Levothyroxine Sodium Topical Solution

Example 5

S. NoIngredientsQuantity per mL

1Levothyroxine sodium0.01-1mg

2L-Arginine0.01-4mg

3Propylene glycol0.02 mL-0.4mL

4Propyl paraben0.05-0.5mg

5Sorbitol0.5-1.5mg

6Sodium hydroxideq.s

7Ultrapure waterq.s to 1.0 mL

Manufacturing Process

Ultrapure water was taken in a compounding vessel and L-Arginine was added and stirred. Propylene glycol was added to the solution and stirred. Propyl paraben was added. Sorbitol was added to the solution and stirred. pH of the solution was adjusted to 11±0.5 by the addition of sodium hydroxide solution. The solution was cooled to 2° C. to 8° C. Levothyroxine sodium was added and stirred till a clear solution was obtained. The solution was filtered, followed by filling into suitable containers.

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US11865180B2. Levothyroxine formulations for oral use (2024-01-09). LEIUTIS PHARMACEUTICALS LLP [IN]. Inventors: Kocherlakota Chandrashekhar [IN], Banda Nagaraju [IN].

Patent 2024

Hydroxide L arginine Levothyroxine Levothyroxine sodium Paraben Propyl paraben Propylene glycol Sodium hydroxide Sorbitol Vessel

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Variable analysis

independent variables

Addition of L-Arginine
Addition of Propylene glycol
Addition of Propyl paraben
Addition of Sorbitol
Adjustment of pH to 11±0.5 using Sodium hydroxide
Addition of Levothyroxine sodium

dependent variables

Formation of a clear solution

control variables

Temperature maintained between 2°C to 8°C
Filtration of the final solution

Annotations

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