Enhanced stability phenylephrine liquid compositions
A technology of phenylephrine and composition, which is applied in the field of oral liquid pharmaceutical compositions, and can solve problems such as being unsuitable for illegally synthesizing substitutes
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example 1
[0065] Exemplary compositions comprising a single first pharmaceutically active substance phenylephrine are provided in Table 1 . The composition is a representative composition and is one of many compositions within the scope of the invention. The example embodiments are provided for illustration purposes.
[0066] Table 1
[0067] ingredients Content (g / 100mlX100) Phenylephrine HCl 0.1%w / v Glycerin (96% USP) 25%w / v Sorbitol (70% solution USP) 10%w / v Micronized Sucralose Powder (NF) 0.2% w / v Virtually aldehyde-free polyethylene glycol (commercially available, <10ppm)
10.0%w / v
[0068] Colorant 0.01%w / v Sodium Citrate / Citric Acid 0.95% w / v sodium benzoate 0.1%w / v Purified H 2 O USP Sufficient amount to achieve final volume
[0069] The compositions of Table 1 were prepared by simple mixing. The ingredients are mixed in a vessel equipped with a mechanical stirrer (eg, a Lightnin mixer)...
example 2
[0071] Exemplary compositions comprising phenylephrine and a second active substance, dextromethorphan hydrobromide, are provided in Table 2. The composition is a representative composition and is one of many compositions within the scope of the invention. The example embodiments are provided for illustration purposes.
[0072] Table 2
[0073] ingredients Content (g / 100mlX100) Phenylephrine HCl 0.1%w / v Dextromethorphan Hydrobromide 0.02% w / v Glycerin (96% USP) 25%w / v Sorbitol (70% solution USP) 10%w / v Micronized Sucralose 0.2% w / v artificial flavoring 0.2% w / v Colorant <0.1%w / v
[0074] The compositions in Table 2 can be prepared using the preparation described in Example 1. The active agents phenylephrine and dextromethorphan were added prior to the addition of other excipients to the aqueous SAF-PEG solution.
example 3
[0076] Table 3 provides exemplary compositions comprising phenylephrine and two second active agents, dextromethorphan and guaiacol. The composition is a representative composition and is one of many compositions within the scope of the invention. The example embodiments are provided for illustration purposes.
[0077] table 3
[0078] ingredients Content (g / 100mlX100) Phenylephrine HCl 0.1%w / v Dextromethorphan Hydrobromide 0.2% w / v Guaifenesin 4% w / v Glycerin (96% USP) 25%w / v Sorbitol (70% solution USP) 10%w / v Micronized Sucralose Powder (NF) 0.2% w / v Colorant 0.01%w / v Sodium Citrate / Citric Acid 0.95% w / v sodium benzoate 0.1%w / v Virtually aldehyde-free polyethylene glycol (commercially available, <10ppm)
[0079] The compositions in Table 3 can be prepared using the preparation described in Example 2.
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