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US 12,527,745 B2Granted
Pharmaceutical dosage form for an emulsion of simethicone and loperamide
AssigneeR.P. Scherer Technologies, LLC
InventorsJing Lin, Humera Ahmad, Ashish Patel
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Abstract
A pharmaceutical dosage form comprises a capsule shell and a fill composition, wherein the fill composition comprises an emulsion of (a) simethicone, (b) loperamide or a pharmaceutically acceptable salt thereof, and (c) at least two surfactants, wherein the emulsion has a hydrophilic lipophilic balance ranging from about 8 to about 12. Also described are methods of making the pharmaceutical dosage forms and methods for treating humans suffering from gastrointestinal distress.
Claims20
An oral pharmaceutical dosage form comprising:
- a capsule shell;
- and
- a fill composition,
- wherein the fill composition comprises a stable emulsion of (a) simethicone, (b) loperamide or a pharmaceutically acceptable salt thereof, and (c) at least one hydrophilic surfactant and at least one lipophilic surfactant,
- wherein the at least one hydrophilic surfactant is selected from the group consisting of polyethylene glycol (PEG) fatty acid esters, PEG esters, PEG ethers, PEG glycerides, saturated polyglycolysed glycerides, and combinations thereof,
- wherein the at least one lipophilic surfactant is selected from the group consisting of macrogolglycerides, sorbitan esters, monoglycerides, diglycerides, glycol monoesters, glycol diesters, glyceryl esters, PEG esters, propylene glycol laurate, glyceryl monooleate, sorbitan monooleate, medium chain monoglycerides, medium chain diglycerides, and combinations thereof, and
- wherein the surfactants have a combined hydrophilic lipophilic balance (HLB) ranging from about 8 to about 12, wherein the HLB is determined via the Griffin equation.
4 more elements
Dependencies are inferred from the claim text.