Dosage form containing multiple drugs

• US 20050266032A1
• Filed: 04/27/2005
• Published: 12/01/2005
• Est. Priority Date: 12/17/2003
• Status: Abandoned Application

• Current Assignee: Sovereign Pharmaceuticals Limited
• Original Assignee: Sovereign Pharmaceuticals Limited
• Inventors: Patel, Himanshu, Brown, David, Brown, Ralph, Balasubramanian, Venkatesh, Srinivasan, Viswanathan, Menendez, Juan Carlos, Suphasawud, Somphet Peter
• Application Number:
  US11/115,321
• Publication Number:
  US 20050266032A1
• Time in Patent Office: Days
• US Class Current: 424/400
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca

Abstract

A pharmaceutical dosage form comprising a first drug and a second drug, both of which are selected from decongestants, antitussives, expectorants, analgesics and antihistamines. The dosage form provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 70% of a period over which the dosage form provides a plasma concentration within a therapeutic range of the first drug. This Abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

Claims

1. A pharmaceutical dosage form comprising (a) a first drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines, and (b) a second drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines, wherein the dosage form provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 70% of a period over which the dosage form provides a plasma concentration within a therapeutic range of the first drug.

2. The dosage form of claim 1, wherein the first drug comprises a decongestant.

3. The dosage form of claim 2, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

4. The dosage form of claim 3, wherein the decongestant comprises at least one of phenylephrine and a pharmaceutically acceptable salt thereof.

5. The dosage form of claim 3, wherein the decongestant comprises at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof.

6. The dosage form of claim 1, wherein the first drug comprises an antitussive.

7. The dosage form of claim 6, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

8. The dosage form of claim 7, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

9. The dosage form of claim 7, wherein the antitussive comprises at least one of carbetapentane and a pharmaceutically acceptable salt thereof.

10. The dosage form of claim 7, wherein the antitussive comprises at least one of chlophedianol and a pharmaceutically acceptable salt thereof.

11. The dosage form of claim 1, wherein the first drug comprises an antihistamine.

12. The dosage form of claim 11, wherein the antihistamine comprises at least one of astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexbrompheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof.

13. The dosage form of claim 11, wherein the antihistamine comprises at least one of promethazine, diphenhydramine, chlorpheniramine and pharmaceutically acceptable salts thereof.

14. The dosage form of claim 11, wherein the antihistamine comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof.

15. The dosage form of claim 1, wherein the first drug comprises an analgesic.

16. The dosage form of claim 15, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

17. The dosage form of claim 1, wherein the first drug comprises an expectorant.

18. The dosage form of claim 17, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

19. The dosage form of claim 2, wherein the second drug comprises an antitussive.

20. The dosage form of claim 19, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

21. The dosage form of claim 19, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

22. The dosage form of claim 2, wherein the second drug comprises an antihistamine.

23. The dosage form of claim 22, wherein the antihistamine comprises at least one of astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexbrompheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof.

24. The dosage form of claim 22, wherein the antihistamine comprises at least one of promethazine, diphenhydramine, chlorpheniramine and pharmaceutically acceptable salts thereof.

25. The dosage form of claim 22, wherein the antihistamine comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof.

26. The dosage form of claim 2, wherein the second drug comprises an analgesic.

27. The dosage form of claim 26, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

28. The dosage form of claim 2, wherein the second drug comprises an expectorant.

29. The dosage form of claim 28, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

30. The dosage form of claim 7, wherein the second drug comprises a decongestant.

31. The dosage form of claim 30, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

32. The dosage form of claim 6, wherein the second drug comprises an antihistamine.

33. The dosage form of claim 32, wherein the antihistamine comprises at least one of astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexbrompheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof.

34. The dosage form of claim 32, wherein the antihistamine comprises at least one of promethazine, diphenhydramine, chlorpheniramine and pharmaceutically acceptable salts thereof.

35. The dosage form of claim 32, wherein the antihistamine comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof.

36. The dosage form of claim 6, wherein the second drug comprises an analgesic.

37. The dosage form of claim 36, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

38. The dosage form of claim 6, wherein the second drug comprises an expectorant.

39. The dosage form of claim 38, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

40. The dosage form of claim 12, wherein the second drug comprises a decongestant.

41. The dosage form of claim 40, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

42. The dosage form of claim 12, wherein the second drug comprises an antitussive.

43. The dosage form of claim 42, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

44. The dosage form of claim 42, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

45. The dosage form of claim 11, wherein the second drug comprises an analgesic.

46. The dosage form of claim 45, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

47. The dosage form of claim 11, wherein the second drug comprises an expectorant.

48. The dosage form of claim 47, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

49. The dosage form of claim 16, wherein the second drug comprises a decongestant.

50. The dosage form of claim 49, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

51. The dosage form of claim 16, wherein the second drug comprises an antitussive.

52. The dosage form of claim 51, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

53. The dosage form of claim 51, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

54. The dosage form of claim 16, wherein the second drug comprises an antihistamine.

55. The dosage form of claim 54, wherein the antihistamine comprises at least one of astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexchlorpheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof.

56. The dosage form of claim 54, wherein the antihistamine comprises at least one of promethazine, diphenhydramine, chlorpheniramine and pharmaceutically acceptable salts thereof.

57. The dosage form of claim 54, wherein the antihistamine comprises promethazine.

58. The dosage form of claim 15, wherein the second drug comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof.

59. The dosage form of claim 58, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

60. The dosage form of claim 1, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 2 hours.

61. The dosage form of claim 1, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 3 hours.

62. The dosage form of claim 1, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 4 hours.

63. The dosage form of claim 61, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 80% of the period of a plasma concentration within the therapeutic range of the first drug.

64. The dosage form of claim 60, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 90% of the period of a plasma concentration within the therapeutic range of the first drug.

65. The dosage form of claim 1, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 95% of the period of a plasma concentration within the therapeutic range of the first drug.

66. The dosage form of claim 1, wherein the period of a plasma concentration within the therapeutic range of the second drug is substantially coextensive with the period of a plasma concentration within the therapeutic range of the first drug.

67. The dosage form of claim 1, wherein the dosage form comprises a tablet.

68. The dosage form of claim 67, wherein the tablet comprises a matrix which comprises one of the first drug and the second drug and has dispersed therein particles which comprise the other one of the first drug and the second drug.

69. The dosage form of claim 1, wherein the dosage form comprises one of a solution and a suspension.

112. A process of making the pharmaceutical dosage form of claim 1, wherein the method comprises preparing a first composition which comprises the first drug and a second composition which comprises the second drug, and combining the first and the second compositions.

113. The process of claim 112, wherein the first and second compositions are combined by using a tablet press.

152. The dosage form of claim 1, wherein the dosage form comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof as a first drug and at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof as a second drug.

70. A bi-layered tablet which comprises a first layer and a second layer, the first layer comprising a first drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines, and the second layer comprising a second drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines and is different from the first drug, wherein the bi-layered tablet provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 70% of a period over which the bi-layered tablet provides a plasma concentration within a therapeutic range of the first drug.

71. The bi-layered tablet of claim 70, wherein the first drug is selected from one or more of phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine, guaifenesin, astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexchlorpheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof, aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

72. The bi-layered tablet of claim 71, wherein the second drug is different from the first drug and is selected from one or more of phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine, guaifenesin, astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexchlorpheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof, aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

73. The bi-layered tablet of claim 71, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 80% of the period of a plasma concentration within the therapeutic range of the first drug.

74. The bi-layered tablet of claim 72, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 90% of the period of a plasma concentration within the therapeutic range of the first drug.

75. The bi-layered tablet of claim 74, wherein the period of a plasma concentration within the therapeutic range of the second drug is coextensive with at least about 95% of the period of a plasma concentration within the therapeutic range of the first drug.

76. The bi-layered tablet of claim 70, wherein the period of a plasma concentration within the therapeutic range of the second drug is substantially coextensive with the period of a plasma concentration within the therapeutic range of the first drug.

77. The bi-layered tablet of claim 76, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 2 hours.

78. The bi-layered tablet of claim 74, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 3 hours.

79. The bi-layered tablet of claim 70, wherein one of the first and second layers is an immediate release layer.

80. The bi-layered tablet of claim 70, wherein the first and second layers are controlled release layers.

153. The bi-layered tablet of claim 70, wherein the dosage form comprises at least one of carbinoxamine and a pharmaceutically acceptable salt thereof as a first drug and at least one of pseudoephedrine and a pharmaceutically acceptable salt thereof as a second drug.

81. A multi-layered tablet which comprises at least a first layer and a second layer, wherein the first layer comprises a first drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines and the second layer is a controlled release layer and comprises a second drug which is selected from decongestants, antitussives, expectorants, analgesics and antihistamines and is different from the first drug.

82. The multi-layered tablet of claim 81, wherein the first layer is an immediate release layer.

83. The multi-layered tablet of claim 82, wherein the second layer is a controlled release layer.

84. The multi-layered tablet of claim 82, wherein the second drug has a plasma half-life which differs from the plasma half-life of the first drug by at least about 3 hours.

85. The multi-layered tablet of claim 84, wherein the tablet provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 90% of a period over which the tablet provides a plasma concentration within a therapeutic range of the first drug.

86. The multi-layered tablet of claim 81, wherein the layers are discrete zones which are arranged adjacent to each other.

87. The multi-layered tablet of claim 81, wherein one of the first and second layers is partially or completely surrounded by the other one of the first and second layers.

88. A pharmaceutical dosage form which comprises (a) a first drug which is selected from antihistamines and has a first plasma half-life and (b) a second drug which is selected from decongestants, antitussives, analgesics and expectorants and has a second plasma half-life that differs from the first plasma half-life by at least about 3 hours, wherein the dosage form provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 80% of a period over which the dosage form provides a plasma concentration within a therapeutic range of the first drug.

89. The dosage form of claim 88, wherein the first plasma half-life is longer by at least about 4 hours than the second plasma half-life.

90. The dosage form of claim 88, wherein the first plasma half-life is longer by at least about 6 hours than the second plasma half-life.

91. The dosage form of claim 88, wherein the first plasma half-life is at least about 8 hours.

92. The dosage form of claim 89, wherein the period of a plasma concentration within the therapeutic range of the at least one second drug is coextensive with at least about 90% of the period of a plasma concentration within the therapeutic range of the first drug.

93. The dosage form of claim 89, wherein the period of a plasma concentration within the therapeutic range of the at least one second drug is coextensive with at least about 95% of the period of a plasma concentration within the therapeutic range of the first drug.

94. The dosage form of claim 88, wherein the period of a plasma concentration within the therapeutic range of the at least one second drug is substantially coextensive with the period of a plasma concentration within the therapeutic range of the first drug.

95. The dosage form of claim 88, wherein the dosage form is associated with instructions to administer the dosage form three or fewer times per day.

96. The dosage form of claim 88, wherein the dosage form is associated with instructions to administer the dosage form once or twice per day.

97. The dosage form of claim 88, wherein the dosage form comprises a tablet.

98. The dosage form of claim 97, wherein the second drug comprises a decongestant.

99. The dosage form of claim 98, wherein the antihistamine is selected from astemizole, azatadine, azelastine, bromodiphenhydramine, brompheniramine, carbinoxamine, cetirizine, chlorcyclizine, clemastine, chlorothen, chlorpheniramine, cyclizine, cyproheptadine, desloratadine, dexbrompheniramine, dexchlorpheniramine, dimethindene, diphenhydramine, diphenylpyraline, doxylamine, fexofenadine, hydroxyzine, isothipendyl, loratadine, methapyrilene, montelukast, phenindamine, pheniramine, phenyltoloxamine, promethazine, prophenpyridamine, pyrilamine, terfenadine, thenyldiamine, thonzylamine, trimeprazine, tripelennamine, triprolidine, and pharmaceutically acceptable salts thereof.

100. The dosage form of claim 98, wherein the antihistamine comprises at least one of promethazine, diphenhydramine, chlorpheniramine and pharmaceutically acceptable salts thereof.

101. The dosage form of claim 98, wherein the antihistamine comprises carbinoxamine.

102. The dosage form of claim 99, wherein the second drug comprises a decongestant.

103. The dosage form of claim 102, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

104. The dosage form of claim 99, wherein the second drug comprises an antitussive.

105. The dosage form of claim 104, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

106. The dosage form of claim 104, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

107. The dosage form of claim 99, wherein the second drug comprises an analgesic.

108. The dosage form of claim 107, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

109. The dosage form of claim 99, wherein the second drug comprises an expectorant.

110. The dosage form of claim 109, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

111. A method of alleviating a condition which can be alleviated by administration of an antihistamine and at least one other condition which can be alleviated by administration of a drug which is at least one of a decongestant, antitussive, expectorant, and analgesic, wherein the method comprises administering the dosage form of claim 88 to a subject in need thereof.

114. A pharmaceutical dosage form comprising (a) a first drug which is selected from decongestants, antitussives, expectorants and analgesics, and (b) a second drug which is selected from decongestants, antitussives, expectorants and analgesics and is different from the first drug, wherein the dosage form provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 70% of a period over which the dosage form provides a plasma concentration within a therapeutic range of the first drug and wherein the dosage form is substantially free of antihistamines.

115. The dosage form of claim 114, wherein the first drug comprises a decongestant.

116. The dosage form of claim 115, wherein the decongestant comprises at least one of phenylephrine, pseudoephedrine and pharmaceutically acceptable salts thereof.

117. The dosage form of claim 114, wherein the first drug comprises an antitussive.

118. The dosage form of claim 117, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

119. The dosage form of claim 117, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

120. The dosage form of claim 117, wherein the antitussive comprises at least one of carbetapentane and a pharmaceutically acceptable salt thereof.

121. The dosage form of claim 114, wherein the first drug comprises an analgesic.

122. The dosage form of claim 121, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

123. The dosage form of claim 121, wherein the analgesic comprises a NSAID.

124. The dosage form of claim 114, wherein the first drug comprises an expectorant.

125. The dosage form of claim 124, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

126. The dosage form of claim 115, wherein the second drug comprises an antitussive.

127. The dosage form of claim 126, wherein the antitussive comprises at least one of a morphine derivative, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine and pharmaceutically acceptable salts thereof.

128. The dosage form of claim 127, wherein the antitussive comprises at least one of codeine, dihydrocodeine, hydrocodone and pharmaceutically acceptable salts thereof.

129. The dosage form of claim 115, wherein the second drug comprises an analgesic.

130. The dosage form of claim 129, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

131. The dosage form of claim 129, wherein the analgesic comprises a NSAID.

132. The dosage form of claim 115, wherein the second drug comprises an expectorant.

133. The dosage form of claim 132, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

134. The dosage form of claim 117, wherein the second drug comprises an analgesic.

135. The dosage form of claim 134, wherein the analgesic comprises at least one of aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

136. The dosage form of claim 134, wherein the analgesic comprises a NSAID.

137. The dosage form of claim 117, wherein the second drug comprises an expectorant.

138. The dosage form of claim 137, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

139. The dosage form of claim 121, wherein the second drug comprises an expectorant.

140. The dosage form of claim 139, wherein the expectorant comprises at least one of guaifenesin and a pharmaceutically acceptable salt thereof.

141. The dosage form of claim 114, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 2 hours.

142. The dosage form of claim 141, wherein the period of a plasma concentration within the therapeutic range of the second drug is substantially coextensive with the period of a plasma concentration within the therapeutic range of the first drug.

143. The dosage form of claim 114, wherein the dosage form comprises a tablet.

151. A method of alleviating a condition which can be alleviated by administration of at least two drugs which are selected form decongestants, antitussives, expectorants and analgesics, wherein the method comprises administering the dosage form of claim 114 to a subject in need thereof.

154. The dosage form of claim 114, wherein the dosage form comprises an NSAID as a first drug and at least one of pseudoephedrine, phenylephrine, guaifenesin, codeine, dihydrocodeine, hydrocodone, carbetapentane and pharmaceutically acceptable salts thereof as a second drug.

155. The dosage form of claim 154, wherein the NSAID comprises at least one of ibuprofen, ketoprofen, naproxen and sodium naproxen.

144. A bi-layered tablet which comprises a first layer and a second layer, the first layer comprising a first drug which is selected from decongestants, antitussives, expectorants and analgesics, and the second layer comprising a second drug which is different from the first drug and is selected from decongestants, antitussives, expectorants and analgesics, wherein the bi-layered tablet provides a plasma concentration within a therapeutic range of the second drug over a period which is coextensive with at least about 70% of a period over which the bi-layered tablet provides a plasma concentration within a therapeutic range of the first drug and wherein the bi-layered tablet is substantially free of antihistamines.

145. The bi-layered tablet of claim 144, wherein the first drug is selected from one or more of phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine, guaifenesin, and pharmaceutically acceptable salts thereof, aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

146. The bi-layered tablet of claim 145, wherein the second drug is different from the first drug and is selected from one or more of phenylephrine, pseudoephedrine, codeine, dihydrocodeine, hydrocodone, dextromethorphan, carbetapentane, chlophedianol, benzonatate, caramiphen, noscapine, guaifenesin, and pharmaceutically acceptable salts thereof, aspirin, acetaminophen, ibuprofen, ketoprofen, naproxen, sodium naproxen, meloxicam, hydrocodone, oxycodone, morphine, meperidine, and fentanyl.

147. The bi-layered tablet of claim 144, wherein the period of a plasma concentration within the therapeutic range of the second drug is substantially coextensive with the period of a plasma concentration within the therapeutic range of the first drug.

148. The bi-layered tablet of claim 147, wherein a plasma half-life of the second drug differs from a plasma half-life of the first drug by at least about 2 hours.

149. The bi-layered tablet of claim 144, wherein one of the first and second layers is an immediate release layer.

150. The bi-layered tablet of claim 144, wherein the first and second layers are controlled release layers.

156. The bi-layered tablet of claim 144, wherein the dosage form comprises an NSAID as a first drug and at least one of pseudoephedrine, phenylephrine, guaifenesin, codeine, dihydrocodeine, hydrocodone, carbetapentane and pharmaceutically acceptable salts thereof as a second drug.