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Claims for Patent: 7,250,176

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Claims for Patent: 7,250,176

Title:Method of treating a bacterial infection
Abstract:Bacterial infections may be treated using a high dosage regimen of amoxicillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.
Inventor(s): Storm; Kevin H. (Bristol, TN), Conley; Creighton P. (Bristol, TN), Roush; John A. (Kingsport, TN)
Assignee: Beecham Pharmaceuticals (Pte) Limited (Jurong, SG)
Application Number:09/689,483
Patent Claims: 1. A method for treating a bacterial infection in a patient, the method comprising: administering to the patient in need thereof a therapeutically effective amount of a composition in solid form comprising amoxicillin and potassium clavulanate and comprising a first release phase and a second release phase; the first release phase comprising potassium clavulanate and a first portion of the amoxicillin; the second release phase comprising a second portion of amoxicillin, which is a pharmaceutically acceptable soluble salt of amoxicillin, and at least one pharmaceutically acceptable organic acid which are admixed in intimate contact at a ratio of from 20:1 to 1:2.

2. A method according to claim 1 in which the bacterial infection is caused by at least one of the organisms S. pneumoniae, H. influenzae, and M. catarrhalis.

3. A method according to claim 2 wherein the S. pneumoniae are Drug Resistant S. pneumoniae and Penicillin Resistant S. pneumoniae organisms.

4. A method according to claim 1 wherein the amount of amoxicillin in the first release phase is released upon exposure to an aqueous environment.

5. A method according to claim 1 wherein the ratio of the pharmaceutically acceptable soluble salt of amoxicillin to the at least one pharmaceutically acceptable organic acid in the second release phase is from about 2:1 to about 1:1.2.

6. A method according to claim 1 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin in the second release phase is from about 3:1 to about 1:3.

7. A method according to claim 1 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin in the second release phase is from about 2:1 to about 2:3.

8. A method according to claim 5 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin the second release phase is from about 2:1 to about 2:3.

9. A method according to claim 1 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin in the second release phase is from about 3:2 to about 1:1.

10. A method according to claim 5 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin in the second release phase is from about 3:2 to about 1:1.

11. A method according to claim 1 wherein the ratio of the amoxicillin in the first release phase to the amoxicillin in the second release phase is about 9:7.

12. A method according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of pharmaceutically acceptable monocarboxylic and polycarboxylic acids having from 2 to 25 carbon atoms, pharmaceutically acceptable monocyclic aryl and polycyclic aryl acids, and pharmaceutically acceptable monohydrogen and dihydrogen metal salts of multi-valent acids.

13. The method according to claim 12 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of pharmaceutically acceptable monocarboxylic acids having from 2 to 10 carbon atoms, and polycarboxylic acids having from 2 to 10 carbon atoms.

14. The method according to claim 5 wherein the at least one pharmaceutically acceptable organic acid is selected from pharmaceutically acceptable monocarboxylic acids having from 2 to 10 carbon atoms, or polycarboxylic acids having from 2 to 10 carbon atoms.

15. The method according to claim 9 wherein the at least one pharmaceutically acceptable organic acid is selected from pharmaceutically acceptable monocarboxylic acids having from 2 to 10 carbon atoms, or polycarboxylic acids having from 2 to 10 carbon atoms.

16. A method according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of C.sub.(2-10) alkyl- and C.sub.(2-10) alkenyl-carboxylic acids having one, two, or three carboxylic acid groups, and optionally at least one hydroxy substituent, and optionally at least one --CO group in the carbon chain.

17. A method according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.

18. A method according to claim 5 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.

19. A method according to claim 15 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.

20. A method according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

21. A method according to claim 5 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

22. A method according to claim 9 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

23. A method according to claim 22 wherein the citric acid is citric acid anhydrous.

24. A method according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxicillin is sodium amoxicillin.

25. A method according to claim 5 wherein the pharmaceutically acceptable soluble salt of amoxicillin is sodium amoxicillin.

26. A method according to claim 9 wherein the pharmaceutically acceptable soluble salt of amoxicillin is sodium amoxicillin.

27. A method according to claim 19 wherein the pharmaceutically acceptable soluble salt of amoxicillin is sodium amoxicillin.

28. A method according to claim 22 wherein the pharmaceutically acceptable soluble salt of amoxicillin is sodium amoxicillin.

29. A method according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxicillin is crystallized sodium amoxicillin.

30. A method according to claim 22 wherein the pharmaceutically acceptable soluble salt of amoxicillin is crystallized sodium amoxicillin.

31. A method according to claim 1 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate is from about 2:1 to about 20:1.

32. A method according to claim 1 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate is from about 12:1 to about 20:1.

33. A method according to claim 1 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate is from about 14:1 to about 16:1.

34. A method according to claim 5 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate is from about 14:1 to about 16:1.

35. A method according to claim 9 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate is from about 14:1 to about 16:1.

36. A method according to claim 22 wherein the ratio of the amount of amoxicillin in the composition to the amount of potassium clavulanate-is from about 14:1 to about 16:1.

37. A method according to claim 31 wherein the pharmaceutically acceptable soluble salt of amoxicillin is crystallized sodium amoxicillin and the at least one pharmaceutically acceptable organic acid is citric acid anhydrous.

38. A method according to claim 1 wherein all of the potassium clavulanate of the composition is present in the first release phase.

39. A method according to claim 18 wherein all of the potassium clavulanate of the composition is present in the first release phase.

40. A method according to claim 28 wherein all of the potassium clavulanate of the composition is present in the first release phase.

41. A method according to claim 1 wherein the first release phase comprises at least one pharmaceutically acceptable soluble salt of amoxicillin, amoxicillin trihydrate, or a mixture thereof.

42. A method according to claim 39 wherein the first release phase comprises at least one pharmaceutically acceptable soluble salt of amoxicillin, amoxicillin trihydrate, or a mixture thereof.

43. A method according to claim 1 wherein the amount of amoxicillin in the composition is from about 700 mg to about 2600 mg.

44. A method according to claim 33 wherein the amount of amoxicillin in the composition is from about 700 mg to about 2600 mg.

45. A method according to claim 1 wherein the amount of amoxicillin in the composition is from about 700 mg to about 1300 mg.

46. A method according to claim 33 wherein the amount of amoxicillin in the composition is from about 700 mg to about 1300 mg.

47. A method according to claim 40 wherein the amount of amoxicillin the composition is from about 700 mg to about 1300 mg.

48. A method according to claim 1 wherein the amount of amoxicillin in the composition is from about 950 mg to about 1300 mg.

49. A method according to claim 36 wherein the amount of amoxicillin in the composition is from about 950 mg to about 1300 mg.

50. A method according to claim 1 wherein the amount of amoxicillin in the composition is from about 1400 mg to about 2600 mg.

51. A method according to claim 36 wherein the amount of amoxicillin in the composition is from about 1400 mg to about 2600 mg.

52. A method according to claim 1 wherein the amount of amoxicillin in the composition is from about 1900 mg to about 2600 mg.

53. A method according to claim 40 wherein the amount of amoxicillin-in the composition is from about 1900 mg to about 2600 mg.

54. A method according to claim 1 wherein the amount of amoxicillin in the composition is about 1000 mg or about 2000 mg.

55. A method according to claim 42 wherein the amount of amoxicillin in the composition is about 1000 mg or about 2000 mg.

56. A method according to claim 1 wherein the amount of amoxicillin administered to the patient is about 2000 mg.

57. A method according to claim 1 wherein the amount of amoxicillin in the second release phase is from about 60% to about 80% by weight of the second release phase.

58. A method according to claim 39 wherein the amount of amoxicillin in the second release phase is from about 60% to about 80% by weight of the second release phase.

59. A method according to claim 53 wherein the amount of amoxicillin in the second release phase is from about 60% to about 80% by weight of the second release phase.

60. A method according to claim 47 wherein the amount of amoxicillin in the second release phase is from about 60% to about 80% by weight of the second release phase.

61. A method according to claim 1 wherein the amount of amoxicillin in the first release phase is 563 mg +/-5% and the amount of amoxicillin in the second release phase is 438 mg +/-5%.

62. A method according to claim 22 wherein the amount of amoxicillin in the first release phase is 563 mg +/-5% and the amount of amoxicillin in the second release phase is 438 mg +/-5%.

63. A method according to claim 37 wherein the amount of amoxicillin in the first release phase is 563 mg +/-5% and the amount of amoxicillin in the second release phase is 438 mg +/-5%.

64. A method according to claim 40 wherein the amount of amoxicillin in the first release phase is 563 mg +/-5% and the amount of amoxicillin in the second release phase is 438 mg +/-5%.

65. A method according to claim 1 wherein the first release phase and the second release phase of the solid form composition is divided into multiple dosage form units.

66. A method according to claim 44 wherein the first release phase and the second release phase of the solid form composition is divided into multiple dosage form units.

67. A method according to claim 50 wherein first release phase and the second release phase of the solid form composition is divided into multiple dosage form units.

68. A method according to claim 65 wherein the amoxicillin present in one of the multiple dosage form units is amoxicillin trihydrate.

69. A method according to claim 44 wherein the amoxicillin present in one of the multiple dosage form units is amoxicillin trihydrate.

70. A method according to claim 51 wherein the amoxicillin present in one of the multiple dosage form units is amoxicillin trihydrate.

71. A method according to claim 68 wherein the amoxicillin in the first release phase is amoxicillin trihydrate and the amoxicillin in the second release phase is a soluble salt of amoxicillin.

72. A method according to claim 40 wherein the first release and the second release phase of the solid form composition is divided into multiple dosage form units.

73. A method according to claim 51 wherein the first release and the second release phase of the solid form composition is divided into multiple dosage form units.

74. A method according to claim 59 wherein the first release and the second release phase of the solid form composition is divided into multiple dosage form units.

75. A method according to claim 1 wherein the composition is in the form of a compressed tablet.

76. A method according to claim 75 wherein the composition is in the form of a monolith tablet.

77. A method according to claim 8 wherein the composition is in the form of a compressed tablet.

78. A method according to claim 19 wherein the composition is in the form of a compressed tablet.

79. A method according to claim 27 wherein the composition is in the form of a compressed tablet.

80. A method according to claim 79 wherein the composition is in the form of a monolith tablet.

81. A method according to claim 37 wherein the composition is in the form of a compressed tablet.

82. A method according to claim 49 wherein the composition is in the form of a compressed tablet.

83. A method according to claim 64 wherein the composition is in the form of a compressed tablet.

84. A method according to claim 75 wherein the compressed tablet comprises at least two layers.

85. A method according to claim 78 wherein the compressed tablet comprises at least two layers.

86. A method according to claim 81 wherein the compressed tablet comprises at least two layers.

87. A method according to claim 77 wherein all of the first release phase is in a first layer and all of the second release phase is in a second layer.

88. A method according to claim 78 wherein all of the first release phase is in a first layer and all of the second release phase is in a second layer.

89. A method according to claim 79 wherein all of the first release phase is in a first layer and all of the second release phase is in a second layer.

90. A method according to claim 75 wherein the second release phase of the tablet further comprises at least one release retarding excipient which is selected from the group consisting of pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment.

91. A method according to claim 90 wherein the at least one release retarding gellable polymer is selected from the group consisting of methylcelluloses, carboxymethylcelluloses, low-molecular weight hydroxypropylmethylcelluloses, low-molecular weight polyvinylalcohols, polyoxyethyleneglycols, and noncross-linked polyvinylpyrrolidones.

92. A method according to claim 19 wherein the second release phase of the tablet further comprises at least one release retarding excipient which is selected from the group consisting of pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment.

93. A method according to claim 27 wherein the second release phase of the tablet further comprises at least one release retarding excipient which is selected from the group consisting of pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment.

94. A method according to claim 37 wherein the second release phase of the tablet further comprises at least one release retarding excipient which is selected from the group consisting of pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment.

95. A method according to claim 90 wherein the at least one release retarding excipient is xanthan gum.

96. A method according to claim 92 wherein the at least one release retarding excipient is xanthan gum.

97. A method according to claim 93 wherein the at least one release retarding excipient is xanthan gum.

98. A method according to claim 94 wherein the at least one release retarding excipient is xanthan gum.

99. A method according to claim 95 wherein the xanthan gum is present in an amount from about 0.5% to about 8% by weight of the second release phase.

100. A method according to claim 97 wherein the xanthan gum is present in an amount from about 0.5% to about 8% by weight of the second release phase.

101. A method according to claim 95 wherein the xanthan gum is pharmaceutical grade xanthan gum, 200 mesh.

102. A method according to claim 97 wherein the xanthan gum is pharmaceutical grade xanthan gum, 200 mesh.

103. A method according to claim 99 wherein the xanthan gum is pharmaceutical grade xanthan gum, 200 mesh.

104. A method according to claim 1 wherein the pharmaceutically acceptable soluble salt of amoxicillin and the at least one pharmaceutically acceptable organic acid of the second release phase are admixed in intimate contact such that upon exposure to an aqueous environment they interact such that the rate of release of amoxicillin from the solid form of the second release phase is reduced compared to the rate of release of amoxicillin from the solid form of the first release phase.

105. A method according to claim 28 wherein the sodium amoxicillin and the at least one pharmaceutically acceptable organic acid of the second release phase are admixed in intimate contact such that upon exposure to an aqueous environment they interact such that the rate of release of amoxicillin from the solid form of the second release phase is reduced compared to the rate of release of amoxicillin from the solid form of the first release phase.

106. A method according to claim 37 wherein the crystallized sodium amoxicillin and the citric acid anhydrous acid of the second release phase are admixed in intimate contact such that upon exposure to an aqueous environment they interact such that the rate of release of amoxicillin from the solid form of the second release phase is reduced compared to the rate of release of amoxicillin from the solid form of the first release phase.

107. A method according to claim 1 wherein the composition has an in vitro dissolution profile such that about 45% to about 65% of the total amoxicillin is dissolved within 30 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

108. A method according to claim 37 wherein the composition has an in vitro dissolution profile such that about 45% to about 65% of the total amoxicillin is dissolved within 30 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

109. A method according to claim 1 wherein the composition has an in vitro dissolution profile such that about 50% to about 75% of the total amoxicillin is dissolved within 60 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

110. A method according to claim 1 wherein the composition has an in vitro dissolution profile such that about 55% to about 85% of the total amoxicillin is dissolved within 120 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

111. A method according to claim 1 wherein the composition has an in vitro dissolution profile such that about 70% to about 95% of the total amoxicillin is dissolved within 180 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

112. A method according to claim 1 wherein the composition has an in vitro dissolution profile such that about 70% to about 100% of the total amoxicillin is dissolved within 240 minutes, as determined by the <711> Dissolution Test, Apparatus 2, provided in USP 23, 1995, in 900 mL of deionized water, at a paddle speed of 75 rpm.

113. A method according to claim 56 wherein the composition provides, a mean maximum plasma concentration (C.sub.max) of amoxicillin of at least 12 ug/mL.

114. A method according to claim 56 wherein the composition provides, a mean maximum plasma concentration (C.sub.max) of amoxicillin of at least 16 ug/mL.

115. A method according to claim 56 wherein the composition provides, a mean plasma concentration of amoxicillin of at least 4 ug/mL for at least 4.4 hours.

116. A method according to claim 113 wherein the composition provides, a mean plasma concentration of amoxicillin of at least 4 ug/mL for at least 4.4 hours.

117. A method according to claim 56 wherein the composition provides, a mean plasma concentration of amoxicillin of at least 4 ug/mL for at least 4.8 hours.

118. A method according to claim 117 wherein the composition provides, a mean maximum plasma concentration (C.sub.max) of amoxicillin of at least 16 ug/mL.

119. A method according to claim 56 wherein the composition provides an area under the curve (AUC) of the total amount of amoxicillin in the composition that is at least 80% of that of the corresponding dosage of amoxicillin taken as a immediate release formulation, over the same dosage period.

120. A method according to claim 56 wherein the composition provides an area under the curve (AUC) of the total amount of amoxicillin in the composition that is at least 90% of that of the corresponding dosage of amoxicillin taken as a immediate release formulation, over the same dosage period.

121. A method according to claim 56 wherein the composition provides an area under the curve (AUC) of the total amount of amoxicillin in the composition that is at least 100% of that of the corresponding dosage of amoxicillin taken as a immediate release formulation, over the same dosage period.

122. A method according to claim 56 wherein the composition provides an area under the curve (AUC) of the total amount of amoxicillin in the composition that is at least 110% of that of the corresponding dosage of amoxicillin taken as a immediate release formulation, over the same dosage period.

123. A method according to claim 56 wherein the composition provides an area under the curve (AUC) of the total amount of amoxicillin in the composition that is at least 120% of that of the corresponding dosage of amoxicillin taken as a immediate release formulation, over the same dosage period.

124. A method according to claim 56 wherein the composition provides an AUC, C.sub.max, and T.sub.max substantially according to FIG. 5, profile A of Formulation VI.

125. A method according to claim 56 wherein the composition, provides an AUC, C.sub.max, and T>MIC substantially according to FIG. 5, profile A of Formulation VI.

126. A method according to claim 56 wherein the composition provides an AUC, C.sub.max, and T.sub.max substantially according to FIG. 5, profile B of Formulation VII.

127. A method according to claim 56 wherein the composition provides, an AUC, C.sub.max, and T>MIC substantially according to FIG. 5, profile B of Formulation VII.

128. A method according to claim 1 wherein the ratio of the pharmaceutically acceptable soluble salt of amoxicillin to the at least one pharmaceutically acceptable organic acid in the second release phase is about 1:1.

129. A method according to claim 5 wherein the ratio of amoxicillin in the first release phase to amoxicillin in the second release phase is about 9:7.

130. A method according to claim 128 wherein the ratio of amoxicillin in the first release phase to amoxicillin in the second release phase is about 9:7.

131. A method according to claim 20 wherein the citric acid is citric acid anhydrous.

132. A method according to claim 23 wherein the pharmaceutically acceptable soluble salt of amoxicillin is crystallized sodium amoxicillin.

133. A method according to claim 56 wherein the amount of amoxicillin administered is at a dosage regimen interval of about 12 hours.

134. A method according to claim 1 wherein the composition is administered at a dosage regimen interval of about 12 hours.

135. A method according to claim 43 wherein the amount of amoxicillin administered is at a dosage regimen interval of about 12 hours.

136. A method according to claim 45 wherein the amount of amoxicillin administered is at a dosage regimen interval of about 12 hours.

137. A method according to claim 48 wherein the amount of amoxicillin administered is at a dosage regimen interval of about 12 hours.

138. A method for treating a bacterial infection in a patient, the method comprising administering to the patient in need thereof a composition in solid dosage form comprising amoxicillin and potassium clavulanate, such that the amount of amoxicillin is about 2000 mg and comprising a first release phase and a second release phase; the first release phase comprising potassium clavulanate and a first portion of the amoxicillin; the second release phase comprising a second portion of amoxicillin, which is a pharmaceutically acceptable soluble salt of amoxicillin, and at least one pharmaceutically acceptable organic acid selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, and citric acid, which are admixed in intimate contact at a ratio of from 20:1 to 1:2; such that the weight ratio of amoxicillin to potassium clavulanate is from 2:1 to 20:1, and the solid dosage is administered at a regimen interval of about 12 hours, and wherein the second release phase of the tablet further comprises at least one release retarding excipient which is selected from the group consisting of pH sensitive polymers, release-retarding polymers which exhibit swelling characteristics when in an aqueous environment, polymeric materials which exhibit gelling characteristics when in an aqueous environment, and polymeric materials which exhibit both swelling and gelling characteristics when in an aqueous environment; and wherein the solid dosage is such that the amount of amoxicillin released over thirty minutes is in the range about 45 to about 65% of the total amoxicillin content, over sixty minutes is in the range about 50 to about 75% of the total amoxicillin content, over two hours is in the range about 55% to about 85% of the total amoxicillin content, over 180 minutes is in the range about 70% to 95% of the total amoxicillin content and over 240 minutes is in the range about 70 to about 100% of the total amoxicillin content, as tested by the USP Dissolution Test, Apparatus 2, method at 37 degrees C., a paddle speed of 75 rpm and in 900 ml deionized water, over a period of 8 hours; and which provides a mean maximum plasma concentration (Cmax) of at least 12 micrograms/ml and a mean time that the plasma concentration exceeds 4 micrograms/ml for at least 4.4 hours, when tested in a group of at least 7 healthy humans, based on blood sampling at half hourly intervals for the first two hours and thereafter at hourly intervals.

139. A method according to claim 2 wherein the bacterial infection is a respiratory tract infection.

140. A method according to claim 139 wherein the respiratory tract infection is community acquired pneumoniae (CAP), acute exacerbation of chronic bronchitis (AECB), or acute bacterial sinusitis (ABS).

141. A method according to claim 140 wherein the duration of treatment is from 7 to 14 days.

142. A method according to claim 138 in which the bacterial infection is caused by at least one of the organisms S. pneumoniae, H. influenzae, and M. catarrhalis.

143. A method according to claim 142 wherein the S. pneumoniae are Drug Resistant S. pneumoniae and Penicillin Resistant S. pneumoniae organisms.

144. A method according to claim 142 wherein the bacterial infection is a respiratory tract infection.

145. A method according to claim 144 wherein the respiratory tract infection is community acquired pneumoniae (CAP), acute exacerbation of chronic bronchitis (AECB), or acute bacterial sinusitis (ABS).

146. A method according to claim 145 wherein the duration of treatment is from 7 to 14 days.

147. A method according to claim 27 wherein the composition is in the form of a bilayer tablet.

148. A method according to claim 64 wherein first release phase and the second release phase of the solid form composition is divided into multiple dosage form units, and the multiple dosage form units are compressed into a bilayer tablet.

149. A method according to claim 64 wherein the first release phase comprises at least one pharmaceutically acceptable soluble salt of amoxicillin, amoxicillin trihydrate, or a mixture thereof.

150. A method according to claim 149 wherein the amoxicillin is present in the second release phase is sodium amoxicillin.

151. A method according to claim 150 wherein the at least one pharmaceutically acceptable organic acid is selected from malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, sorbic acid, tartaric acid, malic acid, ascorbic acid, or citric acid.

152. A method according to claim 151 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

153. A method according to claim 100 wherein the at least one pharmaceutically acceptable organic acid is citric acid.

154. A method according to claim 153 wherein the first release phase comprises at least one pharmaceutically acceptable soluble salt of amoxicillin, amoxicillin trihydrate, or a mixture thereof.

155. A method according to claim 154 wherein the first release phase and the second release phase of the solid form composition is divided into multiple dosage form units.

156. A method according to claim 155 wherein the multiple dosage form units of the solid form composition are a compressed bi-layer tablet.

157. A method according to claim 74 wherein the multiple dosage form units of the solid form composition are a compressed bi-layer tablet.

158. A method according to claim 1 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, and sorbic acid.

159. A method according to claim 1 at least one pharmaceutically acceptable organic acid is selected from the group consisting of tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.

160. A method according to claim 5 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, and sorbic acid.

161. A method according to claim 5 at least one pharmaceutically acceptable organic acid is selected from the group consisting of tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.

162. A method according to claim 15 wherein the at least one pharmaceutically acceptable organic acid is selected from the group consisting of malonic acid, succinic acid, fumaric acid, maleic acid, adipic acid, lactic acid, levulinic acid, and sorbic acid.

163. A method according to claim 15 at least one pharmaceutically acceptable organic acid is selected from the group consisting of tartaric acid, malic acid, ascorbic acid, citric acid, and an acidic salt thereof.
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