In Vitro:Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≦ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Minitab Omeprazole Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Rifabutin-based compositions and methods for treating
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 4 61.9 USP < 905 > Limit 5 82.5 L1 ≦ 15 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP<905>Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Dissolution:Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≦ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Minitab Omeprazole Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Rifabutin-based compositions and methods for treating
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 4 61.9 USP < 905 > Limit 5 82.5 L1 ≦ 15 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP<905>Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Formulation:Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≦ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Minitab Omeprazole Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Rifabutin-based compositions and methods for treating
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 4 61.9 USP < 905 > Limit 5 82.5 L1 ≦ 15 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP<905>Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Capsules:Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≦ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Minitab Omeprazole Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Rifabutin-based compositions and methods for treating
Article Snippet: : 3 95.7 USP < 905 > Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 4 61.9 USP < 905 > Limit 5 82.5 L1 ≦ 15 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
Article Title: Pharmaceutical compositions for the treatment of
Article Snippet: : 3 95.7 USP<905>Limit 4 61.9 L1 ≤ 15 5 82.5 6 76.1 7 64.3 8 67.6 9 66.4 10 69.2 Average 73.2 % RSD 13.8 Minimum 61.9 Maximum 95.7 AV (L1) 50 ND = not detected TABLE 11 Omeprazole Related Substances Omeprazole Omeprazole Minitab Omeprazole Minitab Omeprazole 10 mg API 10 mg API T = 0 T = 1 month RRT % area % area % area % area 0.39 1.98 ND 1.73 0.92 0.51 0.43 0.73 0.03 0.53 0.03 0.48 0.28 ND 0.31 0.52 0.65 ND 0.66 0.03 0.55 0.08 0.02 0.18 0.02 0.60 0.16 0.02 0.21 0.18 0.73 ND <0.01 0.19 0.78 0.05 0.02 0.10 0.06 0.81 0.05 <0.01 0.22 1.13 0.10 0.02 0.08 0.05 1.35 0.09 0.08 1.54 0.05 0.05 2.72 0.04 3.71 0.21 0.39 3.74 0.24 3.83 0.50 Total 4.22 0.24 4.92 2.46 In some embodiments, an average of 0% of omeprazole is released in an acid stage (pH1), and 90, 90, and 86% of the omeprazole is released in an in vitro dissolution assay at 20, 30, and 45 minutes following the acid stage, respectively.
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