pharmaceutical composition, can further comprise a sugar in an amount from about 4,000 mg to 5,000 mg. The sugar can be in an amount from about 4,100 mg to 4,900 mg; 4,250 mg to 4,750 mg; 4,400 mg to 4,700 mg; or 4,400 mg to 4,600 mg. The sugar can be an amount of about 4,000 mg, 4,100 mg, 4,200 mg, 4,300 mg, 4,400 mg, 4,500 mg, 4,600 mg, 4,700 mg, 4,800 mg, 4,900 mg, or 5,000 mg. The sugar can be in anamount of about 4,500 mg. The sugar can be sucrose, cane sugar, brown sugar, fructose, sucralose, or a combination thereof. The sugar can be cane sugar.

[0018] In an embodiment, the composition, optionally a pharmaceutical composition, further comprises one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, optionally nature flavor(s), or a combination thereof. The natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof can be in an amount of about 100 mg to about 2000 mg. The natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof can be in an amount between about 100 mg and 1,000 mg; 250 mg and 1,750 mg; 500 mg, and 1,500 mg; or 750 mg and 1,250 mg. The natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof can be in an amount about 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407,408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426,427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445,446, 447, 448, 449, 450, 451, 452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464,465, 466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483,484, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 501, 502,503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 517, 518, 519, 520, 521,522, 523, 524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540,541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559,560, 561, 562, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578,579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597,598, 599, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760,770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950,960, 970, 980, 990, 1,000, 1100, 1200, 1210, 1220, 1230, 1240, 1250, 1260, 1270, 1280, 1290, 1295, 1300, 1310, 1320, 1330, 1340, 1350, 1360, 1370, 1380, 1390, 1400, 1401, 1402, 1403,1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418,1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427, 1428, 1429, 1430, 1431, 1432, 1433,1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1444, 1445, 1446, 1447, 1448,1449, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1459, 1460, 1461, 1462, 1463,1464, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474, 1475, 1476, 1477, 1478,1479, 1480, 1481, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1489, 1490, 1491, 1492, 1493,1494, 1495, 1496, 1497, 1498, 1499, 1500, 1501, 1502, 1503, 1504, 1505, 1506, 1507, 1508,1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1519, 1520, 1521, 1522, 1523,1524, 1525, 1526, 1527, 1528, 1529, 1530, 1531, 1532, 1533, 1534, 1535, 1536, 1537, 1538,1539, 1540, 1541, 1542, 1543, 1544, 1545, 1546, 1547, 1548, 1549, 1550, 1551, 1552, 1553,1554, 1555, 1556, 1557, 1558, 1559, 1560, 1561, 1562, 1563, 1564, 1565, 1566, 1567, 1568,1569, 1570, 1571, 1572, 1573, 1574, 1575, 1576, 1577, 1578, 1579, 1580, 1581, 1582, 1583,1584, 1585, 1586, 1587, 1588, 1589, 1590, 1591, 1592, 1593, 1594, 1595, 1596, 1597, 1598,1599, 1600, 1610, 1620, 1630, 1640, 1650, 1660, 1670, 1680, 1690, 1700, 1710, 1720, 1730,1740, 1750, 1760, 1770, 1780, 1790, 1800, 1810, 1820, 1830, 1840, 1850, 1860, 1870, 1880,1890, 1900, 1910, 1920, 1930, 1940, 1950, 1960, 1970, 1980, 1990, or 2,000 mg.

[0019] In an embodiment, the artificial sweetener is stevia extract.

[0020] In an embodiment, the composition further comprises calcium carbonate is in an amount from about 10 mg to 100 mg. The calcium carbonate can be in an amount from about 10 mg to about 75 mg, from about 20 mg to about 80 mg, from about 30 to about 70 mg, and from about 40 to about 60 mg. The calcium carbonate can be in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35,36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61,62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87,88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mg.

[0021] In an embodiment, the composition, optionally a pharmaceutical composition, is in the form of a capsule, tablet, or powder.

[0022] In an embodiment, the composition, optionally a pharmaceutical composition, is not in the form of tablet and only in the form of a capsule and / or powder formulations.

[0023] In an embodiment, the composition, optionally a pharmaceutical composition, is formulated as a capsule dosage form.

[0024] In an embodiment, the composition, optionally a pharmaceutical composition, is formulated as a powder dosage form.

[0025] In an embodiment, the composition, optionally a pharmaceutical composition, is mixed with water.

[0026] In an embodiment, the composition, optionally a pharmaceutical composition, is dissolved in between about 100 mb and 1,000 mL of water. The composition can be dissolved in about 100 mL, 200 mL, 300 mL, 400 mL, 425 mL, 450 mL, 475 mL, 500 mL, 525 mL, 550 mL, 575 mL, 600 mL, 650 mL, 675 mL, 700 mL, 800 mL, 900 mL, or 1,000 mL of water.

[0027] In an embodiment, the composition, optionally a pharmaceutical composition, does not comprise an H2 blocker.

[0028] In an embodiment, the composition, optionally a pharmaceutical composition, does not comprise a proton pump inhibitor.

[0029] In an embodiment, the composition, optionally a pharmaceutical composition, further comprises a preservative, optionally Nipagin, Nipasol, alcohol, antimicrobial agents, benzoic acid, sodium benzoate, polylysine, benzyl alcohol, sorbic acid, grapefruit seed extract, parabens, isopropyl alcohol, or a mixture thereof.

[0030] In an embodiment, the composition, optionally a pharmaceutical composition, further comprises an inert diluent, optionally dibasic calcium phosphate, kaolin, water, optionally deionized water, lactose, dextrose, magnesium carbonate, sucrose, mannitol, microcrystalline cellulose, powdered cellulose, precipitated calcium carbonate, calcium sulfate, sorbitol, starch, or a mixture thereof.

[0031] In an embodiment, the composition, optionally a pharmaceutical composition, is formulated as a powder, hard capsule, soft capsule, pill, gel, gum, compressed tablets manufactured from a composition, gel, gum, colloid, suspension, paste, or a slurry.

[0032] In an embodiment, the composition, optionally a pharmaceutical composition, is formulated as a gel.

[0033] In an embodiment, the composition, optionally a pharmaceutical composition, is formulated as a gum.

[0034] In an embodiment, the composition, optionally a pharmaceutical composition, does not dissolve in a solution, optionally water.

[0035] In an embodiment, a method of treating acid reflux disease in an individual in need thereof, can comprise administering to an individual in need thereof a composition, optionally a pharmaceutical composition, described herein.

[0036] In an embodiment, the acid reflux disease is gastroesophageal reflux disease, laryngopharyngeal reflux, or erosive esophagitis.

[0037] In an embodiment, the acid reflux disease is gastroesophageal reflux disease.

[0038] In an embodiment, the acid reflux disease is laryngopharyngeal reflux.

[0039] In an embodiment, the acid reflux disease is erosive esophagitis.

[0040] In an embodiment, the acid reflux disease is not gastroesophageal reflux disease.

[0041] In an embodiment, the acid reflux disease is not gastroesophageal reflux disease and only patients diagnosed with laryngopharyngeal reflux are treated.

[0042] In an embodiment, the composition is in the form of a powder dosage form is dissolved in one-quarter or half cup of water.

[0043] In an embodiment, the composition is formulated to be administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day to a patient in need thereof.

[0044] In an embodiment, the composition is formulated is administered in a dose of two capsules at a rate of two, three, or four times daily to a patient in need thereof.

[0045] In an embodiment, the two capsules are formulated to be administered to a patient in need thereof at a rate of about three times daily.

[0046] Definitions

[0047] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In case of conflict, the present document, including definitions, will control. Preferred methods and materials are described below, although methods and materials similar or equivalent to those described herein can be used in practice or testing of the present invention. All publications, patent applications, patents and other references mentioned herein are incorporated by reference in their entirety. The materials, methods, and examples disclosed herein are illustrative only and not intended to be limiting.

[0048] “Acid reflux disease,” as used herein, refers broadly to any disease or condition characterized by stomach contents coming back up, or refluxing, into the esophagus resulting in symptoms or complications, including the taste of acid in the back of the mouth, heartburn, bad breath, chest pain, vomiting, burping, dyspepsia, respiratory problems, erosion of the teeth, esophagitis, esophageal strictures, and Barrett’s esophagus.

[0049] ‘ ‘Proton pump inhibitor,” as used herein, refers broadly to any agent within the class of antisecretory compounds, which suppress gastric acid secretion by irreversible inhibition of the H+ / K+ ATPase enzyme system at the secretory surface of the parietal cell.

[0050] ‘ ‘H2 blocker,” as used herein, refers to any agent within the class of antisecretory compounds, which suppress the normal secretion of gastric acid by parietal cells and the meal- stimulated secretion of acid by blocking the binding of histamine to H2 receptors in parietal cells in the lining of the fundus and the body of the stomach.

[0051] “Effective amount,” as used herein, refers broadly to the amount of an agent, e.g., a compound, antibody, vector or cells that, when administered to a patient for treating a disease, is sufficient to affect such treatment for the disease. The effective amount can be an amount effective for prophylaxis, and / or an amount effective for prevention. The effective amount can be an amount effective to reduce, an amount effective to prevent the incidence of signs / symptoms, to reduce the severity of the incidence of signs / symptoms, to eliminate the incidence of signs / symptoms, to slow the development of the incidence of signs / symptoms, to prevent the development of the incidence of signs / symptoms, and / or effect prophylaxis of the incidence of signs / symptoms. The “effective amount” can vary depending on the disease and its severity and the age, weight, medical history, susceptibility, and pre-existing conditions, of the patient to be treated. The term “effective amount” is synonymous with “therapeutically effective amount” for purposes described herein.

[0052] “ Gastrointestinal disorder,” as used herein, refers broadly to any infection, disease or other disorder(s) of the upper gastrointestinal tract. Such disorders include, for example, heartburn; sour stomach; acid ingestion; upset stomach and / or pain associated with heartburn, sour stomach and acid ingestion; bloating; fullness; dyspepsia; hiatus hernia; esophagitis; nocturnal heartburn; erosive esophagitis; disorders not manifested by the presence of ulcerations in the gastric mucosa, including chronic active or atrophic gastritis, Zollinger-Ellison syndrome; non-ulcer dyspepsia, esophageal reflux disease and gastric motility disorders; peptic ulcer disease, i.e., pre-pyloric, marginal, and / or gastric, duodenal ulcers; and combinations thereof. Preferred for treatment by the present invention includes heartburn with and without stomach pain, dyspepsia, esophagitis, chronic active or atrophic gastritis and esophageal reflux disease. Preferred for treatment by the compositions described herein comprises heartbum with and without stomach pain, dyspepsia, esophagitis, chronic active or atrophic gastritis and esophageal reflux disease.

[0053] “Mammal,” as used herein, refers broadly to any and all warm-blooded vertebrate animals of the class Mammalia, characterized by a covering of hair on the skin and, in thefemale, milk-producing mammary glands for nourishing the young. Mammals include, but are not limited to, humans, domestic and farm animals, and zoo, sports, or pet animals. Similarly, the term “subject” or “patient” includes both human and veterinary subjects and / or patients. The mammal can be a human. The subject or patient can be a human.

[0054] “Protection of the stomach and intestine,” as used herein, refers broadly to the prevention and / or treatment of gastrointestinal diseases, in particular those which are non-cancerous in origin, especially gastrointestinal inflammatory diseases and lesions (such as, for example, gastric ulcer, duodenal ulcer, gastritis and stomach irritation caused by hyperacidity or medicaments), which can be caused, for example, by microorganisms, bacterial toxins, medicaments (for example certain anti-inflammatories and antirheumatics), other chemicals (for example ethanol), gastric acid or stress situations.

[0055] “ Treatment” refers broadly to both therapeutic treatment and prophylactic or preventative measures. Those in need of treatment include those already with the disorder as well as those in which the disorder is to be prevented. As used herein, the term “treating,” refers broadly to treating a disease, arresting, or reducing the development of the disease or its clinical symptoms, and / or relieving the disease, causing regression of the disease or its clinical symptoms. Therapy encompasses prophylaxis, treatment, remedy, reduction, alleviation, and / or providing relief from a disease, signs, and / or symptoms of a disease. Therapy encompasses an alleviation of signs and / or symptoms in patients with ongoing disease signs and / or symptoms. Therapy also encompasses “prophylaxis”. The term “reduced”, for purpose of therapy, refers broadly to the clinical significant reduction in signs and / or symptoms. Therapy includes treating relapses or recurrent signs and / or symptoms. Therapy encompasses but is not limited to precluding the appearance of signs and / or symptoms anytime as well as reducing existing signs and / or symptoms and eliminating existing signs and / or symptoms. Therapy includes treating chronic disease (“maintenance”) and acute disease. For example, treatment includes treating or preventing relapses or the recurrence of signs and / or symptoms.DETAILED DESCRIPTIONAcid Reflux Diseases

[0056] Presently, there are no commercially available, approved medications for treating LPR specifically. All currently available reflux medications are directed to treating GERD.

[0057] Suggested management of LPR includes: following a bland diet (i.e., low acid levels, low in fat, not spicy); eating frequent, small meals; weight loss; avoiding alcohol, tobacco and caffeine; not eating within two hours before going to bed; and sleeping with the head and torso raised to prevent reflux into the throat. Accordingly, there is a need to develop compositions and / or methods that are capable of treating LPR.

[0058] Existing drugs for treating GERD include H2 receptor antagonists and proton pump inhibitors.

[0059] H2 receptor antagonists (or “H2 blockers”) were the first effective drugs for peptic ulcer and have been a mainstay of treatment for ulcers, GERD, and LPR.

[0060] In addition to affecting Hl receptors on the nasal mucosa, bronchi, and skin that participate in allergic reactions such as hay fever and hives, histamine also stimulates cells in the stomach lining to produce hydrochloric acid. H2 blockers compete with histamine for H2 receptors on the stomach’s parietal cells, thereby leading to a decrease in production of hydrochloric acid. Acid-suppression lasts for several hours, allowing peptic ulcers to heal. Additionally, H2 blockers counteract the corrosive effects of refluxing acid.

[0061] However, unwanted side effects and possible interactions with other drugs are associated with H2 blockers. For example, safety has not been proven in pregnant women and H2 blockers appear in breast milk. Furthermore, H2 blockers are not the most effective drug for treating GERD, LPR, and other reflux diseases.

[0062] Presently, proton pump inhibitors are the most common modern pharmacologic class for treatment of hyperacidity and reflux associated therewith. They act by selectively blocking the H+-K+-ATPase enzyme of stomach parietal cells, resulting in a reduction in production of acid by stomach parietal cells. Examples of proton pump inhibitors used for treating reflux include omeprazole, lansoprazole, esomeprazole, pantoprazole, rabeprazole and the like.

[0063] Although, proton pump inhibitors are known to be effective in patients with GERD, LPR, and erosive esophagitis, and are among the most commonly recommended medications for treatment of acid reflux, proton pump inhibitors have been found to be unsuccessful in suppressing acid in some patients.

[0064] Moreover, proton pump inhibitors do not have immediate effect. Their effect is long because they necessarily have to be absorbed in order to exert their activity. Therefore, for example, absorption of omeprazole takes place in the small intestine and is completed withinthree to six hours. Furthermore, even after absorption has taken place, proton pump inhibitors may not begin working until as late as an additional 24 hours later. This behavior causes some technical inconveniencies for the design of a composition.

[0065] Similarly, in several randomized, placebo-controlled trials of proton-pump inhibitors in the treatment of LPR, it has been found that a majority of patients with LPR experienced no significant benefit in symptom scores as compared to the placebo.

[0066] Suppression of gastric reflux should be effective against both vagally mediated throat clearing and coughing responses caused by irritation of the distal esophagus, and laryngeal injury caused by direct contact with erosive gastric refluxate. However, in the case of proton pump inhibitors, reflux is only modified by removal of its acid component, rather than prevented completely. Other damaging gastric reflux components such as pepsins and bile acids may still be present and active even in the absence of strong gastric acid.Alginate Containing Compositions

[0067] The inventor found that alginate-containing compositions successfully treat and prevent acid reflux diseases, even in the absence of proton pump inhibitors and H2 blockers. To date, compositions comprising proton pump inhibitors or H2 blockers as active ingredients have been preferred for treating reflux diseases.

[0068] The post-prandial acid pocket is an area of unbuffered gastric acid that accumulates in the proximal stomach following meals and which serves as a reservoir for acid reflux in both healthy individuals and acid reflux patients. The acid pocket is an attractive target for reflux treatment.

[0069] Alginates treat reflux diseases via a unique mechanism by creating a mechanical barrier, or raft, in the fundus of the stomach, which displaces the acid pocket in the proximal stomach. Although increasing evidence indicates that alginates displace the post-prandial acid pocket and thus inhibit acid exposure in the esophagus.

[0070] When alginates come into contact with gastric acid, a mechanical foam barrier is formed. The resulting barrier physically prevents any refluxing acid from ascending into the esophagus or pharynx. The foam barrier can last for several hours, allowing for prolonged relief from reflux symptoms.

[0071] Specifically, when sodium alginate comes into contact with gastric acid, alginic acid is formed, which is an insoluble linear polymer. Preferably, an alginic acid raft that persists for aprolonged period can be formed by adding components such as sodium bicarbonate and calcium carbonate. The addition of sodium bicarbonate allows for a reaction between gastric acid and sodium bicarbonate, which gives off carbon dioxide. The carbon dioxide gas driven off by this reaction aids in lifting the raft to the surface of the stomach contents where the raft can prevent reflux. The compositions described herein, in an embodiment, do not dissolve in a solution, instead they form a solid raft that floats to the fundus of the stomach, which displaces the acid pocket in the proximal stomach, and forms a mechanical barrier. This raft physically prevents the reflux of stomach contents, optionally stomach acid, into the esophogus.

[0072] The addition of calcium carbonate provides a further source of carbon dioxide, as well as a source of calcium ions. Calcium ions are useful for cross-linking the alginic acid polymer formed by reacting sodium alginate with gastric acid, thereby stabilizing the alginic acid raft for prolonged reflux relief.

[0073] Prolonged stabilization of the alginic acid raft is preferred as the raft is gradually broken up over time mechanically by stomach contractions.

[0074] By providing an impediment to distal esophageal acid exposure, alginates are a promising class for treatment and prevention of acid reflux diseases, especially for individuals who do not respond to anti -secretory therapies such as proton pump inhibitors or H2 blockers.

[0075] As compared to proton pump inhibitors and H2 blockers, alginates have been found to provide superior benefit over antacids and could be considered as an initial treatment for patients, in particular for patients for whom chronic acid suppression is either undesirable or unnecessary.

[0076] Further, the sodium alginate is a thickening agent that forms a raft over the acid pocket in the stomach. The stomach acid precipitates alginic acid and forms carbon dioxide to form the buoyant raft. Calcium ions strengthen the raft. Where the acid pocket may have a pH of around 1.5, the pH above the raft is closer to neutral, e.g., pH 7.0. This prevents the stomach acid from coming up into the patient’s esophagus and throat. Calcium carbonate and sodium bicarbonate help strengthen the raft and neutralize acid in the stomach.

[0077] Unlike proton pump inhibitors, which require absorption over the course of three to six hours and may take up to an additional 24 hours to work, alginates show immediate effect. Control of hyperacidity by alginates is rapid as they act in the stomach, not the small intestine, and require no prior absorption.

[0078] To date, alginates have been incorporated only as inactive ingredients and the medical and pharmaceutical communities have favored usage of proton pump inhibitors and / or H2 blockers.

[0079] However, the inventor found that alginates provide a promising alternative for reflux treatment as active ingredients.Alginate

[0080] The compositions described herein can comprise one or more alginates as an active ingredient in an amount from about 1.0 mg to about 10,000 mg, or from about 5.0 mg to about 5,000 mg, or from about 10 mg to about 2,500 mg, or from about 100 mg to about 1,000 mg, depending on the severity of the condition being treated, the nature of the oral formulation and the age, weight and condition of the patient. The compositions described herein can be a pharmaceutical composition. The compositions described herein can be pharmaceutical compositions.

[0081] The alginate can be sodium alginate.

[0082] The alginate salt can comprise sodium alginate.

[0083] The alginate salt, optionally sodium alginate, can be in an amount from about 250 mg to about 1,000 mg, from about 300 mg to about 900 mg, from about 400 to about 600 mg, from about 450 mg to about 550 mg, from about 450 mg to about 500 mg, from about 300 to about 500 mg, from about 700 mg to about 900 mg, from about 400 mg to about 600 mg, from about 100 mg to 10,000 mg, or from about 400 mg to 10,000 mg.

[0084] The composition described herein can comprise an alginate salt, optionally sodium alginate, in an amount of about 100, 125, 150, 175, 200, 225, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410,411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429,430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448,449, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620,630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810,820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or1,000 mg.

[0085] The composition described herein can comprise an alginate salt, optionally sodium alginate, in an amount of about 200 mg, 300 mg, 400 mg, 500 mg, 900 mg, 1,000 mg, 2,000 mg, 3,000 mg, 4,000 mg, 5,000 mg, 6,000 mg, 7,000 mg, 8,000 mg, 9,000 mg, or 10,000 mg. For example, the alginate salt, optionally sodium alginate, can be in an amount from about 100 mg to 10,000 mg, 500 mg to 5,000 mg, or 400 mg to 10,000 mg.

[0086] The composition described herein can comprise an alginate salt, optionally sodium alginate, in an amount of about 425 mg. The composition can be a pharmaceutical composition.

[0087] The composition described herein, in an embodiment, does not dissolve in a solution, optionally water. Instead, the alginate raft forms in situ and floats to the fundus of the stomach, which displaces the acid pocket in the proximal stomach, and forms a mechanical barrier.Sodium Bicarbonate

[0088] The compositions described herein can comprise sodium bicarbonate. The compositions described herein can be a pharmaceutical composition.

[0089] Sodium bicarbonate is a known antacid. As a component of the present invention, sodium bicarbonate is useful in neutralizing the gastric acid beneath the foam barrier formed by sodium alginate coming into contact with the gastric acid. Thus, the mechanism of this embodiment of the present invention is two-fold, comprising the formation of a mechanical barrier to prevent reflux, and further comprising the neutralization of the acid contained by the foam barrier.

[0090] Sodium bicarbonate can neutralize the gastric acid beneath the foam barrier formed by sodium alginate coming into contact with the gastric acid. Thus, the mechanism of this embodiment of the compositions described herein is two-fold, comprising the formation of a mechanical barrier to prevent reflux, and further comprising the neutralization of the acid contained by the foam barrier.

[0091] Additionally, reaction of sodium bicarbonate with gastric acid produces carbon dioxide gas, which assists in lifting the alginic acid raft to the stomach contents’ surface.

[0092] The composition described herein can comprise sodium bicarbonate in an amount from about 10 mg to about 1,000 mg, or from about 50 mg to about 500 mg, or from about 10 mg to about 125 mg, or from about 125 mg to about 175 mg. For example, the sodium bicarbonate can be in an amount from about 10 mg to 5,000 mg, 10 mg to 1,000 mg, 25 mg to 2,500 mg, 30 mg to 3,000 mg, 400 mg to 4,000 mg, or 10 mg to 5,000 mg.

[0093] The composition described herein can comprise sodium bicarbonate in an amount of about 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408,409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427,428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446,447, 448, 449, 450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600,610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790,800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980,990, or 1,000 mg.

[0094] The composition described herein can comprise sodium bicarbonate in an amount of about 1,000 mg, 1,100 mg, 1,200 mg, 1,300 mg, 1,400 mg, 1,500 mg, 1,600 mg, 1,700 mg, 1,800 mg, 1,900 mg, 2,000 mg, 2,100 mg, 2,200 mg, 2,300 mg, 2,400 mg, 2,500 mg, 2,600 mg, 2,700 mg, 2,800 mg, 2,900 mg, 3,000 mg, 3,100 mg, 3,200 mg, 3,300 mg, 3,400 mg, 3,500 mg, 3,600 mg, 3,700 mg, 3,800 mg, 3,900 mg, 4,000 mg, 4,100 mg, 4,200 mg, 4,300 mg, 4,400 mg, 4,500 mg, 4,600 mg, 4,700 mg, 4,800 mg, 4,900 mg, or 5,000 mg. The compositions described herein can be a pharmaceutical composition.Calcium Carbonate

[0095] The composition described herein can further comprises calcium carbonate. The compositions described herein can be a pharmaceutical composition.

[0096] Calcium carbonate is a known antacid. Thus, compositions comprising calcium carbonate are useful for neutralizing increased acidity in the stomach. Additionally, reaction of calcium carbonate with gastric acid produces carbon dioxide gas, which assists in lifting the alginic acid raft to the stomach contents’ surface.

[0097] The composition described herein can comprise calcium carbonate in an amount from about 1.0 mg to about 1,000 mg, from about 1 mg to 5,000 mg, from about 5.0 mg to about 500 mg, from about 10 mg to about 100 mg, or from about 25 to about 75 mg. The composition described herein can further comprise calcium carbonate is in an amount from about 10 mg to about 75 mg, from about 20 mg to about 80 mg, from about 30 to about 70 mg, and from about 40 to about 60 mg.

[0098] The composition described herein can comprise calcium carbonate in an amount from about 1.0 mg to about 5,000 mg, 5.0 mg to about 2,500 mg, or from about 10 mg to about 1,000mg, or from about 25 to about 4,750 mg. The composition described herein can comprise calcium carbonate is in an amount from about 10 mg to about 75 mg, from about 20 mg to about 80 mg, from about 30 to about 70 mg, and from about 40 to about 60 mg.

[0099] The composition described herein can comprise calcium carbonate in an amount from about 1 mg to about 1,000 mg, or from about 5 mg to about 5,000 mg, or from about 1 mg to about 1,250 mg, or from about 12.5 mg to about 1,750 mg. For example, the sodium bicarbonate can be in an amount from about 1 mg to 5,000 mg, 1 mg to 1,000 mg, 2.5 mg to 2,500 mg, 3 mg to 3,000 mg, 4 mg to 4,000 mg, or 10 mg to 5,000 mg.

[0100] The composition described herein can comprise calcium carbonate is in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53,54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, or 100 mg.

[0101] The composition described herein can comprise calcium carbonate in an amount of about 1,000 mg, 1,100 mg, 1,200 mg, 1,300 mg, 1,400 mg, 1,500 mg, 1,600 mg, 1,700 mg, 1,800 mg,1,900 mg, 2,000 mg, 2,100 mg, 2,200 mg, 2,300 mg, 2,400 mg, 2,500 mg, 2,600 mg, 2,700 mg,2,800 mg, 2,900 mg, 3,000 mg, 3,100 mg, 3,200 mg, 3,300 mg, 3,400 mg, 3,500 mg, 3,600 mg,3,700 mg, 3,800 mg, 3,900 mg, 4,000 mg, 4,100 mg, 4,200 mg, 4,300 mg, 4,400 mg, 4,500 mg,4,600 mg, 4,700 mg, 4,800 mg, 4,900 mg, or 5,000 mg. The composition can be a pharmaceutical composition.D-calcium pantothenate (Vitamin B5)

[0102] The composition described herein can comprise D-calcium pantothenate (Vitamin B5) in an amount from about 1 mg to 250 mg. The compositions described herein can be a pharmaceutical composition.

[0103] The composition described herein can comprise D-calcium pantothenate in an amount from about 10 mg to about 200 mg, 100 mg to about 1,000 mg, from about 20 mg to about 180 mg, from about 30 to about 170 mg, from 10 mg to 1,000 mg, from about 50 to about 150 mg.

[0104] The composition described herein can comprise D-calcium pantothenate in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79,80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140,150, 160, 170, 180, 190, 200, 210, 220, 225, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320,330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411,412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430,431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449,450, 460, 470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620, 630,640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810, 820,830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or 1,000 mg.

[0105] The composition described herein can comprise D-calcium pantothenate in an amount of about 100 mg. The composition can be a pharmaceutical composition.Citric Acid

[0106] The composition described herein can comprise citric acid in an amount between about 100 mg and 1,000 mg. The compositions described herein can be a pharmaceutical composition.

[0107] As a component of the present invention, citric acid is used to enhance the flavor of powder formulations, which optionally may comprise further flavorants and / or sweeteners.Furthermore, the citric acid and sodium bicarbonate components react to cause an effervescent effect whereby carbon dioxide bubbles are produced when the powder formulation is dissolved in water. The citric acid and sodium bicarbonate components react to cause an effervescent effect whereby carbon dioxide bubbles are produced when the formulation is dissolved in water.

[0108] Also, the citric acid and sodium bicarbonate components react to cause an effervescent effect whereby carbon dioxide bubbles are produced when the formulation is dissolved in water. The citric acid and sodium bicarbonate components react to cause an effervescent effect whereby carbon dioxide bubbles are produced when the formulation is dissolved in water.

[0109] Citric acid is used to enhance the flavor of compositions described herein, which optionally may comprise further flavorants and / or sweeteners.

[0110] The composition described herein can comprise citric acid in an amount from about 10 mg to about 10,000 mg, or from about 100 mg to about 5,000 mg, or from about 250 mg to about 1,000 mg, or from about 250 mg to about 750 mg.[oui] The composition described herein can comprise citric acid in an amount from about 100 mg to about 800 mg, from about 200 mg to about 600 mg, from about 300 to about 700 mg, or from about 450 to about 550 mg.

[0112] The composition described herein can comprise citric acid in an amount of about 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119,120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295,300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408,409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427,428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446,447, 448, 449, 450, 451, 452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465,466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484,485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 501, 502, 503,504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 517, 518, 519, 520, 521, 522,523, 524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541,542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560,561, 562, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579,580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598,599, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770,780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960,970, 980, 990, or 1,000 mg.

[0113] The composition described herein can comprise citric acid in an amount of about 500 mg. The composition can be a pharmaceutical composition.

[0114] Potassium Bicarbonate

[0115] The composition described herein can comprise potassium bicarbonate in an amount of about 250 mg. The composition can be a pharmaceutical composition.

[0116] The composition described herein can comprise potassium bicarbonate in an amount from about 200 mg to about 500 mg, from about 200 mg to about 400 mg, from about 100 to about 300 mg, from about 150 to about 350 mg, from about 200 mg to 1,000 mg, from about 500 mg to 750 mg, from about 300 mg to 900 mg, or 750 mg to 1,000 mg.

[0117] The composition described herein can comprise potassium bicarbonate in an amount of about 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117,118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 201, 202, 203, 204, 205, 206, 207, 208,209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227,228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245, 246,247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259, 260, 270, 280, 290, 300, 310,320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410,411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429,430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448,449, 450, 451, 452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467,468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486,487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 510, 520, 530, 540, 550,560, 570, 580, 590, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740,750, 760, 770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930,940, 950, 960, 970, 980, 990, or 1,000 mg.

[0118] The composition described herein can comprise potassium bicarbonate in an amount of about 250 mg. The compositions described herein can be a pharmaceutical composition.Sweeteners

[0119] The composition described herein can further comprise one or more natural or artificial sweeteners. Natural and artificial sweeteners include but are not limited to stevia extract, sucrose, acesulfame potassium, cane sugar, aspartame, neotame, saccharin, sucralose, sorbitol, xylitol, mannitol, or combinations thereof.

[0120] The sweetener can be stevia extract.

[0121] The composition described herein can further comprise a sugar in an amount from about 500 mg to about 4,000 mg, about 1,000 mg to about 5,000 mg, 4,000 mg to 5,000 mg, over 50 mg, over 100 mg, over 200 mg, over 500 mg, over 1000 mg, over 2000 mg. The composition described herein can further comprise a sugar in an amount from about 4,100 mg to 4,900 mg; 4,250 mg to 4,750 mg; 4,400 mg to 4,700 mg; or 4,400 mg to 4,600 mg. The composition described herein can further comprise a sugar in an amount of about 4,000 mg, 4,100 mg, 4,200 mg, 4,300 mg, 4,400 mg, 4,500 mg, 4,600 mg, 4,700 mg, 4,800 mg, 4,900 mg, or 5,000 mg. The composition described herein can further comprise a sugar in an amount of about 4,500 mg. The sugar can be sucrose, cane sugar, brown sugar, fructose, sucralose, or a combination thereof. The sugar can be cane sugar. In an aspect, the sugar may be artificial sugar or sugar alcohol.Natural and / or Artificial Flavorants

[0122] The composition described herein can further comprise one or more natural or artificial flavorants. Natural flavorants include, but are not limited to, essential oils, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose significant function in food is flavoring rather than nutritional. Artificial flavorants include, but are not limited to, any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof.

[0123] The composition described herein can further comprise an artificial or natural sweetener or flavorant in an amount from about 1.0 mg to about 10,000 mg, or from about 10 mg to about 5,000 mg, or from about 100 mg to about 1,000 mg, or from about 250 mg to about 750 mg, over 10 mg, over 100 mg, over 250 mg, over 500 mg. The composition can be a pharmaceutical composition.

[0124] The composition described herein can further comprise one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof. The composition can be a pharmaceutical composition.

[0125] The composition described herein can further comprise one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof in an amount of about 100 mg to about 2000 mg. The composition can be a pharmaceutical composition.

[0126] The composition described herein can further comprise one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof in an amount between about 100 mg and 1,000 mg; 250 mg and 1,750 mg; 500 mg, and 1,500 mg; or 750 mg and 1,250 mg.

[0127] The composition, optionally a pharmaceutical composition, described herein can further comprise one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof in an amount of about 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405,406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424,425, 426, 427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443,444, 445, 446, 447, 448, 449, 450, 451, 452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462,463, 464, 465, 466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481,482, 483, 484, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500,501, 502, 503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 517, 518, 519,520, 521, 522, 523, 524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538,539, 540, 541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557,558, 559, 560, 561, 562, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576,577, 578, 579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595,596, 597, 598, 599, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740,750, 760, 770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930,940, 950, 960, 970, 980, 990, 1,000 mg, 1100, 1200, mg 1210, 1220, 1230, 1240, 1250, 1260, 1270, 1280, 1290, 1295, 1300, 1310, 1320, 1330, 1340, 1350, 1360, 1370, 1380, 1390, 1400,1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414, 1415,1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427, 1428, 1429, 1430,1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1444, 1445,1446, 1447, 1448, 1449, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1459, 1460,1461, 1462, 1463, 1464, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474, 1475,1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1489, 1490,1491, 1492, 1493, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1501, 1502, 1503, 1504, 1505,1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1519, 1520,1521, 1522, 1523, 1524, 1525, 1526, 1527, 1528, 1529, 1530, 1531, 1532, 1533, 1534, 1535,1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1546, 1547, 1548, 1549, 1550,1551, 1552, 1553, 1554, 1555, 1556, 1557, 1558, 1559, 1560, 1561, 1562, 1563, 1564, 1565,1566, 1567, 1568, 1569, 1570, 1571, 1572, 1573, 1574, 1575, 1576, 1577, 1578, 1579, 1580,1581, 1582, 1583, 1584, 1585, 1586, 1587, 1588, 1589, 1590, 1591, 1592, 1593, 1594, 1595,1596, 1597, 1598, 1599, 1600, 1610, 1620, 1630, 1640, 1650, 1660, 1670, 1680, 1690, 1700,1710, 1720, 1730, 1740, 1750, 1760, 1770, 1780, 1790, 1800, 1810, 1820, 1830, 1840, 1850,1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1960, 1970, 1980, 1990, or 2,000 mg. The composition can be a pharmaceutical composition.

[0128] In an embodiment, the composition described herein does not comprise an H2 blocker.

[0129] The compositions described herein can comprise a mixture of alginate, calcium pantothenate, sodium alginate, and sodium bicarbonate.

[0130] A composition comprising alginate, calcium pantothenate, sodium alginate, and sodium bicarbonate, the mixture can be a total of between about 100 mg and 1,000 mg.

[0131] A composition comprising alginate, calcium pantothenate, sodium alginate, and sodium bicarbonate, the mixture can be a total of about 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407,408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426,427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445,446, 447, 448, 449, 450, 451, 452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464,465, 466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483,484, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 501, 502,503, 504, 505, 506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 517, 518, 519, 520, 521,522, 523, 524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540,541, 542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559,560, 561, 562, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578,579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597,598, 599, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760,770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950,960, 970, 980, 990, 1,000 mg.Acid Reflux Diseases

[0132] The composition described herein can be used in methods for the treatment of acid reflux diseases.

[0133] The composition described herein can be used in methods for treating acid reflux diseases comprising administering a composition described herein in a capsule dosage form. Each capsule dosage according to the claimed method is may ultimately be at the discretion of an attendant physician or may be within a pre-defined range for self-administration by the patient. The capsule dosage can be two capsules. The method allows for administration of up to three doses daily, as needed, preferably following meals.

[0134] The composition described herein, as either a capsule or powder dosage form, may be administered alone. The composition described herein can be administered in combination with a proton pump inhibitor medication to enhance the proton pump inhibitor’s effect. The composition can be a pharmaceutical composition.

[0135] The composition described herein can be used in methods of treating acid reflux diseases comprising administering a composition described herein in a powder dosage form. Each powder dosage according to the claimed method is may ultimately be at the discretion of an attendant physician or may be within a pre-defined range for self-admini strati on by the patient. The powder dosage can be dissolved in one-quarter cup of water. The method allows for administration of up to three doses daily, as needed, preferably following meals.

[0136] The composition described herein can be used in methods of treating acid reflux diseases comprising administering a composition described herein in a dosage form, optionally a powder, capsule, gel, slurry, or a tablet. Each dosage according to the claimed method is may ultimately be at the discretion of an attendant physician or may be within a pre-defined range for selfadministration by the patient. The dosage can be dissolved in one-quarter cup of water. The method allows for administration of up to three doses daily, as needed, preferably following meals. The dosage may be taken directly by the patient without dissolution in water.

[0137] The composition described herein are effective for protection of the stomach and intestine and for treating gastrointestinal disorders including, but not limited gastroesophageal reflux disease, laryngopharyngeal reflux, erosive esophagitis, and other acid reflux diseases.

[0138] The patient in need thereof may be or may have been diagnosed with acid reflux. The acid reflux disease can be selected from the group consisting of gastroesophageal reflux disease, laryngopharyngeal reflux, and erosive esophagitis.

[0139] The acid reflux disease may not be gastroesophageal reflux disease. In another aspect, the acid reflux disease is not gastroesophageal reflux disease and only patients diagnosed with laryngopharyngeal reflux are treated.Formulations

[0140] Suitable formulations and dosage forms of the present invention include, but are not limited to, powders, hard capsules, soft capsules, pills, suppositories, gels, and compressed tablets manufactured from a composition of the present invention. The dosage forms can be any shape, including regular or irregular shapes. These formulations may be prepared by methodsknown in the art, e.g., by means of conventional pan-coating, mixing, granulation or lyophilization processes. The composition can be a pharmaceutical composition.

[0141] The compositions described herein can be formulated as a gel, colloid, suspension, paste, or a slurry. The compositions described herein can be formulated as a gel.

[0142] The composition can comprise:Sodium Alginate 425 mgSodi urn Bicarbonate 100 mgD-Calcium Pantothenate 100 mgCane Sugar 4500 mgC tric Acid 00 mgPotassium Bicarbonate 50 mg

[0143] The inventor surprisingly discovered that the composition had a better taste and exhibited less clumping due to the fizzing nature when the powder is placed in the water. It also helps push the raft to the top of the fluid bolus faster. If citric acid and potassium bicarbonate are not added the sodium alginate is reported as tasting “slimy like the algae”. The fizzing component also allows to dissolve better in the water.

[0144] The composition can be a pharmaceutical composition. For example, a pharmaceutical composition can comprise:Sodium Alginate 425 mgSodium Bicarbonate 100 mgD-Calcium Pantothenate 100 mgCane Sugar 4500 mgCitric Acid 500 mgPotassium Bicarbonate 250 mg

[0145] Solid dosage forms for oral administration (capsules, tablets, pills, dragees, powders, granules and the like) may be prepared, e.g., by mixing the active ingredient(s) with one or more pharmaceutically-acceptable carriers and, optionally, one or more fillers, extenders, binders, humectants, disintegrating agents, solution retarding agents, absorption accelerators, wetting agents, absorbents, lubricants, and / or coloring agents. Solid compositions of a similar type maybe employed as fillers in soft and hard-filled gelatin capsules using a suitable excipient. A tablet may be made by compression or molding, optionally with one or more accessory ingredients. Compressed tablets may be prepared using a suitable binder, lubricant, inert diluent, preservative, disintegrant, surface-active or dispersing agent. Molded tablets may be made bymolding in a suitable machine. The tablets, and other solid dosage forms, such as dragees, capsules, pills and granules, may optionally be scored or prepared with coatings and shells, such as enteric coatings and other coatings well known in the pharmaceutical-formulating art. They may also be formulated so as to provide slow or controlled release of the active ingredient therein. They may be sterilized by, for example, fdtration through a bacteria-retaining filter. These compositions may also optionally contain opacifying agents and may be of a composition such that they release the active ingredient only, or preferentially, in a certain portion of the gastrointestinal tract, optionally, in a delayed manner. The active ingredient can also be in microencapsulated form. The composition can be a pharmaceutical composition.

[0146] A composition described herein can be administered in any desired and effective manner. Further, a composition described herein can be administered in conjunction with other treatments. A composition described herein can be encapsulated or otherwise protected against gastric or other secretions, if desired.

[0147] The composition described herein can be in a unit dosage form. The unit dosage form can be a capsule.

[0148] The composition described herein can be administered in a hard-shell (e. ., two-piece) capsule. The composition described herein can be administered in a soft-shell (e.g., single-piece) capsule. The capsule dosage form can be of any standard size, selected from the sizes 5, 4, 3, 2, 1, 0, 0E, 00, 00E, 000, 13, 12, 12el, 11, 10, 7, and Su07. The capsule dosage form can be a hardshell capsule of size 0, 0E, 00, 00E, 000 or 1. The capsule dosage form can be a hard-shell capsule of size 00.

[0149] The capsule dosage form can be a rapid-release capsule. Rapid release of the active ingredient is preferred. If the active ingredient (e.g., the alginate salt) is released too slowly, reflux of stomach acid into the pharynx can cause digestion of the dosage form (e.g., the capsule) before the active ingredient can take effect (e.g., form an alginate raft).

[0150] The composition described herein can be formulated as a dry powder.

[0151] The compositions described herein are pharmaceutically acceptable and comprise one or more active ingredients in admixture with one or more pharmaceutically acceptable carriers and, optionally, one or more other compounds, drugs, ingredients and / or materials. Regardless of the route of administration selected, the agents / compounds of the present invention are formulated into pharmaceutically acceptable dosage forms by conventional methods known to those of skillin the art. See, e.g., Remington, The Science and Practice of Pharmacy (21stEdition, Lippincott Williams and Wilkins, Philadelphia, PA.). The carrier can be water, optionally deionized water. The composition can be a pharmaceutical composition.

[0152] The compositions described herein can comprise one or more pharmaceutically acceptable excipients.

[0153] The compositions described herein can comprise water, optionally deionized water. The compositions described herein can comprise a buffer, water, or a mixture thereof.

[0154] The compositions described herein can be substantially free of glycerin.

[0155] The compositions described herein can be substantially free of paraben.

[0156] Pharmaceutically acceptable carriers are well known in the art (see, e g., Remington, The Science and Practice of Pharmacy (21. sup. st Edition, Lippincott Williams and Wilkins, Philadelphia, Pa.) and The National Formulary (American Pharmaceutical Association, Washington, D.C.)) and include sugars (e.g., lactose, sucrose, mannitol, and sorbitol), starches, cellulose preparations, calcium phosphates (e.g., dicalcium phosphate, tricalcium phosphate and calcium hydrogen phosphate), sodium citrate, water, aqueous solutions (e.g., saline, sodium chloride injection, Ringer’s injection, dextrose injection, dextrose and sodium chloride injection, lactated Ringer’s injection), alcohols (e g., ethyl alcohol, propyl alcohol, and benzyl alcohol), polyols (e.g., glycerol, propylene glycol, and polyethylene glycol), organic esters (e.g., ethyl oleate and tryglycerides), biodegradable polymers (e.g., polylactide-polyglycolide, poly(orthoesters), and poly(anhydrides)), elastomeric matrices, liposomes, microspheres, oils (e.g., corn, germ, olive, castor, sesame, cottonseed, and groundnut), cocoa butter, waxes (e.g., suppository waxes), paraffins, silicones, talc, silicylate, etc. Each pharmaceutically acceptable carrier used in a pharmaceutical composition of the invention must be "acceptable" in the sense of being compatible with the other ingredients of the formulation and not injurious to the subject. Carriers suitable for a selected dosage form and intended route of administration are well known in the art, and acceptable carriers for a chosen dosage form and method of administration can be determined using ordinary skill in the art. The pharmaceutical compositions described herein can, optionally, comprise additional ingredients and / or materials commonly used in such pharmaceutical compositions. These ingredients and materials are well known in the art and include (1) fdlers or extenders, such as starches, lactose, sucrose, glucose, mannitol, and silicic acid; (2) binders, such as carboxymethylcellulose, alginates, gelatin, polyvinyl pyrrolidone,hydroxypropylmethyl cellulose, glucose, sucrose, acacia, compressible sugar (e.g., NuTab), cellulose, methylcellulose, ethylcellulose, povidone and pregelatinized starch; (3) humectants, such as glycerol; (4) disintegrating agents, such as agar-agar, potato or tapioca starch, corn starch, pre-gelatinized and modified starches, clays such as bentonite, alginates, alginic acid, certain silicates, sodium starch glycolate, methyl cellulose, cross-linked sodium carboxymethyl cellulose, microcrystalline cellulose (e.g., Avicel), sodium carbonate, calcium carbonate, hydroxy propylcellulose-low substituted, colloidal silicon dioxide, cellulose polyacrilin potassium (e.g., Amberlite), gums, guar, locust bean, karaya, xanthan, pectin, tragacanth, and polyvinylpyrrolidone; (5) solution retarding agents, such as paraffin; (6) absorption accelerators, such as quaternary ammonium compounds; (7) wetting agents, such as cetyl alcohol and glycerol monostearate; (8) absorbents, such as kaolin and bentonite clay; (9) lubricants, such as sodium oleate, sodium stearate, calcium stearate, zinc stearate, magnesium stearate, polyethylene glycol, talc, mineral oil, stearic acid, sodium benzoate, sodium acetate, sodium chloride, and sodium lauryl sulfate; (10) suspending agents, such as ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, microcrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar and tragacanth; (11) buffering agents, such as potassium metaphosphate, potassium phosphate, monobasic sodium acetate and sodium citrate anhydrous and dihydrate; (12) excipients, such as lactose, milk sugars, polyethylene glycols, animal and vegetable fats, oils, waxes, paraffins, cocoa butter, starches, tragacanth, cellulose derivatives, polyethylene glycol, silicones, bentonites, silicic acid, talc, salicylate, zinc oxide, aluminum hydroxide, calcium silicates, and polyamide powder; (13) inert diluents, such as dibasic calcium phosphate, kaolin, lactose, dextrose, magnesium carbonate, sucrose, mannitol, microcrystalline cellulose, powdered cellulose, precipitated calcium carbonate, calcium sulfate, sorbitol, starch, and water or other solvents, other solvents include but are not limited to water, optionally deionized water; (14) preservatives, such as Nipagin, Nipasol, alcohol, antimicrobial agents, benzoic acid, sodium benzoate, polylysine, benzyl alcohol, sorbic acid, grapefruit seed extract, parabens, and isopropyl alcohol ; (15) surface-active agents; (16) dispersing agents, such as synthetic and natural gums including tragacanth, acacia, alginate, dextran, sodium carboxymethylcellulose, methylcellulose, polyvinylpyrrolidone and gelatin; (17) control-release or absorption-delaying agents, such as hydroxypropylmethyl cellulose, other polymer matrices, biodegradable polymers, liposomes, microspheres, aluminum monosterate, gelatin, and waxes; (18) opacifying agents; (19)adjuvants; (20) wetting agents; (21) emulsifying and suspending agents; (22), solubilizing agents and emulsifiers, such as ethyl alcohol, isopropyl alcohol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1,3-butylene glycol, oils (in particular, cottonseed, groundnut, com, germ, olive, castor and sesame oils), glycerol, tetrahydrofuryl alcohol, polyethylene glycols and fatty acid esters of sorbitan; (23) propellants, such as chlorofluorohydrocarbons and volatile unsubstituted hydrocarbons, such as butane and propane; (24) antioxidants, such as ascorbic acid, ascorbyl palmitate, butylated hydroxyanisole, butylated hydroxytoluene, hypophophorous acid, monothioglycerol, propyl gallate, sodium ascorbate, sodium bisulfite, sodium formaldehyde sulfoxylate and sodium metabisulfite; (25) agents which render the formulation isotonic with the blood of the intended recipient, such as sugars and sodium chloride; (26) thickening agents; (27) coating materials, such as lecithin; and (28) sweetening, flavoring, coloring, perfuming and preservative agents, e.g., polylysine. Each such ingredient or material must be “acceptable” in the sense of being compatible with the other ingredients of the formulation and not injurious to the subject. Ingredients and materials suitable for a selected dosage form and intended route of administration are well known in the art, and acceptable ingredients and materials for a chosen dosage form and method of administration may be determined using ordinary skill in the art.

[0157] A composition for treatment of acid reflux diseases can comprise:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 4,500 mg cane sugar.Table I

[0158] A pharmaceutical composition for treatment of acid reflux diseases can comprise:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 4,500 mg cane sugar.

[0159] In an aspect, compositions described herein are pharmaceutical compositions. The compositions described herein can be formulated to be suitable for oral use in dosage forms of capsules and dry powders. The disclosure further provides for processes and methods for making compositions described herein. The compositions described herein can be a pharmaceutical composition.EXAMPLESExample 1Capsule Formulation

[0160] The formulation of this Example provides for representative pharmaceutical formulations in, for example, capsules. A representative formulation per capsule includes, for example:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 4,500 mg cane sugar.

[0161] The formulation may be formulated in a standard 00 sized hard-shell capsule. Two capsules (as a dose) may be administered to a patient in need thereof three times daily (for a total of six capsules per day). The formulation described herein can be a pharmaceutical composition.Example 2Capsule Formulation

[0162] The formulation of this Example provides for representative pharmaceutical formulations in, for example, capsules. A representative formulation per capsule includes, for example:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 4,500 mg cane sugar.

[0163] The formulation may be formulated in a standard 1 sized hard-shell capsule. Two capsules (as a dose) may be administered to a patient in need thereof three times daily (for a total of six capsules per day). The formulation described herein can be a pharmaceutical composition.Example 3Capsule Formulation

[0164] The formulation of this Example provides for representative pharmaceutical formulations in, for example, capsules. A representative formulation per capsule includes, for example:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 4,500 mg cane sugar.

[0165] The formulation may be formulated in a standard 00E sized hard-shell capsule. Two capsules (as a dose) may be administered to a patient in need thereof three times daily (for a total of six capsules per day). The formulation described herein can be a pharmaceutical composition.Example 4Powder Formulation

[0166] The formulation of this Example provides for representative pharmaceutical formulations in, for example, powder form. A representative formulation powder formulation includes, for example:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 500 mg artificial or natural sweetener, optionally stevia extract

[0167] The formulation may be formulated in a dry powder to be mixed with one-quarter cup of water and swallowed. A dose may be administered to a patient in need thereof up to three times daily. The formulation described herein can be a pharmaceutical composition.Example 5Powder Formulation

[0168] The formulation of this Example provides for representative pharmaceutical formulations in, for example, powder form. A representative formulation powder formulation includes, for example:(a) 425 mg sodium alginate;(b) 100 mg sodium bicarbonate;(c) 100 mg D-calcium pantothenate;(d) 500 mg citric acid; and(e) 250 mg potassium bicarbonate, and, optionally,(f) 50 mg artificial or natural sweetener, optionally stevia extract.

[0169] The formulation may be formulated in a dry powder to be mixed with one-quarter cup of water and swallowed. A dose may be administered to a patient in need thereof up to three times daily. The formulation described herein can be a pharmaceutical composition.

Claims

CLAIMS1. A composition comprising(a) an alginate salt in an amount from about 250 mg to about 1,000 mg,(b) sodium bicarbonate in an amount from about 1 mg to about 250 mg,(c) D-calcium pantothenate (Vitamin B5) in an amount from about 1 mg to 250 mg,(d) citric acid in an amount from about 100 mg to 1,000 mg;(e) potassium bicarbonate in an amount from about 1 mg to about 500 mg.

2. The composition of claim 1, wherein the alginate salt comprises sodium alginate.

3. The composition of claim 1 or 2, wherein the alginate salt, optionally sodium alginate, is in an amount from about 250 mg to about 1,000 mg, from about 300 mg to about 900 mg, from about 400 to about 600 mg, from about 300 to about 500 mg, from about 700 mg to about 900 mg, or from about 400 mg to about 600 mg.

4. The composition of any one of claims 1-3, wherein the alginate salt, optionally sodium alginate, is in an amount 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415,416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433,434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 460,470, 480, 490, 500, 510, 520, 530, 540, 550, 560, 570, 580, 590, 600, 610, 620, 630, 640,650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800, 810, 820,830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980, 990, or 1,000 mg.

5. The composition of any one of claims 1-4, wherein the alginate salt, optionally sodium alginate, is in an amount of about 425 mg.

6. The composition of any one of claims 1-5, wherein the sodium bicarbonate is in an amount from about 10 mg to about 200 mg, from about 20 mg to about 180 mg, from about 30 to about 170 mg, or from about 50 to about 150 mg.

7. The composition of any one of claims 1-6, wherein the sodium bicarbonate is in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25,26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50,51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75,76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99,100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, or 250 mg.

8. The composition of any one of claims 1-7, wherein the sodium bicarbonate is in an amount of about 100 mg.

9. The composition of any one of claims 1-8, wherein the D-calcium pantothenate is in an amount from about 10 mg to about 200 mg, from about 20 mg to about 180 mg, from about 30 to about 170 mg, or from about 50 to about 150 mg.

10. The composition of any one of claims 1-9, wherein the D-calcium pantothenate is in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48,49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73,74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98,99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117,118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, or 250 mg.

11. The composition of any one of claims 1-10, wherein the D-calcium pantothenate is in an amount of about 100 mg.

12. The composition of any one of claims 1-11, wherein the citric acid is in an amount from about 100 mg to about 800 mg, from about 200 mg to about 600 mg, from about 300 to about 700 mg, or from about 450 to about 550 mg.

13. The composition of any one of claims 1-12, wherein the citric acid is in an amount of about100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117,118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270,280, 290, 295, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402, 403, 404,405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420, 421, 422,423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438, 439, 440,441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 451, 452, 453, 454, 455, 456, 457, 458,459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 471, 472, 473, 474, 475, 476,477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487, 488, 489, 490, 491, 492, 493, 494,495, 496, 497, 498, 499, 500, 501, 502, 503, 504, 505, 506, 507, 508, 509, 510, 511, 512,513, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523, 524, 525, 526, 527, 528, 529, 530,531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541, 542, 543, 544, 545, 546, 547, 548,549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 563, 564, 565, 566,567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577, 578, 579, 580, 581, 582, 583, 584,585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595, 596, 597, 598, 599, 600, 610, 620,630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730, 740, 750, 760, 770, 780, 790, 800,810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910, 920, 930, 940, 950, 960, 970, 980,990, or 1,000 mg.

14. The composition of any one of claims 1-13, wherein the citric acid is in an amount of about 500 mg.

15. The composition of any one of claims 1-14, wherein the potassium bicarbonate is in an amount from about 200 mg to about 500 mg, from about 200 mg to about 400 mg, from about 100 to about 300 mg, or from about 150 to about 350 mg.

16. The composition of any one of claims 1-15, wherein the potassium bicarbonate is in an amount of about 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 130, 140, 150, 160, 170, 180, 190, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213, 214, 215, 216, 217, 218, 219, 220, 221, 222,223, 224, 225, 226, 227, 228, 229, 230, 231, 232, 233, 234, 235, 236, 237, 238, 239, 240,241, 242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258,259, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 401, 402,403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415, 416, 417, 418, 419, 420,421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433, 434, 435, 436, 437, 438,439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 451, 452, 453, 454, 455, 456,457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469, 470, 471, 472, 473, 474,475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487, 488, 489, 490, 491, 492,493, 494, 495, 496, 497, 498, 499, or 500 mg.

17. The composition of any one of claims 1-16, wherein the potassium bicarbonate is in an amount of about 250 mg.

18. The composition of any one of claims 1-17, wherein the composition further comprises a sugar in an amount from about 4,000 mg to 5,000 mg.

19. The composition of any one of claims 1-18, wherein the composition further comprises a sugar in an amount from about 4,100 mg to 4,900 mg; 4,250 mg to 4,750 mg; 4,400 mg to 4,700 mg; or 4,400 mg to 4,600 mg.

20. The composition of any one of claims 1-19, wherein the composition further comprises a sugar in an amount of about 4,000 mg, 4,100 mg, 4,200 mg, 4,300 mg, 4,400 mg, 4,500 mg, 4,600 mg, 4,700 mg, 4,800 mg, 4,900 mg, or 5,000 mg.

21. The composition of any one of claims 1-20, wherein the composition further comprises a sugar in an amount of about 4,500 mg.

22. The composition of any one of claims 1-21, wherein the sugar is sucrose, cane sugar, brown sugar, fructose, sucralose, or a combination thereof.

23. The composition of any one of claims 1-22, wherein the sugar is cane sugar.

24. The composition of any one of claims 1-23, wherein the composition further comprises one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof.

25. The composition of any one of claims 1-24, wherein the composition further comprises one or more natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof in an amount of about 100 mg to about 2000 mg.

26. The composition of claim 25, wherein the amount of the natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof is between about 100 mg and 1,000 mg; 250 mg and 1,750 mg; 500 mg, and 1,500 mg; or 750 mg and 1,250 mg.

27. The composition of claim 25, wherein the amount of the natural sweetener, artificial sweetener, dye, excipient, lubricant, filler, flavorant, or a combination thereof is about 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 295, 300, 310, 320, 330, 340, 350, 360, 370,380, 390, 400, 401, 402, 403, 404, 405, 406, 407, 408, 409, 410, 411, 412, 413, 414, 415,416, 417, 418, 419, 420, 421, 422, 423, 424, 425, 426, 427, 428, 429, 430, 431, 432, 433,434, 435, 436, 437, 438, 439, 440, 441, 442, 443, 444, 445, 446, 447, 448, 449, 450, 451,452, 453, 454, 455, 456, 457, 458, 459, 460, 461, 462, 463, 464, 465, 466, 467, 468, 469,470, 471, 472, 473, 474, 475, 476, 477, 478, 479, 480, 481, 482, 483, 484, 485, 486, 487,488, 489, 490, 491, 492, 493, 494, 495, 496, 497, 498, 499, 500, 501, 502, 503, 504, 505,506, 507, 508, 509, 510, 511, 512, 513, 514, 515, 516, 517, 518, 519, 520, 521, 522, 523,524, 525, 526, 527, 528, 529, 530, 531, 532, 533, 534, 535, 536, 537, 538, 539, 540, 541,542, 543, 544, 545, 546, 547, 548, 549, 550, 551, 552, 553, 554, 555, 556, 557, 558, 559,560, 561, 562, 563, 564, 565, 566, 567, 568, 569, 570, 571, 572, 573, 574, 575, 576, 577,578, 579, 580, 581, 582, 583, 584, 585, 586, 587, 588, 589, 590, 591, 592, 593, 594, 595,596, 597, 598, 599, 600, 610, 620, 630, 640, 650, 660, 670, 680, 690, 700, 710, 720, 730,740, 750, 760, 770, 780, 790, 800, 810, 820, 830, 840, 850, 860, 870, 880, 890, 900, 910,920, 930, 940, 950, 960, 970, 980, 990, 1,000, 1100, 1200, 1210, 1220, 1230, 1240, 1250,1260, 1270, 1280, 1290, 1295, 1300, 1310, 1320, 1330, 1340, 1350, 1360, 1370, 1380, 1390,1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414,1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427, 1428, 1429,1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440, 1441, 1442, 1443, 1444,1445, 1446, 1447, 1448, 1449, 1450, 1451, 1452, 1453, 1454, 1455, 1456, 1457, 1458, 1459,1460, 1461, 1462, 1463, 1464, 1465, 1466, 1467, 1468, 1469, 1470, 1471, 1472, 1473, 1474,1475, 1476, 1477, 1478, 1479, 1480, 1481, 1482, 1483, 1484, 1485, 1486, 1487, 1488, 1489,1490, 1491, 1492, 1493, 1494, 1495, 1496, 1497, 1498, 1499, 1500, 1501, 1502, 1503, 1504,1505, 1506, 1507, 1508, 1509, 1510, 1511, 1512, 1513, 1514, 1515, 1516, 1517, 1518, 1519,1520, 1521, 1522, 1523, 1524, 1525, 1526, 1527, 1528, 1529, 1530, 1531, 1532, 1533, 1534,1535, 1536, 1537, 1538, 1539, 1540, 1541, 1542, 1543, 1544, 1545, 1546, 1547, 1548, 1549,1550, 1551, 1552, 1553, 1554, 1555, 1556, 1557, 1558, 1559, 1560, 1561, 1562, 1563, 1564,1565, 1566, 1567, 1568, 1569, 1570, 1571, 1572, 1573, 1574, 1575, 1576, 1577, 1578, 1579,1580, 1581, 1582, 1583, 1584, 1585, 1586, 1587, 1588, 1589, 1590, 1591, 1592, 1593, 1594,1595, 1596, 1597, 1598, 1599, 1600, 1610, 1620, 1630, 1640, 1650, 1660, 1670, 1680, 1690,1700, 1710, 1720, 1730, 1740, 1750, 1760, 1770, 1780, 1790, 1800, 1810, 1820, 1830, 1840,1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1960, 1970, 1980, 1990, or 2,000 mg.

28. The composition of any one of claims 1-27, wherein the artificial sweetener is stevia extract.

29. The composition of any one of claims 1-28, wherein the composition further comprises calcium carbonate is in an amount from about 10 mg to 100 mg.

30. The composition of any one of claims 1-29, wherein the composition further comprises calcium carbonate is in an amount from about 10 mg to about 75 mg, from about 20 mg to about 80 mg, from about 30 to about 70 mg, and from about 40 to about 60 mg.

31. The composition of any one of claims 1-30, wherein the composition further comprises calcium carbonate is in an amount of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41,42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66,67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91,92, 93, 94, 95, 96, 97, 98, 99, or 100 mg.

32. The composition of any one of claims 1-31, wherein the composition further comprises a preservative, optionally Nipagin, Nipasol, alcohol, antimicrobial agents, benzoic acid, sodium benzoate, polylysine, benzyl alcohol, sorbic acid, grapefruit seed extract, parabens, isopropyl alcohol, or a mixture thereof.

33. The composition of any one of claims 1-32, wherein the composition further comprises an inert diluent, optionally dibasic calcium phosphate, kaolin, water, optionally deionized water, lactose, dextrose, magnesium carbonate, sucrose, mannitol, microcrystalline cellulose, powdered cellulose, precipitated calcium carbonate, calcium sulfate, sorbitol, starch, or a mixture thereof.

34. The composition of any one of claims 1-33, wherein the composition is in the form of a capsule, gel, slurry, tablet, or powder.

35. The composition of any one of claims 1-34, wherein the composition is not in the form of tablet and only in the form of a capsule and / or powder formulations.

36. The composition of any one of claims 1-35, wherein the composition is formulated as a capsule dosage form.

37. The composition of any one of claims 1-36, wherein the composition is formulated as a powder dosage form.

38. The composition of any one of claims 1-37, wherein the composition is formulated as a powder, hard capsule, soft capsule, pill, gel, gum, compressed tablets manufactured from a composition, gel, gum, colloid, suspension, paste, or a slurry.

39. The composition of any one of claims 1-38, wherein the composition is formulated as a gel.

40. The composition of any one of claims 1-39, wherein the composition is formulated as a gum.

41. The composition of any one of claims 1-40, wherein the composition is mixed with water.

42. The composition of any one of claims 1-41, wherein the composition is dissolved in between about 100 mb and 1,000 mb of water.

43. The composition of any one of claims 1-42, wherein the composition is dissolved in about100 mb, 200 mL, 300 mL, 400 mL, 425 mL, 450 mL, 475 mL, 500 mb, 525 mL, 550 mL, 575 mL, 600 mL, 650 mL, 675 mL, 700 mL, 800 mL, 900 mL, or 1,000 mL of water.

44. The composition of any one of claims 1-43, wherein the composition does not comprise an H2 blocker.

45. The composition of any one of claims 1-44, wherein the composition does not comprise a proton pump inhibitor.

46. The composition of any one of claims 1-45, wherein the composition does not dissolve in a solution, optionally water.

47. The composition of any one of claims 1-47, wherein the composition is a pharmaceutical composition.

48. The composition of claim 47, wherein the composition further comprises a carrier.

49. A method of treating acid reflux disease in an individual in need thereof, comprising administering to an individual in need thereof the composition of any one of claims 1-48.

50. The method of claim 49, wherein the acid reflux disease is gastroesophageal reflux disease, laryngopharyngeal reflux, or erosive esophagitis.

51. The method of claim 48 or 49, wherein the acid reflux disease is gastroesophageal reflux disease.

52. The method of claim 48 or 49, wherein the acid reflux disease is laryngopharyngeal reflux.

53. The method of claim 48 or 49, wherein the acid reflux disease is erosive esophagitis.

54. The method of any one of claims 49-53, wherein the acid reflux disease is not gastroesophageal reflux disease.

55. The method of any one of claims 49-54, wherein the acid reflux disease is not gastroesophageal reflux disease and only patients diagnosed with laryngopharyngeal reflux are treated.

56. The method of any one of claims 49-55, wherein the composition is in the form of a powder dosage form is dissolved in one-quarter or half cup of water.

57. The method of any one of claims 49-56, wherein the composition is administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times per day to a patient in need thereof.

58. The method of any one of claims 49-57, wherein the composition is administered in a dose of two capsules at a rate of two, three, or four times daily to a patient in need thereof.

59. The method of any one of claims 49-58, wherein two capsules are administered to a patient in need thereof at a rate of about three times daily.

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