Bile preparations for colorectal disorders
A colonic, rectal technology in the field of bile preparations for colorectal conditions that addresses logistical and financial constraints, difficulty identifying high-risk populations, and high costs
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Embodiment 1
[0119] Example 1: Preparation of Bile Acid Solution - Formulation 60
[0120] Sodium hydroxide solution was prepared by dissolving 5.2 g of ultra-pure grade (EP) NaOH in 100 mL of USP pharmaceutical grade water. Next, 48 g of UDCA was added to prepare clear solution A.
[0121] Clear solution B was prepared by completely dissolving 320 g of food grade (NF) maltodextrin and 320 g of food grade (NF) soluble resistant starch in 300 mL of USP pharmaceutical grade water.
[0122] Solution A and solution B were combined under stirring, then an appropriate amount of food grade sodium bisulfite (0.3 g / kg) was added to the clear solution. Food grade dilute phosphoric acid was added to adjust the pH of the final solution (pH: 6-7.5). The final solution can be filtered and / or heated to sterilize at 80°C to 100°C, if desired.
Embodiment 2
[0123] Example 2: Preparation of Bile Acid Solution - Formulation 25
[0124] A sodium hydroxide solution was prepared by dissolving 2.7 g of EP NaOH in 100 mL of USP pharmaceutical grade water. Next, 25 g of UDCA was added to prepare clear solution A.
[0125] Clear solution B was prepared by completely dissolving 500 g of NF maltodextrin and 150 g of NF soluble resistant starch in 400 mL of USP pharmaceutical grade water.
[0126] Solution A and solution B were combined under stirring, then an appropriate amount of food grade sodium bisulfite (0.3 g / kg) was added to the clear solution. Food grade dilute phosphoric acid was added to adjust the pH of the final solution (pH: 6-7.5). The final solution can be filtered and / or heated to sterilize at 80°C to 100°C, if desired.
Embodiment 3
[0127] Example 3: Preparation of Bile Acid Solution - Formulation 20
[0128] A sodium hydroxide solution was prepared by dissolving 2.2 g of EP NaOH in 100 mL of USP pharmaceutical grade water. Next, 20 g of UDCA was added to prepare a clear solution A.
[0129] Clear solution B was prepared by completely dissolving 500 g of NF maltodextrin and 150 g of NF soluble resistant starch in 400 mL of USP pharmaceutical grade water.
[0130] Solution A and solution B were combined under stirring, then an appropriate amount of food grade sodium bisulfite (0.3 g / kg) was added to the clear solution.
[0131] Food grade dilute phosphoric acid was added to adjust the pH of the final solution (pH: 6-7.5). The final solution can be filtered and / or heated to sterilize at 80°C to 100°C, if desired.
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