Source: https://patents.google.com/patent/US9907769B2/en
Timestamp: 2019-07-24 09:19:43
Document Index: 746069479

Matched Legal Cases: ['§ 371', '§ 119', 'Application No. 60', 'Application No. 200680026773', 'Application No. 2013', 'Application No. 06848675']

US9907769B2 - Compositions and methods for the sustained release of betaalanine - Google Patents
Compositions and methods for the sustained release of betaalanine Download PDF
US9907769B2
US9907769B2 US15/240,460 US201615240460A US9907769B2 US 9907769 B2 US9907769 B2 US 9907769B2 US 201615240460 A US201615240460 A US 201615240460A US 9907769 B2 US9907769 B2 US 9907769B2
US15/240,460
US20160354329A1 (en
2013-06-27 Priority to US13/929,251 priority patent/US8980307B2/en
2015-02-19 Priority to US14/626,739 priority patent/US9636315B2/en
2016-08-18 Priority to US15/240,460 priority patent/US9907769B2/en
2016-08-18 Assigned to NATURAL ALTERNATIVES INTERNATIONAL, INC. reassignment NATURAL ALTERNATIVES INTERNATIONAL, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HARRIS, ROGER, WISE, JOHN
2016-08-18 Application filed by Natural Alternatives International Inc filed Critical Natural Alternatives International Inc
2016-12-08 Publication of US20160354329A1 publication Critical patent/US20160354329A1/en
2018-03-06 Publication of US9907769B2 publication Critical patent/US9907769B2/en
This application is a continuation of U.S. application Ser. No. 14/626,739, filed Feb. 19, 2015, which is a continuation of U.S. application Ser. No. 13/929,251, filed Jun. 27, 2013, now U.S. Pat. No. 8,980,307, issued Mar. 17, 2015, which is a continuation of U.S. application Ser. No. 13/755,954, filed Jan. 31, 2013, now U.S. Pat. No. 8,496,958, issued Jul. 30, 2013, which is a continuation of U.S. application Ser. No. 13/646,184, filed Oct. 5, 2012, now U.S. Pat. No. 8,394,402, issued Mar. 12, 2013, which is a divisional of U.S. application Ser. No. 12/064,005, filed Apr. 30, 2009, now U.S. Pat. No. 8,329,207, issued Dec. 11, 2012, which is a National Stage application under 35 U.S.C. § 371, which claims benefit under 35 U.S.C. § 119(a) of International Application No. PCT/US2006/020104, filed May 23, 2006, which claims benefit of U.S. Provisional Patent Application No. 60/683,985, filed May 23, 2005, all of which are herein incorporated by reference.
The pharmaceutical composition can include about 0.1-200.0; about 1.0-9.0; about 2.0-8.0; about 3.0-7.0; or about 4.0-6.0 grams (g) of free beta-alanine or the equivalent amount of a biological source thereof. The pharmaceutical composition can be formulated for humans and can include about 0.1-200.0; about 1.0-9.0; about 2.0-8.0; about 3.0-7.0; or about 4.0-6.0 g of free beta-alanine or the equivalent amount of a biological source thereof.
Along with the beta-alanine or a biological source thereof, the composition can contain any number of additional components. For example, a composition containing beta-alanine also can include: a diluent such as lactose, sucrose, dicalcium phosphate, or carboxy methylcellulose; a lubricant, such as magnesium stearate, calcium stearate and talc; and/or a binder such as starch, natural gums, such as gum acaciagelatin, glucose, molasses, polvinylpyrrolidine, celluloses and derivatives thereof, povidone, crospovidones and other such binders known to those of skill in the art. Compositions of the invention further can include disintegrating agents, coloring agents (e.g., any of the approved certified water soluble FD&C dyes), flavoring agents, and wetting agents. Flavoring and sweetening agents are useful, as are preservatives, stabilizers, buffer substances and antioxidants.
The concentrations of free beta-alanine or a biological source thereof in the compositions disclosed herein are effective for increasing the anaerobic working capacity of a tissue by providing an amount of free beta-alanine to blood or blood plasma effective to increase the synthesis of beta-alanylhistidine peptides, particularly carnosine, in muscle and other tissues. A sustained release formulation of beta-alanine is administered in an amount effective to attenuate the metabolic acidosis encountered during high-intensity exercise and thus delay the onset of fatigue during anaerobic exercise without inducing symptoms of paraesthesia.
Furthermore, many of the conventional pharmaceutical binders, excipients and additives, when used in sufficient quantities, can act as controlled-release polymers and produce a sustained release effect. These include, but are not limited to, gelatin, natural sugars such as raw sugar or lactose, lecithin, mucilage, plant gums, pectins or pectin derivatives, algal polysaccharides, glucomannan, agar and lignin, guar gum, locust bean gum, acacia gum, xanthan gum, carrageenan gum, karaya gum, tragacanth gum, ghatti gum, starches (e.g., corn starch or amylose), dextran, polyvinyl pyrrolidone, polyvinyl acetate, gum arabic, alginic acid, tylose, talcum, lycopodium, silica gel (e.g., colloidal), cellulose and cellulose derivatives (e.g., cellulose ethers, cellulose ethers in which the cellulose hydroxy groups are partially etherified with lower saturated aliphatic alcohols and/or lower saturated, aliphatic oxyalcohols; e.g., methyloxypropyl cellulose, methyl cellulose, hydroxypropyl methyl cellulose, hydroxypropyl methyl cellulose phthalate, cross-linked sodium carboxymethylcellulose, cross-linked hydroxypropylcellulose, high-molecular weight hydroxymethylpropylcellulose, carboxymethyl-cellulose, low-molecular weight hydroxypropylmethylcellulose medium-viscosity hydroxypropylmethylcellulose hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, sodium carboxymethylcellulose, alkylcelluloses, ethyl cellulose, cellulose acetate, cellulose propionate (low, medium or high molecular weight), cellulose acetatepropionate, cellulose acetate butyrate, cellulose triacetate, methyl cellulose, hydroxypropyl cellulose, or hydroxypropylmethyl cellulose), fatty acids as well as magnesium, calcium or aluminum salts of fatty acids with 12 to 22 carbon atoms, in particular saturated fatty acids (e.g., stearates such as magnesium stearate), polycarboxylic acids, emulsifiers, oils and fats, in particular vegetable (e.g., peanut oil, castor oil, olive oil, sesame oil, cottonseed oil, corn oil, wheat germ oil, sunflower seed oil, cod liver oil, in each case also optionally hydrated); glycerol esters and polyglycerol esters of saturated fatty acids (e.g., C12H24O2 to C18H36O2) and their mixtures, it being possible for the glycerol hydroxy groups to be totally or also only partly esterified (e.g., mono-, di- and triglycerides); high melting point hydrogenated vegetable oils suitable for microencapsulation; pharmaceutically acceptable mono- or multivalent alcohols and polyglycols such as polyethylene glycol and derivatives thereof, esters of aliphatic saturated or unsaturated fatty acids (e.g., 2 to 22 carbon atoms, e.g., 10-18 carbon atoms) with monovalent aliphatic alcohols (e.g., 1 to 20 carbon atoms) or multivalent alcohols such as glycols, glycerol, diethylene glycol, pentacrythritol, sorbitol, mannitol and the like, which may optionally also be etherified, esters of citric acid with primary alcohols, acetic acid, urea, benzyl benzoate, dioxolanes, glyceroformals, tetrahydrofurfuryl alcohol, polyglycol ethers with C1-C12 alcohols, dimethylacetamide, lactamides, lactates, ethylcarbonates, silicones (e.g., medium-viscous polydimethyl siloxanes), calcium carbonate, sodium carbonate, calcium phosphate, sodium phosphate, magnesium carbonate and the like.
In another embodiment, dietary supplements containing free-beta alanine or a biological source of beta-alanine are food products wherein the free beta-alanine or a biological source of beta-alanine is suspended in an edible supporting matrix to form an edible suspension. The term “suspension” is intended to mean compositions containing free beta-alanine or a biological source of beta-alanine as provided herein, comprise flee beta-alanine in solid form (e.g. as crystals, power or the like), distributed within an edible viscous liquid or semi-liquid, or a solid, supporting matrix, typically such that settling (under the influence of gravity) of the solid beta-alanine is inhibited or prevented.
Other ingredients that can be included in the presently disclosed sustained release beta-alanine compositions can include, for example, anti-oxidants, alpha-lipoic acid, tocotrienols, N-acetylcysteine, co-enzyme Q-10, extracts of rosemary such as carnosol, botanical anti-oxidants such as green tea polyphenols, grape seed extract, COX-1 type inhibitors such as resveratrol, ginkgo biloba, and garlic extracts. Other amino acids such as L-cysteine or L-citrulline may be added. Combination with an acetylcholine precursor such as choline chloride or phosphatidylcholine may be desirable, for example, to enhance vasodilation. It is to be understood that such combination therapy constitutes a further aspect of the compositions and methods of treatment provided herein.
1. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following ingestion of the dietary supplement by a human a concentration of beta-alanine in the human's blood does not exceed 200 μmol/L within 15 minutes following ingestion, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provide in an amount ranging from about 0.1 to about 10.0 grams.
2. The dietary supplement of claim 1 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
3. The dietary supplement of claim 1 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
4. The dietary supplement of claim 1 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
5. The dietary supplement of claim 1 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
6. The dietary supplement of claim 1 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
7. The dietary supplement of claim 1 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
8. A dietary supplement comprising an amount of microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following ingestion of the dietary supplement by a human a concentration of beta-alanine in the human's blood does not exceed 375 μmol/L within 30 minutes following ingestion, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
9. The dietary supplement of claim 8 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
10. The dietary supplement of claim 8 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
11. The dietary supplement of claim 8 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
12. The dietary supplement of claim 8 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
13. The dietary supplement of claim 8 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
14. The dietary supplement of claim 8 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
15. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following ingestion of the dietary supplement by a human a concentration of beta-alanine in the human's blood does not exceed 300 μmol/L within 45 minutes following ingestion, wherein the free beta-alanine or salt thereof, in the sustained released formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
16. The dietary supplement of claim 15 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
17. The dietary supplement of claim 15 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
18. The dietary supplement of claim 15 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
19. The dietary supplement of claim 15 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
20. The dietary supplement of claim 15 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
21. The dietary supplement of claim 15 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
22. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following ingestion of the dietary supplement by a human a concentration of beta-alanine in the human's blood does not exceed 100 μmol/L within 75 minutes following ingestion, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
23. The dietary supplement of claim 22 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
24. The dietary supplement of claim 22 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
25. The dietary supplement of claim 22 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
26. The dietary supplement of claim 22 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
27. The dietary supplement of claim 22 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
28. The dietary supplement of claim 22 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
29. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following dissolution in 0.1N hydrochloric acid for 1 hour the percentage of beta-alanine dissolved is less than, or equal to 27%, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
30. The dietary supplement of claim 29 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
31. The dietary supplement of claim 29 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
32. The dietary supplement of claim 29 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
33. The dietary supplement of claim 29 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
34. The dietary supplement of claim 29 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
35. The dietary supplement of claim 29 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
36. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following dissolution in 0.1N hydrochloric acid for 2 hours the percentage of beta-alanine dissolved is less than, or equal to 47%, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
37. The dietary supplement of claim 36 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
38. The dietary supplement of claim 36 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
39. The dietary supplement of claim 36 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
40. The dietary supplement of claim 36 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
41. The dietary supplement of claim 36 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
42. The dietary supplement of claim 36 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
43. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following dissolution in 0.1N hydrochloric acid for 3 hours the percentage of beta-alanine dissolved is less than, or equal to 63%, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
44. The dietary supplement of claim 43 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
45. The dietary supplement of claim 43 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
46. The dietary supplement of claim 43 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
47. The dietary supplement of claim 43 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
48. The dietary supplement of claim 43 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
49. The dietary supplement of claim 43 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
50. A dietary supplement comprising an amount of a microencapsulated, sustained release free beta-alanine, or a salt thereof in a microencapsulated, sustained release formulation, wherein following dissolution in 0.1N hydrochloric acid for 6 hours the percentage of beta-alanine dissolved is less than, or equal to 82%, wherein the free beta-alanine or salt thereof, in the sustained release formulation of the dietary supplement is provided in an amount ranging from about 0.1 to about 10.0 grams.
51. The dietary supplement of claim 50 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 10.0 grams.
52. The dietary supplement of claim 50 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 1.0 to about 9.0 grams.
53. The dietary supplement of claim 50 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 2.0 to about 8.0 grams.
54. The dietary supplement of claim 50 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 3.0 to about 7.0 grams.
55. The dietary supplement of claim 50 wherein the free beta-alanine, or salt thereof, in the sustained release formulation is provided in an amount ranging from about 4.0 to about 6.0 grams.
56. The dietary supplement of claim 50 wherein the sustained release formulation is in a solid, liquid or semi-liquid.
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HARRIS, ROGER;WISE, JOHN;SIGNING DATES FROM 20080924 TO 20080926;REEL/FRAME:039476/0541