Shilpa Medicare. has filed a patent for pharmaceutical compositions in the form of an oral solution. The compositions contain an active pharmaceutical ingredient, a buffering agent, and water, with a pH range of 5 to 8. The active ingredient can be selected from various drugs including ramipril, solifenacin, vigabatrin, losartan potassium, warfarin, and melatonin. GlobalData’s report on Shilpa Medicare gives a 360-degree view of the company including its patenting strategy. Buy the report here.
According to GlobalData’s company profile on Shilpa Medicare, Nanoparticle drug conjugates was a key innovation area identified from patents. Shilpa Medicare's grant share as of September 2023 was 19%. Grant share is based on the ratio of number of grants to total number of patents.
A recently filed patent (Publication Number: US20230263796A1) describes a liquid pharmaceutical composition containing vigabatrin, or a pharmaceutically acceptable salt thereof, as the active ingredient. The composition also includes a preservative, a buffering agent, a sweetener, a flavoring agent, and various other additives such as solubilizers, co-solvents, antioxidants, surfactants, antifoaming agents, chelating agents, suspending agents, viscosity builders, and coloring agents. The composition is formulated with water and is stable for up to 3 months at room temperature, with total impurities not exceeding 0.06% during this period.
In claim 10, it is specified that the vigabatrin content in the composition ranges from 0.1 wt % to 20 wt %. Additionally, the preservative can be methyl 4 hydroxy benzoate, propyl 4 hydroxy benzoate, or a combination of both. The buffering agent can be sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, or a combination of both. The sweetener can be maltitol, sucralose, or a combination of both. The flavoring agent can be selected from a wide range of options, including synthetic flavor oils, natural oils, extracts from plants, and various specific oils such as cinnamon oil, oil of wintergreen, peppermint oils, clove oil, bay oil, anise oil, eucalyptus, thyme oil, cedar leaf oil, oil of nutmeg, oil of sage, oil of bitter almonds, cassia oil, vanilla, citrus oil, fruit essence, and combinations thereof.
Claim 13 specifies that the pharmaceutical composition is free of polyhydric alcohol with 2 to 6 carbon atoms. This exclusion is reiterated in claim 17.
The patent also includes alternative embodiments in claims 14-21, which describe similar liquid pharmaceutical compositions containing vigabatrin as the active ingredient. These embodiments provide specific ranges for the amounts of the active pharmaceutical ingredient, preservative, sweetener, and flavoring agent, as well as the pH range of the composition. The options for flavoring agents include citrus oils such as lemon, orange, grape, lime, and grapefruit, as well as fruit essences such as apple, banana, pear, peach, strawberry, raspberry, cherry, plum, pineapple, apricot, strawberry, and tutti-fruity flavor.
Overall, this patent describes a stable liquid pharmaceutical composition containing vigabatrin, or a pharmaceutically acceptable salt thereof, as the active ingredient. The composition is formulated with various additives, including preservatives, buffering agents, sweeteners, and flavoring agents, to enhance its palatability and stability. The exclusion of certain polyhydric alcohols ensures the composition's compatibility with specific patient needs.
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