Film shreds and delivery system incorporating same

• US 20080292683A1
• Filed: 05/24/2007
• Published: 11/27/2008
• Est. Priority Date: 05/24/2007
• Status: Abandoned Application

• Current Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Original Assignee: Monosol Rx LLC (Kuraray Company Limited)
• Inventors: Fuisz, Richard C., Sanghvi, Pradeep
• Application Number:
  US11/805,753
• Publication Number:
  US 20080292683A1
• Time in Patent Office: Days
• US Class Current: 424/443
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/1617 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: A61K 9/1635 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/1664 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/1617
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution

Abstract

Compositions are provided that include water soluble or water dispersible film shreds, a carrier and an active, such as, but not limited to a drug, flavoring agent or coloring agent. Also provided are methods of use of the film shreds, such as in improving the dissolution, stability, aesthetics, or taste of a composition or its components, and in reducing a disease risk associated with an active.

Claims

1. A composition for delivery of at least one active comprising:

at least one active;

a carrier; and

a plurality of water soluble or water dispersible polymeric film shreds.

2. The composition of claim 1, wherein the film shreds are in the carrier.

3. The composition of claim 1, wherein the carrier is in a solid form.

4. The composition of claim 3, wherein the solid is a particulate or powder.

5. The composition of claim 3, wherein the solid is a film.

6. The composition of claim 1, wherein the carrier is in a semisolid form.

7. The composition of claim 6, wherein the semisolid is an ointment or a gel.

8. The composition of claim 1, wherein the carrier is in a liquid form.

9. The composition of claim 8, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

10. The composition of claim 8, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

11. The composition of claim 1, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet, suppository and sachet.

12. The composition of claim 1, wherein the film shreds are the carrier.

13. The composition of claim 12, wherein the at least one active is contained in the film shreds.

14. The composition of claim 13, wherein the active in the film shreds is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals, foods, coloring agents, flavoring agents, taste-masking agents, drug absorption or permeation enhancers, and drug stability enhancers.

15. The composition of claim 14, wherein the botanical is nicotine.

16. The composition of claim 13, wherein the active in the film shreds is a drug.

17. The composition of claim 13, wherein the active in the film shreds is a flavoring agent.

18. The composition of claim 13, wherein the active in the film shreds is a taste masking agent.

19. The composition of claim 13, wherein the active in the film shreds is at least one coloring agent.

20. The composition of claim 13, wherein the film shreds are of different colors.

21. The composition of claim 13, wherein the active in the film shreds is a drug absorption or permeation enhancer.

22. The composition of claim 13, wherein the active in the film shreds is a drug stability enhancer.

23. The composition of claim 1, wherein the at least one active is contained in the carrier.

24. The composition of claim 23, wherein the carrier active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals and foods.

25. The composition of claim 23, wherein the carrier active is a drug.

26. The composition of claim 1, wherein the film shreds are of different shapes.

27. The composition of claim 1, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

28. The composition of claim 27, wherein the polymeric film shreds further comprises a water insoluble polymer.

29. The composition of claim 1, wherein the polymeric film shreds comprise a water insoluble polymer selected from the group consisting of ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate and combinations thereof.

30. The composition of claim 1, wherein the polymeric film shreds comprise a combination of hydroxypropylmethyl cellulose and polyethylene oxide.

31. The composition of claim 1, wherein the polymeric film shreds comprise a combination of polydextrose and polyethylene oxide.

32. The composition of claim 1, wherein the polymeric film shreds comprise a combination of polydextrose, hydroxy propylmethyl cellulose and polyethylene oxide.

33. A composition comprising:

a carrier comprising an active; and

a plurality of water soluble or water dispersible polymeric film shreds comprising a second active.

34. The composition of claim 33, wherein the film shreds are in the carrier.

35. The composition of claim 33, wherein the carrier is in a solid form.

36. The composition of claim 35, wherein the solid is a particulate or powder.

37. The composition of claim 35, wherein the solid is a film.

38. The composition of claim 33, wherein the carrier is in a semisolid form.

39. The composition of claim 38, wherein the semisolid is an ointment or a gel.

40. The composition of claim 33, wherein the carrier is in a liquid form.

41. The composition of claim 40, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

42. The composition of claim 40, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

43. The composition of claim 33, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet, suppository and sachet.

44. The composition of claim 33, wherein the carrier active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals, and foods.

45. The composition of claim 33, wherein the active in the film shreds is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals, foods, coloring agents, flavoring agents, taste-masking agents, drug absorption or permeation enhancers and drug stability enhancers.

46. The composition of claim 33, wherein the active in the film shreds is a drug absorption or permeation enhancer, which is capable of increasing the absorption of the carrier active across cell membranes.

47. The composition of claim 33, wherein the active in the film shreds is a taste masking agent, which is capable of masking off-tastes associated with the carrier active.

48. The composition of claim 33, wherein the active in the film shreds is a coloring agent, which is capable of providing a colorful appearance to the composition.

49. The composition of claim 33, wherein the film shreds are of different colors.

50. The composition of claim 33, wherein the active in the film shreds is a flavoring agent, which is capable of providing flavor or flavor enhancing properties to the composition.

51. The composition of claim 33, wherein the film shreds are of different shapes.

52. A method of increasing dissolution of an active and/or carrier, the method comprising:

providing a carrier; and

combining the carrier with water soluble or water dispersible polymeric film shreds including an active to form a composition, the film shreds being capable of increasing dissolution of the active and/or the carrier when the composition is in contact with bodily fluids and/or water.

53. The method of claim 52, wherein the active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals, foods, coloring agents, flavoring agents, taste-masking agents, drug absorption or permeation enhancers.

54. The method of claim 52, wherein the active is a drug.

55. The method of claim 52, wherein the film shreds are in the carrier.

56. The method of claim 52, wherein the carrier is in a solid form.

57. The method of claim 56, wherein the solid is a particulate or powder.

58. The method of claim 56, wherein the solid is a film.

59. The method of claim 52, wherein the carrier is in a semisolid form.

60. The method of claim 52, wherein the semisolid is an ointment or a gel.

61. The method of claim 52, wherein the carrier is in a liquid form.

62. The method of claim 61, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

63. The method of claim 61, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

64. The method of claim 52, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet, suppository and sachet.

65. The method of claim 52, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

66. A method of increasing dissolution of an active, the method comprising:

providing a carrier comprising an active; and

combining the carrier with water soluble or water dispersible polymeric film shreds to form a composition, the film shreds being capable of increasing dissolution of the carrier active when the composition is in contact with bodily fluids and/or water.

67. The method of claim 66, wherein the carrier active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals and foods.

68. The method of claim 66, wherein the active is a drug.

69. The method of claim 66, wherein the film shreds are in the carrier.

70. The method of claim 66, wherein the carrier is in a solid form.

71. The method of claim 70, wherein the solid is a particulate or powder.

72. The method of claim 70, wherein the solid is a film.

73. The method of claim 66, wherein the carrier is in a semisolid form.

74. The method of claim 66, wherein the semisolid is an ointment or a gel.

75. The method of claim 66, wherein the carrier is in a liquid form.

76. The method of claim 75, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

77. The method of claim 75, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

78. The method of claim 66, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet, suppository and sachet.

79. The method of claim 66, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

80. A method of providing flavor or flavor enhancing properties to a composition, the method comprising:

providing a carrier;

combining the carrier with water soluble or water dispersible polymeric film shreds including a flavoring agent to form a composition, the film shreds being capable of providing flavor or flavor-enhancing properties to the composition when the composition is in contact with bodily fluids and/or water.

81. The method of claim 80, wherein the carrier comprises an active.

82. The method of claim 80, wherein the carrier active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals and foods.

83. The method of claim 82, wherein the active is a drug.

84. The method of claim 80, wherein the film shreds are in the carrier.

85. The method of claim 80, wherein the carrier is in a solid form.

86. The method of claim 85, wherein the solid is a particulate or powder.

87. The method of claim 85, wherein the solid is a film.

88. The method of claim 80, wherein the carrier is in a semisolid form.

89. The method of claim 88, wherein the semisolid is an ointment or a gel.

90. The method of claim 80, wherein the carrier is in a liquid form.

91. The method of claim 90, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

92. The method of claim 90, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

93. The method of claim 80, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet and sachet.

94. The method of claim 80, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

95. A method of masking off-tastes of an active, the method comprising:

providing a carrier comprising an active; and

combining the carrier with water soluble or water dispersible polymeric film shreds including a taste-masking agent to form a composition, the film shreds being capable of masking off-tastes associated with the carrier active when the composition is in contact with bodily fluids and/or water.

96. The method of claim 95, wherein the carrier active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals and foods.

97. The method of claim 95, wherein the carrier active is a drug.

98. The method of claim 95, wherein the film shreds are in the carrier.

99. The method of claim 95, wherein the carrier is in a solid form.

100. The method of claim 99, wherein the solid is a particulate or powder.

101. The method of claim 99, wherein the solid is a film.

102. The method of claim 95, wherein the carrier is in a semisolid form.

103. The method of claim 95, wherein the semisolid is an ointment or a gel.

104. The method of claim 95, wherein the carrier is in a liquid form.

105. The method of claim 104, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

106. The method of claim 104, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

107. The method of claim 95, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet and sachet.

108. The method of claim 95, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

109. A method of providing a colorful appearance to a composition, the method comprising:

providing a carrier; and

combining the carrier with water soluble or water dispersible polymeric film shreds comprising at least one coloring agent to form a composition, the film shreds being capable of providing a colorful appearance to the composition when the composition is in contact with bodily fluids and/or water.

110. The method of claim 109, wherein the film shreds are of different colors.

111. The method of claim 109, wherein the composition includes a drug.

112. The method of claim 109, wherein the film shreds are in the carrier.

113. The method of claim 109, wherein the carrier is in a solid form.

114. The method of claim 113, wherein the solid is a particulate or powder.

115. The method of claim 113, wherein the solid is a film.

116. The method of claim 109, wherein the carrier is in a semisolid form.

117. The method of claim 109, wherein the semisolid is an ointment or a gel.

118. The method of claim 109, wherein the carrier is in a liquid form.

119. The method of claim 109, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

120. The method of claim 118, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

121. The method of claim 109, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet and sachet.

122. The method of claim 109, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

123. A method of reducing a disease risk associated with an active, the method comprising:

providing a chewable matrix; and

combining the chewable matrix with water soluble or water dispersible polymeric film shreds including an active associated with a disease risk to form a composition, the film shreds being capable of reducing the disease risk associated with the active when the chewable matrix is chewed.

124. The method of claim 123, wherein the film shreds provide a modified release profile to the active.

125. The method of claim 123, wherein the active associated with a disease risk is nicotine.

126. The method of claim 123, wherein the active is a drug.

127. The method of claim 123, wherein the film shreds are in the chewable matrix.

128. The method of claim 123, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

129. A method of preparing an edible composition, the method comprising:

providing a carrier; and

combining the carrier with water soluble or water dispersible polymeric film shreds.

130. The method of claim 129, wherein the provided carrier includes an active.

131. The method of claim 129, wherein the polymeric film shreds include an active.

132. The method of claim 129, wherein the active is a drug.

133. The method of claim 129, wherein the film shreds are in the carrier.

134. The method of claim 129, wherein the carrier is in a solid form.

135. The method of claim 134, wherein the solid is a particulate or powder.

136. The method of claim 134, wherein the solid is a film.

137. The method of claim 129, wherein the carrier is in a semisolid form.

138. The method of claim 137, wherein the semisolid is an ointment or a gel.

139. The method of claim 137, wherein the carrier is in a liquid form.

140. The edible composition of claim 139, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

141. The method of claim 139, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

142. The method of claim 129, the carrier being present in a form selected from the group consisting of film, chewable matrix, capsule, tablet, caplet, suppository and sachet.

143. The method of claim 129, wherein the polymeric film shreds comprise a water soluble polymer selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

144. A method of preparing a composition comprising:

preparing a flowable matrix including at least one water soluble and/or water dispersible polymer;

at least one polar solvent; and

at least one active;

forming a solid film from the flowable matrix;

cutting or shredding the film into shreds; and

combining the film shreds with a carrier.

145. The method of claim 144, wherein the film shreds combined with the carrier are prepackaged.

146. The method of claim 144, wherein the active is selected from the group consisting of drugs, vitamins, minerals, herbals, botanicals, animal extracts or products, plant extracts or products, cosmetic ingredients, cosmeceuticals, nutraceuticals, foods, coloring agents, flavoring agents, taste-masking agents, drug absorption or permeation enhancers.

147. The method of claim 144, wherein the polar solvent is water.

148. The method of claim 144, wherein the water soluble polymer is selected from the group consisting of polydextrose, pullulan, hydroxypropylmethyl cellulose (HPMC), hydroxyethyl cellulose (HPC), hydroxypropyl cellulose, carboxymethyl cellulose, sodium aginate, xanthan gum, tragacanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, polyethylene oxide, polyvinylpyrrolidone, polyvinyl alcohol, polyethylene glycol, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, and combinations thereof.

149. The method of claim 144, wherein the film shreds are in the carrier.

150. The method of claim 144, wherein the carrier is in a solid form.

151. The method of claim 150, wherein the solid is a particulate or powder.

152. The method of claim 150, wherein the solid is a film.

153. The method of claim 144, wherein the carrier is in a semisolid form.

154. The method of claim 153, wherein the semisolid is an ointment or a gel.

155. The method of claim 144, wherein the carrier is in a liquid form.

156. The method of claim 155, wherein the liquid is selected from the group consisting of a dispersion, a solution and a solvent.

157. The method of claim 155, wherein the liquid is selected from the group consisting of aqueous solvents, organic solvents and combinations thereof.

158. The method of claim 144, the carrier being present in a form selected from the group consisting of chewable matrix, capsule, tablet, caplet, suppository and sachet.

159. A method of improving the stability of at least one active in a composition, comprising:

providing a carrier; and

combining the carrier with a prepackaged plurality of water soluble and/or water dispersible film shreds comprising at least one active, thereby forming a composition in which the at least one active has improved stability as compared to in the absence of the film shreds.

160. The method of claim 159, wherein the carrier is a liquid.

161. The method of claim 159, wherein the carrier is a solid.

162. The method of claim 159, wherein the carrier is a semi-solid.

163. The method of claim 161, wherein the method further comprises adding a liquid to the composition.

164. The method of claim 159, wherein the composition is suitable for oral, nasal, topical, buccal, sublingual, vaginal, rectal, ocular or parenteral administration.

165. The method of claim 159, wherein the prepackaged film shreds comprise:

a first plurality of film shreds comprising a first active; and

a second plurality of film shreds comprising a second active;

wherein the prepackaged film shreds improve the stability of the two actives together.

166. A method of increasing the stability of at least one active in a composition comprising:

providing a carrier comprising a first active; and

combining the carrier comprising the first active with prepackaged film shreds comprising a second active to form a composition in which at least one of the first and second actives has improved stability as compared to in the absence of the film shreds.

167. The method of claim 166, wherein both of said actives have improved stability as compared to in the absence of the film shreds.

168. The method of claim 166, wherein the carrier is a liquid.

169. The method of claim 166, wherein the carrier is a solid.

170. The method of claim 166, wherein the carrier is a semi-solid.

171. The method of claim 169, wherein the method further comprises adding a liquid to the composition.

172. The method of claim 166, wherein the composition is suitable for oral, nasal, topical, buccal, sublingual, vaginal, rectal, ocular or parenteral administration.